Appendix A: ARRA Projects Classified as HSR1 (Listed Alphabetically by Principal Investigator, Within Institute)
Project Number
2
Project Title
Principal Investigator
Performing
Organization
Abstract
Total Cost
Fogarty International Center (FIC)
1
3D43TW007784-04S1
TRAINING FOR EVIDENCEBASED HEALTH CARE
RESEARCH, ARGENTINA
BUEKENS, PIERRE
TULANE UNIVERSITY OF
LOUISIANA
3D43TW000007-22S1
AIDS INTERNATIONAL TRAINING
AND RESEARCH PROGRAM
FARQUHAR, CAREY
UNIVERSITY OF
WASHINGTON
3D43TW000018-22S1
AIDS INTERNATIONAL TRAINING
AND RESEARCH PROGRAM
JOHNSON, WARREN D.
WEILL MEDICAL COLLEGE
OF CORNELL UNIV
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): The Center for Evidence-Based Global Health (CEBGH) of the Tulane
School of Public Health and Tropical Medicine proposes to establish a training program in maternal and child health research, in collaboration with the
Institute for Clinical Effectiveness and Health Policy (IECS) in Buenos Aires, Argentina, as the Primary Foreign Collaborating Institution. The training
program, entitled 'Training for Evidence-Based Health Care Research, Argentina,' is closely linked to the ongoing NICHD Global Network (GN) for
Women's and Children's Health Research 'parent' grant (U01 HD40477) and will build upon the previous experiences achieved through the Fogarty
International Maternal and Child Health Research Training Program (D43 TW005492). The program's main objective is to provide training in evidencebased health care research for Argentinean health professionals, linked to IECS and the network of hospitals and communities participating in the GN
research projects. The use of randomized controlled trials to evaluate maternal and child health interventions will be especially emphasized. The
program will be administered through the CEBGH, located at Tulane University in New Orleans, LA. Mentored research trainings will be offered at the
Tulane CEBGH. Master's programs and short-term trainings will be taught at IECS in Argentina. Upon completion of the program, trainees will be
actively involved in GN research activities. They will therefore enhance the research quality and sustainability of the GN's projects and future protocols
in Argentina. To attain the United Nations' maternal and child Millennium Development Goals by 2015, Argentina has 10 years to decrease the
maternal mortality ratio from 44 to less than 15 per 100,000 live births and to decrease the under five mortality rate from 19 to less than seven per
1,000 live births. The proposed program will train researchers who will contribute to this effort by identifying evidence-based maternal and child health
interventions.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): For the last 20 years, the University of Washington (UW) AIDS International
Training and Research Program (AITRP) has addressed the growing AIDS epidemic in Africa, Southeast Asia and Latin America through providing
training to promising research scientists working in these regions. The UW AITRP has been highly successful at developing local capacity to perform
multidisciplinary research on HIV prevention, care and treatment. Among more than 180 foreign trainees, many have made important scientific
contributions, assumed leadership positions in research and health care, and influenced HIV/AIDS policies in their respective countries, as well as
globally. During the last 15 years, training efforts have focused on 4 target countries, Kenya, Peru, Mozambique, and Thailand, and 96% of trainees
from these countries have returned to their home countries where they now conduct HIV-related work. India was added as a target country in 2003,
and this year Uganda will be added to provide new opportunities in HIV-associated malignancy research. This is possible because UW investigators in
Thailand succeeded in obtaining separate Fogarty funding for Thai trainees. The proposed training plan is designed to respond to research priorities of
each target country through implementation of a successful existing program that has been tailored over the last 5 years to include several new
approaches. Director Or. Carey Farquhar and Co-Director Dr. King Holmes will oversee all activities related to the program, while 3 Track Directors will
manage programs in Epidemiology, Biostatistics, and Basic Sciences. Within each of the tracks, special emphasis will be placed on training in 3areas
identified as being high priority: Sociobehavioral Research, International Clinical Trials, and Operations Research. An outstanding pool of 32 Core and
56 Resource Faculty ensures excellent mentorship for trainees and expertise across a range of disciplines. Each year, we anticipate funding 3-4
trainees in UW degree programs, for a total of 15-20 new appointments. In addition, the UW AITRP will fund 1 new trainee every other year in a
distance learning master's program in Biostatistics and 2-4 trainees annually in medium-term trainees. To provide a bridge for exceptional trainees
completing UW degree programs, support will be awarded to 1 advanced in-country scholar per year. Several regional conferences and short courses
on HIV/AIDS research methods will also be funded, including new courses targeting the emphasis areas described above. The UW AITRP will make a
sustained effort this grant cycle to lay the groundwork for transferring training responsibility to the two most established UW AITRP sites: Kenya and
Peru. This will be accomplished by supporting medium-training for curriculum development and long-term training at the PhD level for faculty at
collaborating institutions, thus promoting independent research and training programs in Kenya and Peru, as well as in other UW target countries in
the future.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): This proposal requests support for Weill Cornell Medical College (WMC or
Cornell) to continue training Haitian scientists in the performance of biomedical, epidemiological, laboratory, clinical, operational, health services and
behavioral research on HIV and related opportunistic infections. The program is based in the Division of International Medicine and Infectious
Diseases at Cornell, with an interdisciplinary group of investigators who have extensive collaborations with Haiti. Strengthened collaborations with
Vanderbilt, Harvard, University of California (Berkeley), the Hastings Center, and the Aaron Diamond AIDS Research Center offer diverse training
opportunities. The program will continue to emphasize medium and long-term advanced research training in Haiti. Since its inception, the AITRP
program has provided medium- and long-term training to 121 Haitian biomedical personnel, with 98% currently conducting HIV/AIDS work in Haiti. The
training offered will be related to six general HIV/AIDS research categories: 1) HIV vaccine trials; 2) antiretroviral clinical trials; 3) pediatrics and
maternal-infant transmission research; 4) HIV associated opportunistic infections - tuberculosis and human papilloma virus infection (HPV); 5) ethics
and behavioral research, with an emphasis on adolescents; and 7) pathogenesis, immunology, and virology. The proposed training will be conducted
largely in Haiti, with much of the training done by the former Fogarty trainees. The training program is imbedded in the ongoing collaborative CornellGHESKIO HIV research and clinical activities, including the following: HIV Clinical Trials Unit (CTU) for HIV vaccine and antiretroviral clinical trials;
WHO/TDR tuberculosis and syphilis research; United Nations Global Fund for AIDS, Tuberculosis and Malaria; President's Emergency Plan for AIDS
$42,241
$172,560
$172,800
Project Number
2
2
Project Title
Principal Investigator
Performing
Organization
3D43TW000018-22S2
AIDS INTERNATIONAL TRAINING
AND RESEARCH PROGRAM
JOHNSON, WARREN D.
WEILL MEDICAL COLLEGE
OF CORNELL UNIV
3U2RTW006901-05S1
HAITI AIDS RESEARCH
TRAINING: MODELS TO
IMPLEMENTATION
JOHNSON, WARREN D.
WEILL MEDICAL COLLEGE
OF CORNELL UNIV
1RC1TW008567-01
USE OF ELECTRONIC
PROTOCOLS TO IMPROVE
PROVIDER AND CLIENT
ADHERENCE
MITCHELL, MARC D.
HARVARD UNIVERSITY
(SCH OF PUBLIC HLTH)
Abstract
Relief (PEPFAR); Comprehensive International Program Research on AIDS (CIPRA); International Clinical Operational Health Services Research
Training on AIDS (ICOHRTA); Caribbean, Central, and South America Network (CCASAnet); and the Trans-Caribbean HIV/AIDS Research Initiative
(TCHARI). A high priority will be given to training that will facilitate the conduct of HIV vaccine and clinical trials, and operational and health research
programs in Haiti and the Caribbean. In addition to research training in Haiti, trainees will have the opportunity for advanced training with outstanding
US mentors. The program's US core and collaborating training faculty are funded scientists committed to AIDS research. The faculty constitutes a
cohesive unit, with diverse but focused interests.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): This proposal requests support for Weill Cornell Medical College (WMC or
Cornell) to continue training Haitian scientists in the performance of biomedical, epidemiological, laboratory, clinical, operational, health services and
behavioral research on HIV and related opportunistic infections. The program is based in the Division of International Medicine and Infectious
Diseases at Cornell, with an interdisciplinary group of investigators who have extensive collaborations with Haiti. Strengthened collaborations with
Vanderbilt, Harvard, University of California (Berkeley), the Hastings Center, and the Aaron Diamond AIDS Research Center offer diverse training
opportunities. The program will continue to emphasize medium and long-term advanced research training in Haiti. Since its inception, the AITRP
program has provided medium- and long-term training to 121 Haitian biomedical personnel, with 98% currently conducting HIV/AIDS work in Haiti. The
training offered will be related to six general HIV/AIDS research categories: 1) HIV vaccine trials; 2) antiretroviral clinical trials; 3) pediatrics and
maternal-infant transmission research; 4) HIV associated opportunistic infections - tuberculosis and human papilloma virus infection (HPV); 5) ethics
and behavioral research, with an emphasis on adolescents; and 7) pathogenesis, immunology, and virology. The proposed training will be conducted
largely in Haiti, with much of the training done by the former Fogarty trainees. The training program is imbedded in the ongoing collaborative CornellGHESKIO HIV research and clinical activities, including the following: HIV Clinical Trials Unit (CTU) for HIV vaccine and antiretroviral clinical trials;
WHO/TDR tuberculosis and syphilis research; United Nations Global Fund for AIDS, Tuberculosis and Malaria; President's Emergency Plan for AIDS
Relief (PEPFAR); Comprehensive International Program Research on AIDS (CIPRA); International Clinical Operational Health Services Research
Training on AIDS (ICOHRTA); Caribbean, Central, and South America Network (CCASAnet); and the Trans-Caribbean HIV/AIDS Research Initiative
(TCHARI). A high priority will be given to training that will facilitate the conduct of HIV vaccine and clinical trials, and operational and health research
programs in Haiti and the Caribbean. In addition to research training in Haiti, trainees will have the opportunity for advanced training with outstanding
US mentors. The program's US core and collaborating training faculty are funded scientists committed to AIDS research. The faculty constitutes a
cohesive unit, with diverse but focused interests.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): The goal of GHESKIO-Cornell ICOHRTA training program is to increase
capacity in integrated clinical, operational, and health services research in support of Haiti's national scale-up of HIV prevention and care services.
Haiti is the poorest country and has the highest rates of HIV infection in the Western Hemisphere, with an estimated 5% of the adult population
infected. In response, the Haitian Ministry of Health is initiating the Haitian National HIV Care and Prevention Network, a collaboration of public and
private health care organizations across the country that will provide a standardized package of HIV care and prevention services to 300,000
people/year, including voluntary counseling and testing, management of tuberculosis and sexually transmitted infections, prevention of mother to child
HIV transmission and comprehensive HIV care. The Ministry has asked the GHESKIO Centers to lead this network through training, supervision,
monitoring and evaluation, and through the conduct of operational and health services research. The GHESKIO Centers is an international research
and training institution that has benefited from twenty years of research capacity building from Cornell and Vanderbilt Universities, supported by the
Fogarty International Center. GHESKIO is now recognized as an international center of research excellence, and is a member of the NIH HIV Vaccine
Trials Network (HVTN), the AIDS Clinical Trials Group (ACTG), and a field site of the WHO's Tropical Disease Research Programme (TDR). In the
current proposal, GHESKIO will become the primary training institution and extend research capacity to other organizations in Haiti that are
participating in the Haitian National HIV Care and Prevention Network. GHESKIO, in collaboration with Haitian and International partners, will develop
short- and long-term training curricula in clinical, operational, and health services research methodology and in ethics, program management, and
scientific writing. A Masters in Public Health Program offered in Haiti will be the culmination of this curricula development. The objective is to train a
cadre of research leaders and to increase research capacity in the National HIV Care and Prevention Network. The specific areas of integrated
clinical, operational, and health services research that will form the basis of the proposed ICOHRTA training program include: 1) adult antiretroviral
treatment; 2) prevention of mother to child HIV transmission and antiretroviral treatment of HIV-infected mothers and infants; 3) tuberculosis; 4)
sexually transmitted infections; 5) ethics; and 6) health outcomes of HIV care and prevention. Research training will focus on translating models of HIV
care and prevention to large scale national implementation.
DESCRIPTION (provided by applicant): This application addresses broad Challenge Area (01) Behavior, Behavioral Change and Prevention and
Specific Challenge Topic 01-TW-102 Improving health through ICT/mobile technologies: enhancing patient compliance. The Priority topic is
implementation research on the use of ICT to adopt and integrate evidence based health interventions and change practice patterns within specific
settings to enhance patient compliance/adherence. The Integrated Management of Childhood Illness (IMCI) protocols have been adapted and
deployed in over 100 countries. A vast body of evidence indicates that millions of preventable deaths from diseases such as diarrhea, pneumonia, and
malaria could be averted if these protocols were more widely applied and correctly followed. We currently study the use of electronic protocols at the
point of care to improve provider diagnosis and treatment adherence to the IMCI protocols in Tanzania. Our software runs on PDAS or phones and
guides providers step by step through the IMCI protocols to help avoid skipping steps or arriving at the wrong diagnosis or treatments. Our preliminary
evidence suggests the use of these electronic protocols can substantially improve the diagnosis/treatment adherence by the provider to IMCI. We
propose to now investigate how ICT can be used at the point of care to improve patient adherence to IMCI recommendations through provider and
patient actions. This broadly includes the quality and frequency of the treatment and follow-up instructions given by the provider, the patient's ability to
understand these instructions, whether the patient adheres to instructions, and the patients' follow-up actions and future care seeking behavior. ICT
Total Cost
$43,200
$20,000
$490,516
Project Number
2
Project Title
Principal Investigator
Performing
Organization
Abstract
Total Cost
has the potential to address many of the challenges connected to these elements of patient adherence including the provider's reluctance to consult
paper guidelines in front of patients, the difficulty of supervising health workers in remote clinics, and the lack of information needed for refining
protocols and program management. However, while there is anecdotal evidence for these benefits of mobile technology, there has been little careful
investigation of these claims, and even less that focuses on the patients' experience of ICT-supported encounters. The study will be carried out in
clinics run by the Evangelical Lutheran Church of Tanzania (ELCT), who runs more than 180 health care institutions corresponding to about 15% of
health services in Tanzania. These health facilities are currently using paper based IMCI protocols for the treatment of children, as mandated by the
National Policy of Tanzania. This research will extend and assess our current system, e-IMCI, for guiding clinicians step by step through the IMCI
protocols with an additional module for patient adherence. The research will include three phases. During the first phase, we will assess and improve
e-IMCI through a rapid iterative prototyping methodology in which ideas are quickly implemented, tested, and either accepted, rejected or improved.
During this time, we will observe how e-IMCI impacts provider-patient interaction and solicit feedback from the caregivers of the patients after the
interactions. During Phase II, we will field test the improved version of e-IMCI in one clinic using paper IMCI serving as a control to prepare for the
study in the next phase, ensuring that the systems and data collection instruments work efficiently. Finally, in our third phase we will conduct a clusterrandomized control trial in 20 clinics (10 using ICT, 10 using paper IMCI) with follow up of patients 1 week following their clinic visit. We will investigate
the link between improved adherence by the patient/caregiver to health outcomes. We will also do a cost study and qualitative survey of perceptions of
providers and patients to ICT supported clinical care. PUBLIC HEALTH RELEVANCE: This research has high relevance to public health in its
potential to improve health outcomes in children who are seen in clinics for acute illness. Our hypothesis is that the use of ICT can improve adherence
by the caretaker to treatment instructions and advice given by the provider and improve adherence to the IMCI algorithms by the provider and that
improved adherence by the provider and caretaker will lead to improved health outcomes. This is based on previous research by the PI and his team
that concluded that ICT can improve assessment and correct classification and treatment of the child. Further, since these illnesses are the leading
cause of mortality in children in low income countries, this research has the potential to significantly improve child mortality in these countries.
National Cancer Institute (NCI)
3
1R21TW008436-01A2
A HOME-BASED INTERVENTION
FOR YOUNG CHILDREN WITH
INTELLECTUAL DISABILITIES
SHIN, JIN
HOFSTRA UNIVERSITY
3K07CA124851-02S1
TRACKING SYMPTOMS DURING
CHEMOTHERAPY VIA ONLINE
PATIENT SELF-REPORTING
BASCH, ETHAN
SLOAN-KETTERING
INSTITUTE FOR CANCER
RES
3K05CA115571-03S1
UNDERSTANDING RACIAL
DISPARITIES IN CANCER
SURGERY
BIRKMEYER, JOHN D
UNIVERSITY OF MICHIGAN
AT ANN ARBOR
DESCRIPTION (provided by applicant): The objectives of this project are: 1) to conduct a home-based early intervention project for children with
intellectual disabilities in Vietnam and to evaluate the children and family outcomes; and 2) to develop the research capacity of the collaborating team
in early intervention research at the Hue Medical College. Home-based intervention is a potentially ideal method of delivering services to children with
intellectual disabilities and their families where there are no center-based services available. Parents can be involved and trained to effectively work
with their children in their home environment. Additionally, the project will be conducted using naturally occurring activities in the home and community.
The specific aims of the project are to conduct a home-based intervention for one year that involves parent training and to evaluate both child and
parent outcomes. The project also adopts the ecological systems model as a conceptual framework used to examine the effects of the intervention in
a broad ecological context. These effects include how the characteristics of the child's experience affect the parent's experience and vice versa. The
social experiences of stigma that accompany having a child with a disability and the social support available are considered social experiences that
influence parent and child outcomes. It is expected that the intervention will positively affect child development, improve parental competence and
reduce parental stress. The child outcome will also be evaluated as it relates to the familial and social experiences as a result of intervention and time.
The parent outcome will also be evaluated as influenced by child, family and societal experiences that change relatively as an effect of time and
intervention. The Vietnamese collaborators will develop their research capacity by participating in various research activities that involve data analysis,
interpretation and writing. PUBLIC HEALTH RELEVANCE: The objectives of this project are: 1) to conduct a home-based early intervention project for
children with intellectual disabilities in Vietnam and to evaluate the children and family outcomes; and 2) to develop the research capacity of the
collaborating team in early intervention research at the Hue Medical College. Home-based intervention is a potentially ideal method of delivering
services to children with intellectual disabilities and their families where there are no center-based services available. Parents will be trained to
effectively work with their children in their home environment.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): This proposal envisions a comprehensive plan for the career development
of Dr. Ethan Basch in cancer outcomes research. Through mentored research, coursework, and independent study, Dr. Basch will develop
collaborative relationships and methodologic skills to support his research agenda in clinical informatics and patient symptom management. This work
focuses on the use of novel technologies to improve symptom monitoring during cancer care and trials, specifically through the evaluation of patientcentered treatment models which integrate patient reported outcomes (PROs). Currently, it is not standard to use patients' own self-reported symptom
information to monitor cancer care. Rather, clinicians are relied upon to elicit, filter and report this information - an approach which is mandated in NCI
and industry-sponsored trials. This stands in contrast to quality of life or symptom research, in which PROs are standard. The overall objective of this
research program is to explore the application of patient self-reporting to symptom monitoring in oncology treatment, as a possible new paradigm. The
specific aims are: 1) to assess the feasibility of routinely collecting symptom PROs via the web during cancer care and trials; 2) to measure the
relationship between patient and clinician symptom reporting using the standard U.S. instrument for this purpose, the NCI's Common Terminology
Criteria for Adverse Events (CTCAE); and 3) to evaluate the impact of patient self-reporting on clinical and administrative outcomes. This agenda will
be accomplished through a series of IRB-approved studies Dr. Basch has designed and is systematically conducting at Memorial Sloan-Kettering
Cancer Center, as well as nested in multicenter NCI and industry-sponsored clinical trials. RELEVANCE: Patient self-reporting may increase the
efficiency of clinical operations, foster early detection of serious adverse events, and improve patient satisfaction. Engaging patients as active
participants in research and in their own care conveys the message that treatment tolerance is an important endpoint. This work will help determine
how new technologies may be deployed to improve traditional models of care.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): Racial disparities in outcomes after cancer surgery are becoming
increasingly apparent. Black patients have both increased risks of operative mortality and lower 5-year survival rates. This project will pursue the
$141,046
$99,992
$100,333
Project Number
4
2
Project Title
Principal Investigator
Performing
Organization
3R01CA092447-08S1
SOUTHERN COMMUNITY
COHORT STUDY
BLOT, WILLIAM J.
VANDERBILT UNIVERSITY
1RC2CA148576-01
SEARCH: CANCER SCREENING
EFFECTIVENESS AND
RESEARCH IN COMMUNITYBASED HEALTHCARE
BUIST, DIANA SM
;DOUBENI, CHYKE
ABADAMA;
GROUP HEALTH
COOPERATIVE
1RC2CA148577-01
COMPARATIVE EFFECTIVENESS
BUIST, DIANA
GROUP HEALTH
Abstract
Hypothesis that these disparities primarily reflect the suboptimal health care systems in which black patients tend to receive their care. In exploring
hospital-level differences in quality of care, we have 3 specific aims: Aim I. To explore racial disparities in the structure and process of care with
cancer surgery - Using both national Medicare database (2000-4) and linked SEER-Medicare files (1995-2004), we plan to study structure and
process of care variables potentially related to both race and surgical quality in patients with lung, breast, and colorectal cancer. Aim II. To identify
which factors help explain racial disparities in surgical outcomes - Using hierarchical models, we will assess the extent to which racial disparities in
surgical outcomes are explained by differences in specific structural factors and processes of care (from Aim 1). Aim III. To delve deeper into
structure and process with clinical data - To add clinical 'granularity' to our research, we will repeat Aims 1 and 2 using prospective clinical data from
the Michigan Surgical Quality Collaborative, which involves 17 of the largest hospitals in Michigan (including several with predominantly minority
populations). This project will serve as a platform for mentoring several surgeon scientists interested in quality of care issues and racial disparities in
bladder, breast, colorectal, and other cancers. With mentored research opportunities and further instruction in health services research, these junior
investigators will acquire the skills necessary to develop clinically-oriented research agendas exploring quality of care problems in their fields. They will
also acquire insights necessary to develop and evaluate interventions aimed at reducing racial disparities.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): This is a revised application to enable renewal of the Southern Community
Cohort Study (SCCS). It has long been known that rates of cancer incidence and mortality are elevated among African Americans. The SCCS is a
landmark prospective investigation into the determinants of these disparities. Over the past 5 years, by partnering with Community Health Centers
(CHCs), facilities providing basic health care mainly to the uninsured, across 12 southern states, we have overcome barriers that have traditionally
restricted participation of African Americans in health studies. The first renewal of the SCCS, proposed herein, will enable completion of enrollment so
that the cohort will include approximately 90,000 men and women, nearly 70% African American, age 40-79. The new enrollees will be recruited from
CHCs and complete an in- person interview about medical, lifestyle and other characteristics, with > 90% expected to provide biologic specimens
(blood, buccal cells, and/or urine). Follow up of the entire cohort to identify deaths and incident cancers and update exposure profiles will be carried
out. We describe in the revised application enhanced approaches to active follow up, as requested by the initial reviewers, and indicate how they have
already improved response rates in our pilot follow up study. Longitudinal analyses and nested case-cohort studies utilizing the interview data and
biologic specimens will be initiated during the renewal period to evaluate specific hypotheses about cancer among African Americans which can
uniquely or with special advantage be assessed within the SCCS. The hypotheses are related to energy balance (weight gain, obesity and physical
inactivity), vitamin D, inflammation, selenium and other nutrient intakes, tobacco metabolism, and cancer screening practices and their impact on
incidence and/or mortality of the major cancers (lung, prostate, breast, and colon/rectum). Initial SCCS data show sometimes marked racial
differences in these variables. The cohort possesses attributes, such as a 44% prevalence of obesity (reaching 57% among Black women) and a 44%
prevalence of current smoking which place it at exceptionally high risk of cancer. The SCCS is thus unique among all cohorts and comprises a
population of urban and rural blacks and whites, often of low income, seldom if ever included in previous studies. The renewal will enable the SCCS to
be a national resource, with comprehensive biologic and questionnaire data available for assessing, both within the SCCS and in combination with
other molecular epidemiology consortia, the etiology of cancer and reasons for the largely unexplained higher rates among blacks. The ultimate public
health benefit will be Progress towards the development of measures aimed at cancer prevention, the elimination of cancer inequalities and the
reduction of the cancer burden among all groups.
DESCRIPTION (Provided by the applicant): Improvements in cancer screening effectiveness, higher participation rates and faster introduction of new
screening tests could have pronounced effects on the health of the community by reducing cancer burden. Cancer screening effectiveness in realworld settings depends not only on the efficacy of individual tests but also on patients, health care providers, and the systems and context in which
health care is delivered. Large and well defined populations of enrollees with diverse data sources are fundamental for comparative effectiveness
research that addresses health policy questions about cancer screening delivery. In response to the Grand Opportunity (GO), we propose to create an
innovative and sustainable multi-disciplinary and multi-institutional virtual center for cancer SEARCH: Screening Effectiveness And Research in
Community-based Healthcare within the NCI-funded Cancer Research Network (CRN). Because SEARCH is set in CRN-affiliated health care delivery
systems across the United States, it will benefit directly from the strong foundation of an existing and well-established network of NCI-funded research
infrastructure. An innovative portion of SEARCH will be our ability to translate and disseminate of our findings directly into practice. We have identified
and engaged a national Advisory Board of cancer screening experts and have proposed a new collaboration with the Cancer Intervention and
Surveillance Modeling Network (CISNET). Together, we will pursue high priority comparative effectiveness research (CER) that has relevance to
clinicians, patients, policy makers, payers, public health practitioners and medical associations. Our specific aims over the two-year grant period are
to: 1) Create a multi-disciplinary, multi-site team for CER focused on the delivery of cancer screening in community-based settings; 2) Develop
methodological capacity for future large-scale, population-based CER studies; 3) Demonstrate our ability to conduct CER in the area of cancer
screening to address important evidence gaps. Eight CRN sites will be involved in this application with four sites (Group Health, Kaiser Northwest and
Hawaii, and Fallon) contributing data for the proof of principle studies. We expect SEARCH will serve as a productive platform for launching larger
CER studies. During the two year funding period, we will build necessary infrastructure and collaborations, and will seek additional funding to address
important questions on the quality and effectiveness of cancer screening care delivery in community-based health care systems. PUBLIC HEALTH
RELEVANCE: Large and well defined populations of enrollees with diverse data sources are fundamental for comparative effectiveness research that
addresses health policy questions about cancer screening delivery. We plan to study approaches to effectively deliver cancer screening to populations
in order to enhance detection, diminish morbidity and other adverse effects, and ultimately reduce mortality. The SEARCH: Screening Effectiveness
And Research in Community-based Healthcare research team will be based within the geographically diverse health care systems of the NCI-funded
Cancer Research Network, which is a consortium of 14 health plans across the US, and will enable translation of our findings directly into clinical
practice in community settings.
DESCRIPTION (Provided by the applicant): The overall goal of this project is to conduct comparative effectiveness research on breast cancer
Total Cost
$4,721,145
$1,997,154
$1,999,896
Project Number
2
Project Title
OF BREAST IMAGING
STRATEGIES IN COMMUNITY
PRACTICE
5
Principal Investigator
Performing
Organization
SM;GELLER, BERTA
M;KERLIKOWSKE, KARLA
M;MANDELBLATT,
JEANNE ;MIGLIORETTI,
DIANA L ;YANKASKAS,
BONNIE ;
COOPERATIVE
3K07CA126985-02S1
A COMMUNICATION
INTERVENTION FOR PHYSICAL
ACTIVITY IN UNDERSERVED
COMMUNITIES
CARROLL, JENNIFER
KATE
UNIVERSITY OF
ROCHESTER
3U01CA114640-05S3
ASIAN AMERICAN NETWORK
FOR CANCER AWARENESS
RESEARCH & TRAINING
CHEN, MOON S
UNIVERSITY OF
CALIFORNIA DAVIS
Abstract
imaging modalities and strategies to inform evidence gaps on how to optimize breast cancer screening in community practice. The Breast Cancer
Surveillance Consortium (BCSC) is uniquely positioned to conduct rigorous comparative effectiveness studies on conventional and new breast
imaging technologies to inform how screening strategies could be personalized based on patient demographic and risk factor information and optimize
the balance of screening benefits and harms. The BCSC includes detailed longitudinal information throughout the cancer care continuum: from cancer
screening and diagnosis through treatment, surveillance, and death on over 2 million women and 95,000 breast cancers. It is the only resource of this
size with risk factor information (including mammographic breast density) that is also linked to: mammography examinations accurately identified as
either screening or diagnostic and as either film-screen or digital; cancer registry and pathology databases to determine both benign and malignant
outcomes; Medicare and Group Health managed care claims data to obtain comorbidities and healthcare utilization; and death data to ascertain vital
status and cause of death. Over the next two years we will: 1) Use existing BCSC screening data with long-term follow-up (overall and breast cancer
mortality) and newly linked BCSC-Medicare data to compare the clinical effectiveness of 1- vs. 2- year mammography screening intervals for
subgroups of women; 2) Use BCSC-Medicare data to compare the downstream healthcare utilization and costs of digital versus film-screen
mammography; 3) Use BCSC data in four Cancer Intervention and Surveillance Modeling Network (CISNET) breast cancer simulation models to
compare the clinical and cost-effectiveness of various breast cancer screening strategies; 4) Implement a prospective data collection system
specifically designed to capture clinically and scientifically relevant data on breast magnetic resonance imaging (MRI) across our network of BCSC
community practice facilities; 5) Expand the BCSC Statistical Coordinating Center's capacity to design and conduct comparative effectiveness
research in community settings by developing epidemiologic and statistical methods focused on sampling and design strategies for prospective
observational and community-based randomized trials. This Grand Opportunity will increase the capacity of the BCSC and CISNET to provide
evidence on how to deliver the most effective breast cancer screening in defined subgroups of women. PUBLIC HEALTH RELEVANCE: The overall
goal of this project is to conduct comparative effectiveness research on breast cancer imaging modalities and strategies to inform evidence gaps on
how to optimize breast cancer screening in community practice. The Breast Cancer Surveillance Consortium (BCSC) is the only resource with breast
cancer risk factor information on over 2 million women linked to: mammography examinations accurately identified as either screening or diagnostic
and as either film-screen or digital; cancer registry and pathology databases to determine both benign and malignant outcomes; Medicare and Group
Health managed care claims data to obtain comorbidities and healthcare utilization; and death data to ascertain vital status and cause of death. We
will use the BCSC infrastructure and network of mammography facilities to examine screening intervals, screening modalities, and risk factors to
determine their influence on breast cancer detection and mortality and associated costs. This research will set standards and methodology for
comparative effectiveness studies in community practice and enable evidence-based recommendations that maximize screening effectiveness,
minimize harms of screening, and optimize healthcare utilization.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): Overview: Jennifer Carroll, MD, MPH, a family physician, is applying for a
mentored career development award to become an independent investigator in health communication, physical activity interventions, and cancer
prevention. Her research goal is to evaluate a primary care-based clinician communication intervention to promote physical activity in underserved
primary care populations. Communication about physical activity is a cornerstone to primary prevention of cancer linked to sedentary behavior. The
proposed research is theoretically guided by principles of patient-centered communication and the 5A (Ask, Advise, Agree, Assist, Arrange) model
positing that a primary care clinician intervention linked to a community program improves communication about physical activity in this population.
Career Development Plan: Dr. Carroll's background in health promotion and underserved communities and cross-cultural communication research
provide a strong foundation to her career plan. Her previous research experience will be enhanced by a specific, measurable career development plan
in communication theory and measurement, practice-based research, physical activity interventions, advanced statistics, and behavioral medicine. An
experienced, multidisciplinary mentoring team supports her plan. Her mentoring team provides internationally recognized expertise in research
involving communication, biobehavioral clinical trials, health disparities and health services research. Additional advisory board members will provide
expertise in cancer prevention, physical activity design issues, and research with underserved populations. Research Plan: The proposed study, along
with mentoring and educational activities, will expand the promising findings of previous research conducted by Dr. Carroll and her mentors. The
proposed study is a pilot two-arm randomized clinical trial to examine the effect of a primary care clinician communication intervention (n=15 clinicians)
linked to a community-based exercise program on the primary outcome, use of the 5As in discussion of physical activity in 371 office visits in an
ethnically diverse, primarily low income patient population. Secondary and exploratory aims are to provide pilot information on [feasibility and
sustainability of the intervention from the patients' and clinicians' perspective and derive effect sizes on the intervention's effect on objective changes
in physical activity in a subset of participants.] Study results will help Dr. Carroll to successfully apply for R01-level funding to conduct larger-scale
cancer prevention trials to promote physical activity via communication interventions in primary care focusing on underserved populations.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): The overall mission of the Asian American Network for Cancer Awareness,
Research and Training (AANCART) is to reduce cancer health disparities by conducting community-based participatory education, training, and
research by, for, and with Asian Americans in Sacramento, CA (also serves as Headquarters); San Francisco, CA; Los Angeles, CA; Seattle, WA;
Hawaii (state); and Houston, TX. This Network is a national one, comprised of seven NCI cancer centers and their associated universities, the
California Department of Health Services, Chinese Community Health Care Association, and the Hmong Women's Heritage Association.
Cumulatively, this Network serves nearly 50 percent of all Asian Americans. Consistent with RFA-CA-05-012, AANCART's deliverables are: (1)
Sustenance of a highly interactive Network among AANCART regions to catalyze cancer education for Asian Americans; (2) Establishment of
research training programs that address Asian American cancer health disparities; and (3) Process and impact data to document the extent to which
specific cancer health disparities are reduced among Cambodians, Chinese, Filipino, Hmong, Korean, and Vietnamese. Examples of Asian American
disparities to be addressed include those associated with smoking-related lung and hepatitis B-induced liver cancers, low breast and cervical cancer
screening rates, and emerging cancer threats posed by acculturation, diet, and insufficient ethnically-specific representation in clinical trials. Aims will
Total Cost
$100,064
$306,083
Project Number
6
2
Project Title
Principal Investigator
Performing
Organization
3U01CA114696-05S1
SOUTHWEST AMERICAN INDIAN
COLLABORATIVE NETWORK
COE, MARY KATHRYN
INTER TRIBAL COUNCIL
OF ARIZONA, INC.
3U10CA021661-33S1
RADIATION THERAPY
ONCOLOGY GROUP
CURRAN, WALTER J
AMERICAN COLLEGE OF
RADIOLOGY
3U10CA021661-33S2
RADIATION THERAPY
ONCOLOGY GROUP
CURRAN, WALTER J
AMERICAN COLLEGE OF
RADIOLOGY
1R03CA136444-01
INFLUENCE OF HEALTH
LITERACY AND CANCER AMONG
DIGNAN, MARK B.
;HUNTER, ELIZABETH G;
UNIVERSITY OF
KENTUCKY
Abstract
be achieved through both Network-wide and regional activities by the AANCART Steering Committee and involving Asian American-oriented
community-based organizations, Cancer Information Service staff, and other supportive entities tied together through past histories of collaboration
and memoranda of understanding and letters of support. Universities associated with AANCART, the California Department of Health and the
Chinese Community Health Plan are committed to additional support for AANCART.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): The Intertribal Council of Arizona proposes to create a Southwest
American Indian Community Cancer Network (SAICCN). The goal of this network is to eliminate cancer health disparities among American Indians by
closing the gap between the health needs of the community and the promise of cancer prevention and cure made possible by a responsive health
delivery and research system. The core partners in the project have both local and regional programs and activities. This proposal envisions a
regional program with the following aims: 1) Further develop a core organizational infrastructure to support community-based participatory activities
and effective partnerships between communities, cancer prevention/care delivery systems, and research discovery/development systems at many
levels to increase and sustain delivery of beneficial interventions; 2) Strengthen existing partnerships and create new partnerships with communities
that suffer cancer health disparities and create opportunities to work with other organizations with an interest in reducing health disparities; 3)
Strengthen existing collaborations with Cancer Information Services and establish and formalize collaborations with three additional NCI programs; 4)
Increase the utilizations of beneficial interventions to reduce cancer health disparities and perform community-based participatory educational
activities that reduce cancer health disparities by increasing cancer education and community use of beneficial cancer interventions; 5) leverage
SAICCN activities by obtaining funding from various sources for community-based participatory activities. To accomplish these aims and provide
direction, synergy, and coordination, four core services will be formed: administration, outreach, research, and training and education, each of which
will include a community-based evaluation program
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (Provided by applicant):
The Radiation Therapy Oncology Group (RTOG) is the leading
multicenter and multidisciplinary research organization systematically testing novel radiotherapy (RT) approaches against cancer and pursuing fully
integrated translational research to enhance this effort. The group will build on its outstanding scientific accomplishments in the current funding period
to conduct research based on three fundamental initiatives: 1. Physical Targeting: RTOG will implement and test advances in imaging and highprecision RT planning and delivery technologies in clinical trials. 2. Molecular Targeting: Combined with RT: RTOG will design and conduct
hypothesis-driven trials testing the integration of novel molecular targeted anti-cancer agents with optimized RT or chemo-RT. 3. Translational
Research: RTOG will implement powerful biostatistical and medical informatics approaches to its unique and inter-linked clinical, biophysical, biologic,
and outcomes databases that will faciliate hypothesis-driven analyses of these resources. The RTOG's research is primarily directed toward patients
with brain tumors, head and neck cancer, lung cancer, gastrointestinal cancer, and genitourinal cancer. More limited research strategies have been
developed for patients with gynecologic and breast cancer and sarcoma. RTOG research is supported by outstanding contributions from the Advanced
Technology Integration, the Translational Research Program, and the Health Services Research and Outcomes Committees as well as the newly
relocated Biospecimen Resource and from the four core committees of Medical Oncology, Medical Physics, Pathology, and Surgical Oncology. These
contributions are well coordinated by a strong administrative and scientific infrastructure and have resulted in increased productivity in the current as
compared with the prior funding cycle in terms of: 1. publication record; 2. clinical trials activated and completed; 3. overall patient accrual; 4. public
and private funding of group research; 5. collaboration with other cooperative groups and other NIH-funded organizations; and 6. increased
participation and leadership of Canadian investigators, with 8 of 37 full member institutions being Canadian. Close to two-thirds of all cancer patients
receive radiation therapy for cure or for symptom relief. Novel technology, molecular targeted drugs and advances in radiation and cancer biology will
improve the success rate of radiation therapy through clinical research over the next six years.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (Provided by applicant):
The Radiation Therapy Oncology Group (RTOG) is the leading
multicenter and multidisciplinary research organization systematically testing novel radiotherapy (RT) approaches against cancer and pursuing fully
integrated translational research to enhance this effort. The group will build on its outstanding scientific accomplishments in the current funding period
to conduct research based on three fundamental initiatives: 1. Physical Targeting: RTOG will implement and test advances in imaging and highprecision RT planning and delivery technologies in clinical trials. 2. Molecular Targeting: Combined with RT: RTOG will design and conduct
hypothesis-driven trials testing the integration of novel molecular targeted anti-cancer agents with optimized RT or chemo-RT. 3. Translational
Research: RTOG will implement powerful biostatistical and medical informatics approaches to its unique and inter-linked clinical, biophysical, biologic,
and outcomes databases that will faciliate hypothesis-driven analyses of these resources. The RTOG's research is primarily directed toward patients
with brain tumors, head and neck cancer, lung cancer, gastrointestinal cancer, and genitourinal cancer. More limited research strategies have been
developed for patients with gynecologic and breast cancer and sarcoma. RTOG research is supported by outstanding contributions from the Advanced
Technology Integration, the Translational Research Program, and the Health Services Research and Outcomes Committees as well as the newly
relocated Biospecimen Resource and from the four core committees of Medical Oncology, Medical Physics, Pathology, and Surgical Oncology. These
contributions are well coordinated by a strong administrative and scientific infrastructure and have resulted in increased productivity in the current as
compared with the prior funding cycle in terms of: 1. publication record; 2. clinical trials activated and completed; 3. overall patient accrual; 4. public
and private funding of group research; 5. collaboration with other cooperative groups and other NIH-funded organizations; and 6. increased
participation and leadership of Canadian investigators, with 8 of 37 full member institutions being Canadian. Close to two-thirds of all cancer patients
receive radiation therapy for cure or for symptom relief. Novel technology, molecular targeted drugs and advances in radiation and cancer biology will
improve the success rate of radiation therapy through clinical research over the next six years.
DESCRIPTION (provided by applicant): Health literacy has emerged as an important construct because it's four components: cultural and conceptual
knowledge, listening and speaking (oral literacy), writing and reading (print literacy), and numeracy affect the health outcomes of individuals. As
Total Cost
$251,361
$789,614
$324,683
$89,684
Project Number
2
Project Title
Principal Investigator
Performing
Organization
RURAL PATIENTS IN
REHABILITATION
7
3K01CA127118-03S1
UNDERSTANDING RACIAL AND
ETHNIC DIFFERENCES IN
SURVIVAL FROM COLORECTAL
CANCER
DOUBENI, CHYKE
ABADAMA
UNIV OF
MASSACHUSETTS MED
SCH WORCESTER
3U01CA116885-05S1
PATIENT NAVIGATION
RESEARCH PROGRAM
DUDLEY, DONALD J
UNIVERSITY OF TEXAS
HLTH SCI CTR SAN ANT
3K07CA101780-04S1
BREAST AND CERVICAL CANCER
SCREENING IN OBESE WOMEN
FERRANTE, JEANNE M
UNIV OF MED/DENT NJ-R
W JOHNSON MED SCH
Abstract
individuals don't live in a vacuum, it is important to understand the complex interaction of health literacy at multiple levels of interaction from the
individual to the family, health care system and community. Describing how these multiple points of view connect and influence each other for
individuals with cancer and other chronic illnesses, from rural Appalachian communities who are in a rehabilitation setting is the under explored focus
of this study. The current study is the first step in developing a program of research designed to address these complex interactions and gaps in the
literature. Through in-depth interviews and focus groups, the goal of the present study is to explore the influence of health literacy from the individual,
family, health care facility and the patient's rural home community point of view. We propose to achieve three specific aims: 1.) Describe the health
literacy level of this population. 2.) Determine the supports and barriers found in an inpatient rehabilitation facility in terms of facilitating health
communication and addressing potential health literacy issues. 3.) Address the impact of health literacy on the transition from a rehabilitation facility
back to a person's rural home community. This descriptive pilot study is a critical first step toward our ultimate goal of developing and empirically
assessing health literacy interventions for this population. Later inquiries will include an examination of current processes in a rehabilitation setting and
how they positively or negatively support health communication particularly in terms of health literacy in rural populations. The long-term goal is to
develop interventions that will decrease the barriers and enhance the supports in health communication to decrease poor health outcomes, decrease
health disparities in rehabilitation and positively influence transitions between settings for individuals with cancer and other chronic disease. PUBLIC
HEALTH RELEVANCE: Low health literacy has the potential to negatively impact individuals with cancer and other chronic illness who are in a
rehabilitation setting in terms of health and well-being. Low health literacy can negatively impact issues such as self-management of cancer and other
chronic illness and medication adherence. This problem is possibly compounded if the individual is from a rural community, transplanted to a
metropolitan inpatient rehabilitation setting and then sent back to their rural community. It is important to understand how low health literacy interacts
with the individual in their complex social setting, including family, health care setting and home community with the goal of reducing potential health
disparities among this population.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): Colorectal cancers are the third most common invasive cancers among
men and women in the United States. Improvements in prevention, screening and treatment have resulted in decreasing case-fatality rates from
colorectal cancer since the 1980s. Paradoxically, disparities in survival from this cancer especially between Blacks and Whites have widened over
time. Although there is no consensus in existing literature, current evidence suggests that factors related to access to health care including
socioeconomic differences contribute to these disparities. The goal of the proposed research program is to identify potentially modifiable causes of
disparities in cancer survival with a long range goal of reducing or eliminating the disproportionate burden of colorectal cancer among certain patient
populations. The specific aims for this project are to: 1) compare colorectal cancer survival rates by race/ethnicity over the period 1993 through 2004;
2) compare the distribution of tumor stage at diagnosis for colorectal cancer by race/ethnicity; 3) examine potential mediators of the relationship of
survival and race/ethnicity among colorectal cancer patients; 4) examine the patterns of care of survivors of colorectal cancer; and 5) explore the effect
of socioeconomic status on the relationship between race/ethnicity and survival among colorectal cancer patients. This project will be conducted on a
large racially diverse cohort comprised of patients 20 years and older diagnosed with colorectal cancer (1993 to 2004) while enrolled in one of four
integrated health care systems that are affiliated with the National Cancer Institute-funded Cancer Research Network. This research plan is part of a
career development program aimed at providing the training and experience needed for Dr. Doubeni to become an independently funded clinicianinvestigator focusing on disparities in cancer survival. The objectives of the career development plan are to acquire knowledge and skills in: 1) cancer
biology, epidemiology and treatment; 2) advanced research methods; 3) scientific writing; and 4) the translation of research into practice and policy.
The career development program will be accomplished through mentoring and targeted advanced courses. The studies encompassed under the
proposed research program will make important contributions to our understanding of racial/ethnic differences in cancer survival rates. The proposed
project will lay the foundation for the candidate's long-term career goal of designing system-based interventions aimed at eliminating disparities in
cancer care and survival, a major objective of HealthyPeople 2010.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): Although Hispanics are the largest ethnic minority population in the United
States, Hispanics remain underserved by healthcare systems and are less likely to seek or receive health care, contributing to disparities in health
status and mortality. The University of Texas Health Science Center at San Antonio (UTHSCSA) is uniquely positioned to mitigate disparities in health
and cancer care for the disadvantaged regional Hispanic population. The UTHSCSA National Center of Excellence in Women's Health (NCoEWH),
recently designated by the Office of Women's Health, addresses health disparities in a newly identified population of intense need in conjunction with
the San Antonio Metropolitan Health District (SAMHD) and University Health System (UHS) Patient Navigation is a key feature of the NCoEWH and
the proposed Patient Navigation Research Project will build on this element to assist patients in gaining access to cancer care in a coordinated
manner using SAMHD clinics, UHS clinics, community-based agencies, and University Hospital. The PNRP approach to Navigation is unique in its
matrix organization and focus on coordination between community sites and agencies, facilitated through active involvement of clinical oncologists
using evidence-based guidelines. Data will be systematically gathered to assess and eliminate barriers through process improvement and community
involvement in addressing issues that impede effective cancer care. The project, combining the efforts of Navigators and Promoters, will build cultural
competence, optimal communication, community cooperation, interdisciplinary investigation, and sound research to provide solid evidence concerning
the cost-effectiveness and clinical efficacy of highly coordinated care. Carefully designed, theoretically sound metrics will be incorporated into the
development and implementation of a Program to address questions concerning cost-effectiveness, improving the timeliness of care, and the impact
of Navigation on patient satisfaction, cancer outcomes, and the general health of the population
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators.DESCRIPTION (provided by applicant): The candidate's long-term career goal is to understand how primary medical
care impacts cancer outcomes and to develop interventions that will improve primary medical care in this regard. Primary medical care is important in
helping to decrease cancer incidence and mortality and to understand the causes of health disparities in cancer stage and survival. UMDNJ- New
Total Cost
$65,281
$248,025
$50,000
Project Number
8
2
Project Title
Principal Investigator
Performing
Organization
3U01CA116892-05S4
PATIENT NAVIGATION IN THE
SAFETYNET: CONNECTEDD""
FREUND, KAREN
BOSTON MEDICAL
CENTER
3K07CA109064-05S1
ADHERENCE AMONG OLDER
WOMEN WITH BREAST CANCER
GIORDANO, SHARON
HERMES
UNIVERSITY OF TEXAS
MD ANDERSON CAN CTR
1RC1CA144705-01
INSTITUTIONAL VARIATION IN
SURGICAL CARE FOR BREAST
CANCER IN US COMMUNITY
HOSPIT
GREENBERG, CAPRICE
CHRISTIAN
BRIGHAM AND WOMEN'S
HOSPITAL
Abstract
Jersey Medical School, located in Newark, New Jersey is surrounded by a community affected by heavier burdens of cancer incidence, late stage
cancer at diagnosis, and cancer mortality. The adjacent counties surrounding the school contain 27.3 % of New Jersey's total population, but 52.4%
of its African-American population and 49.7% of the state's Hispanic population. This population is ideal for studying the causes of late stage cancer
diagnosis and racial disparities in cancer stage and survival. In collaboration with the Cancer Institute of New Jersey, the institution is developing, as a
top priority, research and clinical programs to address deficits in cancer care in northern New Jersey and major health disparities evident in Newark
and its environs. The PI's career objectives of this proposal are to increase quantitative skills in data analysis, to refine skills in survey research, to
learn qualitative research methods, and to learn how to integrate culture, language, and literacy into cancer control interventions. The research career
development plan includes: completion of a Masters in Public Health degree program, the NCI's 'Principles and Practice of Cancer Prevention and
Control Course,' a review course on SAS statistical software, a training course on SUDAAN Statistical Software, completion of the Cancer, Culture,
and Literacy Institute, various other cancer and research forums, and the conduct of mentored multi-method research. This multi-method research
project will focus on breast and cervical cancer screening in an at risk subpopulation: obese women. Obese women are more likely than non obese
women to be delayed in breast and cervical cancer screening. Since African-American and Hispanic women are disproportionately obese compared
to other races, this study may impact racial disparities in cancer. First, new analyses will be conducted using data from the National Health Interview
Survey to quantify the extent of the association of obesity to delayed cancer screening, and the impact of race/ethnicity and comorbidity on this
association. Next, focus groups will be conducted with obese women to identify their barriers to cancer screening. In addition, in-depth interviews and
a mail survey will be administered to physicians to identify their barriers to cancer screening in obese women and to elicit suggestions to overcome
those barriers. Finally, an interventional plan and materials will be developed that are appropriate for a multicultural target group and evaluated for
appropriateness, readability, and feasibility through focus groups of patients and physicians.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): Despite advances in early detection and treatment options, racial/ethnic
minority and low socioeconomic status women continue to suffer advanced stage at diagnosis and higher mortality for both breast and cervical cancer.
Delays in diagnosis and treatment, which contribute to poorer outcomes, have been associated with well known barriers to care. These disparities
persist despite this knowledge represents a gap between discovery and delivery of cancer care resulting in a pressing need for effective interventions.
The objective of this study is to design, implement and evaluate a patient navigator intervention at six community health centers in Boston,
Massachusetts. These sites represents a wide range of racial/ethnic minority and low socioeconomic status women served by an urban safety net
institution that mirrors the infrastructure of this country's urban health systems. The intervention is a model based on Andersen's Model of Health
Services Use. Aided by an Electronic Medical Record tracking system and theory based cultural competency training, patient navigators will: identify
cases, provide service coordination and direct patient support. Our specific aims are to determine if the intervention will: 1. Reduce time to diagnosis
(or resolution of abnormality) after an abnormal mammogram or Pap smear; 2. Reduce time to complete treatment and provide higher quality
treatment after a cancer diagnosis; 3. Improve patient satisfaction with health care services; 4. Have critical components (time with patient vs. time
coordinating care) which drive its success; 5. Result in more cost-effective care. We will use a quasi-experimental design with block randomization of
six community health centers whose primary affiliation is with Boston Medical Center. Each site will be randomly assigned to either Breast or Cervical
Patient Navigation. Thus, each of the Breast intervention sites will serve as a continuous comparison site for the Cervical intervention sites and vice
versa. We expect that the results of this study will inform the design of a generalizable standard, effective and cost efficient patient navigation model
that will eliminate barriers to timely, quality cancer care among racial/ethnic minority and lower income populations
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators.DESCRIPTION (provided by applicant): The objective of this career development award is to provide Dr. Sharon
Giordano with the experience and knowledge necessary to become an independent health services researcher in the field of breast cancer. Dr.
Giordano, who is a medical oncologist and MPH candidate, will accomplish this goal through a combination of directed reading, seminars, coursework,
and mentored research. A highly qualified team of mentors will supervise her training and ensure that she meets her goals. Dr. Giordano will be
examining adherence to a standard course of adjuvant treatment among older women with breast cancer using two different approaches: secondary
data analyses using the SEER-Medicare database and primary data collection. The specific aims of this proposal are: 1 ) to describe lack of
adherence to chemotherapy and radiotherapy in a population-based sample of older women with breast cancer; 2) to determine the effect of specific
comorbidities as well as patient, physician, and environmental characteristics on adherence to chemotherapy and radiotherapy; and 3) to prospectively
identify factors, including the potentially unrecognized comorbidities of depression and dementia, that affect adherence to therapy in older women with
breast cancer. The first two specific aims will be accomplished using the population-based SEER-Medicare database, and the third specific aim
through a prospective study. The proposed research will provide important knowledge regarding the patterns and predictors of adherence to adjuvant
therapy among older women. In addition, these studies will provide the applicant with expertise in the use of cancer registry data and claims data, in
primary data collection, and in data analysis. The proposed studies and career development activities will provide the applicant with the skills to
develop into an independent investigator.
DESCRIPTION (provided by applicant): This application addresses broad challenge area (05) Comparative Effectiveness Research and specific
challenge topic, 05-CA-104: Comparative Effectiveness Research on Cancer Treatment. Broad Objectives: The long-term objective of this work is to
improve the quality of surgical care for breast cancer. One approach to improving the quality of care focuses on understanding and decreasing
variations in practice across institutions. Specific Aims: This proposal seeks to investigate the degree of institutional variation in the surgical treatment
of breast cancer in community hospitals. The majority of surgery for breast cancer is performed in community hospitals yet the majority of research is
performed at academic medical centers. For that reason, a thorough understanding of practice patterns in community hospitals is crucial to improving
the quality of care for breast cancer. In particular, this proposal investigates whether the supply of plastic surgeons and radiation oncologists at a given
institution correlates with the type of surgery preferentially performed. This project has 3 specific aims: Aim 1. To determine the degree of institutional
variation in the type of surgical procedure for early stage breast cancer in a cohort of U.S. community hospitals Aim 2. To evaluate the impact of
Total Cost
$336,981
$48,963
$499,935
Project Number
9
2
Project Title
Principal Investigator
Performing
Organization
3R01CA129091-03S1
QUIT-PRIMO:WEB-DELIVERED
CLINICAL MICROSYSTEM
INTERVENTION FOR TOBACCO
CONTROL
HOUSTON, THOMAS K
UNIV OF
MASSACHUSETTS MED
SCH WORCESTER
1RC1CA145799-01
A COMPREHENSIVE MODEL TO
ASSESS THE COSTEFFECTIVENESS OF PATIENT
NAVIGATION
JONES, LOVELL
ALLAN;SHIH, YA-CHEN
TINA ;
UNIVERSITY OF TEXAS
MD ANDERSON CAN CTR
Abstract
institutional supply of sub-specialty care on the type of surgical procedure for early stage breast cancer Aim 3. To develop empirically evaluated,
reusable, and freely available natural language processing software that can be used to access the ever increasing amount of electronic medical
record data available Research Design and Methods: This project is a collaborative effort of government, non-profit and academic hospital information
and research systems. Our cohort will include an estimated 4,500 breast cancer patients who underwent a definitive operation during 2007 or 2008 at
one of 80 community hospital partners of IHM. Available data includes administrative and billing data, as well as free text reports from the electronic
medical record. The first step is to design the software necessary to automatically and reliably extract data from the free text fields. This will provide
accurate pathologic and other cancer-specific data required for this and any other analysis of cancer care in IHM hospitals. The second step is to use
this data to compare the surgical treatment of breast cancer across institutions. Multivariable modeling will be used to investigate the relationship
between institution and the type of surgery performed after controlling for patient and cancer-specific variables. In particular, the supply of plastic
surgeons and radiation oncologists will be considered as possible explanations for institutional variations in the use of reconstruction and breast
conserving surgery. Potential Impact: This study has the potential to have a major impact as follows: 1. Improve the quality of surgical care for breast
cancer, affecting approximately 160,000 American women per year 2. Provide a new data source for comparative effectiveness and other health
services research in a cohort of 80 community hospitals, representing an understudied sector of the U.S. healthcare system 3. Develop a modular
approach to natural language processing software that can be re-used to access electronic medical record data and advance the field of comparative
effectiveness and other health services research This proposal investigates institutional variation in the surgical treatment of breast cancer at
community hospitals. In particular, we seek to determine whether the supply of plastic surgeons and radiation oncologists at a given institution
correlates with the type of surgery preferentially performed. This project is a collaborative effort of government, non-profit and academic hospital
information and research systems and will provide a new data source for comparative effectiveness and other health services research in community
hospitals, an understudied sector of the U.S. healthcare system.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): This is our first resubmission of a randomized trial of QUIT-PRIMO Quality
Improvement in Tobacco - Provider Referrals & Internet-delivered Microsystem Optimization in response to PA-06-226 Information Technologies and
the Internet in Health Services and Intervention Delivery. Our Overall Goal is to advance science related to the use and impact of the Internet in health
services delivery, specifically smoking cessation, by targeting primary care clinical microsystems. A clinical microsystem is defined as the smallest
functional healthcare unit. A clinical microsystem is not simply equivalent to a clinical team doctors and nurses, but also includes the panel of patients
cared for by the providers and the processes of care that are used. The Institute for Healthcare Improvement (IHI) states interventions targeted to
clinical microsystems are a crucial component in improving health care quality. We have the following Specific AIMS: Aim 1. Randomize 160
community- based primary care microsystems into a trial comparing the QUIT-PRIMO with a paper- based information prescription; Aim 2. Evaluate
the impact of QUIT-PRIMO on referral rates using patient-reported measures; Aim 3. Evaluate the impact of QUIT- PRIMO on six-month smoking
cessation of primary care patients. The QUIT-PRIIMO Intervention is a multi-component Internet-delivered clinical microsystem intervention with: 1.
Refer2Quit A point-of-care patient referral portal providers can use to enroll patients into a self-management system, with summary reports of provider
and patient activity, and secure messaging templates providers can use to efficiently encourage patients to quit during follow-up; AND 2. Decide2Quit
A patient self-management portal organizing interactive, tailored, patient education, cessation planning, links to other high-quality web (smokefree.gov)
and offline resources (1-800-QUIT-NOW), and secure messaging patients can use. The Control is a paper-based information prescription providers
print to refer patients to a previously developed patient self-management website not linked into the clinical microsystem. The significance of the
proposed study is that it will be the first Internet-delivered Intervention targeted to the clinical microsystem with the specific purpose of increasing
smoking cessation. Our intervention is also unique among web resources for smoking cessation because a major goal is to enhance follow-up and
increase treatment-seeking. QUIT-PRIMO builds upon our previous NCI-funded R21 (Ford, PI), where we our control self-management system for this
study. PUBLIC HEALTH RELEVANCE: This is our first resubmission of a randomized trial of QUIT-PRIMO Quality Improvement in Tobacco - Provider
Referrals & Internet-delivered Microsystem Optimization in response to PA-06-226 Information Technologies and the Internet in Health Services and
Intervention Delivery. Our Overall Goal is to advance science related to the use and impact of the Internet in health services delivery, specifically
smoking cessation, by targeting primary care clinical microsystems. The QUIT-PRIIMO Intervention is a multi-component Internet-delivered clinical
microsystem intervention with: 1. Refer2Quit A point-of-care patient referral portal providers can use to enroll patients into a self-management system,
with summary reports of provider and patient activity, and secure messaging templates providers can use to efficiently encourage patients to quit
during follow-up; AND 2. Decide2Quit A patient self-management portal organizing interactive, tailored, patient education, cessation planning, links to
other high-quality web (smokefree.gov) and offline resources (1-800-QUIT-NOW), and secure messaging patients can use.
DESCRIPTION (provided by applicant): Patient navigation (PN) is a community-centered approach that can potentially reduce health disparities by
enhancing access to care at an earlier stage of the disease continuum for underserved populations, such as racial/ethnic minorities or individuals with
low socioeconomic status. To date there are two large-scale federally-funded programs that involve PN interventions; one is the patient navigation
research program sponsored by the National Cancer Institute (NCI); the other is a series of demonstration projects supported by Centers for Medicare
and Medicaid Services (CMS). The NCI-sponsored sites mostly initiate PN services at the time an abnormal screening result is detected, whereas the
CMS- sponsored sites attempt to engage PN services at an earlier stage so as to increase the uptake of cancer screening. Little is known about the
cost-effectiveness of PN compared to usual care (UC) for either type of PN services. The objective of the proposed study is to develop a
comprehensive research framework to assess the cost-effectiveness of a PN program targeted at various points in the continuum of cancer care screening, diagnosis, and treatment. The study has three specific aims: (1) to evaluate the cost-effectiveness between usual care and patient
navigation started at the time that an abnormal screening result was detected; (2) to compare the cost-effectiveness between usual care and patient
navigation targeted at improving the uptake of cancer screening; and (3) to assess the cost-effectiveness between patient navigation programs
initiated at various time points of the cancer care continuum. The study will utilize databases developed from the CMS demonstration site at University
of Texas M.D. Anderson Cancer Center, supplemented with Medicare claims and information obtained from the literature, to evaluate the short-term
Total Cost
$317,255
$357,468
Project Number
2
Project Title
Principal Investigator
Performing
Organization
3K05CA111340-03S1
QUALITY OF CANCER CARE
EVALUATION AND
INTERVENTIONS
KATZ, STEVEN J.
UNIVERSITY OF MICHIGAN
AT ANN ARBOR
1R21CA132671-01A1
PROSTATE CANCER HEALTH
LITERACY IN RURAL VERSUS
URBAN AFRICAN-AMERICAN
MEN.
KILBRIDGE, KERRY LAING
MASSACHUSETTS
GENERAL HOSPITAL
3K01CA124581-03S1
RACIAL DISPARITIES IN THE
TREATMENT OF LUNG CANCER
IN AFRICAN AMERICANS
LATHAN, CHRISTOPHER
S
DANA-FARBER CANCER
INSTITUTE
10
Abstract
and long-term cost-effectiveness of PN versus UC. Study perspective will include that of society, payors, and health care providers that employ patient
navigators to facilitate services for their patients or the at-risk population in the surrounding neighborhood. We will employ appropriate statistical
methods of cost-effectiveness analyses using patient-level data in the short-term analysis and will develop cancer-specific Markov models to assess
the long-term cost-effectiveness. Findings from the proposed study will inform policy makers on the costs, comparative effectiveness, and costeffectiveness of PN versus UC initiated at various time points of the cancer care continuum, as well as the comparison between PN services started at
different time points. In addition, a user-friendly model will be developed for the study of the cost- effectiveness of PN; the model will be available to
other intervention sites of PN services upon request. Patient navigation is a community-centered approach that can potentially reduce health
disparities by enhancing access to care at an earlier disease stage for underserved populations. This study will develop a comprehensive and userfriendly model to compare the cost-effectiveness of patient navigation and usual care for navigation services initiated at different time points of the
cancer care continuum. We will address both short-term and long- term cost-effectiveness PN services from three different interest groups: societal as
a whole, insurance payors, and health care providers.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): My current research agenda falls into two main areas. The first area is my
focus on a population-based approach to examining the quality of care for women with breast cancer. The second area is the evaluation of online
communication and service tools to improve the quality of cancer early detection initiatives in primary care settings. My research agenda over the next
five years will extend my current work in several ways. First, I plan to expand my current SEER-based population research program to address the
quality of care for women with breast cancer. This will include: 1) additional population-based studies of determinants and outcomes of other
potentially marginalized patient populations; and 2) population-based intervention studies to improve communication, treatment processes and
outcomes for women with breast cancer. Second, I will build and evaluate novel online communication and service tools for patients and providers to
improve cancer screening processes and outcomes in primary care settings. The goals of my mentoring plan are 1) to increase the quantity and
quality of NIH investigator-initiated proposals in oncology health services research from the University of Michigan; 2) to foster interest in oncologyrelated health services research by fellows and junior investigators through my leadership on clinical training programs at the University of Michigan;
and 3) recruit new investigators to the medical school focused on health services research in oncology. In order to address the goals above I will lead
the following initiatives: 1) to obtain intramural and extramural funding to recruit and support clinician investigators and non-clinician research scientists
in oncology health services research; 2) to personally mentor these investigators towards a successful career; 3) to develop and direct educational
programs to support this area of research; and 4) to coordinate efforts in this area across professional schools at Michigan. The structure, process and
outcomes of my personal mentoring program are described in detail in the application.
DESCRIPTION (provided by applicant): Prostate cancer is the most commonly diagnosed noncutaneous cancer in United States men and the
second leading cause of cancer death. It is estimated that 186,320 men will be diagnosed with prostate cancer in 2008 and 28,660 men will die of it.
Prostate cancer disproportionately affects African American men, who have a 1.7 fold greater incidence and a 2.4 fold greater mortality than white
men. As a result, prostate cancer is an important source of health disparities. We will use the Ottawa Decision Support Framework (ODSF) from the
field of shared decision making to examine prostate cancer health literacy among African American men from two clinics caring for large underserved
populations. Values clarification and risk communication are central to the process of prostate cancer screening decisions because screening has not
been shown to decrease cancer mortality but the side effects of treatment are prevalent and long term. It is critical for physicians and patients to be
able to accurately discuss the impotence, incontinence, and bowel symptoms that often result from treatment, so patients can decide whether to be
screened for prostate cancer. In preliminary studies, we reviewed patient education materials to identify six specific domains of prostate cancer health
literacy. These domains include the skills that patients need to learn new information and the knowledge that patients are assumed to have at
baseline. In preliminary structured interviews among African American men in two low-income clinics, we showed that many patients did not have the
health literacy skills or knowledge that consumers are assumed to possess. Consequently, we hypothesize that patients are unlikely to learn enough
about prostate cancer from standard materials provided by the Centers for Disease Control (CDC) and the National Cancer Institute (NCI) to
participate in shared decision making as currently recommended by most health agencies. We have established a collaboration with the NCI's Cancer
Information Service, Howard University, and the Tug River Health Association in rural West Virginia to explore this hypothesis. Using structured
interviews, we will characterize understanding of CDC and NCI prostate cancer decision guides with a focus on numerical and graphical risk
communication among men with poor reading skills. We will link our study to other work in the field using recently developed numeracy scales to relate
mathematical skills and reading skills to how patients understand the uncertainties of the screening decision. We will use qualitative methods and
conceptual metaphor to explore ways to improve communication and shared decisions for African American men with low literacy skills. Results will be
used to revise prostate cancer education materials to be more accessible to men with low literacy skills. PUBLIC HEALTH RELEVANCE: Prostate
cancer mortality is an important source of health disparities among African American men. In preliminary studies, we have identified barriers to
prostate cancer health literacy among African American men recruited from two rural, low-income clinics. We will use qualitative methods to identify
techniques to overcome these barriers and compare any differences between rural and urban African American men.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): Lung cancer is the leading cause of cancer mortality in the United States.
African American men have the highest incidence and mortality for lung cancer in the US, and yet continue to obtain treatment at lower rates than
White patients. The causes of racial disparities in cancer care and treatment are likely multifactorial, requiring both quantitative and qualitative
research approaches. This proposal will comprise three projects that aim to shed further light on the causes of racial disparities in lung cancer: (Project
1) to identify further potential causes of racial disparities in lung cancer treatment, using large administrative databases, (Project 2) to examine the role
of race in tumor registry under-representation, and (Project 3) to obtain qualitative data investigating themes and perceptions of African-Americans
regarding lung cancer. The first and second projects involve secondary data analysis, while the third project will involve collection of qualitative data
regarding patient factors that might influence treatment choices. Project 1 proposes to use the SEER-Medicare database to further elucidate the role
Total Cost
$108,000
$222,297
$83,551
Project Number
2
Project Title
Principal Investigator
Performing
Organization
3K23CA117864-04S1
IMPROVING
PARENT/ADOLESCENT
COMMUNICATION ABOUT
TOBACCO
MAHABEE-GITTENS, E.
MELINDA MELINDA
CHILDREN'S HOSPITAL
MED CTR (CINCINNATI)
3P20CA119192-04S1
PLANNING GRANT FOR BOWIE
STATE/UNIVERSITY OF
MARYLAND CANCER RESEARCH
TRAINING AN
MISHRA, SHIRAZ I
UNIVERSITY OF
MARYLAND BALTIMORE
1RC1CA145117-01
DETERMINANTS OF
PARTICIPATION IN AN ANAL
CANCER PREVENTION TRIAL
PALEFSKY, JOEL
UNIVERSITY OF
CALIFORNIA SAN
FRANCISCO
11
Abstract
of gender, race, economics, and racial composition of the hospital in explaining the treatment gap in lung cancer for African Americans. Project 2 will
utilize the unique data in the CANCORS initiative to obtain information on tumor registry validity for African Americans. Project 3 is a focus group
project that will explore the perception of risk for lung cancer, community knowledge about the disease, fatalism, mistrust of the medical system, as
well as perception of the treatment experience of African American lung cancer patients. Racial disparities in cancer care are a pervasive and complex
problem that requires a combination of both quantitative and qualitative research methods. The completion of these study projects would further inform
the field of disparities, and provide new insights on potential causes racial disparities in lung cancer. The candidate's career plan involves courses in
qualitative data analysis, as well as courses in public policy. The education plan, in conjunction with the research projects would give the candidate the
training and tools to be a leading researcher in the disparities field.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): Inner-city children of low socioeconomic status are at high risk for initiating
tobacco use during adolescence and continuing its use throughout adulthood. The high utilization of acute-care services for non-emergent health
problems by adolescents suggests that the emergency department (ED) offers a promising and innovative setting for the prevention of tobacco use.
Furthermore, because adolescent patients seeking urgent care typically are accompanied by parents, an intervention delivered in the ED can reach
child and parent simultaneously. The rationale for coincident child/parent intervention derives from the strong association of adolescent smoking with
perceived parental leniency toward smoking. The K23 award will provide the time, resources, and mentorship for the Candidate to integrate her
research interest in tobacco prevention with her clinical experience in emergency medicine. Her long-term goal is to develop tailored interventions that
will help parents prevent tobacco initiation and use by their adolescent children. The research plan proposed for the Award period centers on the pilot
testing, revision, implementation, and evaluation of a tobacco prevention strategy entitled Improving Parent/Adolescent Communication about
Tobacco (IMPACT). The strategy was developed by the research team and is based on the Theory of Planned Behavior. The intervention consists of:
culturally appropriate verbal and written messages about tobacco use that can be conveyed by parents to their adolescent children aged 11-14 years;
a videotape that models effective parent-adolescent discussion of these messages, and; a survey instrument to test the effectiveness of the
intervention. Focused interviews, quantitative evaluation, and expert review of IMPACT will result in revision of the materials, followed by evaluation of
the effects of IMPACT using a six-month longitudinal, randomized design. The proposed research seeks to explore the effect of IMPACT on validated
measures of adolescent intention and willingness to smoke, as well as potential mediators and moderators of the effect. Hypothesized mediators
include adolescent knowledge of tobacco risk; adolescent perceptions of parental attitudes, social acceptance, and prevalence of tobacco use; and the
self-efficacy of adolescents to avoid, and parents to prevent, use. Hypothesized moderators include adolescent race/ethnicity, adolescent gender, and
parent smoking behavior. The career development plan proposed for the Award period incorporates coursework in advanced qualitative and
quantitative methods, health behavior theory, adolescent addiction, as well as field observation of existing tobacco prevention programs. By the end of
the Award period, the Candidate expects to submit an R01 grant application for a longitudinal study designed to assess the effect of IMPACT on
adolescent experimentation, initiation, and ongoing use of tobacco.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): Cancer in Maryland, and its impact on the health of minority and
underserved rural populations, is a particularly serious health care dilemma. In fact, Maryland now ranks 7th nationally in cancer incidence, and
significant disparities are seen between African American and Caucasian populations in stage of diagnosis, access to early detection, cancer
screening follow-up, treatment, and health services utilization. The unequal burden of cancer in minority and underserved communities nationally and
in Maryland's minority and underserved communities is a compelling crisis that requires intensive scientific, community outreach and translation and
application of research. Bowie State University (BSU), a Minority Serving Institution (MSI) and the University of Maryland School of Medicine
(UMSOM) and its Program In Oncology and the Marlene and Stewart Greenebaum Cancer Center propose to establish a partnership with the overall
goal of reducing and eventually eliminating cancer health disparities experienced by minority populations in Prince George's county and Baltimore
City, Maryland by increasing the number of minority scientists pursuing successful cancer research careers and developing effective cancer education
programs specifically targeting minority students and faculty, and the community. The specific aims of the BSU-UMSOM partnership are: (1) To
collaboratively develop and implement a joint minority cancer research career development training program ('Cancer Research Training Program') in
cancer health disparities research for BSU junior faculty; (2) To collaboratively enhance the science curriculum at BSU through the development,
implementation, and evaluation of a cancer health disparities education curriculum ('Undergraduate Cancer Education Program') to prepare BSU
students for mentored undergraduate cancer research training at UMSOM; and (3) To collaboratively develop, implement, and pilot test an enhanced
community-based caner outreach education program ('Community Cancer Outreach Education Program') in price George's County specifically
targeting minority, underserved communities (i.e., African Americans). The partnership's objectives blend the existing expertise at the collaborating
institutions in the form of high- quality educational programs and a rich source of talent at BSU and the state-of-the-art cancer research, investigator
training, and community outreach programs at UMSOM. This partnership is based on prior informal collaborations between members of faculty at BSU
and UMSOM. The proposed partnership between BSU and UMSOM will address both community and institutional needs to effectively address cancer
health disparities.
DESCRIPTION (provided by applicant): This application addresses broad Challenge Area (05) Comparative effectiveness research (CER) and specific
Challenge Topic, 05-CA-102* Comparative Effectiveness Research on Cancer Screening. The project, 'Determinants of participation in an anal cancer
prevention trial' is designed to provide information that will be critical to the performance of a pivotal randomized clinical trial of screening and
treatment of anal intraepithelial neoplasia (AIN) to prevent anal cancer. Anal cancer is a growing problem in the United States. Increasing by
approximately 2 percent per year among both men and women in the general population, it is particularly common among certain high-risk groups
such as HIV-positive men and women. Among HIV-positive individuals, the incidence of anal cancer has continued to increase despite the availability
of effective anti-retroviral therapy (ART). The current incidence of anal cancer among HIV-positive men who have sex with men (MSM) may be as high
as 137/100,000, or more than 10 times the current incidence of cervical cancer in the screened population of women in the U.S., and is higher than the
Total Cost
$49,926
$112,350
$499,999
Project Number
2
Project Title
Principal Investigator
Performing
Organization
1RC1CA144744-01
A WEB-BASED INTERVENTION
WITH ADOLESCENT SMOKERS
OF APPALACHIAN OHIO
REYNOLDS, BRADY A
RESEARCH INST
NATIONWIDE CHILDREN'S
HOSP
1R01CA134997-01A1
CONJOINT ANALYSIS:
OVERCOMING OBSTACLES TO
ROUTINE FORMAL PREFERENCE
ASSESSMENT I
SAIGAL, CHRISTOPHER
UNIVERSITY OF
CALIFORNIA LOS
ANGELES
12
Abstract
highest incidence of cervical cancer in unscreened populations of women world-wide. The incidence of anal cancer is almost 7-fold higher among HIVpositive women compared with the general population. Like cervical cancer, anal cancer is associated with human papillomavirus (HPV) and is
preceded by a series of precancerous changes known as anal intraepithelial neoplasia (AIN). The incidence of cervical cancer has been sharply
reduced by screening with cervical cytology to identify women with high-grade cervical intraepithelial neoplasia (CIN), which is then treated to prevent
progression to cancer. Like cervical cancer anal cancer may be preventable through treatment of the anal equivalent, high-grade AIN (HGAIN). The
combination of an unacceptably high incidence of anal cancer with the likelihood that anal cancer is preventable calls for urgent intervention. At this
time however, there are no formal guidelines recommending anal screening and treatment of HGAIN. This is because no studies have yet been done
to demonstrate that screening for and treatment of HGAIN reduced the incidence of anal cancer. The USPHS guidelines for the care of HIV-positive
individuals currently state that 'anal cytology screening of HIV-seropositive MSM and of women may be useful preventive measures. However, studies
of screening and treatment programs for AIN 2 or 3 need to be implemented before definitive recommendations for anal cytology screening can be
made'. This application will provide critical information that will support the conduct of such a study, namely determinants of participation in a
randomized clinical trial in which 50 percent of participants with HGAIN will be screened and treated, and 50 percent will be observed without
treatment. At the end of a 5-year period, the number of anal cancer cases will be compared in both arms. Given the complexities of the underlying
clinical issues that might govern willingness to participate, the increasing proportion of underrepresented minorities that comprise the HIV epidemic
and the varying issues around participation that each of these racial/ethnic groups might have, a rigorous study to measure these determinants in
geographically and racially/ethnically diverse groups that comprise the HIV epidemic in the U.S. is critical. The specific aims of this application are
therefore to: 1. To identify and assess the determinants of provider willingness to refer eligible participants; 2. To identify and assess the determinants
of patient willingness and motivation to participate in the RCT; and 3. To determine the optimum study design and sample size, and recruitment
strategies based on the analysis of data from Aims 1 and 2. This application is responsive to this challenge topic in which data from earlier
observational studies would be augmented with physician and patient acceptability data to permit the pivotal RCT to proceed. Although the results of
the RCT will set standard of care for HIV-positive men and women, they will also have wide implications beyond that of the HIV-positive population.
The results will guide screening and treatment for HIV-negative populations as well, and the study will provide a biobank of clinical specimens that will
be invaluable to understanding molecular determinants of progression from anal intraepithelial neoplasia to anal cancer. These results will also be
applicable to understanding the factors underlying progression to cervical cancer, and will be particularly important since assembly of such as biobank
of women at risk for cervical cancer would be currently impossible given that the standard of care is to treat high-grade CIN to prevent cervical cancer.
Finally, this study will have broad influence by informing strategies to enhance participation in clinical studies by underrepresented minority groups. 7.
Project Narrative (for lay audience) The incidence of anal cancer among people with HIV is higher than cervical cancer was before routine cervical
cytology screening was introduced, but unlike cervical cancer, there are currently no screening recommendations in place for anal cancer. The
proposed focus group/survey study will be essential to planning a large definitive randomized controlled trial (RCT) in HIV-positive men and women to
test whether treatment of anal cancer precursors identified through anal cytology screening can prevent anal cancer. The RCT planned with the
assistance of this proposed study will set the standard of care for HIV- positive men and women, but will also have wide implications for screening and
treatment for HIV- negative populations, as well as understanding the factors underlying progression to cervical and anal cancer.
DESCRIPTION (provided by applicant): Adolescence may represent a uniquely challenging but important life period for smoking-cessation efforts.
Many of the challenges in working with adolescent smokers are compounded for adolescents living in rural Appalachian regions of the country.
Consistent with this notion are findings that smoking rates for adults and adolescents are considerably higher in Appalachia than national averages.
Also, adolescents in Appalachia appear to start smoking at younger ages, which has been associated with greater difficulties quitting smoking later in
life. In response to the need for treatments appropriate for adolescent smokers in rural Appalachia, this research (utilizing a two-group randomizedcontrol design, n = 35 per group) will evaluate the effectiveness and efficacy of a new and innovative Web-based contingency management (CM)
program for smoking abstinence with adolescent smokers living in Appalachian Ohio. Because this CM program is Web-based it can be completed
from home, which stands to be more viable as a treatment option for rural adolescent smokers than other treatments requiring frequent trips to a
clinical facility. From preliminary work with adult and adolescent smokers, it is expected this program will be highly effective in promoting smoking
abstinence among adolescent smokers in Appalachian Ohio. This research also will involve six weekly post-treatment follow-up sessions to determine
consistencies or changes in smoking behavior following treatment. A secondary goal of this research is to explore pre-treatment assessments of
different dimensions of impulsive behavior as predictors of treatment outcome. We will complete this aspect of the research using a Mobile Behavioral
Research Lab. These behavioral assessments will provide highly detailed information about the specific behavioral styles of adolescent smokers who
are unable to effectively change their smoking behavior during treatment. This information should provide new points of emphasis for program
modifications to improve these programs to be more effective for Appalachian adolescents most challenged in their efforts to quit or reduce smoking.
Cigarette smoking is the top preventable cause of death in the United States, and rates of smoking for adults and adolescents are consistently higher
in Appalachian regions than national averages. This study will evaluate a novel behavioral treatment for cigarette smoking cessation with Appalachian
adolescent smokers. Further, this study will advance our understanding of the different behavioral styles associated with these adolescents' ability to
quit or reduce smoking during a treatment program for smoking cessation. This latter aim is expected to guide smoking treatment modifications to
make these treatments more effective for adolescents who are trying to quit or reduce smoking.
DESCRIPTION (provided by applicant): A man with localized prostate cancer faces a bewildering constellation of treatment options. Most of these
options provide similar chances of survival, so the optimal choice for any particular individual is crucially dependant on the strength of his preferences
for various clinical and non-clinical treatment characteristics. Helping these men identify their optimal treatment choice will reduce the burden of this
illness on these men, part of the mission of the NIH. In research, measuring the strength of these preferences has traditionally been approached with
several methods of 'utility assessment.' Unfortunately, each of these existing methods has significant limitations, ranging from basic concerns about
validity to practical concerns regarding the cognitive burden placed on patients, which have presented barriers to their clinical use. Investigators in
Marketing have also faced the challenge of characterizing individual preferences, albeit for goods and services, when designing new consumer
Total Cost
$373,978
$319,550
Project Number
2
Project Title
Principal Investigator
Performing
Organization
3U10CA031946-28S1
CANCER AND LEUKEMIA GROUP
B
SCHILSKY, RICHARD L
UNIVERSITY OF CHICAGO
3U01CA114591-05S3
WINCART: WEAVING AN
ISLANDER NETWORK FOR
CANCER CONTROL
TANJASIRI, SORA P
CALIFORNIA STATE
UNIVERSITY FULLERTON
3U01CA114591-05S1
WINCART: WEAVING AN
ISLANDER NETWORK FOR
CANCER CONTROL
TANJASIRI, SORA P
CALIFORNIA STATE
UNIVERSITY FULLERTON
13
Abstract
products. In Marketing, 'conjoint analysis' has emerged as a powerful methodology with which to characterize consumer preferences and to predict
consumer purchasing behavior. Given its simplicity and predictive validity, this method may be a solution to limitations of existing preference
assessment methods. We believe that conjoint analysis has potential to improve decisions in clinical settings. Our primary hypotheses are twofold.
First, we hypothesize that conjoint analysis-based preference assessment and educational support will improve decision quality in men with prostate
cancer as compared to educational support alone. Second, we hypothesize that conjoint analysis has superior construct validity in measuring the
preferences of men with prostate cancer compared to traditional methods of preference assessment, specifically time trade-off and rating scale
methods. To test these hypotheses, we will undertake two randomized controlled studies. This will be done by first recruiting men who have been
treated for prostate cancer and identifying treatment attributes of importance to them. Based on these data, we will use established software platforms
to develop preference assessment applications for conjoint analysis-based and traditional assessment methods, to be used in the randomized trials.
One randomized trial using the conjoint analysis application will examine metrics of decision quality in men who undergo conjoint analysis, along with
an educational intervention, compared with decision quality in men who undergo the educational intervention only. The second will compare criterion
validity of these applications using metrics published in the literature This work is guided by the promise of eventually deploying point-of-care decision
aids to improve the quality of decision making for men with prostate cancer. Public Health Relevance: This research aims to improve our ability to
individualize prostate cancer care and improve decision quality for men with this disease. We will test whether a method taken from consumer
marketing research can more accurately identify individual patients' values better than existing methods used in healthcare research. We will test
whether use of this method improves the quality of the treatment decisions that are made by patients.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (Provided by applicant): The CALGB is comprised of 26 academic medical centers and over 200
affiliated community hospitals joined in the pursuit of improved cancer treatment and better understanding of tumor biology and cancer treatment
outcomes via the conduct of controlled clinical trials. Over 4,000 members of the Group including oncology physicians, radiologists, pathologists,
statisticians, clinical research associates, oncology nurses, pharmacists, health outcomes researchers, and basic scientists participate in these
studies. From 25-30 phase III protocols are active at any one time, along with phase II and phase I studies that provide preliminary data required for
the appropriate design of large scale randomized trials. Multidisciplinary disease committees of the Group design and implement protocols for the
treatment of patients with leukemia, lymphoma, breast, respiratory, Gl and GU cancer. Modality committees, including Leukemia Correlative Sciences,
Imaging, Pharmacology and Experimental Therapeutics, Surgery, Transplant, Cancer in the Elderly, Cancer Control and Health Outcomes, and
Oncology Nursing provide expertise that enhances the contribution of these disciplines to CALGB studies. Scientific resources committees, including
Clinical Research Associates, Pathology and Radiation Oncology, provide essential quality assurance and training activities for the Group. Major
areas of emphasis in CALGB include development of innovative treatments for patients with cancer; studies of molecular predictors of prognosis and
response to therapy; studies of the pharmacokinetics, pharmacodynamics and pharmacogenetics of new and established anticancer drugs; evaluation
of minimally invasive surgical techniques and novel imaging technologies; determining the cost and cost-effectiveness of new cancer therapies;
evaluating the impact of cancer and its treatment on the quality of life of cancer patients and their caregivers; developing new strategies for cancer
prevention; and addressing the needs of special populations, particularly minorities and the elderly. A new core facility in cancer imaging was
established to provide central review and archiving of PET and CT images and to set standards for image acquisition and transmission at CALGB
institutions. Three new molecular reference laboratories are proposed in this application to provide biomarker assessments that are necessary to
determine patient eligibility or treatment assignment in CALGB studies of targeted therapies. Three established biorepositories collect, archive and
distribute frozen and paraffin-embedded solid tumor tissues, leukemia cells, plasma, serum, urine and DNA for correlative science studies.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): The California State University, Fullerton proposes to spearhead a
university-community consortium to undertake community-based participatory research processes for development of a sustainable network to reduce
preventable cancer incidence and mortality among five Pacific Islander (PI) communities (Chamorros, Marshallese, Native Hawaiians, Samoans and
Tongans) in Southern California. The specific aims of this project, Weaving an Islander Network for Cancer Awareness, Research and Training
(WINCART), are to: 1) identify individual, community, and health service barriers to cancer control among PIs; 2) improve access to and utilization of
existing cancer prevention and control services; 3) facilitate the development, implementation, and evaluation of community-based participatory
research studies; 4) create opportunities to increase the number of well-trained PI researchers through training, mentorship and participatory research
projects; 5) sustain community-based education, training and research activities by increasing partnerships with governmental and community
agencies, funders, and policymakers; and 6) disseminate research findings to aid in the reduction of cancer health disparities for PIs. WINCART will
convene two steering committees (one each for community and research) to coordinate the network activities. Project methods include implementation
and evaluation of community awareness activities in each PI population (working with CIS to develop culturally and linguistically appropriate
materials), conducting cancer prevention and control research (with a focus on obesity, tobacco, cancer screening, survivorship, and enhanced
recruitment of PIs into clinical trials), and recruitment/training/mentorship of PI researchers for the development of pilot other NIH research awards.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): The California State University, Fullerton proposes to spearhead a
university-community consortium to undertake community-based participatory research processes for development of a sustainable network to reduce
preventable cancer incidence and mortality among five Pacific Islander (PI) communities (Chamorros, Marshallese, Native Hawaiians, Samoans and
Tongans) in Southern California. The specific aims of this project, Weaving an Islander Network for Cancer Awareness, Research and Training
(WINCART), are to: 1) identify individual, community, and health service barriers to cancer control among PIs; 2) improve access to and utilization of
existing cancer prevention and control services; 3) facilitate the development, implementation, and evaluation of community-based participatory
research studies; 4) create opportunities to increase the number of well-trained PI researchers through training, mentorship and participatory research
projects; 5) sustain community-based education, training and research activities by increasing partnerships with governmental and community
Total Cost
$800,000
$210,448
$44,135
Project Number
2
Project Title
Principal Investigator
Performing
Organization
1R21CA139018-01
COMMUNICATION PATTERNS IN
CANCER SCREENING
NAVIGATION WITH AFRICAN
AMERICANS
THOMPSON, HAYLEY
SUZETTE
YESHIVA UNIVERSITY
3U10CA086780-10S1
NEW MEXICO MINORITY-BASED
COMMUNITY CLINICAL
ONCOLOGY PROGRAM
VERSCHRAEGEN, CLAIRE
F
UNIVERSITY OF NEW
MEXICO
3R01CA124402-03S1
IMPLEMENTING SYSTEMIC
INTERVENTIONS TO CLOSE THE
DISCOVERY-DELIVERY GAP
WEINER, BRYAN J
UNIVERSITY OF NORTH
CAROLINA CHAPEL HILL
14
Abstract
agencies, funders, and policymakers; and 6) disseminate research findings to aid in the reduction of cancer health disparities for PIs. WINCART will
convene two steering committees (one each for community and research) to coordinate the network activities. Project methods include implementation
and evaluation of community awareness activities in each PI population (working with CIS to develop culturally and linguistically appropriate
materials), conducting cancer prevention and control research (with a focus on obesity, tobacco, cancer screening, survivorship, and enhanced
recruitment of PIs into clinical trials), and recruitment/training/mentorship of PI researchers for the development of pilot other NIH research awards.
DESCRIPTION (provided by applicant): Patient navigation (PN) is a widely used intervention approach in initiatives to reduce cancer health disparities
and facilitate access to care, particularly in African American (AA) populations. However, the results of PN vary and little is known about the elements
that make PN effective. Furthermore, resources for navigator training are limited and unstandardized. Such knowledge is critically important as PN is a
widely accepted and used clinical tool and the patient navigator workforce is expected to undergo tremendous growth as a result of the Patient
Navigator Outreach and Chronic Disease Prevention Act, recently passed legislation. One compelling area for investigation is the quality of
communication within navigation encounters. Effective communication is essential to a navigator's efforts to identify the full range of barriers to
healthcare a patient faces and to develop feasible strategies to overcome these barriers. Guided by Communication Accommodation Theory, the
proposed research will focus on patient-centered and empathic communication with the goal of identifying concrete verbal behaviors associated with
effective PN. The goal of the proposed research will be achieved through collaboration with a funded R01 parent study that is investigating the impact
of PN on adherence to colonoscopy referral among AA primary care patients (R01- CA120658). The parent study includes a randomized clinical trial
comparing two telephone-based navigation arms: 1) patient navigation conducted by a peer-lay navigator who is matched to the patient's age and has
had a recent screening colonoscopy and 2) navigation conducted by a degreed health professional. The proposed R21 study will randomly select 220
audiotapes of these navigation encounters stratified on two variables: patients' actual adherence to colonoscopy referral (yes vs. no) and type of
navigator (peer vs. professional). The audiotapes will then be analyzed using two complementary coding schemes: the Roter Interaction Analysis
System and the Empathic Communication Coding System. The specific aims of this proposed research are 1) to examine the effect of patientcentered and empathic communication within patient navigation encounters on adherence to colonoscopy referral among AA primary care patients,
and 2) to investigate differences between peer and professional navigators in terms of their patient-centered and empathic communication exchanges
with AA primary care patients referred for colonoscopy. Results will yield data on key communication strategies that can be translated into
disseminable and evidence-based training modules to enhance existing navigator training curricula. Such training can increase the effectiveness of
new navigators who may have limited experience interacting with AA patients in the context of a cancer screening intervention, as well as those who
are continuing in the relatively new and rapidly growing and evolving area of PN. Although the focus of the proposed research is PN, results are likely
to be generalizable beyond PN and should provide insight for health education and promotion in general. PUBLIC HEALTH RELEVANCE: The
proposed research titled 'Communication Patterns in Cancer Screening Navigation with African Americans' is relevant to public health because it
focuses on key communication behaviors in the context of a widely applied intervention approach: patient navigation. The proposed research will
identify specific communication behaviors associated with adherence to colonoscopy referral among African American primary care patients and will
support future efforts to both increase colonoscopy and reduce colorectal cancer burden in this population. These data can then be translated into
training curricula for patient navigators that directly supports 1) the Patient Navigator Outreach and Chronic Disease Prevention Act of 2005 which
mandates and funds the recruitment and training of patient navigators in order to reduce cancer health disparities, and 2) the strategic objectives
stated within the National Cancer Institute Strategic Plan related to the development of a cadre of healthcare workers, including researchers and
clinicians, prepared to effectively address cancer health disparities.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. Description (provided by applicant): With the highest proportion of Hispanics and American Indians of any State
(42% Hispanic, and 10% American Indian), New Mexico's 1.9 million people have tremendous cancer health disparities. Ranking only 47th in per
capita income, New Mexico's population is relatively young, poor (27%), and uninsured (22%). Nearly 50% live in rural areas with limited access to
healthcare. Tracked by The New Mexico Tumor Registry, a founding member of the NCI SEER Program, New Mexico's multiethnic populations has
strikingly different patterns of cancer incidence and mortality. While Northern NM Hispanics are derived primarily from early Spanish land grant
families, Southern NM Hispanics are more frequently of Mexican descent. The Tribal communities of New Mexico are particularly diverse, with 19
Pueblos, the Navajo Nation and three Navajo Bands, and the Jicarilla and Mescalero Apaches. In this rich context, the goals of The New Mexico
Minority-Based Community Clinical Oncology Program (NM MBCCOP) are to build community capacity for clinical research through cancer education
and outreach programs, and, to overcome significant socioeconomic and cultural barriers to increase access and accrual to NCI-sponsored cancer
treatment and prevention clinical trials. Funded since 2000 (U10CA86780), the NM MBCCOP has worked diligently to build a build a collaborative
statewide community clinical trials network (The New Mexico Cancer Care Alliance (NMCCA)) through cooperating legal agreements with shared
governance, a single IRB, and integrated operations. The 102 physician participants (61 types A and 41 type B) cover the entire State. The primary
regulatory and data management functions of the NM MBCCOP and the NMCCA are located at The University of New Mexico Cancer Center
(UNMCC) with 8 other component and 2 affiliate community sites. The NMCCA is primarily responsible for implementing and managing the NM
MBCCOP in community settings. In the past funding period, the NM MBCCOP surpassed its accrual goals, averaging 85.7 annual therapeutic and
65.34 annual prevention/control accrual credits. Therapeutic trial accruals have increased 25%. In the last funding period, 521 patients were accrued
to NM MBCCOP trials, 319 (61.2%) of whom were ethnic minorities (180 Hispanic, 36 American Indian, and 103 mixed race, other minority, or
undeclared). The NM MBCCOP is now poised to significantly increase overall accrual and to improve its prevention and cancer control clinical trial
menu in order to increase accrual to prevention and control trials. In summary, the NM MBCCOP has a strong, well functioning statewide
infrastructure, a successful accrual record, and a strategic plan for future growth.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): The NIH and other federal agencies see provider-based research networks
(PBRNs) as a promising model for disseminating and implementing evidence-based clinical services in community-based practice settings. PBRNs
Total Cost
$258,085
$317,201
$261,811
Project Number
2
3K07CA136995-02S1
Project Title
CLINICAL AND SOCIAL
IMPLICATIONS OF COST
SHARING FOR CANCER DRUGS
Principal Investigator
Performing
Organization
WONG, YU-NING
FOX CHASE CANCER
CENTER
Abstract
are collaborative partnerships between community-based providers and academic institutions to conduct clinical research on an ongoing basis. As an
indicator of its commitment to PBRNs, the NIH is investigating the feasibility of training 50,000 community-based health-care practitioners to
participate in clinical research and integrate new research findings into routine health care delivery. Yet, reports indicate that PBRNs are challenging to
implement and sustain. Further, the extent to which PBRNs actually promote the use of evidence-based clinical services in community-based practice
settings remains largely unknown. This project will examine the implementation, impact, sustainability, and business case of the NCI's Community
Clinical Oncology Program (CCOP), a federally funded national PBRN that the NIH sees as a model for PBRNs in other disease areas. Specifically,
the project will (1) investigate the implementation of the CCOP in community-based practice settings through in-depth case studies of three newly
funded CCOP organizations and a survey of all 50 CCOP organizations; (2) examine the impact of the CCOP on clinical practice through longitudinal
analysis of adoption rates of evidence-based cancer therapies by CCOP- affiliated and non-CCOP-affiliated providers using SEER-Medicare data; (3)
assess the factors affecting sustainability of the CCOP in community-based practice settings through a longitudinal analysis of all CCOP organizations
active from 1991 through 2003; and (4) investigate the business case for CCOP participation by providers through analysis of financial and statistical
data and in-depth case studies. The project will provide the NIH with much-needed information about what it takes to implement and sustain PBRNs
and what it can expect from PBRNs as a model for disseminating and implementing evidence-based clinical services in community-based practice
settings.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): Dr. Yu-Ning Wong, a Medical Oncologist at Fox Chase Cancer Center is
dedicated to a career in cancer health services research. Her goal is to develop a multidisciplinary research program to understand the impact of
insurance design on cancer drug utilization and clinical outcomes. This Career Development Award will provide the means to take two important steps
towards accomplishing this goal. First, it will allow for additional intensive mentored education and training in public policy research, health economics,
and advanced statistical methods that will augment the candidate's previous rigorous training in epidemiology, biostatistics, and clinical medicine.
Second, it will support the development of an original clinical research program using rigorous epidemiologic, econometric and survey methods to
examine the impact of prescription drug insurance coverage on cancer outcomes. As new costly cancer drugs are introduced, patients with both public
and private insurance are facing higher out- of-pocket costs. Cost sharing between insurers and patients (though co-payments and deductibles) has
been traditionally used to control costs based on an expectation that unnecessary health care utilization will be reduced. However this expectation
may result in worse socioeconomic disparities in care since some patients may be unable to afford highly effective cancer treatments. The candidate
proposes three complementary studies to address the important, unanswered questions about the impact of cost sharing on cancer outcomes. Project
A is a conjoint analysis-based survey to measure how patients make decisions among treatments of varying efficacy, toxicity and cost. Project B uses
the results from Project A in a decision analysis model to measure the sensitivity of clinical outcomes to price and patient preferences. This will also
allow us to determine if is possible to improve clinical outcomes by using low cost sharing to increase adherence to high value treatments. Project C is
a natural experiment using insurance claims to measure the effect of insurance design and sociodemographic factors on the receipt of a new,
expensive anti-nausea medication and subsequent outcomes. This research program will triangulate on the nexus of issues central to the
understanding of cost sharing on cancer drug utilization and clinical outcomes and form the foundation for the candidate's transition to an independent
investigator in cancer health services research. This project will have broad implications for the financing of high cost medical interventions because it
will help policy makers, insurers and physicians understand how current models of cost sharing may contribute to socioeconomic disparities in cancer
care. Our results may suggest consideration of a novel benefit design that encourages patients to make decisions based on relative value, rather than
cost alone.
Total Cost
$108,000
National Center for Research Resources (NCRR)
3UL1RR024128-04S2
DUKE CTSI
CALIFF, ROBERT M
DUKE UNIVERSITY
3UL1RR024128-04S3
DUKE CTSI
CALIFF, ROBERT M
DUKE UNIVERSITY
3UL1RR024128-04S4
DUKE CTSI
CALIFF, ROBERT M
DUKE UNIVERSITY
1RC1RR028329-01
A MEDICAL HOME PILOT
EVALUATION: A MODEL FOR
COMPARATIVE EFFECTIVENESS
RESEARCH
DUNN, KIM DUNN
UNIVERSITY OF TEXAS
HLTH SCI CTR HOUSTON
15
Robert Califf of Medicine-Cardiology has received an award from the National Institutes of Health which is for a project entitled, "Duke CTSI
Supplement - Translational." Total funding will be $998,996 for 2 years.
Robert Califf of Medicine-Cardiology has received an award from the National Institutes of Health which is for a project entitled, "Duke CTSI
Supplement - Community Engagement." Total funding will be $598,935 for 2 years.
Robert Califf of Medicine-Cardiology has received an award from the National Institutes of Health which is for a project entitled, "CTSI Supplement Research Workforce Development and Dissemination." Total funding will be $599,581 for 2 years.
Description (provided by applicant): Pilot/demonstration projects using collaborations between academic health centers and community-based
organizations or community-based research networks that bring CER into community settings. To embed comparative effectiveness research (CER)
into community practice, we must consider the current US healthcare system which is in crisis, particularly primary care. Even for those with insurance,
the system is fragmented, increasingly costly, difficult to access and navigate, duplicates services, does not connect patients, primary care physicians,
and specialists, nor assures treatment and prevention guidelines are followed for a given patient. People expect their primary care physician to be their
point of access to healthcare and to assure that the care they receive within the system is evidence-based, cost-effective, coordinated, and safe.
Unfortunately, primary care providers do not have the systems in place and are not paid to coordinate care. This results in emergency rooms, the most
costly sites for care, being a major site for primary care problems for both uninsured and insured patients and a portal of access for indigent specialty
care. There has not been a business model to support the necessary services and technology-supported processes to assure a patient has an
accountable healthcare delivery system. To address these issues, we propose to pilot a Medical Home intervention in a community-based setting. The
Medical Home model is seen as a key component for reforming care by all major clinical and payer organizations, although to date, there has been
little rigorous evaluation of the medical home model. The Medical Home model is based on an electronic data infrastructure that we have built that
allows physicians to coordinate care, evaluate the quality of the care provided, and participate in quality improvement initiatives. In addition, this data
infrastructure provides the opportunity for community based comparative effectiveness research to be carried out and to have an impact. The Medical
Home intervention we propose, the Your Doctor Program Medical Home System (YDP-MHS), overcomes three key barriers to the implementation of
$998,996
$598,935
$599,581
$475,086
Project Number
1RC1RR028876-01
16
2
Project Title
RESEARCH AND TREATMENT IN
COMPARATIVE EFFECTIVENESS,
QI AND IND RESEARCH
Principal Investigator
FADEN, RUTH R ;KASS,
NANCY E;
Performing
Organization
JOHNS HOPKINS
UNIVERSITY
Abstract
an integrated continuity of care model providing high quality care. The first is a health information system infrastructure for collecting information
across the silos of care (primary care physician, specialist, hospital, laboratory, pharmacy, et cet.). The National Commission on Quality Assurance
(NCQA) has standards for the Medical Home but does not provide a health information system infrastructure that supports its rapid, large scale
implementation. We have developed an approach for a Health Information Exchange that collects information across the silos of care as part of the
YDP-MHS. This data bases infrastructure also forms the basis for community based comparative effectiveness research. The second is the barriers to
physician collecting quality of care data and adopting guidelines for quality improvement. Physicians often feel quality outcomes comparisons are
inaccurate because they rely on billing data and do not adequately adjust for risk. The YDP-MHS supports the implementation of the NCQA standards
in a physician's practice and engages physicians in collecting quality of care data and in outcomes improvement initiatives. The third barrier is
payment models for physicians to coordinate care and collect quality of care data. Private and public insurance payers have agreed to pay private and
safety net physicians' incentives for participation in the YDP-MHS. This demonstration pilot offers the opportunity for embedding a comparative
effectiveness research infrastructure into a community setting. Technical proof of concept in up to fifty primary care practices Aim 1: Assess Your
Doctor Program Medical Home System (YDP-MHS) impact on avoidable emergency center visits for primary care problems for safety net and private
patients. Aim 2: Assess the YDP-MHS impact on the patient's experience of the health care system using the Consumer Assessment of Physicians
and Healthcare Survey. Aim 3: Develop and field test with physicians the metrics to compare the effectiveness of physician treatment patterns on
clinical indicators while incorporating measures for patient adherence and risk adjustment factors. Cost-effectiveness analysis of YDP-MHS Aim 1:
Develop and test a cost-effectiveness model of the YDP-MHS intervention by comparing the costs of care and outcomes before and after the
intervention. Diffusion of YDP-MHS Aim 1: Based on lessons learned with the YDP-MHS community model, develop an expansion plan. PUBLIC
HEALTH RELEVANCE: Our aims are to evaluate a rapid implementation of a medical home model on costs, patient acceptance, doctor acceptance,
and impact on quality of care indicators. The model is supported by an open source technology stack that is highly scalable. The short implementation
timeframe for physician adoption and the financial incentives for data management to assure quality are of a sufficient nature to gain widespread
acceptance by primary care physicians. We believe that the approach with the medical home / health information exchange strategy will accomplish
four things that will impact public health: First, we plan to overcome resistance in building health information exchanges / community clinical data
warehouses to share data among competing groups. However, because of HIPAA, patients have a right to have access to their health information.
Given that within our model, they have designated their medical home physician as the co-manager of their personal record, the YDP-MHS
organization 'deposits' the data into the patient's Quality Health Record that combines the Personal Health Record and the Health Information
Exchange, thus increasing the completeness of patient data available for analysis. Second, outcomes data and encounter data is not routinely
collected or analyzed on all patient encounters with the healthcare system. We will be gaining experience on how to define processes to assure its
collection on all major encounters, including the ability to risk adjust it for analysis. Third, we believe the financial models that will emerge with these
payers will be important for defining broader payer adoption for expanding the medical home model. Fourth, we will have a data set to compare safety
net and private patients, treatments, and effectiveness to be used for comparative effectiveness research in community settings
Description (provided by applicant): Research Area: Challenge Area: Bioethics Challenge Topic: 02-OD (OSP)-105* More than two million Americans
with cancer, heart disease, infectious diseases, diabetes, neurological disorders and other conditions are enrolled in clinical research in the United
States each year. For many of these patient-subjects, participation is viewed, by them and by their physicians, as a means of treating or responding to
their medical condition. Moreover, the infusion of billions of dollars into comparative effectiveness research and quality improvement research over the
coming years ensures that soon many more patients will be receiving care that, in one way or another, is integrated with clinical and health services
systems research. Indeed, there is growing recognition that high value health care will be achievable only if the outcomes of medical interventions and
practices are continuously under study. As such, research methods and funding are rapidly changing to respond to this practical need. . The challenge
with this shifting environment is to adapt traditional paradigms for the ethics of research to this new paradigm for a research and treatment interface,
where research and treatment are increasingly, yet to varying degrees, integrated in what some have called the total learning environment. This
project is intended to begin to fill the knowledge and policy gap in research ethics created by the increasing integration of research with treatment.
Useful policy guidance is critically needed that is responsive to the integrated nature of research and treatment across research approaches, including
the three research areas on which this project will focus: ' Traditional clinical trials of unapproved drugs/devices; ' Comparative Effectiveness research;
' Quality Improvement research. Without such guidance, much needed research may be inappropriately impeded by oversight norms ill suited to this
evolving context. Thus, we expect this work to be a significant down payment on much needed rethinking of the how best to craft human research
protections for the broadening federal research program and the health system of the future in which research and treatment are increasingly
intertwined. This project will accomplish its work through ongoing, collaborative meetings of a core group of six experts in research ethics, clinical
trials, comparative effectiveness, quality improvement, and/or public policy. Through sub-group and core group interactions, the development of rich
case studies, and empirical data collection, this project will produce a conceptual analysis that considers a research-treatment interface rather than
exclusively a separation, and will produce policy guidance and safeguards relevant to our evolving research agenda. The aims of this project include:
Aim 1: Produce a clear, conceptual analysis that defines and characterizes the constitutive elements of 'research' and 'treatment' through the
development of rich case studies of specific examples of (a) clinical trials of unapproved drugs and devices (CTUn); (b) comparative effectiveness
(CE) research; and (c) quality improvement (QI) research, against which the conceptual analysis can be tested and refined; Aim 2: Examine the
implications of this conceptual analysis for the moral and policy purposes to which the research-treatment distinction has been and continues to be
put, with particular focus on rich case studies developed from CTUn, CE, and QI research; Aim 3: Conduct empirical research with investigators who
conduct CTUn, CE, and QI research to (a) list a range of designs and examples within their area and discuss how constitutive elements of research
and treatment apply; and (b) later, with additional inclusion of federal officials, to elicit reactions to draft conceptual and moral analyses and policy
recommendations for feasibility and applicability; Aim 4: Based on our conceptual, moral, and empirical findings, develop policy guidance and
safeguards for research participants in CTUn, CE, and QI research specific to investigators, to informed consent, and to research oversight. This
project examines the research-treatment interface in the context of traditional clinical trials, comparative effectiveness research, and quality
Total Cost
$489,396
Project Number
2
Project Title
Principal Investigator
Performing
Organization
Abstract
Total Cost
improvement research. Through the regular interaction of a small, collaborative expert working group, development of rich case studies, and empirical
data collection, we will draft an original conceptual framework for the research-treatment interface as well as policy recommendations for research
oversight and informed consent.
National Center for Minority Health and Health Disparities (NCMHD)
1RC1MD004588-01
REDUCING ETHNIC AND RACIAL
BIAS IN SCREENING FOR
PSYCHIATRIC DISORDERS IN
ADOLESC
ALEGRIA, MARGARITA
CAMBRIDGE HEALTH
ALLIANCE
1RC1MD004418-01
IDENTIFYING STRATEGIES TO
INCREASE ENGAGEMENT IN
CLINICAL TRIALS IN PEDIATRIC
SCD
BARAKAT, LAMIA P
CHILDREN'S HOSPITAL OF
PHILADELPHIA
17
Description (provided by applicant): The proposal, entitled 'Reducing Ethnic and Racial Bias in Screening for Psychiatric Disorders in Adolescents' is
designed to improve the effectiveness of identification, referral and screening for mental health disorders potentially associated with ethnic/racial
disparities in adolescents' receipt of mental health care. For racial and ethnic minority youth, there is a great disparity in the receipt of mental health
services and, as a result, these youth are more likely to experience persistent impairment from psychiatric disorders. Preliminary data on referrals for
mental health treatment appear to indicate that minority children are under-identified for services by their schools and families, the two major referral
sources. The research to be generated can help us achieve needed enhancement in school screening, a previously under-funded area of health
services research in general, and comparative effectiveness research more specifically. This project provides the opportunity to support the analysis
and dissemination of data from the National Comorbidity Survey Adolescent Supplement (NCS-A), the most comprehensive national data available to
study screening and referral patterns for ethnic/racial minority children. We propose four specific aims that allow us to examine a broad range of
possible causes for under- recognition and lack of treatment for ethic and racial minority youth as well as alternative methods for enhancing screening
tools used to assess them. Aim 1 intends to determine whether schools are equally likely to encourage parents of ethnic/racial minority youth who
have psychiatric disorders to seek services for their child as they are to encourage non-Latino white parents, and whether school, community, and
family characteristics explain any disparities in referral. Aim 2 then tries to identify ethnic/racial differences in parents' assessment of youth with
psychiatric disorders associated with ethnic/racial disparities in service access. Aim 3 plans to evaluate meaning and response bias in the screening
questions used to assess major depression and generalized anxiety disorders in non-Latino white and racial/ethnic minority adolescents. Finally in Aim
4, we compare the accuracy of predictions of mood and anxiety disorders using screening scales specific to blacks, to Latinos or to whites, with
universalistic screening scales, in order to help improve detection for ethnic and racial minorities, and to determine if the scales should be groupspecific or universal. Study results will be distilled to provide basic information about biases in the identification, referral and screening process by
schools, and factors that influence whether parents identify 'mental health problems' and follow-up on service referrals. Findings will be disseminated
through a website for teachers and school mental health service providers, via newsletters of professional organizations, and by submission to annual
conventions of school- based practitioners, thus bringing critical information to those most poised to affect change. The proposed research is designed
to improve the effectiveness of identification, referral and screening for mental health disorders potentially associated with ethnic/racial disparities in
adolescent receipt of mental health care. Using data from the National Comorbidity Survey Adolescent Supplement (NCS-A), the most comprehensive
national data available to study screening and referral patterns for ethnic/racial minority children, we propose four specific aims that allow us to
examine a broad range of possible causes for under- recognition and lack of treatment for ethic and racial minority youth as well as alternative
methods for enhancing screening tools used to assess them. The project intends to distill and disseminate research results to those most poised to
affect change, including creating a list of basic information about biases in the identification, referral and screening process by schools, and factors
that influence whether parents identify 'mental health problems' and follow-up on referrals for services, thus working towards the goal of diminishing
the impact of early onset disorders and preventing the development of comorbid and more serious mental health problems.
Description (provided by applicant): This application responds to broad challenge grant area (04): Clinical Research and specific Challenge Topic, 04MD-101: Enhancing Recruitment and Retention of Ethnic Minorities in Clinical Trials. Sickle cell disease (SCD) is a genetic disorder affecting primarily
African-Americans in the United States. Since the 1970s, efforts have been made to develop efficacious treatments for SCD; however, low overall
enrollment and poor retention has slowed progress towards identification of efficacious medical and psychosocial treatments. We aim, in Phase 1, to
delineate factors associated with engagement in clinical trials for pediatric patients with SCD and their caregivers using questionnaires (n = 50) and
follow-up interviews (n = 10-15) from 4 groups: (1) pediatric patients with SCD (ages 6-18 years) and their caregivers treated at the Marian Anderson
Sickle Cell Center of St. Christopher's Hospital for Children; (2) pediatric patients with SCD (ages 6-18 years) and their caregivers treated in the
community; (3) pediatric patients with asthma (ages 6-18 years) and their caregivers treated at St. Christopher's Hospital for Children; and (4) young
adults with SCD (ages 18-39 years) and their caregivers. Based on Phase 1 findings, we will develop a structured recruitment and retention protocol
implemented through patient navigation. The protocol will include screening for perceived barriers and benefits to participation and provide targeted
strategies to decrease barriers and increase acceptability. In Phase 2, we will test the feasibility and effectiveness of the protocol with patient
navigation (a health care professional from the SCD community) to increase recruitment and retention rates and socioeconomic diversity of
participants with SCD and their caregivers in a current NHLBI-funded psychosocial clinical trial. Through collaboration among The Children's Hospital
of Philadelphia (CHOP), the Marian Anderson Sickle Cell Center, and community organizations, we will develop community-generated, empiricallybased strategies to support engagement in clinical trials for pediatric patients with SCD and their caregivers and increase the likelihood that current
and future clinical trials will meet their aims in identifying efficacious treatments. CHOP contributes substantially to the local economy. In 2008,
CHOP's operations created and supported over 16,882 jobs in the region, total economic impact was over $2.01 billion, and CHOP received more total
research support than any other children's hospital in the United States. St. Christopher's Hospital for Children is a major pediatric center including a
150-bed in-patient facility, a teaching and education center and research laboratories (through its affiliation with Drexel University College of
Medicine), which serves as a regional referral hospital for children from around Philadelphia and the Delaware Valley. This proposal will create 3
positions for ethnic minority health care professionals (Research Coordinator; Research Assistant, Patient Navigator), bolster 3 community agencies
that advocate for ethnic minority patients, families, and health care providers, and provide support for 7 additional positions. The proposed study seeks
to: (1) delineate factors associated with engagement in clinical trials for pediatric patients with sickle cell disease (SCD) and their caregivers and (2)
develop and pilot test a structured recruitment and retention protocol implemented through patient navigation. Low overall enrollment and poor
retention has slowed progress towards identification of efficacious medical and psychosocial treatments for SCD, a genetic disorder affecting primarily
African-Americans in the United States. Use of community-generated, empirically-based strategies to support engagement in clinical trials for pediatric
$499,950
$388,364
Project Number
2
Project Title
Principal Investigator
Performing
Organization
1R24MD005095-01
NUESTRO FUTORO SALUDABLE:
THE JP PARTNERSHIP FOR
HEALTHY CARIBBEAN LATINO
YOUTH
BRUGGE, DOUGLAS
M;SPRAGUE MARTINEZ,
LINDA SUSAN ;
TUFTS UNIVERSITY
MEDFORD
1RC2MD004764-01
BIOETHICS INITIATIVE FOR
EQUITY IN HEALTH CARE AND
RESEARCH AT THE UNIVERSITY
OF
CHILTON, JANICE A
UNIVERSITY OF TEXAS
MD ANDERSON CAN CTR
1R24MD004930-01
A COMMUNITY PARTICIPATOR
APPROACH TO IMPROVING
HEALTH IN A HISPANIC
POPULATION
DULIN, MICHAEL F
CAROLINAS MEDICAL
CENTER
18
Abstract
patients with SCD and their caregivers will improve health care services for this population, by increasing access to clinical trials and enhancing the
success of pediatric SCD clinical trials, and has applicability to other pediatric health disparity chronic illnesses.
Description (provided by applicant): Through a community-based participatory research partnership, we will plan for, develop, implement, evaluate and
disseminate an intervention to address health disparities in the Caribbean Latino population in the Jamaica Plain neighborhood of Boston,
Massachusetts. The Specific Aims of this project are: (1) To establish a community advisory board to guide the development, implementation and
dissemination of an intervention that is culturally appropriate and community specific. (2) Assure that community needs, advisory board
recommendations, and steering committee decisions and actions are aligned. (3) We will a) determine the specific disease/chronic condition to serve
as the basis for intervention and b) identify appropriate aspects of the built environment to be targeted by the intervention; and (4) We will a) design
and pilot test a community-level disease-specific intervention to address deficiencies and maximize any existing advantages in the built environment,
and/or to mitigate the direct and/or indirect effects of the built environment on health, b) conduct both a process and outcome evaluation of the
intervention, and c) disseminate findings and develop a full intervention trial. Latinos are and will remain the country's largest minority group well into
the future. In the northeast Caribbean Latinos (Puerto Ricans and Dominicans) represent the largest segment of the Latino population. Because of the
youthfulness of the demographic, Latino children/youth are a priority age group. By addressing the causes of health disparities among Latino children
and youth early and life, it is possible to provide children with living environments and social conditions conducive to good health, which can create
pathways to health as opposed to disparities. This project is significant because, (1) it is a within-group intervention research project targeting a not
well-understood sub-population of the Latino demographic; (2) the project is unique because it brings together a diverse group of community
stakeholders; (3) key personnel are primarily people of color, with a majority of bilingual Latina women of varying backgrounds; and (4) the project
introduces two new investigators of color. RELEVANCE (See instructions): Characteristics of the built environment can create/sustain health
disparities, hence tackling them requires interventions to address macro-level factors that influence health. By addressing the causes of health
disparities among Latino children/youth early and life, it is possible to create living environments and social conditions conducive to good health, which
can create pathways to health as opposed to disparities.
Description (provided by applicant): Bioethics Initiative For Equity In Health Care And Research At The University Of Texas M. D. Anderson Cancer
The overarching goal of the proposed Bioethics Initiative for Equity in Health Care and Research will be to develop a diverse, multidisciplinary,
research workforce capable of the translation of research findings into evidence-based policies and practices for improving health care and research
equity among racial and ethnic populations. The aims of the proposed project are: 1) to develop a institutionally linked, but free-standing program: the
Bioethics Initiative for Equity in Health Care and Research dedicated to the training of racial and ethnic minorities in bioethics to address the
underrepresentation of minorities in clinical trials, 2) to increase the number of and to advance women and underrepresented ethic and racial
individuals to the bioethics academic enterprise, and 3) to develop and use of non-traditional methods to build trust in the health care system to
increase racial and ethnic participation in clinical trials. The proposed project will be a joint effort between researchers in the University of Texas M.D.
Anderson's (UTMDACC) Center for Research on Minority Health, the nation's only congressionally mandated center for the study of Health Disparities,
and UTMDACC's Section for Integrated Ethics in Cancer Care in the Department of Critical Care. The aims of the proposed program will be
accomplished through the following objectives: 1. to recruit highly qualified racial and ethic minority scholars from a broad spectrum of disciplines to
participate in bioethics training and rotations in the nationally recognized bioethics center at UTMDACC and in the Texas Medical Center (TMC); 2. to
implement a core curriculum across UTMDACC and through rotations in TMC institutions to provide knowledge, skills, and experiences necessary to
carry out multidisciplinary research to develop and use non-traditional methods to reach racial and ethnic minority populations to rebuild their trust in
the health care system; 3. to develop and use non-traditional methods to reach racial and ethnic minority populations to increase participation in
clinical trials; 4. to consistently advance bioethics and clinical research toward higher levels of evidence and evidence-based practice through research
endeavors aimed at improving health literacy, cultural competency, and linguistic proficiency. The goal of the Bioethics Initiative for Equity in Health
Care and Research at the University of Texas M. D. Anderson Cancer Center will be to develop a diverse, multidisciplinary, research workforce
capable of the translation of research findings into evidence-based practices for improving health care and research equity among racial and ethnic
populations in Texas, and in keeping with the overall mission of UTMDACC, the nation and the world.
DESCRIPTION (provided by applicant): Charlotte, NC is home to one of the nation's fastest growing Hispanic communities. As in other parts of the
U.S., Hispanics here face significant health disparities in part because of lack of access to medical services. Charlotte's Hispanic community
experiences disparities in the incidence of sexually transmitted infections; immunization rates; death from motor vehicle accidents and homicide; and
obesity. Our community provides the ideal setting for designing and implementing interventions to minimize these health disparities using the
principles of community-based participatory research (CBPR). First, the principal investigator has founded a unique practice based research network
that has created partnerships between researchers, community members, and health providers using ideals of CBPR. Second, this network brings
together health services and social science researchers with a broad depth of research expertise in the use of CBPR, qualitative analysis, and
geographic information systems (CIS). Third, Charlotte's rapidly growing Hispanic population provides a model community in which to develop and test
interventions that can be translated to other transitioning communities. Fourth, our network includes the 3rd largest hospital system in the nation. This
system has a shared clinical database for all hospitals and clinics that can be used to evaluate changes in overall community health and patterns of
healthcare utilization. The long-term goal of this project is to leverage the resources within our network and community to eliminate Hispanic health
disparities using principles of CBPR. This will be accomplished by: enhancing community partnerships; performing a needs assessment; identifying a
disease to be addressed; and designing and implementing an intervention. The intervention will be evaluated by examining its impact on community
health indicators, the changes that occur in patterns of healthcare utilization, and the overall cost effectiveness. The strength of the CBPR process
itself will also be measured and used for process improvement. RELEVANCE (See instructions): The U.S. Hispanic immigrant population is growing
rapidly and faces many health disparities. Charlotte, NC provides a model community to study the use of community-based participatory research to
develop, implement, and evaluate interventions that can eliminate Hispanic health disparities. This study will measure the intervention's impact on
community health, healthcare utilization, and overall medical costs.
Total Cost
$483,613
$1,033,950
$386,999
Project Number
2
Project Title
Principal Investigator
Performing
Organization
1RC1MD004257-01
BIO-BEHAVIORAL CHRONIC
DISEASE MANAGEMENT BY
FAMILIES OF YOUNG MINORITY
CHILDREN
EDELSTEIN, BURTON L
COLUMBIA UNIVERSITY
HEALTH SCIENCES
1RC2MD004778-01
GO-ING FORWARD
FOUAD, MONA N.
;SCARINCI, ISABEL C;
UNIVERSITY OF ALABAMA
AT BIRMINGHAM
1R24MD004902-01
IMPROVING THE HEALTH OF
CAMBODIAN AMERICAN WOMEN:
A CBPR APPROACH
LEE, JULIET P
PACIFIC INSTITUTE FOR
RES AND EVALUATION
19
Abstract
DESCRIPTION (provided by applicant): This application addresses broad Challenge Area (09) Health Disparities and specific Challenge Topic 09-MD102 Trans-disciplinary Research to Integrate the Biological and Non-biological Determinants of Health to Address Health Disparities. Description 'Biobehavioral chronic disease management by families of young minority children' seeks to reduce health disparities by investigating methods to close
the gap between health information and health behaviors- specifically, the gap between instruction provided by clinicians to families of young children
with chronic diseases and the capacity of economically stressed families to act on that instruction. Whether addressing asthma, diabetes, obesity, or
tooth decay, needed now is trans-disciplinary translational research that tailors pharmacological and behavioral interventions to care management
plans that parents are able to implement successfully. Envisioned is a computer 'Tool' for use in community sites that assists community health
workers in collaboration with families to: (1) determine children's level of risk for chronic diseases, (2) match them to clinicians and care plans, (3)
characterize a family's capacity to engage in such plans, and (4) modify care plans to meet family's capacities. Target families are those
disadvantaged by low-income, low-literacy, cultural barriers and minority status. Specific research aims are to develop, pilot test, and refine two
'Instruments' that are integral to this Tool: (1) a 'disease risk assessment instrument' and (2) a culturally adaptable 'family capacity assessment
instrument.' Early childhood caries ('ECC') was selected as the exemplar chronic disease for this research by an existing 12-member multi-disciplinary
Project Team comprised of social and behavioral scientists, clinicians, educational and informatics technologists, and health services researchers.
ECC was selected because it is highly prevalent in young children, because preventive and therapeutic bio- behavioral therapies are available but
underused, and because significant cost savings may accrue to governmental programs, insurers, and families if the need for dental repair can be
reduced. The proposed 'disease risk assessment instrument' will experiment with inputting recognized biological (clinical, laboratory, psychological,
and pharmacologic), and non biological (knowledge, logistic, socio-cultural, and environmental) risk factors into algorithm-supported 'classification and
regression tree analyses' and machine learning 'artificial neural networks' to improve on current professionally-endorsed methods of classifying young
children by risk. As the proposed 'family capacity assessment instrument' has been less developed to date by the Project Team, its ultimate form will
be determined by this research. Success in developing and implementing the Tool and its two assessment Instruments can result in better oral health
outcomes at lower cost through risk-based early intervention, disease suppression, individualized care, family engagement, and elimination of the
need for dental surgery in children under the age of six. Findings of this research will support clinical trials of risk-based caries management in
vulnerable minority child populations and is adaptable to management of other chronic diseases in young children. 'Bio-behavioral chronic disease
management by families of young minority children' seeks to reduce health disparities by investigating methods to close the gap between health
information and health behaviors-specifically, the gap between instruction provided by clinicians to families of young children with chronic diseases
and the capacity of economically stressed families to act on that instruction. Specific research aims are to develop, pilot test, and refine two 'Tools' that
are integral to this Instrument: (1) a 'disease risk assessment tool' and (2) a culturally adaptable 'family capacity assessment tool.'
DESCRIPTION (provided by applicant): The overall goal of this two-year research study is to develop a comprehensive and effective multisystem
measurement model to understand the underlying causes of the social determinants of health (SDH) and their relation to health disparities. Specific
aims: 1) Establish a diverse coalition of policy makers, community members, and representatives and stakeholders from multiple systems and sectorseconomic development, business, education, labor, housing, transportation, environment, agriculture, and healthcare-as well as academic
investigators from disciplines such as clinical and social sciences, health services, law, education, engineering, business and economics, and
anthropology; 2) As a coalition, define measures, identify gaps, and develop measurement methods to assess health inequities, health outcomes,
SDH, and the consequences of poor health; 3) Create working groups to implement the measurement model developed in Aim 2 in urban city
(Birmingham) and rural town (Selma); 4) Analyze and interpret the findings of the working groups in the context of one combined data system to
identify relationships and pathways of SDH as they relate to health disparities. 5) Based on the analyses in Aim 4, develop recommendations for new
research questions, education and training programs, and policy changes to address the SDH and reduce health inequities. Design and Methods: The
development, implementation, and evaluation will be rooted in and guided by the social ecological model, the community-based participatory approach
(CBPA), and the empowerment theory. We have assembled a coalition that includes investigators from the fields of medicine, public health, sociology,
psychology, anthropology, law, engineering, nursing, and education, as well as organizations, community experts, and local and state officials
representing the areas of urban planning, economic development, agriculture, education, banking, transportation, law, and faith-based organizations.
The project will target urban and rural environments (represented by the city of Birmingham and the town of Selma, Alabama). Both locales have a
high proportion of low-income African Americans (70%) who suffer from higher mortality and morbidity rates of major health conditions. Significance:
By using the above multisystem, trans-disciplinary approach, the project will identify in-depth patterns and pathways, which will enable us to
understand the underlying causes of the SDH and their interaction. Study results will help develop a set of recommendations and a sustainable action
plan to reduce the inequities. These recommendations and action plan will generate further research to develop and disseminate evidence-based
interventions; they will also necessitate education and training in order to improve the health-care delivery; and inform policy and stimulate political
action, which will impact public health. The overall goal of the proposed research study, GO-ing Forward, is to develop a comprehensive and effective
multisystem measurement model to understand the underlying causes of the social determinants of health (SDH) and their relation to health
disparities. Such model will allow for systematic analysis of the health impact of SDH and will help develop recommendations to reduce the inequities.
These recommendations will 1) generate further research to develop and disseminate evidence-based interventions, 2) necessitate education and
training to improve health-care delivery, 3) and inform policy and stimulate political action, which will impact public health. 1
DESCRIPTION (provided by applicant): In response to RFA-MD-09-006 (NCMHD Community Participation in Health Disparities Intervention
Research Planning Phase), this application details a two-year pilot intervention project to plan and implement a community-based participatory
research (CBPR) program aimed at reducing substance abuse and related issues among Cambodian American women in the East San Francisco Bay
Area city of Oakland, CA. The PI, an anthropologist, and colleagues at the Berkeley office of PI RE are developing this proposal in partnership with
Community Health for Asian Americans (CHAA), a community-based organization with whom they have been working for several years, as well as
with two community-based organizations serving Oakland Cambodian Americans with whom the partners have also previously collaborated. The local
Cambodian American community is represented by: 1) a Community Work Group of Cambodian American women who are at risk for or have personal
Total Cost
$445,660
$826,730
$534,144
Project Number
2
3R24MD001619-05S1
Project Title
HEP COMMUNITY APPROACHES
TO CARDIOVASCULAR HEALTH:
PATHWAYS TO HEART HEALTH
Principal Investigator
SCHULZ, AMY J
Performing
Organization
UNIVERSITY OF MICHIGAN
AT ANN ARBOR
Abstract
experience with substance abuse, and who will select the priority issue and design, direct and conduct all research and intervention activities; 2) a
Community Advisory Board, as required by this RFA, to provide community leadership, recruit women for the work group and thereafter support and
oversee the project; and 3) two Community Host organizations who will provide the facilities and culturally-competent services in support of the group
and board activities. Within the tight timeframe and structure specified in the RFA, the specific aims of the proposal are: 1) Conduct collaborative
research on substance use and misuse among Cambodian American women, select a priority area, and design a pilot intervention with leadership
from Cambodian American women of the East Bay Area. While substance use will provide a starting place, the co-research may direct intervention
activities toward underlying causes of substance abuse (6-month planning phase). 2) Carry out a pilot intervention study to address the priority issue
through continued collaboration, as well as evaluate these efforts (18-month intervention phase). 3) Build the capacities of the Cambodian American
community to assess health issues affecting members and respond proactively, and of scientific researchers to partner with communities (on- going).
RELEVANCE (See instructions): Traditional approaches to mental health services may not meet the needs of Cambodian Americans. Research on
substance abuse treatment and prevention for Cambodian Americans has specifically recommended many elements of the CBPR approach. Utilizing
participants' life experiences together with existing research and theory, the proposed project may address unmet needs underlying mental health and
substance use and misuse of Cambodian American women as well as strengthen their capacities to address these conditions and execute
intervention activities to effect positive change in their community.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): Community Approaches to Cardiovascular Health: Pathways to Heart
Health (CATCH-PATH) proposes to implement and evaluate a community-based participatory research (CBPR) intervention designed to reduce and
ultimately eliminate disparities in cardiovascular disease by improving heart health in Detroit, Michigan, a city in which 88% of residents are African
American or Latino/a. The project will be carried out by the Healthy Environments Partnership (HEP), a CBPR partnership that has been working
together since 2000 to assess community environments, and to develop, implement and evaluate multilevel evidence-based interventions to reduce
the risk of heart disease in three geographically defined communities - eastside, northwest, and southwest Detroit. The CATCH-PATH Intervention
Research Project builds directly on results from the CATCH Planning Phase that engaged community residents and representatives from communitybased organizations (CBOs), health service providers, and academic institutions in identifying, prioritizing and piloting strategies to promote heart
health in Detroit. The HEP Steering Committee, made up of representatives from CBOs from each of the involved communities, Detroit based health
service providers, and academic researchers from the University of Michigan, has been actively engaged in the development and pilot testing of the
Walk Your Heart to Health intervention, and will be actively engaged in implementation, analysis, evaluation, and dissemination of the proposed PATH
intervention. Specifically, we aim to promote cardiovascular health by: (1) implementing & evaluating a multilevel CBPR intervention (i.e., individual,
family, organizational) to increase active living (specifically walking groups) in three communities in Detroit; (2) implementing & evaluating a multilevel
CBPR intervention (i.e., organization, community, policy) to promote leadership development, community action, and policies that support active living;
(3) maintaining and evaluating the HEP CBPR partnership process and outcomes of engaging community members in providing input and scientific
and community oversight for all aspects of the CATCH-PATH project; and (4) disseminating preliminary results and developing a Dissemination Plan
to share research findings through community and peer reviewed outlets, to assure translation of results from this multilevel CBPR intervention into
programmatic and policy efforts to improve heart health.
Total Cost
$563,242
National Eye Institute (NEI)
1RC1EY020140-01
COMPARATIVE EFFECTIVENESS
& MEDICAL INTERVENTIONS FOR
PRIMARY OPEN ANGLE
GLAUCOMA
National Heart, Lung and Blood Institute (NHLBI)
20
DICKERSIN, KAY
JOHNS HOPKINS
UNIVERSITY
DESCRIPTION (provided by applicant): This application addresses broad Challenge Area (05) Comparative Effectiveness Research (CER) and
specific Challenge Topic, 05-EY-103: Eyes and Vision Systematic Reviews. Comparative effectiveness research is 'a rigorous evaluation of the
effectiveness and harms of many treatment options available for a given medical condition for a particular set of patients'. Mixed treatment comparison
(MTC) meta-analysis is a novel technique attracting considerable interest because of its potential for comparative effectiveness research. It expands
the scope of a typical systematic review by comparing the relative benefits and harms among a range of available interventions for a given condition,
through synthesizing simultaneously evidence not only within the same trials ('direct evidence') but also across trials ('indirect evidence'). In doing so,
MTC meta-analysis efficiently utilizes existing information and parallels more closely the decisions facing clinicians, patients and policymakers who
must choose among a variety of alternative interventions. Working in collaboration with leaders in the field, we propose to assess the comparative
effectiveness of multiple medical interventions available for primary open angle glaucoma (POAG) using the state-of-art Bayesian MTC meta-analysis
models. POAG poses substantial burdens on patients and health care resources. Utilizing data from existing high quality randomized controlled trials,
we will perform MTC meta-analysis and rank multiple medical treatment options for POAG. We will validate the MTC meta-analysis models and
assess the impact of publication bias. We will report and disseminate our findings on the comparative effectiveness of medical interventions for POAG,
as well as utility and validity of MTC meta-analysis techniques for comparative effectiveness research. By providing evidence on comparative
effectiveness of interventions, the outcome of our work will have substantial impact on clinical practice, and influence on development of methodology
for comparative effectiveness research. This study will also demonstrate and validate a meta-analytical model for generating comparative
effectiveness evidence in an accelerated and practical format, which can be attractive and applied across all health care fields. This application
addresses broad Challenge Area (05) Comparative Effectiveness Research (CER) and specific Challenge Topic, 05-EY-103: Eyes and Vision
Systematic Reviews.
$454,142
Project Number
2
Project Title
Principal Investigator
Performing
Organization
1RC2HL101838-01
WEBSYSTEM TO INCREASE
RESEARCH PARTICIPATION OF
UNDERREPERESENTED
POPULATIONS
COTTLER, LINDA B
WASHINGTON
UNIVERSITY
1P30HL101312-01
ENHANCING THE OBESITY
PREVENTION PROGRAM AT
HARVARD'S DACP
GILLMAN, MATTHEW W
HARVARD PILGRIM
HEALTH CARE, INC.
1RC1HL101071-01
A CARDIOVASCULAR RISK
REDUCTION LEARNING
COMMUNITY IN DARTNET
HAMMERMEISTER, KARL
UNIVERSITY OF
COLORADO DENVER
21
Abstract
DESCRIPTION (provided by applicant): The ultimate goal of this 2 year NIH-NHLBI RC2 GO Grant (RFA-OD-09-004), 'Comparative Effectiveness', is
to develop a web system that facilitates Community Based Participatory Research (CBPR) to identify populations underrepresented in research. This
effort builds on our 20 year community based model. Recently scaled up for the Washington University's Clinical & Translational Science Award
(CTSA), our community based model called Health Street is a one-stop portal of entry for navigating underrepresented populations (URPs) to social,
medical and psychiatric services, and to research opportunities. Health Street relies on Community Health Workers (CHWs) for engagement and is
complementary to planned national self-guided participant registries. The deliverables will be the model, its protocols and manuals, and its
concomitant web system that automates its work flow; they would be made available for replication nationally. The system will be an important
component of the recruitment armamentarium to boost URPs in research. A web system to track and facilitate all functions of this approach, along with
all decision logic, is mandatory to scale up the effort for better efficiency of field-based recruitment on a local and national level. Specific Aim 1. Refine
the workflow for our novel Health Street model, to reduce disparities in research participation, and make it complementary to both local and national
registry based efforts. Specific Aim 2. Design and develop a sophisticated web system that automates all of the work flow described above and allows
CHWs to capture individual data from underrepresented populations, from portal of entry forward. It will also longitudinally track need for services,
health priorities and concerns, risk factors, referrals made, Health Street services provided, and community recruitment, navigation, and enrollment
rates. Specific Aim 3. Test the web system for relevance locally with the input of the CHWs, the Recruitment Enhancement and Bio-Informatics Cores,
and the local Community Advisory Board; and nationally with the input of the Program Advisory Board and CTSA Community Engagement Cores.
Specific Aim 4. Make the web system available nationally; begin a Sentinel Network for ongoing multi-site monitoring of increased enrollment of URPs
into relevant research studies. Specific Aim 5. Plan a collaborative comparative effectiveness study of the web system vs current models to
longitudinally monitor recruitment, navigation, enrollment and retention yields among URPs. This pioneering work can be accomplished in 2 years, and
will have a substantial transformative and sustainable impact as it brings research from the bench and bedside to the 'curbside'.
PUBLIC HEALTH
RELEVANCE: The public health impact of the Health Street approach to recruit more underrepresented populations into research and link them to
needed services is significant. When samples enrolled for research studies are comprised of diverse populations, there is greater generalizability and
applicability of the findings to the larger population to which they relate. This increases the effectiveness and speedy approval of treatments and
interventions that are tested in various research studies, thereby positively impacting public health outcomes. Thus, the use of a comprehensive web
system, deployed by Community Health Workers, and based on the principles of community based participatory research, is pioneering.
DESCRIPTION (provided by applicant): Cardiovascular diseases (CVD) are the leading causes of death and disability in the US. Obesity and its
behavioral components, lack of physical activity and poor diet, are major determinants of CVD. Prevention of obesity and its CVD sequelae are clinical
and public health priorities. Yet the origins of obesity remain poorly understood and many potential solutions to the problem are understudied. To
address these challenges, four years ago we established the Obesity Prevention Program at the Department of Ambulatory Care and Prevention, a
joint department of Harvard Medical School and Harvard Pilgrim Health Care situated at the fulcrum of academia, medical delivery systems, and public
health. The mission of this interdisciplinary research Program is to lessen the burden of obesity-related disorders by conducting epidemiologic,
intervention, and health services research studies within defined populations of children and adults. After a competitive international search, we
successfully recruited Dr. Jason Block, a general internist just finishing a highly productive fellowship in health services and health policy, to join our
full-time faculty as of June 2009. A base of solid financial support as he joins the ranks of our junior faculty will allow him to take off as a Newly
Independent Investigator. The goal of the proposed NHLBI PSO Core Center is to support Dr. Block's salary and startup research activities along with
a pilot grants program. so that the Obesity Prevention Program can expand and intensify its research in health services, health policy, and
comparative effectiveness research The Program's location within Harvard's Department of Ambulatory Care and Prevention provides unparalleled
resources for conducting this type of research. Because of a precipitous drop in endowment funds, Harvard Medical School will eliminate its financial
support to the department that we intended to use for Dr. Block's initial salary and startup research activities. While the department will use other
resources to honor its commitment to Dr. Block's salary, it does not have committed resources to pay for his initial research activities. Having startup
support for staff, equipment, and supplies and the ability to obtain pilot project funding from the proposed Core Center will be critical to Dr. Block's
ability to take advantage of time-limited research opportunities. In addition, because the proposed Core Center will support Dr. Block's salary during
his first two years on the OPP faculty, it will free the department to guarantee his salary for at least two more years. Thus the proposed NHLBI PSO
Core Center grant will provide a crucial boost to Newly Independent Investigator Dr. Block, and will benefit not only his own career but also the Obesity
Prevention Program as a whole. Obesity has grown unchecked in recent years and has thus far eluded easy answers despite its powerful adverse
effects on health. New solutions may very well come from research in health services, health policy, and comparative effectiveness. By funding a
Newly Independent Investigator, startup research activities, and a pilot grants program, this NHLBI PSO Core Center grant comes at just the right time
to support the Obesity Prevention Program at Harvard's Department of Ambulatory Care and Prevention to expand and intensify its research in these
increasingly important areas.
DESCRIPTION (provided by applicant): The goals of this project are: 1) Form a Cardiovascular Risk Reduction Learning Community; 2) Electronically
collect and analyze data on trajectories of hypertension and LDL-cholesterol control, antihypertensive and hypolipidemic drug prescription and
fulfillment data, and relatively mutable and relatively immutable factors associated with hypertension and LDL control; 3) Develop a system for
electronic feedback of aggregate data to compare clinic performance and of patient-level data to assist care providers in focusing their efforts in
improving blood pressure and LDL control; and 4) Assess incidence and changes in blood pressure and LDL control before and after implementation
of feedback to calculate sample size for a randomized controlled trial. Methods: This project will be conducted in the Distributed Ambulatory Research
in Therapeutics Network (DARTNet), a distributed computing network capable of extracting standardized data from electronic health records.
DARTNet, composed of 79 practices with about 500 clinicians providing primary care for about 400,000 patients, has demonstrated the ability to
conduct observational comparative effectiveness research in a completed pilot project on oral hypoglycemic agents. Working collaboratively with
DARTNet care providers, we will analyze three groups of factors associated with hypertension and LDL-cholesterol control to ascertain: 1) The
comparative effectiveness of classes of antihypertensive and hypolipidemic drugs in this real-life setting, 2) Other factors within the control of care
Total Cost
$950,662
$701,233
$499,926
Project Number
2
Project Title
Principal Investigator
Performing
Organization
3R01HL085420-04S1
PEER SUPPORT--CONGESTIVE
HEART FAILURE SELFMANAGEMENT
HEISLER, MARY ELLEN
MICHELE
UNIVERSITY OF MICHIGAN
AT ANN ARBOR
1RC2HL101811-01
COMPARATIVE EFFECTIVENESS
AND OUTCOMES IMPROVEMENT
(CEOI) CENTER
HIRSCH, JAN D;KAPLAN,
ROBERT M ;
UNIVERSITY OF
CALIFORNIA LOS
ANGELES
22
Abstract
providers (relatively mutable factors, such as drug doses, patient compliance, etc.), and 3) Relatively immutable factors beyond the control of care
providers (e.g., age, gender, race/ethnicity). Feedback of clinic-level performance will adjust for the relatively immutable factors, while care provider
feedback will focus on patient-specific data on relatively mutable factors. Then, we will assess changes in hypertension and LDL control before and
after implementation of the audit and feedback. If these results are promising, we will collaboratively plan a large-scale randomized trial to test the
hypothesis that the audit and feedback described above will enhance hypertension and LDL-control. PUBLIC HEALTH RELEVANCE: Coronary
heart disease, stroke, and heart failure remain major causes of mortality and morbidity in the United States. Uncontrolled hypertension is present in
13.7% of all Americans >18 years of age; more than one fifth of adult Americans report never having had their blood cholesterol measured, while a
quarter of those with measurements have high cholesterol. This project proposes to improve the control high blood pressure and elevated cholesterol,
two of the major reversible risk factors for all three of these serious cardiovascular problems, through innovative electronic audit and feedback to
primary care providers of more than 320,000 patients in the Distributed Ambulatory Research in Therapeutics Network.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): Congestive heart failure (CHF) outcomes depend critically on patients'
effective self-management of their condition. Yet, patients with CHF are often frail, indigent, and socially isolated, factors that limit their ability to
manage their self-care and access clinic-based services, leading to preventable hospitalizations and poor outcomes. This randomized trial will
evaluate a six-month intervention that consists of group visits with CHF nurse managers in conjunction with a low-cost interactive voice response (IVR)
telephone exchange system that promotes peer-to-peer communication and facilitates communication with care managers. The intervention is based
on research on the positive impact of group visits and peer support on chronic disease outcomes and self-care behaviors, our own studies showing
the effectiveness of IVR-based self-management supports, and a successful pilot study. The Specific Aims are:1)To evaluate the effect of group visits
+ IVR-facilitated peer support on CHF patients' health-related quality of life, survival, and rates of hospital readmission; 2) To assess the impact of the
intervention on patients' self-management behaviors, use of guideline-concordant medications, perceived social support, depressive symptoms, and
satisfaction with care; 3) To identify the mediating factors influencing the intervention's effectiveness; and 4) To determine the incremental costeffectiveness of the intervention. 408 moderate to high-risk CHF patients will be recruited in a community health care system serving large numbers of
racial minority and socioeconomically vulnerable CHF patients. We will pair eligible patients based on gender and illness severity. Pairs will be
randomized to either: 1) usual care; or 2) usual care in conjunction with the intervention. Participants in the intervention arm will receive brief training in
Motivational Interviewing-based peer communication techniques and participate in an initial care manager- led interactive group visit. They will then be
asked to communicate at least weekly with their partner using the IVR exchange. Pairs will be able to talk by phone but without divulging their home
phone number, incurring the cost of long distance calls, or having primary responsibility to ensure that the peer contacts occur regularly. The IVR
system also will support 'asynchronous' communication between peers using voicemail, as well as between participants and care managers. At
months 3 and 6 of the intervention, participants will be invited to participate in group visits encouraging exchange and discussion on CHF selfmanagement. Research staff will monitor the process via the Internet, and outcomes will be measured at six and 12-months. The intervention
addresses multiple barriers to effective disease management common among CHF patients. If found effective, this approach could be used to improve
health outcomes among patients with other chronic conditions, such as depression, chronic pain, or diabetes.
DESCRIPTION (provided by applicant): Despite many initiatives over the past three decades to improve healthcare quality and outcomes in the United
States, progress remains slow, particularly for chronic disease care, where many patients still receive the recommended care only about half the time.
Even when current 'best practices' are followed, outcomes in many population groups are far from optimal. Chronic disease care and outcomes for
patients in California are no exception, where the performance rates for many standard chronic care quality measures, such as control of high LDL
cholesterol or blood pressure, rank substantially below those of other states, despite the fact that California has one of the highest concentrations of
managed care in the country. In response, the California Office of Managed Care, healthcare industry leaders, employer groups, and other key
stakeholders initiated the Right Care Initiative (RCI)-a novel, public- private partnership to improve care and outcomes in California that spans the
entire state, with the nine participating commercial health plans responsible for the care of more than 15 million residents or one third of the state's
population. The RCI seeks to improve cardiovascular care and outcomes by promoting evidence-based practices and, when evidence is lacking, by
comparing the effectiveness of usual and novel approaches to help providers provide the right care to the right patient at the right time in the right
setting. And while RCI emphasizes improving cardiovascular care within healthcare settings, it also values prevention beyond the clinic wallsemphasizing collaborative approaches between multiple stakeholders at the community and regional level. Now in its second year, RCI health plans
and other entities have begun sharing and pooling data and reviewing promising practices to identify opportunities for interventions to improve
outcomes at local and regional levels. Although RCI is off to a promising start, it currently lacks the organizational and technical infrastructure to
effectively design, implement, and evaluate the range of multisite, multilevel interventions being considered. The Go Grant will allow us to rapidly
implement the infrastructure RCI needs to initiate studies and obtain additional funding on an ongoing basis. Specifically, we propose to establish a
research center-the California Comparative Effectiveness and Outcomes Improvement (CEOI) Center-that would support the goals of the RCI while
also significantly increasing the available evidence base on the comparative effectiveness of different strategies for improving the primary and
secondary prevention of cardiovascular disease (CVD). Once operational, the CEOI would be able to support a wide range of interventions and
comparative studies. And by capitalizing on existing research and the data infrastructure of participating members, CEOI is likely to yield substantial
returns, both with respect to new knowledge generated and actual improvements in delivery and outcomes of care. Indications are also good that once
the CEOI is operational obtaining additional funding from public and private sources will not be difficult. Indeed, because of the size and scale of the
RCI healthcare networks involved in CEOI research projects, practices that prove effective are likely to be widely disseminated and to have a
significant impact on population health far more quickly than usual. This impact is likely to extend beyond California, since many of the regional health
plans involved are part of larger national plans that together care for more than a quarter of the U.S population. The likely spread of effective practices
beyond California through these networks is increased by the fact that RAND and other partner organizations involved already have strong working
relationships with those national plans and other regional quality or translational research initiatives. While the CEOI will initially support efforts of the
Total Cost
$98,658
$1,864,353
Project Number
2
Project Title
Principal Investigator
Performing
Organization
1RC1HL100301-01
WIRELESS PAIN INTERVENTION
PROGRAM FOR AT RISK YOUTHS
WITH SICKLE CELL DISEASE
JACOB, EUFEMIA
UNIVERSITY OF
CALIFORNIA LOS
ANGELES
1RC2HL101759-01
NOVEL METHODS OF
MEASURING HEALTH
DISPARITIES
MOKDAD, ALI H;MURRAY,
CHRISTOPHER J.L. ;
UNIVERSITY OF
WASHINGTON
23
Abstract
RCI and focus on preventing CVD, we expect it will gradually expand its scope and capacity to support comparative effectiveness studies for entities
not formally part of the RCI and to include care for health conditions besides CVD. PUBLIC HEALTH RELEVANCE: We propose to develop
sustainable statewide infrastructure for Comparative Effectiveness Research on primary and secondary prevention of cardiovascular disease (CVD)
among managed care populations. Our project builds on the Right Care Initiative (RCI)-an existing public-private, multidisciplinary collaboration of
health plans, provider groups, public health authorities, and other key stakeholders. RCI was established to address poor performance in clinical
outcomes of chronic conditions, including CVD. Now in its second year, health plans and other entities that are part of RCI have begun sharing and
pooling data and reviewing promising practices to identify opportunities for interventions to improve outcomes at local and regional levels. Although
RCI is off to a promising start, it lacks the organizational and technical infrastructure necessary to effectively design, implement, and evaluate the
range of multisite, multilevel interventions being considered. The Go Grant will allow us to rapidly implement this infrastructure, initiate studies, and
obtain additional funding for a sustainable statewide laboratory for practice- and community-based comparative effectiveness research and a center
for innovation and dissemination of evidence-based practices.
DESCRIPTION (provided by applicant): This project addresses the broad challenge area (06): Enabling Technologies and the specific challenge topic
(06-MD-101) Development of Telehealth Tools to Promote Health and Connect At-Risk Youth to the Health System via Low-Cost, Mobile, and
Wireless Technologies. Sickle cell disease (SCD) is an inherited disorder that affects red blood cells, by causing them to form a sickle shape, blocking
blood flow, and causing a tremendous amount of pain in times of physiological or psychosocial stress. Youths with SCD are at risk for
pseudoaddiction. This phenomenon occurs when pain is poorly controlled, and their attempts to obtain medications are perceived by clinicians as drug
seeking. Because SCD predominantly affects ethnic minorities, many believe that large proportions of youths with SCD are addicted, when in fact their
pain is physiologically based. Most youths manage painful episodes at home and delay seeking treatments until pain becomes intolerable. The delay
in treatment for pain leads to poor coping, interference with function, and sleep disturbance. Eventually, these youths are at risk for poor academic
achievement, decrease in quality of life, and other negative outcomes that may interfere with overall health. Effective coping in youths with SCD pain
will require different strategies that would encourage them to connect with the health care system in a timely manner. Advances in telehealth and
internet technology are innovative approaches that may improve access to knowledgeable health care providers, and improve pain management
through wireless communications. The handheld wireless technology and web-based applications may potentially minimize barriers that limit access to
timely pain relief. We propose to test the effectiveness of an innovative wireless pain intervention program in sickle cell disease that utilizes 1) a cell
phone/PDA with a program (e-Ouch) that has questions about pain; 2) a web link that will connect to resources including educational materials, a
psychologist, and nurse practitioner, and 3) a peer social support network using cell phone/PDA. We will compare two groups of youths with SCD and
randomly assign them to: 1) standard care, 2) standard care + wireless pain intervention program. Measurements will occur at baseline, then at 3 and
6 months following intervention. The youths (8 to 17 years old) in the standard care group will be asked to complete the paper diary three times a day
on the days that they are having pain. The psychologist/youth counselor will explain the content in a booklet 'Coping with Pain: Strategies that Help'
during the orientation session. The 14-page booklet is a short summary of strategies that help cope with pain (deep breathing, muscle relaxation,
information on pain and the five senses, imagery), distraction techniques, positive self-statements and positive thinking, trigger analyses and selfmonitoring, behavioral contracts, information on the emotion-pain connection, information on when counseling is needed, and resource/reading list.
The youths in the intervention group will be instructed to use the cell phone/PDA to 1) answer questions on the e-Ouch(c) electronic diary three times
a day on the days they are having pain, 2) link with the resources in the study web site, 3) connect with the psychologist/youth counselor who will be
able to provide support and information about strategies for coping as needed, 4) connect with the nurse practitioner as needed who will be able to
make an assessment, monitor, prescribe, and/or refer to other health care provider (pediatric pain specialist, hematologist), and 5) use the cell
phone/PDA to connect with other youths with SCD, particularly the friendship network that will be connected via cell phone/PDA. We hypothesize that
youths with SCD who participate in the wireless pain intervention program (WPIP) will have 1) increase pain coping; 2) decrease pain interference with
daily activities; 3) improve sleep; 4) increase quality of life; and 5) decrease health care use related to pain. Future studies will more specifically
examine the cost effectiveness of the WPIP and whether this pain intervention program will generalize to other childhood disorders that require pain
management. The study will examine the effectiveness of the Wireless Pain Intervention Program. The program will consist of 1) a cell phone/PDAs
with a program (e-Ouch) that has questions about pain; 2) a web link that will connect to resources including educational materials, a psychologist,
and nurse practitioner, and 3) a peer social support network using cell phone/PDAs.
DESCRIPTION (provided by applicant): This application addresses NHLBI Participation in NIH Research and Research Infrastructure 'Grand
Opportunities' (RC2) (RFA-OD-09-004); NHLBI RC2 topic area 'Novel Methods of Measuring Health Disparities.' The broad goal of this project is to
design a population-based surveillance system that integrates multiple data sources to track disparities in chronic diseases at the local level. This
system will capture the complete spectrum of relevant information from socio-economic context and health risk factors to disease incidence and the
consequent cascade of hospitalizations, outpatient visits, and use of and adherence to interventions. The project will demonstrate the costs and
feasibility of this system in King County, Washington. By demonstrating in this two-year project, the feasibility of such an integrated cost-effective
system, it could be subsequently deployed in a number of sites across the United States. Together these sites would provide important detail on
chronic disease disparities for race/ethnicity groups in different parts of the country. The integrated multi-source data system will need certain key
attributes. First, it should leverage existing data systems including medical record discharge systems, vital registration data, census data, reportable
conditions, payer data systems and Medicare files. Second, it should supplement these sources with additional cost-effective data collection including
household surveys and chart extraction. Third, the quality and utility of the information should be maximized through record linkage across data
platforms. Finally, the methods and strategies used in King County should be applicable in diverse communities across the US. PUBLIC HEALTH
RELEVANCE: Tracking and analyzing the disparities for race/ethnicity groups across counties or local communities requires detailed
measurements for at least four critical domains: health outcomes, health risk factors, health services, and the socio-economic context. The broad goal
of this project is to design a population-based surveillance system that integrates multiple -data sources to track disparities in chronic diseases at the
local level. This will allow more targeted allocation of limited resources and more detailed, specific information that can be used by policy makers to
Total Cost
$500,000
$1,626,800
Project Number
2
Project Title
Principal Investigator
Performing
Organization
Abstract
Total Cost
design appropriate interventions.
1RC2HL101468-01
NOVEL POPULATION HEALTH
APPROACH TO ADDRESS CVD
AND PULMONARY HEALTH
DISPARITIES
NIETO, F JAVIER
UNIVERSITY OF
WISCONSIN MADISON
3R01HL085757-03S1
NOVEL BIOMARKERS IN
CARDIAC SURGERY TO DETECT
ACUTE KIDNEY INJURY
PARIKH, CHIRAG R
YALE UNIVERSITY
3R01HL079173-02S2
FINANCIAL INCENTIVES TO
TRANSLATE ALLHAT INTO
PRACTICE
PETERSEN, LAURA A
BAYLOR COLLEGE OF
MEDICINE
24
DESCRIPTION (provided by applicant): This proposal is in response to the NHLBI's call for 'Novel Methods of Monitoring Health Disparities.' The
University of Wisconsin (UW) School of Medicine and Public Health (SMPH) and its partners propose to build an innovative research network to
monitor the effects of economic and policy changes on cardiovascular and respiratory health in communities. The main focus will be to identify the
determinants of the state's significant health inequities according to place of residence, race/ethnicity, gender, and socioeconomic status. We will
create a model information network called the Wisconsin Health Equity Network (WHEN) by linking unique existing resources that assess the health of
Wisconsin individuals and communities at multiple levels. These resources include: (1) the Survey of the Health of Wisconsin (SHOW): an annual
survey of representative samples of state communities and their adult residents including data on demographics, employment, medical history and
health behaviors, access to health care, quality of life, as well as an individuals' physical exam and blood/urine samples; (2) the Wisconsin County
Health Rankings: an annual summary of the health status of the population in all Wisconsin counties; (3) the Wisconsin Collaborative for Health Care
Quality: a consortium of health care provider organizations (physician groups, health plans, hospital) sharing health care quality data; and (4) What
Works-Policies and Programs to Improve Wisconsin's Health: a compendium of programs and policies that might influence health and reduce health
disparities. Funding for this program will support the expansion of the SHOW by increasing its sample size and recruitment incentives, and by adding
a new rural-based field station in addition to the existing urban-based SHOW facilities in Milwaukee and Madison. It will also support the addition of a
mail survey assessing health status of a representative sample of Wisconsin residents, as well as interviews with public health and health care leaders
in the communities sampled each year. Methods to link the above sources of information will be developed; the use of this network of information on
health, health care quality, and public health resources to assess how concurrent shifts in the global and local economy affect health disparities will be
tested. Building on existing community-academic partnerships within the UW Institute for Clinical and Translational Research and the UW Population
Health Institute, WHEN will engage community organizations and health professionals and will use these resources to disseminate results and identify
strategies for intervention. WHEN have national implications. It provides a finer resolution lacking in national surveys to adequately assess health
disparities at the community level where multiple determinants operate. The proposed funding will leverage resources developed through a strong
UW-SMPH commitment to integrate Medicine and Public Health and improve population health. Consistent with this mission, a sustainable WHEN will
serve as a unique-in-the-nation model for addressing population health and health disparities. PUBLIC HEALTH RELEVANCE: The Wisconsin
Health Equity Network (WHEN) will expand the Survey of the Health of Wisconsin, an infrastructure for population health monitoring, and combine
individual level information with data from three other organizations that monitor the quality of medical care, health care costs and public health
policies in the state of Wisconsin. The Network will be a one-of-a kind model for identifying the cause of population differences in heart and lung
disease, two of the most significant causes of death and disability in the United States. WHEN is built upon a population health foundation and
contributes to NIH goals by enhancing public health and creating opportunities for identification of programs to reduce health inequalities.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): Acute kidney Injury (AKI), a common complication after cardiac surgery,
has a high impact on clinical outcomes. The diagnosis of AKI by serum creatinine usually is delayed and occurs 2-3 days after the surgery. The failure
of prior interventional studies in cardiac surgery to attenuate AKI may be attributed to the delays in the diagnosis of AKI. The TRIBE-AKI (Translational
Research Investigating Biomarkers in Early Acute Kidney Injury) Clinical Consortium was established to accelerate the development of biomarkers.
The consortium is a multi-disciplinary group and includes investigators from five major academic centers and who have expertise in pre-clinical,
translational, epidemiologic, and health services research. In the present project, the consortium will study the following three biomarkers for early
diagnosis of AKI: urine interleukin 18 (IL-18), neutrophil gelatinase associated lipocalin (NGAL), and cystatin C. The consortium will conduct a
prospective multi-center observational cohort study of 1800 patients receiving cardiac surgery. Serial urine and serum samples will be collected from
the participating patients, along with some clinical data during hospitalization. We will compare the timing of increases in biomarker levels with the
clinical diagnosis of AKI and we will demonstrate the ability of the biomarkers for early diagnosis by 24-48 hours. Also, we will evaluate the hypothesis
that compared with serum creatinine, cystatin C will improve pre-operative risk stratification, and urine IL-18 and NGAL levels will be better markers of
post-operative AKI along with a potential to prognosticate its severity. The availability of new biomarkers to replace serum creatinine will allow for the
early and accurate diagnosis of AKI. The ultimate findings of this study will pave the way for larger multi-center studies of these biomarkers in other
clinical conditions and for interventional clinical trials to prevent or to treat AKI.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators.DESCRIPTION (provided by applicant): Despite compelling evidence of the benefits of treatment, hypertension is
controlled in less than 1/4th of US citizens. Inadequate blood pressure control results in excess cases of coronary artery disease, congestive heart
failure, stroke and other diseases. While some of the reasons for poor blood pressure control are due to poor compliance on the part of patients, there
is significant under-treatment of hypertension on the part of physicians. In 1 recent study, people with hypertension received less than 65% of
recommended care. Translation of scientific knowledge from trials such as the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack
Trial [ALLHAT] into clinical practice and improved health for patients is lagging. Heightened awareness of 'bottlenecks' in the translation of research
knowledge into clinical practice has raised enthusiasm about using creative methods, including financial incentives, to improve translation. Indeed,
pharmaceutical companies have been using financial incentives to change physician behavior for decades. Using a randomized controlled trial, we will
test the effect of explicit physician-level financial incentives to promote translation of findings from the ALLHAT trial into clinical practice and improved
control of hypertension in the primary care setting. A total of 130 primary care physicians will be randomized to 2 study arms: 1) physician-level
financial incentive only + audit and feedback; and 2) audit and feedback only. Use of thiazide diuretics among eligible patients according to the
ALLHAT study criteria and the proportion of patients achieving goal blood pressure according to the Seventh Report of the Joint National Committee
on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure goal will be the pdmary dependent variables. We will use analytic
methods appropriate for a cluster-randomized trial, as patients are nested within physicians, who are further nested in hospitals. We will assess
whether financial incentives are a cost-effective intervention. Findings from this study will provide critical information needed to implement methods of
$2,675,080
$313,169
$267,831
Project Number
2
Project Title
Principal Investigator
Performing
Organization
3R01HL08858601A2S1
MARKET COMPETITION AND THE
QUALITY OF HOME HEALTH
SERVICES
POLSKY, DANIEL E
UNIVERSITY OF
PENNSYLVANIA
3R01HL08764301A2S1
TELEMEDICINE FOR SMOKING
CESSATION IN RURAL PRIMARY
CARE
RICHTER, KIMBER P
UNIVERSITY OF KANSAS
MEDICAL CENTER
1R03HL088622-01A2
NEIGHBORHOOD STRUCTURE
AND CARDIOVASCULAR
DISEASE
ROBINSON, PAUL
LANGHAM
CHARLES R. DREW
UNIVERSITY OF MED &
SCI
25
Abstract
'paying for performance' and will be directly applicable to such programs for the 40.5 million Medicare beneficiaries and the more than 18 million
individuals cared for in staff-model health care delivery systems.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): A high quality and well functioning home health care industry is an
essential part of an integrated health care system that strives to reduce health care costs and improve the health outcomes of the population. Recently
the federal government has embraced market-based reforms to improve the quality of the health care system through public reporting of quality
information and by basing reimbursement on the provider performance. These reforms reach the home health care sector in 2004 when the federal
government launched the Home Health Quality Initiative (HHQI) for reporting of quality information. Pay for performance in home health is also
planned. These reforms require a well functioning competitive market to achieve their stated aims. Yet competition may be stifled in home health in
states with binding Certificate of Need (CON) regulations which are designed restrict entry of home health agencies. The goal of this project is to
establish the relationship between competition and quality in the home health industry and the relationship between competition and the market-based
reform of HHQI. We will test whether competition improves quality, whether HHQI improves quality, and whether the quality improvement from HHQI is
greater in more competitive markets. Our approach is to analyze competition and quality for all home health care markets in the U.S. by creating a
hierarchical panel file for the years 2001-2006 of patients, agencies, and markets. The file will be created from Medicare and OASIS data by linking
Medicare claims for hospitals to the home health agency claim and OASIS data for those patients discharged from the hospital to the home health
agency. We will use the Herfindahl-Hirschman Index as our measure of competition and home case visits, functional status improvements,
readmissions, and adverse events as indicators of quality. Our analyses will involve the use of panel and instrumental variables econometric
techniques. Ultimately our goal is to inform policy with respect to policy measures that promote competition on quality through firm entry, information
reporting, and payment for performance. PUBLIC HEALTH RELEVANCE: With an interest in improving the quality of home health care delivery, this
application aims to determine whether more competitive home health markets have higher quality care and whether the Home Health Quality Initiative
of 2004 improved quality more in the more competitive markets.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): In rural America cigarette smoking is prevalent, few cessation services are
available, and physicians often lack the time or resources to help smokers quit. This project examines whether telemedicine counseling that is
integrated into rural physician practices can outperform standard quit line counseling for smoking cessation. This is the second and final revision of
this application. The study is conducted through 25 rural physician practices in Kansas. Medical students on rural preceptorships will recruit patients
who are smokers into the trial. Self-Determination Theory guides the structure of study components and the analytic plan. Patients will be randomly
assigned to receive a standard telephone quit line intervention (QL) or an integrated telemedicine intervention (ITM). Patients in QL will receive 4
sessions of quit line counseling delivered by telephone in their homes. Patients in ITM will receive 4 sessions of telemedicine counseling delivered by
2-way webcams mounted on desktop computers in their physician office examining room. Webcams are paired with powerful software, Polycom PVX,
that permits document sharing and other activities for a highly interactive counseling experience free of the 'freeze-ups' and audio delays common with
standard webcams. QL and ITM counseling will be delivered by professional smoking cessation counselors from the University of Kansas Medical
Center Campus. The counseling protocol involves an autonomy-supportive approach. Fidelity monitoring will ensure the content remains the same
across both study arms. Both groups will receive paper-copy Quit Tips and individually-tailored quit plans and pharmacotherapy guidance. However,
all aspects of ITM will be integrated into primary care practice: sessions will take place in the physician's office; study materials will be completed and
printed for ITM patients during each counseling session via the telemedicine computer printer, and copies of session materials will be printed for
insertion into the patients' medical record. We hypothesize that ITM will outperform QL by enhancing perceived support from the counselor through the
video interface, and by facilitating more autonomy support from the patients' health care team, including support for quitting, support for using
medications to quit, and access to pharmacotherapy prescriptions. We project that 566 patients, 283 in each study arm, are necessary to detect
differences between abstinence rates in QL and ITM at 12-months post enrollment. We hypothesize that ITM will be more costly, but also more costeffective, than QL. Counseling fidelity monitoring and strong clinic support will ensure optimal implementation. The investigative team has expertise in
smoking cessation research, telemedicine, clinical cost- effectiveness research, and quality improvement in primary care. The intervention is delivered
in collaboration with one of the oldest and most successful telemedicine programs in the U.S. This intervention provides a venue for reaching a large
population of rural smokers who have poor access to smoking cessation services. It has strong potential for widespread adoption, and future
adaptation for other pressing issues such as obesity. Public Health Relevance: Cigarette smoking is prevalent in rural areas, and physicians often lack
the time and resources to help smokers quit. This project examines whether telemedicine counseling that is delivered through physician offices is
effective for smoking cessation among rural smokers. The potential health impact is large because the prevalence of smoking is high in rural areas,
access to smoking cessation services is low, and new rules for Medicare reimbursement creates a strong potential for widespread adoption.
DESCRIPTION (provided by applicant): This project will utilize geographic analysis techniques to create measures that detect the influence of key
aspects of the local social and built environmental on cardiovascular disease management at the individual level. The specific community
characteristics that these measures will be constructed for are 1) geographic access to primary care, 2) local nutritional contexts, and 3) proximity to
public opportunities for exercise. The study has the following specific aims: Specific Aim 1: To determine whether self reported cardiovascular disease
related behaviors and outcomes (physical activity, nutritional behaviors, and health outcomes) are independently influenced by geographic
relationships to local nutritional outlets, and proximity to public opportunities for exercise even after controlling for known predisposing, enabling and
need based factors, along with perceptions of public safety. Specific Aim 2: To determine whether the independent effects of local food and exercise
opportunity environments will be differentially distributed, with some age groups, gender groups, income groups and or racial/ethnic groups health
related behaviors and outcomes being disproportionately impacted by the local environmental situation. The analysis will proceed as follows: a)
nesting Los Angeles Health Survey respondents within their local health care accessibility contexts by utilizing street network based gravity models as
indicators of geographic accessibility to primary care providers, b) nesting Los Angeles Health Survey respondents within their local food availability
Total Cost
$25,956
$186,816
$70,499
Project Number
2
Project Title
Principal Investigator
Performing
Organization
1R21HL093129-01A1
BLOOD TRANSFUSIONS:
GENDER DIFFERENCES IN
UTILIZATION, PREDICTORS, AND
OUTCOMES
ROGERS, MARY A. M.
UNIVERSITY OF MICHIGAN
AT ANN ARBOR
3R01HL08791801A2S1
TIME RESOLVED CARDIAC
COMPUTED TOMOGRAPHY WITH
PATIENT DOSE REDUCTION
TAGUCHI, KATSUYUKI
JOHNS HOPKINS
UNIVERSITY
3R21HL084528-03S1
EFFECT OF PARAMEDIC AIRWAY
EXPERIENCE ON PATIENT
OUTCOMES
WANG, HENRY E
UNIVERSITY OF ALABAMA
AT BIRMINGHAM
26
Abstract
contexts by utilizing street network based gravity models to characterize local access to health promoting and health inhibiting food outlets (fresh
produce vs. fast food), derived from geo-coded food license data, c) nesting Los Angeles Health Survey respondents within their local public exercise
space contexts using geographic data on parks and open space to derive street network based gravity models of geographic accessibility to land uses
that have been shown to influence levels of physical activity within a community. These predictor variables will be incorporated within a hierarchical
analytical model that accounts for the known influences on health care utilization and the use of public facilities. PUBLIC HEALTH RELEVANCE: One
of the major obstacles confronting researchers interested in the translation of cardiovascular disease research to clinical practice is a lack of
knowledge concerning the barriers and facilitators to research translation that exist in different types of social and built environments. The proposed
research will utilize geographic analysis techniques to create measures that can detect the influence of local community environment and structure on
cardiovascular related behaviors and management at the individual level. The specific community characteristics that these measures will be
constructed for are, 1) geographic access to primary care, 2) local nutritional contexts, and 3) proximity to public opportunities for exercise.
DESCRIPTION (provided by applicant): Blood transfusion is the most common ICD-9-coded procedure performed in women during hospitalization in
the United States. Transfusions are more frequent in women than men since the criteria for prescribing a transfusion often rests with threshold levels
of hematocrit or hemoglobin which are normally lower in women. While transfusions have been considered life- saving in patients with significant blood
loss, there is increasing evidence of immunomodulatory effects and thrombosis after transfusion. Unfortunately, there are no population-based reports
on the characteristics of people who receive blood transfusions in the United States and little research regarding gender-specific outcomes during the
post-transfusion period. A cohort study is proposed to examine the profiles of women and men who receive transfusions and gender- specific posttransfusion outcomes. Subjects will be a representative sample of Americans, ages 65 years and older, who were enrolled in fee-for-service Medicare
programs. There are three specific aims: (1) to examine the variability in blood transfusion by subject characteristics, type of provider, and region in a
representative sample of elderly Americans; (2) to assess the risk of infection after allogeneic blood transfusion in women and men; and (3) to assess
the risk of thrombotic events after allogeneic blood transfusion in women and men. Linked files from the nationally-representative Health and
Retirement Study (HRS) and the Medicare data will be used. This will include Center for Medicare and Medicaid Services (CMS) data for hospital
stays, physician visits, home health services, skilled nursing facility stays, visits to outpatient clinics and ambulatory surgical centers, emergency
department visits, hospice services, and clinical laboratory services from 1991 through 2007. Information regarding blood transfusion, infection, and
thrombotic events (deep-vein thrombosis, pulmonary embolism, transient ischemic attack, stroke, and myocardial infarction) will be extracted from
CMS files. Data regarding demographic information, lifestyle factors, disabilities, and medical history will be obtained from the HRS. Statistical
analyses will involve weighting to account for the sampling design of the HRS and the results will be presented as national estimates of blood
utilization for elderly women and men in the United States. Public Health Relevance: This study will provide the public, clinicians, and policy-makers
with information regarding blood utilization, predictors of blood transfusion, and outcomes associated with blood transfusion in elderly women and men
in the United States.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): Cardiovascular disease remains the leading cause of death in the western
world, placing an ever-increasing burden on both private and public health services. The electrocardiogram (ECG)-gated cardiac CT imaging is a
promising non-invasive technique for early detection of fatty vulnerable plaque in coronary arteries. However, there are two major problems with the
current technique: large patient radiation dose and insufficient temporal resolution (TR). Currently, the typical radiation dose is 10-15 move, which is 35 times as large as a standard chest CT scan. The current TR is merely 80-165 ms in contrast to the minimum requirement of 10-30 ms to observe the
beating heart motion without motion artifact. Current technique uses the ECG-signals to select projection data acquired in a time window that is placed
within the 'quiet' portion of the cardiac cycle (e.g., mid-diastole). Then, images are reconstructed by neglecting the cardiac motion within the time
window resulting in blurring and artifacts in the reconstructed images. Also, this technique uses only 10-30% of the acquired data and throws away the
rest of 'off-phase' data, resulting in unnecessary radiation dose to the patient. The long-term goal of this research is to develop the time resolved, low
dose cardiac CT imaging. Specifically, we will develop algorithms that estimate the time-dependent motion vector field of the heart from the measured
data and integrate it into the image reconstruction process. The motion will be estimated by maximizing the agreement between the acquired 4D
projection data and the reconstructed time-resolved 4D images. The quality of the image will be significantly improved since the motion is
compensated. In addition, lower tube current could be utilized since all of the acquired data will be used to reconstruct any cardiac phase of interest.
We estimate the reduction of radiation dose to the patient will be 50-75% of the current level. Our specific aims are: (1) to develop computer simulation
tools necessary to study the problem, (2) to develop new methods that integrates the motion estimation and the image reconstruction algorithms for
time resolved, low dose cardiac CT application, (3) to conduct the quantitative and qualitative evaluation of the performance of the new algorithms with
various factors with patients and parameters used in the algorithms. The proposed methods will not only solve the current problems of motion blur and
excessive radiation dose, but also enable future cardiac applications (e.g., correlation between the motion, perfusion and stenos is) that are not
possible with the current techniques.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): This is a proposal for the NHLBI R21 Innovative Research Grant Program,
which encourages the analysis of existing data sets to explore new hypotheses. Endotracheal intubation (ETI) is the insertion of a plastic tube into the
trachea (throat) to assist the breathing of a patient with a critical illness such as cardiopulmonary arrest, heart failure, respiratory failure or major
trauma. While ETI is performed by physicians in the hospital, resuscitation usually begins in the out-of- hospital setting under the care of paramedics.
In many fields of clinical practice, medical errors are known to be associated with both practitioner procedural volume as well as patient outcome.
Many studies have found that paramedics commit errors when performing ETI. Furthermore in a preliminary study, we found that paramedics perform
ETI infrequently in clinical practice and at frequencies far below that needed to maintain procedural proficiency, safety and effectiveness. Few direct
links between the procedure, success and errors, and patients outcomes (including hospital course or resource utilization) exist. We posit that ETI
performed by paramedics with low procedural experience may adversely affect patient outcome and hospital course of care. The goal of this study is
Total Cost
$239,076
$232,888
$4,234
Project Number
2
Project Title
Principal Investigator
Performing
Organization
Abstract
Total Cost
to determine if paramedic (ETI) procedural experience is associated with patient outcomes and in-hospital course of care. In the proposed study we
will probabilistically link three publicly- available statewide administrative databases encompassing paramedic patient encounters, admitted inpatients
and deaths. We will apply multivariable regression to the linked data set to evaluate the connection between paramedic ETI procedural experience
(annual volume of ETI), outcomes (mortality and in-hospital adverse events) and in-hospital resource utilization. We propose a new collaboration
between research teams at the Universities of Pittsburgh and Utah, which have expertise in the areas of out-of-hospital care, health services research,
the analysis of large-scale data sets and probabilistic linkage. These findings may demonstrate that paramedic ETI experience directly impacts patient
outcome, and may promote major changes in the design and delivery of this life-saving out- of-hospital intervention. These findings would also confirm
this linkage method as a new, powerful tool to evaluate the earliest portion of acute medical care - that begun in the out-of-hospital setting.
National Institute of Allergy and Infectious Diseases (NIAID)
3U01AI034993-16S1
WOMEN'S INTERAGENCY HIV
STUDY (WIHS) IV, CHICAGO
CONSORTIUM
COHEN, MARDGE H
HEKTOEN INSTITUTE FOR
MEDICAL RESEARCH
3R03AI082703-01S1
BUILDING PARTNERSHIPS TO
PROMOTE HEALTH IN LOW
LITERACY POPULATIONS
SIA, IRENE G
MAYO CLINIC COLL OF
MEDICINE, ROCHESTER
3R03AI082703-02S1
BUILDING PARTNERSHIPS TO
PROMOTE HEALTH IN LOW
LITERACY POPULATIONS
SIA, IRENE G
MAYO CLINIC COLL OF
MEDICINE, ROCHESTER
27
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. The WIHS is a multi-site prospective epidemiology cohort study of women enrolled in 1994and 2002 who either are
infected with HIV or are at increased risk for acquiring HIV infection. The purpose of the study is to continue follow-up of the WIHS cohort, thereby
supporting studies of the natural and treated history of HIV infection in representative, primarily minority, adult women in the United States, as well as
supporting studies of emerging questions related to long-term HIV infection and treatment. WIHS-IV scientific initiatives will include ongoing core
research projects and the initiation of new projects on the predictors of response to antiretroviral therapy and long term consequences of HIV infection
and HIV therapy in terms of cardiovascular disease, liver disease, hormonal function, neurocognitive impairment, cancer and other morbidities, as well
as progression to AIDS and death. Additionally during the WIHS-IV grant cycle scientific collaborations will continue to expand independent,
investigator-driven research grants. As an ongoing cohort study that, The Chicago site will continue to support the overall WIHS scientific research
agenda by continuing to collect quality data and specimens from participants and maintain superb cohort retention. The Chicago site will also provide
leadership for key areas of interest including HIV virology and host immunology, long term pathogenesis of HIV infection and treatment toxicities, and
impact of viral resistance. Topics of study will include the effect of co-infections such as hepatitis C (HCV) and B virus(HBV), human papilloma virus
(HPV); therapy use and treatment effects in women, behavioral and psychosocial factors influencing HIV disease, effects of metabolic abnormalities,
impact of hormonal factors on HIV disease; the effects of aging and menopause on HIV disease, the interaction of environmental and host genetic
factors on HIV disease; and the assessment of brain structure, neurocognitive functioning, and physical impairment among WIHS participants.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): Low literacy influences individuals' attitudes toward health information and
research, and is associated with poor health outcomes. Low literacy adults are disproportionately racial and ethnic minorities who also have the
highest tuberculosis (TB) prevalence in this country. The overall long-term objective of this application is to strengthen the research collaboration of
Rochester's scientific community and the Hawthorne literacy community for addressing sensitive health issues affecting diverse populations. This
application focuses on the development of innovative ways for communication of culturally sensitive health information and implementation using
community-based participatory research (CBPR) approach. We will build community health research capacity by orienting community members to
research methods. We will use the model of adult informal education to understand socio cultural factors influencing TB evaluation, and develop
culturally sensitive and linguistically appropriate learning approach to TB evaluation for the Hawthorne community. The application is designed to
achieve the aims by basing it in the Hawthorne community, rather than in a scientific institution. Hawthorne community members will be engaged in
the entire process and it is their cultural beliefs and concerns, expressed in focus groups and in-depth interviews that will form the basis of TB
education and evaluation. A health team from the Hawthorne community will be recruited from focus group participants and assigned significant roles
in the design, implementation, and evaluation phases of the project. The Rochester scientific community will bring its strengths in health promotion and
care, research and analysis to the project. Together, the two communities will gain experience as a research team and have an experiential base to
learn about CBPR. In Rochester, MN, a city of 100,000 people, there is a disconnect between the scientific community (Mayo Clinic, University of
Minnesota Rochester, and Winona State University) and the low level literacy community (Hawthorne Education Center). Both literally and figuratively,
these two communities do not speak the same language. Through an established CBPR partnership, these two disparate communities will jointly work
and learn the process of health science research. As the two communities learn and work together, they will build an ongoing relationship based on
respect, trust and a shared commitment to improving the health of the Hawthorne community. This application is of paramount importance in
transforming community perceptions of the scientific process and research, and to public health. This project will promote the active engagement of
affected members of the community to work with researchers to maximize the potential for change in knowledge, attitudes, and behavior as they
pertain to the health needs of the community. It also addresses a vital public health interest by devising and implementing effective communication
strategies for tuberculosis evaluation in some of the highest risk populations in this country.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): Low literacy influences individuals' attitudes toward health information and
research, and is associated with poor health outcomes. Low literacy adults are disproportionately racial and ethnic minorities who also have the
highest tuberculosis (TB) prevalence in this country. The overall long-term objective of this application is to strengthen the research collaboration of
Rochester's scientific community and the Hawthorne literacy community for addressing sensitive health issues affecting diverse populations. This
application focuses on the development of innovative ways for communication of culturally sensitive health information and implementation using
community-based participatory research (CBPR) approach. We will build community health research capacity by orienting community members to
research methods. We will use the model of adult informal education to understand socio cultural factors influencing TB evaluation, and develop
culturally sensitive and linguistically appropriate learning approach to TB evaluation for the Hawthorne community. The application is designed to
achieve the aims by basing it in the Hawthorne community, rather than in a scientific institution. Hawthorne community members will be engaged in
the entire process and it is their cultural beliefs and concerns, expressed in focus groups and in-depth interviews that will form the basis of TB
education and evaluation. A health team from the Hawthorne community will be recruited from focus group participants and assigned significant roles
$111,392
$15,896
$99,998
Project Number
2
1R21AI084060-01
Project Title
DISPARITIES IN SEXUALLY
TRANSMITTED INFECTIONS
AMONG YOUNG WOMEN: ROLE
OF INDIVID
Principal Investigator
WIEHE, SARAH
ELIZABETH
Performing
Organization
INDIANA UNIV-PURDUE
UNIV AT INDIANAPOLIS
Abstract
in the design, implementation, and evaluation phases of the project. The Rochester scientific community will bring its strengths in health promotion and
care, research and analysis to the project. Together, the two communities will gain experience as a research team and have an experiential base to
learn about CBPR. In Rochester, MN, a city of 100,000 people, there is a disconnect between the scientific community (Mayo Clinic, University of
Minnesota Rochester, and Winona State University) and the low level literacy community (Hawthorne Education Center). Both literally and figuratively,
these two communities do not speak the same language. Through an established CBPR partnership, these two disparate communities will jointly work
and learn the process of health science research. As the two communities learn and work together, they will build an ongoing relationship based on
respect, trust and a shared commitment to improving the health of the Hawthorne community. This application is of paramount importance in
transforming community perceptions of the scientific process and research, and to public health. This project will promote the active engagement of
affected members of the community to work with researchers to maximize the potential for change in knowledge, attitudes, and behavior as they
pertain to the health needs of the community. It also addresses a vital public health interest by devising and implementing effective communication
strategies for tuberculosis evaluation in some of the highest risk populations in this country.
DESCRIPTION (provided by applicant): Although there are significant and longstanding racial disparities in sexually transmitted infections (STI)
among young women, their causal mechanisms are unidentified. Unprotected sex, concurrency, and partner choice are well established risk factors,
but they do not account for the differences between racial groups. One factor known to differ significantly by race and correlate strongly with STI risk is
incarceration. High rates of incarceration and crime in a community have also been associated with higher STI prevalence in that community. Despite
these associations and the dramatic differences in incarceration by race, few researchers have studied both individual- and community-level exposure
to incarceration and crime and assessed whether these may partially explain STI disparities among young women. Among young women,
incarceration and crime may influence STI risk both directly and indirectly. Interaction with the justice system may directly influence sexual risk
behavior or substance use social norms. Following incarceration, an individual may have greater difficulty obtaining social services and gainful
employment. Incarceration breaks up existing sexual partnerships and family units, removing and distancing the individual or partner and his/her
economic and/or social support. Less direct effects of high incarceration rates in a community may lead to a paucity of eligible males, contributing to
women having less power to negotiate condom use or being more tolerant of her partner's concurrency. Ex-offenders may change community social
norms and transmit STIs as a result of their own riskier sexual behaviors and increased STI burden. In addition to these direct and indirect effects of
incarceration, the confounding individual and community factors which may contribute to the likelihood of incarceration may also contribute to STI
acquisition. In short, although the existing literature has repeatedly reported associations between incarceration and STIs, the direct, indirect, and
confounding mechanisms have been difficult to tease apart and inadequately addressed to date. By building on relationships with justice system and
public health leaders, our interdisciplinary team will link juvenile detention, incarceration, public health and clinical data sources at an individual-level to
study incarceration, crime and STIs among young women 14 to 25 years old. The 10-year longitudinal data will help answer whether the association
between incarceration and STI is causal or confounding and allow us to investigate further which specific factors of incarceration - timing, duration,
indication, and recidivism history - contribute most to STI risk. We will employ geospatial methodologies to examine the effects of community-level
incarceration in more depth, using point-level data and different extents of exposure. As different mechanisms may contribute to the spread of various
STI differently, we will evaluate Chlamydia, gonorrhea, syphilis, and HIV independently and in combination. Most importantly, we will evaluate how
differences in individual- and community-level incarceration and crime may contribute to STI disparities among African American compared to white
young women. Specifically, we aim to (1) assess whether the association between incarceration and sexually transmitted infections (STI) is stronger
when incarceration precedes first STI; (2) assess whether community incarceration and crime rates are associated with an individual's risk of STI, after
accounting for an individual's incarceration history; and (3) assess whether increased risk of STI among minority young women is diminished when
accounting for an individual's differential incarceration rate and exposure to community incarceration and crime rates. PUBLIC HEALTH RELEVANCE:
As a result of the proposed research, we will better understand the relationship between incarceration, crime and sexually transmitted infection (STI)
among young women and whether it contributes to significant racial disparities in STI. With this increased understanding, we will be better able to
target resources to individuals and communities in need -during or preceding incarceration, in the community and/or through the justice system. From
a public health and health services perspective, this information will aid in guiding policy and individually-targeted action in STI treatment and
prevention.
Total Cost
$199,525
National Institute of Child Health and Human Development (NICHD)
1R03HD057997-01A1
28
HELP SEEKING BEHAVIOR IN
COLLEGE WOMEN
AMAR, ANGELA F
BOSTON COLLEGE
DESCRIPTION (provided by applicant): A significant problem with health implications is intimate partner violence (IPV). College women are at greater
risk for intimate partner violence, rape and other forms of sexual assault, usually in dating experiences, than women in the general population or in a
comparable age group 1, 2. Despite campus prevention and intervention programs, the majority of college women do not report their DV to campus or
local authorities and many do not seek needed health care or mental health services 3, 4. Limited research explores help seeking behavior, defined as
any behavior that one uses to solve a problem, in college women, especially related to violence 5. The purpose of this project is to determine the
significant attitudes and beliefs that are associated with reporting of dating violence in college women. Achieving this goal will guide future research
developing and testing effective prevention and intervention strategies to facilitate and increase reporting of dating violence in this population. The
proposed study uses an exploratory design, guided by the Theory of Planned Behavior (TPB), to test the relationship of attitudes and beliefs with the
help seeking behavior of reporting dating violence and to describe dating violence help seeking behavior of college women. Specific aims and
hypotheses are as follows. Aim 1) to determine significant attitudes and beliefs associated with the help seeking behavior of reporting DV Hypothesis
1) it is expected that a positive relationship of moderate strength will exist between intention to report and a) positive normative beliefs about help
seeking, b) lower perceived barriers to help seeking, c) increased cognitive beliefs about DV. Aim 2) to identify the significant attitudes and beliefs that
differentiate between individuals with intention to report violence and those who do not intend to report violence. Hypothesis 2) individuals who intend
to report DV will be more likely to have increased mental health symptoms of somatization, anxiety depression and general psychological distress and
lower levels of social support than individuals who are not likely to report violence. Aim 3) to identify the significant attitudes and beliefs that
differentiate between victims with intention to report violence and those who do not intend to report violence. Hypothesis 3) victims who intend to
$78,250
Project Number
2
Project Title
Principal Investigator
Performing
Organization
1R03HD057270-01A2
THE EFFECTS OF CHILDHOOD
HEALTH INTERVENTIONS ON
HUMAN CAPITAL DEVELOPMENT
BARHAM, TANIA
UNIVERSITY OF
COLORADO AT BOULDER
1R21HD061644-01
PHYSIOLOGICAL REACTIVITY TO
ACUTE STRESS DURING
PREGNANCY
CHRISTIAN, LISA
MICHELLE
OHIO STATE UNIVERSITY
29
Abstract
report DV will be more likely to have experienced significantly higher levels of violence, increased mental health symptoms of somatization, anxiety
depression and general psychological distress and lower levels of social support than victims who are not likely to report violence; Aim 4) to describe
the formal and informal help seeking behavior of victims of dating violence. A nonprobability purposive sample of 2500 college women will be recruited
for an electronic survey. Hypotheses will be tested, using logistic regression. Determining significant attitudes and beliefs that predict DV help seeking
is necessary to develop interventions that are clinically meaningful and theoretically driven.
PUBLIC HEALTH RELEVANCE: Relevance to Public
Health Violence against women is a significant public health and societal issue. Experiencing DV is associated with immediate and long term physical
and mental health consequences. Many victims do not disclose their experience or seek healthcare or mental health counseling. When violence is
undetected and treatment is not provided, the health consequences increase. Past experiences of violence predict future experiences of violence.
Limited research explores dating violence help seeking of college women. The proposed project seeks to enhance primary and secondary prevention
by providing theoretically driven and clinically relevant intervention strategies. The proposed study offers a conceptual base to understand the attitudes
and beliefs associated with reporting and disclosing intimate partner violence and the influence of friends and peers. The knowledge gained from this
theory-driven study will aid in the planning of an intervention program to target specific attitudes and beliefs in order to increase reporting and
disclosing intimate partner violence. Health professionals will use the findings to enhance the screening and surveillance procedures for identifying
individuals who have experienced intimate partner violence. It is clear from the literature that college students experience IPV and experience health
consequences. Therefore, it is important to determine ways to increase identification of victims so that services can be provided.
DESCRIPTION (provided by applicant): The health and nutrition of young children is of importance not only for the immediate improvement in their
well-being but also because of the longer-term impacts on children's physical and cognitive development. It is believed that improvements in cognitive
development may lead to improved educational achievements, productivity, and labor market opportunities which in turn can break the chain of
intergenerational transmission of poverty. This project seeks to evaluate the effect of early childhood health interventions and a family planning
program typical of developing countries on the cognitive functioning of those same children when they are 6-19 years old. Rigorous empirical
estimates of these types of programs are difficult because community selection into child health programs and household use of health services are
often not random. In addition, estimating long-term effects of early childhood health programs is challenging owing to a lack of detailed, longitudinal
data from well-designed programs that took place 10 or more years ago. Furthermore, inclusion of cognitive functioning outcomes was not common in
survey data in developing countries in the past. The above mentioned challenges have meant that few studies have rigorously examined the role of
early childhood health and family planning programs on later cognitive development. To contribute to this needed body of research, we propose to
take advantage of the quasi-random placement of the Matlab Maternal and Child Health and Family Planning Program (MCH-FP) in Bangladesh which
began in the late 1970s to overcome some of the methodological problems previous studies have faced. In addition, the interventions were phased-in
over time with the family planning activities introduced first and the child health interventions five or more years later. This phasing-in allows a
comparison of the effect of the program on children affected by the family planning and maternal health interventions as young children to those also
eligible for the child health interventions. The analysis will benefit greatly from the unique and rich secondary data sources which are available in the
Matlab area. In particular, the Matlab Health and Demographic Surveillance System has collected monthly demographic data (e.g., births,
vaccinations, death, migration) since 1966 and will aid in the analysis of attrition due to mortality and migration. Census data for the Matlab area are
also available for the years prior to the program 1974. Using these data we show that the treatment and comparison were similar in many respects
prior to the introduction of the MCH-FP program. Finally, the 1996 Matlab Health and Socio-Economic Survey collected data, including a measure of
cognitive functioning, from a random sample of children who were part of the experiment in the 1970s and 1980s. This research will provide critical
analysis on the medium-term benefits of the MCH-FP program for an R01 grant that the University of Colorado at Boulder team along with other plan
to resubmit in 2009. PUBLIC HEALTH RELEVANCE: The health and nutrition of young children is of importance not only for the immediate
improvement in their well-being but also because of the longer-term impacts on children's physical and cognitive development. It is believed that
improvements in cognitive development may lead to improved educational achievements and labor market opportunities which in turn can break the
chain of intergenerational transmission of poverty. Empirical estimates of the long-term effects of early child health interventions on cognitive
functioning later in life are not well established. The proposed research overcomes methodological issues that have hampered pervious research by
examining the cognitive functioning of 6-19 year olds who were part of a quasi-randomly placed experiment.
DESCRIPTION (provided by applicant): Preterm delivery, an increasingly frequent occurrence in the United States, is associated with significant family
burden and an estimated societal cost of at least $26 billion per year. In the U.S., the preterm birth rate is 12-13% as compared to 5-9% in other
developed countries. Persistent racial disparities contribute to this discrepancy. Psychosocial stress and related physiological sequelae may contribute
to preterm birth overall, as well as to racial disparities in preterm birth. The experience of chronic stress, such as that conferred by racial minority
status, may sensitize physiological stress responses. Indeed, as compared to Caucasians, African-Americans exhibit greater cardiovascular reactivity
to a variety of acute stressors. Importantly, blood pressure, glucocorticoid, and catecholamine responses to acute stress are attenuated during healthy
pregnancy as compared to non-pregnancy. This adaptation may protect the mother and fetus from potentially detrimental effects of maternal
physiological activation. Thus, women who exhibit greater and more extended physiological reactions to everyday stressors may be at increased risk
for negative perinatal outcomes. Notably, no studies of acute stress during pregnancy have examined inflammatory immune responses or
mechanisms underlying blood pressure change (i.e., cardiac output, total peripheral resistance). Moreover, limited information is available regarding
effects of race on physiological adaptation to pregnancy. The current study will address important gaps in the literature by examining cardiovascular,
endocrine, and immune reactivity to acute stress among 40 healthy pregnant women (20 Caucasian, 20 African-American) and 40 demographically
matched nonpregnant control women. This research is designed to ultimately lead to the identification of women at greater risk for negative perinatal
outcomes and elucidation of mechanisms underlying increased risk, providing a basis for individualized health care services. Specific Aim #1: To
utilize more comprehensive and advanced methodology to assess physiological reactivity during pregnancy versus nonpregnancy, including measures
of inflammation, impedance cardiography, and glucocorticoid receptor function. Hypothesis #1: Pregnant women will show attenuated physiological
responses to acute stress as compared to nonpregnant women. Specific Aim #2: To examine racial differences in physiological reactivity during
Total Cost
$68,050
$181,209
Project Number
2
Project Title
Principal Investigator
Performing
Organization
3R01HD054880-03S1
A RANDOMIZED TRIAL OF A
MENTORING PROGRAM FOR
HIGH RISK CHILDREN
EDDY, JOHN MARK
OREGON SOCIAL
LEARNING CENTER, INC.
1R21HD060175-01A1
EXPLAINING BLACK-WHITE
DIFFERENCES IN AVOIDABLE
MORTALITY, 1980-2005
ELO, IRMA T. ;MACINKO,
JAMES ;
UNIVERSITY OF
PENNSYLVANIA
3U54HD041748-05S1
THE BIOLOGIC EFFECTS OF
ANDROGENS IN MEN AND
WOMEN
FRIEDMAN, THEODORE C
CHARLES R. DREW
UNIVERSITY OF MED &
SCI
30
Abstract
pregnancy versus nonpregnancy. Hypothesis #2: As compared to Caucasian women, African-American women will exhibit greater physiological
reactivity to stress during pregnancy and nonpregnancy. Specific Aim #3: To examine psychosocial correlates of physiological reactivity during
pregnancy and nonpregnancy. Hypothesis #3: Women reporting greater distress will exhibit greater physiological reactivity during pregnancy and
nonpregnancy. Specific Aim #4: To examine associations between physiological reactivity and length of gestation. Hypothesis #4: Greater
physiological reactivity to acute stress will predict shorter gestational length. PUBLIC HEALTH RELEVANCE: This study will fill important gaps in our
knowledge regarding physiological adaption during pregnancy and effects of race on such adaptation. Information gained from this study will provide
the groundwork for the following: 1) identification of women at greater risk of negative perinatal outcomes; 2) describing physiological mechanisms
underlying the link between stress and risk of preterm delivery; and 3) providing interventions designed to reduce the effects of stress and promote
healthy pregnancy and fetal development.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. Mentoring is widely viewed as an effective preventive intervention for a variety of youth problems and
consequences, including conduct disorder and delinquency, academic failure and school dropout, substance use and abuse, and early sexual
behavior and teen parenthood. In recent years, there has been strong support for mentoring programs from policymakers at the local, state, and
federal levels. While there have been a variety of outcome studies on mentoring, and mentoring appears to have at least small, positive effects on
youth in the short run, little is known about the long term influence of programs on the 'high risk’ children assumed to need mentoring the most, and
almost nothing is known about how characteristics and qualities of the mentoring relationship are related to youth outcomes. We propose to conduct a
longitudinal randomized controlled preventive intervention trial designed to assess the impacts of an established, privately funded, long term, intensive
youth mentoring program called Friends of the Children (FOTC). FOTCpartners with inner city public schools to identify and enroll kindergarten-age
children thought to be at high-risk for conduct disorder, academic failure, and teen parenthood due to serious levels and/or combinations of individual
and family risk factors. FOTC mentors, called 'Friends', are paid, full time employees who are rigorously trained and supervised. Friends work with not
more than eight children at a time. Through FOTC, children are exposed to a variety of skill building and recreational experiences and assisted in
accessing resources in a variety of areas, including academic and physical and mental health services. Participants for the study (N = 256; 80%
minority, 50% girls) will be recruited through existing programs located within impoverished, inner city areas of Boston; San Francisco; Seattle; and
Portland, Oregon. Children will be randomly assigned to either FOTC or a referral control condition. Children, their primary caregivers, and Friends will
be assessed prior to program initiation in kindergarten, and during each subsequent year through the end of third grade. On an annual basis, primary
teachers will be assessed; direct observations of Friend-child social interaction will be conducted; and school and FOTC program records will be
collected. A teach assessment, information will be collected on child behavioral, emotional, and academic adjustment, as well as on the quality and
characteristics of child-peer, child-caregiver relations, child-Friend, and child-other adult (i.e., natural mentor) relationships. Analyses will examine child
outcomes overtime; the impact of Friend-child relationship quality on program satisfaction, engagement, and persistence as well as on child outcomes;
and differential effectiveness based on ethnicity, child gender, and baseline risk status. The findings from this study will have important implications for
mentoring practice and policy.
DESCRIPTION (provided by applicant): Despite unprecedented mortality declines during the 20th century, black-white disparities in all cause and
cause-specific mortality continue to be substantial in the United States. Explanations offered for these disparities include black-white differences in
income, education and wealth, racial discrimination, and disparities in access to health care, including differential treatment in the health care system.
Despite the vast literature on black-white differences in health and mortality there is little consensus regarding how best to reduce them. This project
proposes new ways to analyze black-white mortality disparities in the U.S. between 1980 and 2005 by investigating the contribution of causes of death
considered avoidable by (1) high-quality and timely medical care and (2) policy/behavior interventions. Although the study of avoidable mortality (AM)
originated in the U.S., it has been applied mainly in other countries as an indicator of health system performance and thus its role in explaining B-W
mortality disparities in the U.S. is not known. We will estimate the contribution of various categories of AM and non-AM to black-white differences in life
expectancy at birth and to changes therein between 1980 and 2005; investigate the effect of state-level policies, health system and socioeconomic
characteristics on state-level variation and black-white differences in various categories of AM and non-AM between 1980 and 2005; and examine
effects of individual-level socio-demographic characteristics and health behaviors on black-white differences in various categories of AM and non-AM
from 1986 to 2002. The strengths of the study include the use of multiple data sources (vital statistics and census data; state- level policies, health
resources, and socio-demographic characteristics; and National Health Interview Survey- Multiple Cause of Death data) and methods (demographic,
econometric). The analyses will complement prior individual- and disease-oriented studies of black-white disparities in the leading causes of death by
estimating the impact of causes grouped by the main means of reducing them (e.g. medical care, public policy, behavior). PUBLIC HEALTH
RELEVANCE: The elimination of race/ethnic health disparities is one of the public health priorities in the United States. The proposed project
contributes to this goal by improving our understanding of black-white disparities in mortality due to causes of death that are avoidable by good quality
medical care and amenable by policy /behavior interventions. The results will aid in monitoring health inequalities and help guide public investments to
areas of greatest need.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): With a longstanding history of collaborations in education, health services
research and community service, Drew University, the only historically black medical school west of the Mississippi River, and UCLA, one of this
nation's premier universities, are strategically positioned to establish a multi-disciplinary, collaborative, thematically focused and integrated
reproductive science research program aimed at studying the biologic effects of androgens in men and women. The Drew-UCLA Reproductive
Science Research Center will augment and strengthen the research infrastructure and research capabilities of faculty and trainees at Drew University
by supporting the development of several new translational and clinical research projects deemed to be of high priority and significance because of
their relevance to reproductive health of men and women. The objectives of this grant proposal - to develop an integrated research program that
serves as the foundation for future expansion in reproductive biology, reproductive endocrinology, and reproductive medicine at Drew - are reflected in
Total Cost
$7,696
$243,735
$32,712
Project Number
1R01HD059756-01
31
2
Project Title
ADOLESCENT HEALTH
LITERACY: IMPROVING USE OF
PREVENTIVE HEALTH SERVICES
Principal Investigator
GLIK, DEBORAH C
;PRELIP, MICHAEL LEE;
Performing
Organization
UNIVERSITY OF
CALIFORNIA LOS
ANGELES
Abstract
the following specific aims: 1). Support the implementation of two reproductive science research projects that effectively use the scientific strengths of
our institutions, and promote multi-disciplinary approaches to the specific research topics in the priority areas identified by this RFA; 2) Provide support
for two pilot projects to generate data to facilitate the development of innovative hypotheses and studies, and support the efforts of our investigators to
generate preliminary data and publications that can help assure their transition to independent funding; 3) Facilitate and formalize new collaborative
networks in reproductive science between scientists at Drew University and UCLA; 4) Develop an Administrative and Planning Core to support the
scientific projects. These specific aims will be accomplished by implementing two core research projects and two pilot projects, each having
interrelated specific aims consistent with the Center's long-term objectives. The research projects will be supported by an Administrative and Planning
Core. The proposed core and pilot projects are inter-linked by a common theme, namely, Biologic Effects of Androgens in Men and Women. Energetic
program leadership, cross-disciplinary research projects that are thematically-linked and that evolve logically from our current strengths, enthusiastic
commitment of bi-institutional support, a large pool of talented, participating faculty, deep historical roots of our institution in the minority communities,
and strong infrastructural support from pre-existing Hormone Assay, Body Composition, RCMI [Research Center for Minority Institution] Molecular
Medicine Core, and Exercise Physiology Core laboratories, and University administration, make our institution particularly suitable to benefit from this
NICHD initiative.
s 1 R01 HD059756-01 (Glik, Prelip)Adolescence is characterized by social, physical, cognitive and emotional transitions. Developmental goals for
teens include their becoming responsible and independent. While adolescents have many health issues and programs addressing them, one area of
that is of growing interest is how adolescents interface with the medical care system. Most adolescents have access to healthcare and healthcare
insurance (88% of teens are insured), however, they may have little experience or skill using healthcare effectively, especially those from
disadvantaged backgrounds. Preventing disease and promoting health are integral part of current clinical primary care practice. In the proposed study
we will partner with Health Net of California, a large health insurance corporation, to develop, implement, and assess an intervention to increase their
adolescent patients' utilization of preventive care and decrease emergency services use. We will engage beneficiaries of public health insurance
namely Medicaid (Medi-cal) and SCHIP (Healthy Families) clients whose health care is managed by Health Net. Our goal is to develop a health
literacy training intervention to encourage adolescents aged 12 - 17 to utilize their health care plan more effectively, specifically to increase the rate at
which they receive an annual Adolescent Well Care Visit. Additionally we will attempt to increase their level of engagement in their health care and
their own health. We will use a randomized controlled trial to test the effectiveness of two different interventions, one web based social media
intervention and one that could be called 'usual care'. We will recruit an initial volunteer sample of 8000 Health Net patients out of 155,000 Medi-cal
and Healthy Families teens they serve. We will conduct a 2 wave repeated measures survey to assess intervention impact on utilization patterns,
health care system knowledge, positive encounters with their primary care provider, health information seeking, attitudes towards health care, and
health behaviors. Data will also be collected from Health Net administrative data bases. Based on response rates and attrition we anticipate a final
sample of 3478 participants distributed across the two study conditions (n= 1739 each) which are the treatment condition (social media)and control
condition (usual care). Our goal is to enhance adolescent health literacy, increasing teens' capacity to access and use their insurance and the current
health care system, so they can become empowered health consumers as they transition into adulthood. REVISED SPECIFIC AIMS 1 R01
HD059756-01 (Glik, Prelip)Clinical practices to prevent disease and promote health have become an important component of primary health care.
Adolescents could benefit from these services, yet they often underutilize preventive care and over utilize acute or emergency care. Adolescents are
at risk for numerous health issues including sexually transmitted infections, unplanned pregnancies, anxiety and depression, violence and abuse,
injuries, vaccine preventable infectious diseases, as well as urinary track infections, and upper respiratory tract infections. Additionally adolescents
participate in risky practices such as smoking, alcohol and drug use, may lack healthy diet and exercise patterns, and may not get adequate screening
and immunization services. This study will take place in California where 88% of teens have health care insurance, and as plans for universal health
coverage are enacted those numbers will increase. At the same time it is the responsibility of clients to initiate contact with providers for their care, and
teens who may still rely on parents for arranging health care may not always get the care they need. Thus teaching teens how to use their health
insurance, how to navigate the health care system, and how to access not only curative but preventive services is seen to be an important facet of
health literacy training, especially for teens in minority families who are the first generation to have comprehensive health insurance plans. The goal of
this demonstration project is to document how a large health insurance company can best influence teenage utilization patterns and train the next
generation of health consumers in health literacy defined here as learning how to use and access health care and use their health insurance benefits
appropriately. Study objectives include creating and testing the effectiveness of an innovative health literacy training program using interactive
computer technologies (ICTs) and social media among 12 - 17 years oldadolescents to improve their knowledge, attitudes and health and information
seeking behaviors, their perceptions of care preventive care received, as well as appropriate use of preventive care, curative care, and counseling
services. The target population is a sample of Medi-Cal (Medicaid) and Healthy Families (SCHIP) adolescents whose care is managed by Health Net,
one of the largest health insurance plans in California. It should be noted that California has reproductive rights laws that empower teens (minors over
the age of 12) to engage with their physicians in confidential consultation with no parental permission required. Main aims of this study are:1) Test the
feasibility of creating and maintaining interactive communication technology (ICT) health literacy training materials supplemented with print materials
that have social media components for a Medicaid and SCHIP adolescent population.2) Evaluate the effectiveness of the ICTs and social media
materials produced compared to a control group receiving usual care, by evaluating survey self report data among study participants measuring
changes in knowledge of how to use and when to use health care system, attitudes towards health care, risk reduction behaviors, self report of
utilization and quality of interactions with provider for Annual Adolescent Well Care visits, utilization of primary care services for acute and chronic
conditions, utilization of referrals for specialty care or counseling, decreased utilization of the emergency room. (Slightly revised aim to reflect that
rather than 3 arms of condition there are now 2 the intervention condition and control).3) Evaluate the effectiveness of the health literacy intervention
on quantity of Annual Adolescent Well Care utilization, primary care provider utilization and emergency room utilization for treatment of non
emergency conditions based on Health Net membership, claims, encounter, pharmacy and behavioral health records linked to study condition.4)
Increase adolescents' health literacy about their health care rights and responsibilities as well as concepts of confidentiality, doctor patient
Total Cost
$645,565
Project Number
2
Project Title
Principal Investigator
Performing
Organization
1R03HD058203-01A1
PRIVATE INSURANCE AND
PRESCRIPTION OUTCOMES FOR
CHILDREN
GOLDMAN, DANA P
RAND CORPORATION
1R21HD060217-01
TRENDS IN ETHNIC AND
SOCIOECONOMIC
DIFFERENTIALS IN DIET QUALITY
IN AMERICAN CHIL
KANT, ASHIMA K
QUEENS COLLEGE
32
Abstract
relationships, and referrals to specialists.5) Test how adolescents use online and social media health information resources with content specific to
their health needs and their health plan, and explore relationship between exposure and use of materials and outcomes. (Print media condition has
been deleted to reflect change in study design from 3 arms to 2, see Aim 2).6) Assess differential impact of intervention based on predisposing
participant characteristics of age, gender, health status, ethnicity as well as enabling factors of private and confidential services.7) Test associations
between increased health literacy and e-health health literacy and outcomes of quality and quantity of care provided. Study aims will be achieved by:
1. Developing online materials using social networking methods using formative research with goal of increasing health literacy among low income
adolescents. Current estimates are that 94% of teens I California have access to internet, often through handheld devices. 2. Recruiting 8,000 Health
Net client volunteers aged 12-17 with Medi-Cal or Healthy Families insurance by sending out invitations to a random sample of 80,000 clients out of a
population of approximately 155,000 eligible clients. (Numbers have changed to reflect changed study design and recent survey experience in this
Health Net population that suggests that only 10% of people contacted will volunteer to participate for this type of study). 3. Conducting baseline
mailed survey with online alternative collection opportunity to assess current health literacy, health behaviors, health care utilization, media utilization
as well as socio demographic factors. 4. Randomly assigning participants into 2 groups with goal being to have final sample in each condition to be an
n of 1,739 (0verall n=3478) with the intervention group receiving monthly reminders and links to online materials over a one year period, and control
group participants receiving usual care and the survey only, giving study 85% power with an effect size of 5% based on increase in annual teen
preventive care visits to 41% from baseline of 36%. (The sample numbers have changed to increase power to 85% and narrative now reflects 2 group
study design). 5. Conducting baseline survey at months 5-6 of Year 1 ( 6 months after grant startup) and follow up survey at months 18-19 after
intervention is completed to assess program impacts with final 0verall n=3478 (1,739 in each study condition). Assumption is 50- 60% attrition from
initial recruitment to final sample size. There will be incentives for participants. (This change reflects that there will be only two data collection points
rather than three as well as slightly increased sample size for each condition). 6. Using Health Net membership, claims, encounter, and behavioral
health data to achieve an overview of Health Net utilization, assess impact of intervention as well as compare intervention clients (treatment group with
control group) of Health Net Clients age 12-17 who did not receive intervention. (This change reflects the truncated research design of only two data
collection points and two conditions). 7. Analyzing survey and institutional databases to assess main and interactive program effects, as well as effects
of exogenous and endogenous variables that moderate and mediate program effects. Revised project timeline Grant Activities Year 1 (2009-10) Year
2 (2010-11)1-4mos5-8mos9-12mos1-4 mos5-8mos9-12mosFormative audience research, pretesting with target population Recruit
participants/randomize /implement baseline Health Survey Produce materials for social media and interactive materials Youth participate in message
production Pre-test, revise materials with target population Disseminate material to target population Administrative data collect Qualitative Data
(Process Monitoring) Follow-up Health Survey Data analysis Results dissemination Jobs Retained and Job Created 1 R01 HD059756-01 (Glik,
Prelip)If funded we will be employing people in four different agencies.UCLA At UCLA four positions will be created. This includes a project
coordinator, a project assistant, and two graduate student researchers. HealthNet At Health Net of California a data collection manager will be
employed. EPG Technologies This project will partially support six staff members of this small business for both years of the project. Weinrich
Communications. This project will help support this small enterprise. All together 12 people will be funded each year through this project while many of
part time this will help allay the effects of high employment rates in California as well as help small businesses such EPG Technologies and Weinrich
to survive during a difficult economic period. It should also be noted that Health Net of California the time of five employees to enable this project to
happen.
DESCRIPTION (provided by applicant): Little attention has focused on barriers to coverage among the privately insured children, although, a large
portion of the American children are covered under private insurance. Especially in an era of deteriorating private coverage, it has become very
important to investigate whether privately insured chronically ill children are at risk for treatment. Our study aims to fill this gap using a unique
longitudinal dataset that contains information on a large group of privately insured children and their families. In this project, we will take a first step in
investigating how parents respond to private insurance cost sharing regarding health services use of their children by studying the impact of
prescription drug coverage on outcomes by the chronically ill children. The primary specific aim of the proposed research is to determine how
changes in prescription drug cost sharing affect adherence to prescription drug therapy for various chronic conditions among the privately insured
chronically ill children. As a secondary aim, we propose to identify the effect of prescription drug cost sharing on inpatient and outpatient spending
among the chronically ill children. In both aims, we will control for other health plan characteristics, child's own characteristics, co-morbid conditions,
general family characteristics, and the out-of-pocket burden of other family members.
DESCRIPTION (provided by applicant): American children from ethnic minority and low socioeconomic families have higher rates of poor health and
higher mortality rates. Recent data suggest persistence or widening of these ethnic and socioeconomic differentials in health outcomes of US children.
For example, over the past three decades, overall, injury, and natural-cause mortality in childhood in the US declined. However, children from minority
and lower socioeconomic position families experienced a smaller decline, resulting in a widening of the socioeconomic gap. The trends analysis for
risk factors such as prevalence of obesity, prediabetes, and high blood pressure in US children also suggest similar persistence or increase of
socioeconomic and ethnic disparities. Adverse health risk behaviors that include diet are among the many factors such as access to health care,
environmental exposures, neighborhood contexts, income constraints, and discrimination that may contribute to ethnic and socioeconomic disparities
in the health of US children. The hypothesis that diet may be a mediator of ethnic and socioeconomic disparities in health appears reasonable given
that diet is an acknowledged risk factor for a number of chronic diseases. However, surprisingly little is known about the independent associations of
ethnicity and measures of socioeconomic position-- family income, education, and occupation--with dietary attributes within a multivariate framework in
US children. Also, there is no published information on how the association of diet and socioeconomic position may be changing over time in US
children. Assessment of time trends in dietary disparities due to ethnic and socioeconomic group membership may help us to understand whether diet
may be a contributor to persistence or increase of health disparities among US children. Therefore, the overall objectives of this application are to
examine in US children and adolescents: 1) the independent associations of race/ethnicity and measures of socioeconomic position (family income,
education, and occupation) with attributes of reported diets and objective biomarkers of dietary intake, and 2) the trends in the association of
Total Cost
$89,875
$155,000
Project Number
2
Project Title
Principal Investigator
Performing
Organization
1R01HD057947-01A1
MINDING THE BABY: HOME
VISITING PROGRAM
EVALUATION
SADLER, LOIS S
YALE UNIVERSITY
3U01HD041249-09S2
PELVIC FLOOR DISORDERS
NETWORK-DATA COORDINATING
CENTER
SPINO, CATHERINE A
UNIVERSITY OF MICHIGAN
AT ANN ARBOR
3U01HD041249-09S1
PELVIC FLOOR DISORDERS
NETWORK-DATA COORDINATING
CENTER
SPINO, CATHERINE A
UNIVERSITY OF MICHIGAN
AT ANN ARBOR
33
Abstract
race/ethnicity and socioeconomic position with diet quality from 1971 to 2006. We will use nationally representative data for 2-19 year olds (n= 39,607)
from the National Health and Nutrition Examination Surveys (NHANES) conducted in1971-74, 1976-1980, 1982-1984 (Hispanic HANES), 1988-1994,
an 2001-2006, to address these issues. PUBLIC HEALTH RELEVANCE: The importance of dietary factors in improving health outcomes is
underscored by the fact that dietary factors are amenable to intervention, and diet is universally consumed and even a small relative risk may have a
considerable public health impact. Assessment of time trends in ethnic and socio- economic differentials in diet quality will therefore help in
determining the absolute as well as relative progress in closing the ethnic and socioeconomic gaps in health outcomes that is a stated goal of the
national health promotion agenda. The results of this study will thus help in evaluating the effectiveness of past efforts to promote desirable behavior
changes in these high risk populations, and design of newer strategies to target dietary attributes associated with ethnicity and socioeconomic
position.
DESCRIPTION (provided by applicant): This is an efficacy study of an intensive home visitation intervention, 'Minding the Baby' (MTB). This reflective
parenting program (aimed at enhancing maternal reflective capacities), is focused on first-time young mothers and their infants living in an urban
community. The study, grounded in attachment and human ecology theories integrates advanced practice nursing and mental health care by pairing
master's level clinicians (pediatric nurse practitioner and a social worker) with at-risk young families. Aims of the study are: 1) to determine the efficacy
of the MTB intervention in young mothers and infants with respect to a) maternal outcome variables including the quality of the mother-infant
relationship, maternal reflective capacities, maternal mastery/self- efficacy, parental competence, and maternal health and life course outcomes
(educational success, employment, delaying subsequent child-bearing); and b) infant outcome variables including early attachment, infant health, and
developmental outcomes; 2) to monitor fidelity and dose of the program with young mothers; 3) to describe the evolution of reflective capacities in
adolescent mothers (contrasting intervention group with control group) through descriptive qualitative analyses of transcribed Pregnancy Interviews
(PI) and Parent Development Interviews (PDI) at the last trimester of pregnancy and at 24 months; 4) to conduct cost- benefit/effectiveness analyses
of the program. The longitudinal two-group study (subjects nested within randomly assigned groups), will include multi-method (self report, interview
and direct observation and coding of behaviors) approaches with a cohort of first-time multi-ethnic mothers between the ages of 14-25 (and their
infants). MTB home visits occur weekly for intervention families (n=69) beginning in mid pregnancy and continuing through the first year, and then biweekly through the second year of the child's life. Mothers and infants (n=69) in the control group will receive standard prenatal, postpartum and
pediatric primary care in one of two community health centers (as will the intervention group) and also receive monthly educational materials about
child health and development mailed to their homes. Maternal and infant outcome variables will be followed over time (pregnancy, 4, 12, and 24
months) as well as compared between the 2 groups. Cost analyses and detailed analysis of the dose and sample characteristics linked to efficacy, will
allow us to plan for translation of the model into clinical care, and community sustainability. PUBLIC HEALTH RELEVANCE: This is a study of Minding
the Baby (MTB), a home visiting program (beginning in pregnancy and extending until the child's second birthday) for young families living in an urban
community. MTB is a unique preventive program that is implemented by master's-trained home visitors (nurse and social worker), provides direct
mental health services during home visits, and focuses on the mother's capacity to understand her infant's emotional needs as well as provide the
needed physical care. The study will evaluate the effects and the costs/benefits of the program with young first-time at-risk mothers, their children, and
families.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): Pelvic floor disorders, such as urinary incontinence, pelvic organ prolapse,
and fecal incontinence, are common and significant health-related problems for women in the United States. Outcomes following surgical and nonsurgical intervention for pelvic floor disorders have not been adequately evaluated. As a result, data necessary to fully inform patients and to make
important policy decisions are unavailable. The long-term objective of the Pelvic Floor Disorders Network (PFDN) is to systematically evaluate these
outcomes. This application to be the Data Coordinating Center (DCC) for the pelvic floor disorders network brings together experienced investigators
from biostatistics, urogynecology, urology, quality of life and health services research to prospectively assess the outcomes from various surgical
interventions for female pelvic floor disorders. The specific aims of the DCC are to: 1. Assist in protocol development by providing expertise in the
design, conduct and analysis of clinical trials conducted by the PFDN. 2. Provide expertise in measurement of quality of life and in the selection of the
appropriate instruments to assess treatment outcomes and, when appropriate, to perform the interviews. 3. Coordinate the implementation of the
study protocols approved by the Steering Committee, including design of the case report forms and interviewing protocols, development of a manual
of operations, centralized database management with either centralized or remote data entry, submission of an IND to the FDA when necessary, and
by organizing training and certification sessions, as needed. 4. Establish a database for each study conducted by the PFDN. 5. Implement either
centralized or web-based data entry and verification. 6. Monitor the clinical sites with respect to data quality. 7. Provide infrastructure for monitoring
adverse events and regulatory oversight for the network. 8. Provide logistical support for the Steering Committee, Advisory Board and DSMB, for both
face-to-face meetings and teleconferences. 9. Maintain a website for the PFDN that includes web pages with content for the public, and a passwordprotected site with all study documentation and databases. 10. Manage and distribute protocol funds to the Clinical Centers. To illustrate the work of
the DCC, a randomized clinical trial is proposed to compare surgical procedures for pelvic organ prolapse using a vaginal approach.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): Pelvic floor disorders, such as urinary incontinence, pelvic organ prolapse,
and fecal incontinence, are common and significant health-related problems for women in the United States. Outcomes following surgical and nonsurgical intervention for pelvic floor disorders have not been adequately evaluated. As a result, data necessary to fully inform patients and to make
important policy decisions are unavailable. The long-term objective of the Pelvic Floor Disorders Network (PFDN) is to systematically evaluate these
outcomes. This application to be the Data Coordinating Center (DCC) for the pelvic floor disorders network brings together experienced investigators
from biostatistics, urogynecology, urology, quality of life and health services research to prospectively assess the outcomes from various surgical
interventions for female pelvic floor disorders. The specific aims of the DCC are to: 1. Assist in protocol development by providing expertise in the
design, conduct and analysis of clinical trials conducted by the PFDN. 2. Provide expertise in measurement of quality of life and in the selection of the
Total Cost
$636,723
$2,400,000
$94,400
Project Number
2
Project Title
Principal Investigator
Performing
Organization
Abstract
Total Cost
appropriate instruments to assess treatment outcomes and, when appropriate, to perform the interviews. 3. Coordinate the implementation of the
study protocols approved by the Steering Committee, including design of the case report forms and interviewing protocols, development of a manual
of operations, centralized database management with either centralized or remote data entry, submission of an IND to the FDA when necessary, and
by organizing training and certification sessions, as needed. 4. Establish a database for each study conducted by the PFDN. 5. Implement either
centralized or web-based data entry and verification. 6. Monitor the clinical sites with respect to data quality. 7. Provide infrastructure for monitoring
adverse events and regulatory oversight for the network. 8. Provide logistical support for the Steering Committee, Advisory Board and DSMB, for both
face-to-face meetings and teleconferences. 9. Maintain a website for the PFDN that includes web pages with content for the public, and a passwordprotected site with all study documentation and databases. 10. Manage and distribute protocol funds to the Clinical Centers. To illustrate the work of
the DCC, a randomized clinical trial is proposed to compare surgical procedures for pelvic organ prolapse using a vaginal approach.
National Institute of Dental and Craniofacial Research (NIDCR)
1R21DE019211-01A1
ORAL HEALTH PROMOTION
DURING PRENANCY IN A GROUP
PRENATAL CARE MODEL
ADAMS, SALLY
HENDERSON
UNIVERSITY OF
CALIFORNIA SAN
FRANCISCO
3U54DE019259-02S1
CENTER FOR NATIVE ORAL
HEALTH RESEARCH (CNOHR)
ALBINO, JUDITH E.N.
UNIVERSITY OF
COLORADO DENVER
34
DESCRIPTION (provided by applicant): Pregnancy is often a time marked by increased oral health (OH) concerns, yet dental care utilization rates,
especially among underserved women; indicate that most low-income pregnant women do not receive dental care. Improving the oral health of
pregnant women: 1) safeguards their own oral health; 2) has the potential to improve their overall health and decrease early childhood caries in their
children; and 3) may reduce adverse birth outcomes. Although several national organizations recommend that women receive dental care and
anticipatory guidance for infant oral health care during pregnancy, it is unlikely that many women, particularly those in underserved areas, are
receiving these important preventive health services. The purpose of this project is to develop and pilot test an interactive educational and behavioral
oral health promotion (OHP) intervention to improve maternal and infant OH status, knowledge, attitudes, and behaviors for low-income women
attending a group prenatal care program, Centering Pregnancy (CP(R)), in the San Francisco Bay Area. With a growing number of groups, currently
more than 200 nationally, CP(R) is an innovative group care model designed to provide comprehensive prenatal care and to advance women's sense
of health awareness through assessment, education, and support. The OHP development will be guided by the Social Cognitive Theory, will use the
PRECEDE PROCEED model for planning, and adhere to the essential care components of CP(R): assessment, education, and support. The study
includes two phases: Phase 1: DEVELOPMENT & TRAINING and Phase 2: PILOT TEST & EVALUATION. Phase I aims are to: 1) develop, with
CP(R) staff and participants, an OHP curriculum that will address predisposing (knowledge, attitudes), enabling (skills building, environmental), and
reinforcing (feedback) OH factors; 2) consult with CP(R) community to develop acceptable research procedures to evaluate the OHP intervention; and
3) train 8 CP(R) staff to conduct the OHP pilot intervention. Phase II aims are: 4) pilot test the OHP intervention in 2 CP(R) sites (n= 50 CP(R)
participants) and examine pre-post changes in OH status and OH-related outcomes; and 5) evaluate changes in same OH factors in 2 CP(R) sites (n=
50 CP(R) participants) without the OHP intervention to assess changes due to pregnancy, the CP(R) program without OHP, and other secular factors.
We will assess OH status through on-site study dental exams and self- reports. We will assess OH knowledge, attitudes, and behaviors about
maternal and infant OH through questionnaires. If successful, these results will be used to develop a full-scale clinical research study (RO1), which
would formally test the efficacy of the OHP intervention in improving the oral health of pregnant women and their children. PUBLIC HEALTH
RELEVANCE: Many women receive inadequate oral health care during pregnancy, especially those in low-income and underserved groups. As
proposed in this R21 application, the development of an oral health promotion intervention for women receiving their prenatal care within a wellestablished, innovative, group model of prenatal care, Centering Pregnancy (CP(R)) may provide the opportunity to advance women's oral health and
the oral health of their children, as well as improve their general health across the life span. The results of the proposed application will hopefully
provide the preliminary data needed to submit an R01 application to formally test the efficacy of the oral health promotion intervention, which if
successful, could be implemented widely in CP(R) programs nationally and internationally, as well as other prenatal care groups.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): This Center for Research to Reduce Disparities in Oral Health will focus on
oral health concerns of American Indians and Alaska Natives (AI/ANs) and will be known as the Center for Native Oral Health Research (CNOHR).
The Principal Investigator is Judith E. N. Albino, PhD, President Emeritus of the University of Colorado and Professor, American Indian/Alaska Native
Programs (AIANP) and Craniofacial Biology, and a health psychologist. She will lead the Research Program Administrative Center (RPAC). Dr. Spero
Manson, PhD, Professor and Head, AIANP, and a medical anthropologist, will serve as Co-Investigator and lead the Community Liaison and
Dissemination Core within RPAC. Biostatistician William Henderson, PhD, Professor, Colorado Health Outcomes Program, will lead the Statistics and
Data Coordinating Center (S&DCC). CNOHR takes a comprehensive approach to oral health disparities in the long term, with an initial focus on oral
infections and key roles of behavioral factors and comorbidities. The interdisciplinary team includes scientists trained in anthropology, biostatistics,
dentistry, economics, medicine, psychology, and public health, supported by experienced project management and technology teams. The three initial
projects focus on caries and periodontal disease, and intervene by extending current services and their use as well as adding prevention services and
oral health promotion. The first Research Component (RC1) tests an intervention with pregnant women/mothers of newborns on a Northern Plains
Reservation, which is focused on the use of motivational interviewing in prevention of ECC. RC2 is a randomized clinical trial of two methods for
treating periodontal disease in Southwestern American Indians who also have Type 2 diabetes mellitus. RC3 is a test of a service delivery intervention
in which tribal/community members are trained to apply fluoride varnish and deliver personalized oral health education for 3-5 year old children and
their parents enrolled in reservation-based Indian Head Start programs. A Developmental Research Program will offer opportunities to pilot work
suggested by new investigators, by community participation and planning activities, and by preliminary results of major projects. A focus on
dissemination will include activities aimed at increasing community awareness and influencing health policy. Considerable prior experience with the
participating tribes and communities has shaped the CNOHR methods and approaches, and ongoing community participation in planning will continue
to influence the implementation of the RCs. A robust program of training and career development experiences will include mentoring and support for
students at the secondary, undergraduate, professional and graduate, and post-doctoral levels, with emphasis on recruiting AI/AN investigators to oral
health disparities research. OVERALL CRITIQUE 1: Significance: The application proposes a center that could have an important national role in
eliminating oral health disparities in AI/NA populations. The extensive work already undertaken at the University of Colorado Health Sciences Center
$212,164
$13,103
Project Number
2
Project Title
Principal Investigator
Performing
Organization
Abstract
to address health disparities in various domains highlights the importance of this area. Because of the unique history of American Indians, and the
Indian Health Service that is federal and uniquely designed to provide care, the issue of health disparities among American Indians and Native
Americans is of particular significance. AI/NA populations are entitled to equitable health coverage, and the system has failed to deliver on a promise
that relates to the political history of American tribes and the federal U.S. government. Therefore the population, the location, and the approach
represent highly significant areas of concern for the U.S. government, for tribal governments, and for the people. Approach: The overall proposal
seeks to develop the research and community practice infrastructure to prevent (1) caries; (2) periodontal disease; and (3) the comorbidities that
accompany oral health, examining the oral-systemic connections. There are five overarching aims: build the scientific support structure, much of which
is in place with a new building, technology educational center, and biostatisticians; develop interdisciplinary and culturally sensitive partnerships again, something the co-I, Dr. Manson, especially has a stunning track record in achieving; training and career development, especially through a
pipeline model that is well thought out and started with the Medical Careers Collaborative; and disseminating results and influencing policy, with the
final aim to establish the center as a national resource for all nodes, nationally, studying Indian and Native oral health, which they have tracked and
identified. The conceptual model is adopted from the McCarthur network, and while it permeates each project is nevertheless somewhat a-theoretical.
The reliance on diffusion theory is more compelling. Nevertheless, the community-based partnerships and work that the co-I in particular has already
accomplished speaks well to the potential for replicating such a plan in the area of dental health. The overall goal is to increase access to dental care
from various sources throughout rural areas, demonstrating that culturally appropriate methods can be adapted successfully to improve oral health
outcomes for children and for adults. Innovation: The aims of shaping a community-based oral health program along the lines of thoughtful culturally
appropriate models are innovative. Although Motivational Interviewing has been used in oral health programs, the application describes the first
adaptation of such an approach with American Indians. The apparent aim of integrating the oral health disparities center in the same physical facility
as other funded health disparity centers in Colorado, led largely by the co-Investigator, lends value to the approach and is innovative. Such integration
could give rise to further synergy and intersections between the work being done in the other centers and the new oral health disparities center. More
discussion of such a potential intersection would have further strengthened the application. The pipeline training program, while not innovative in many
other fields and for other populations, is unique to a School of Dental Medicine for Native Americans and American Indians. Investigator/Center
Director/co-Director: The PI is a professor at the University of Colorado-Denver, and had a career for many years as a psychologist studying oral
health before she entered university administration. She was the president of the University of Colorado for 5 years, and enjoys a network of potential
support. She certainly has the experience to oversee a complex project and budget. However, her scientific leadership is less convincing, because it
has been a number of years since she has been an active researcher. The co-Investigator provides an excellent compliment in this regard. He is an
eminent epidemiologist of Native American mental health and as a medical anthropologist brings depth to his analyses that is sometimes missing in
population health studies. The co-Investigator has also been successful in launching careers of American Indians in other fields, especially in the
areas of mental and public health. Whether he can bring such leadership to dental medicine, however, is unclear since he has little direct background
in that particular field. Therefore, a weakness of the application is the lack of participation of a researcher in dental medicine, and someone with a
strong and recent track record in the area of psychosocial interventions to improve oral health outcomes. Environment: The environment is
appropriate for the planned center. There are significant resources to be dedicated to the center, including space in a new building designed for the
study of health disparities among Native Americans. However, the School of Dental Medicine at the University of Colorado has a somewhat weak
profile especially in the area of oral health disparities, which lessens confidence that the investigators could achieve their excellent and ambitious
goals. Overall Evaluation: The application is highly significant, addresses a serious area of oral health disparities and describes various approaches
that are likely to meet with success. The research projects are suitable for the topic, are innovative and have clear merit. The application describes a
training and 'pipeline' model to increase American Indians trained in oral health, which is also important and likely to increase access over time. The
administrative infrastructure appears to be adequate despite some weak links. There is some question as to whether the present team can fully meet
the aims of the Center because there are insufficient oral health researchers and clinicians from the dental school participating. Since one centerpiece
of the proposal is to expand training of paraprofessionals in oral health and increasing the number in the dental medicine pipeline, leadership of a
dental faculty member who is presently active in research and can craft the training program is essential. Protection of Human Subjects from
Research Risks: No concerns. Inclusion of Women, Minorities and Children Plans: Adequate. Data Sharing Plan: Adequate. Budget: The budget
is appropriate. OVERALL CRITIQUE 2: Significance: The focus of the center on Native Americans is excellent and highly worthy of enthusiasm.
Approach: The approach is multi-disciplinary in nature, with a wide range of experts in various fields of Native American culture and society that can
markedly contribute to the overall operations of the center. Innovation: Little is offered that appears to be innovative. Investigator/Center
Director/co-Director: The investigative team has a long and extensive track record in research on Native American populations, which is a major
strength of the application and increases the likelihood for the overall potential success of the center. Environment: Acceptable. There are many
aspects of the center that are already functioning or have a track record of past success. Overall Evaluation: While the periodontal intervention
suffers from a number of deficiencies in study design, the overall center application builds upon an extensive record of proven research experience
with the targeted Native American study population. As a result, enthusiasm is high for the prospects of the center making advancements in reducing
oral health disparities in Native Americans. Budget: Acceptable. RPAC - Research Program and Administrative Center PI: Albino, Judith E.N.,
PhD Score: Excellent DESCRIPTION (provided by applicant): STRUCTURE AND FOCUS. In response to RFA DE-08-008, the American
Indian/Alaska Native Programs (AIANP) within the School of Medicine (SOM) and the School of Dental Medicine (SODM) at the University of Colorado
at Denver and Health Sciences Center (UCDHSC), with our collaborating partner, the University at Buffalo SODM, propose a Center for Research to
Reduce Disparities in Oral Health (CRRDOH), to be funded by the NIDCR as a Cooperative Research Center (U54). Other higher education
institutions with which we have established relationships focused on recruiting students for potential careers in oral health disparities research include
Fort Lewis College, which has a mandate to serve American Indian and Alaska (AI/AN) students; and several tribal colleges, including Sinte Gleska
University on the Rosebud Reservation in South Dakota, Oglala Lakota College at Pine Ridge, and Dine College of the Navajo Nation. The Pine Ridge
Department of Health Administration and the Pine Ridge Indian Health Service (IHS) Unit have worked with us to develop Research Component 1
35
Total Cost
Project Number
2
Project Title
Principal Investigator
Performing
Organization
1RC1DE020455-01
COMPARATIVE EFFECTIVENESS
AND FEASIBILITY OF SBIRT IN A
GENERAL DENTAL CLINIC
BABOR, THOMAS F
UNIVERSITY OF
CONNECTICUT SCH OF
MED/DNT
1RC1DE020303-01
FIRST PREVENTIVE DENTAL
VISIT: DISPARITIES IN NEEDS,
COSTS + BEHAVIORAL INSIGHTS
DAMIANO, PETER C
UNIVERSITY OF IOWA
36
Abstract
(RC1). The Albuquerque Area Service Unit of the IHS will participate in RC2; the Talihina Service Unit (Oklahoma/Choctaw Nation) may also take part.
The Navajo Nation Departments of Dine Education and Head Start are expected to participate in RC3. The Colorado School of Public Health Initiative,
which includes programs offered jointly by the University of Colorado, Colorado State University, and the University of Northern Colorado, will work
with us as well, particularly in the development of new training and career opportunities. Note: Please see Appendix RPAC-1 for abbreviations used in
this application. Although disparities exist for other groups, the poor health status of AI/ANs is unparalleled in many respects. Life expectancy is almost
6 years less than for the general population and both morbidity and mortality are higher for a broad range of diseases and health problems, including
diabetes, tuberculosis, pneumonia, and some forms of cancer.1 Oral infections (caries and periodontal disease) and their sequelae, such as
edentulism, also are significantly higher among AI/ANs than among the general population. 2 As evidence builds to substantiate a link between oral
health status and systemic health conditions-e.g., periodontal disease and diabetes, the seriousness of these disparities is compounded. The center
proposed here will be known as the Center for Native Oral Health Research (CNOHR) and will focus on oral health disparities among AI/AN
populations. (The term 'American Indian and Alaska Native' or 'AI/AN' will refer in this application to those who trace their origins to the indigenous
peoples of the continental US; 'Native' is used synonymously with AI/AN. See Appendix RPAC-1 for glossary of abbreviations.) The initial program of
research will address the 2 most common oral infections, caries and periodontal disease, and will do so within the context of salient patterns of
comorbidities, or oral-systemic connections. Special attention will be given to behavioral and social factors that influence and constitute risk factors for
oral health across the lifespan. To ensure the development of culturally sensitive interventions that will be accepted and promoted by AI/AN
communities, tribes and communities that have been invited to participate in intervention studies have been, and will continue to be, engaged in
planning and dissemination of those interventions. In addition to building on the current research base to develop and conduct interdisciplinary
intervention research that will lead to changes in health care policies, practices, and ultimately oral health, CNOHR will develop training opportunities,
with the goal of cultivating a self-sustaining critical mass of scholars who are prepared to address the disparities identified here. CNOHR also offers
the experience and commitment necessary to develop the enduring community relations and support essential for working in the sometimes politically
charged context of research with tribal and other AI/AN communities/organizations. Finally, CNOHR will serve as a national resource to encourage
and support collaborative research, research training, information dissemination, and technical assistance to the larger AI/AN oral health community.
By extending opportunities for research development and support to other health disparities investigators, CNOHR will enhance capacity for research
dedicated to improving the oral health of America's First Peoples.
DESCRIPTION (provided by applicant): (Abstract) 'Comparative Effectiveness and Feasibility of SBIRT in a General Dental Clinic' addresses the
broad Challenge Area, (05) Comparative Effectiveness Research and specific Challenge Topic, 05-DE-102: Treatment of tobacco and drug
dependence in dental settings. This protocol describes a 2-year, randomized controlled trial designed to achieve two primary aims: 1) to evaluate the
short-term effectiveness of screening, brief intervention and referral services (SBIRT) for tobacco and other psychoactive substance use when
delivered separately and in combined forms and 2) to evaluate the feasibility of implementing SBIRT for patients with at-risk substance use in a
community general dental setting. This research will provide the basis for a more ambitious clinical trial that would be conducted in multiple dental
settings and include a longer follow-up period. To achieve Aim 1, 175 patients who are smokers and at-risk substance users (including at-risk alcohol
users) will be recruited from the general dentistry clinic at the University of Connecticut Health Center. Research staff will use the Alcohol, Smoking
and Substance Involvement Screening Test (ASSIST), developed by the World Health Organization, to identify eligible patients. Participants will be
randomized to one of three experimental conditions: 1) a smoking-only brief intervention group; 2) a smoking + other substance use brief intervention
group; or 3) a wait-list control condition that includes general dental health counseling. Those assigned to the 'active' treatment conditions will be given
a brief intervention that will link the patient's screening assessment data with dental risk factors associated with tobacco only or tobacco + other
substance use. Participants will be re- interviewed at 12-weeks post randomization to assess outcome and process measures using a combination of
quantitative and qualitative interviewing methods. Regarding Aim 2, the timing of this opportunity and implementation of this clinical trial provides a
unique opportunity to follow two cohorts of dental residents to examine the impact of SBIRT residency training on subsequent clinical practice. The
first cohort will already be on staff when the study begins and will not have received SBIRT training as part of the residency requirements. The second
cohort of residents will be exposed to a three-hour SBIRT training session that will supplement the residency requirements for July, 2010. Although
residents will not be asked to provide the brief interventions for the randomized study, they will be encouraged to reinforce the information delivered by
research staff. Differences between the two cohorts with regard to attitudes, knowledge and willingness to engage in SBIRT program activities will be
measured. There has been a remarkable growth in translational research organized around the SBIRT concept, with numerous clinical trials
conducted, new screening tests developed, and implementation programs evaluated to determine the feasibility of SBIRT in primary care and other
medical settings. Despite the obvious relevance of SBIRT to the prevention of dental pathology, there has been little attention to the determination of
its feasibility, effectiveness and implementation in dental settings. We believe there is now a real research opportunity to not only evaluate the
effectiveness of SBIRT with dental patients, but also to improve the technology so that oral health practitioners can feel confident conducting
screening, brief intervention and referrals for at-risk users of tobacco, alcohol and other substances. The research described in this application could
have significant implications on both clinical science and public health dentistry.
DESCRIPTION (provided by applicant): This application addresses the broad challenge area: Health Disparities (09); Challenge Topic: Behavioral and
Social Sciences to Reduce Oral Health Disparities (09-DE-101). Title: First preventive dental visit: Disparities in needs, costs + behavioral insights This
study investigates the predictors and outcomes of age at first preventive dental visit (AFPDV) for Medicaid-enrolled children-a dentally underserved
population. The age when a child receives their first dental check-up helps establish a dental home for the child and provides important preventive
counseling for the mother. Medicaid-enrolled children are known to have less access to dental care. Of particular interest in this study are five
Medicaid subpopulations at high risk of disparities in access to dental care and resulting oral health status: 1) Racial and ethnic minority children, 2)
Rural children, 3) Children in federally designated Dental Health Professions Shortage Areas (HPSAs), 4) Children with less access to medical care
and associated well child visits, and 5) Children who receive care at a Community Health Center (CHC). Since one in four children in the United States
are enrolled in Medicaid, this study could potentially impact a large population of the most vulnerable children in the country. We are proposing a
Total Cost
$485,003
$457,878
Project Number
2
Project Title
Principal Investigator
Performing
Organization
1RC1DE020563-01
ADOPTION FIDELITY AND
EFFECTIVENESS OF ALCOHOL
SBIRT IN DENTAL PRACTICE
NEFF, JAMES ALAN
OLD DOMINION
UNIVERSITY
3R01DE017947-03S2
LONGITUDINAL STUDY OF
NELSON, SUCHITRA S
CASE WESTERN
37
Abstract
multifaceted, interdisciplinary set of studies to explore this issue: Study 1: Determinants of the age at first preventive dental visit for Medicaid-enrolled
children. The first study investigates the predictors of age at first preventive dental visit using Iowa Medicaid claims data for preschool age children
who were enrolled in the program within a month of birth in 2004. We will follow these children in the claims database until they have their first
preventive dental visit, are no longer enrolled in Medicaid or turn six years old. Factors previously identified in dental use models will be included in
these analyses with the added factor of utilization of well-child visits. We will use survival analyses to model these relationships. Study 2: An
evaluation of the effectiveness of earlier FPDVs on the need for dental care at the first visit and the successful completion of treatment plans for
Medicaid-enrolled children who sought care at a CHC in Iowa. Chart reviews will be used to find out how the needs of children at the time of their first
dental visit and whether AFPDV affects outcomes, in particular, the completion of the treatment plan. The chart reviews will be performed at 9
Community Health Centers (CHCs) with electronic health records for 270 children in Iowa. Study 3: Impact of the AFPDV on future dental and medical
care utilization and costs. Iowa Medicaid claims and administrative data will be used to determine if AFPDV affects future dental and medical care
costs for preschool children. Using instrumental variable analyses we will model the factors related to dental use and cost with special attention to
AFPDV. Study 4: Using the Health Belief Model and the Extended Parallel Process Model to determine factors associated with mothers' decisionmaking and preventive dental care seeking behavior related to FPDV. Focus groups will be used to help us understand what factors encourage and
discourage parents from taking their children for preventive dental care. The results of these three studies will serve to inform the contents of a survey
of parents with children in Medicaid. Previous results will help us to include the most critical factors and tailor the surveys to issues important to
parents with children in Medicaid. These surveys will be designed to find out what prompts parents to take their children to the dentist for their first
preventive dental visit and what might discourage them from preventive dental care. These data will be analyzed with OLS regression to determine
what psycho-social factors are related to AFPDV. Goal: This program of research is designed to help us understand the most effective age for the first
preventive dental visit. This work ultimately culminates in the design of an intervention with parents and providers to encourage the effective timing of
children's first preventive dental visit. This study builds on extensive previous research by this team who has demonstrated the ability to successfully
conduct studies regarding dental care for underserved children combining these large administrative databases and primary data collection
methodologies. PUBLIC HEALTH RELEVANCE: This research project will investigate the predictors and outcomes of preschool age children's first
preventive dental visit, improving our understanding of how age at first preventive dental visit is affected by the psychosocial, behavioral, and social
factors and affects the outcomes of dental care over time. We will use this information to design an intervention to encourage the appropriate timing of
a child's first preventive dental visit through education of the parent and providers.
DESCRIPTION (provided by applicant): This application is submitted in response to NIH Challenge Area (05): Comparative Effectiveness Research,
specifically Challenge Topic 05-DE-102: Treatment of Tobacco and Drug Dependency in Dental Settings. The proposed project seeks to tailor existing
Screening, Brief Intervention, Referral and Treatment (SBIRT) protocols for alcohol abuse to be used in dental practice settings. SBIRT protocols have
demonstrated effectiveness in reducing alcohol use and related problems and in motivating treatment utilization in a number of health care settings.
Given their effectiveness and low cost, and the fact that both ADA and ADHA promote preventive initiatives for oral cancer screening and tobacco
cessation, the absence of parallel protocols for alcohol abuse in dental practice is a concern. Given that a minimum of 60% of the U.S. population
visits a dental practitioner at least once per year, the implementation of SBIRTs in dental practice settings could have enormous public health
significance. In response to this Challenge, we propose a multi- level approach to understand and predict facilitators and barriers to the adoption,
implementation fidelity, and effectiveness of alcohol SBIRT in dental practice. Based upon individual-level (e.g., Trans-theoretical Model) and
organizational (Resource Dependency and Institutional) theories, we propose that adoption, implementation fidelity, and effectiveness of SBIRT will be
impacted by factors at the practitioner level and practice level. This application seeks Challenge funding to extend our research by inviting 30 dental
practices in the Hampton Roads area of Virginia who participated in our previous study to take part in a study of SBIRT adoption, implementation
fidelity, and effectiveness. Dental practices agreeing to adopt SBIRT will be randomized to either SBIRT or control (assessment only). Approximately
400 patients meeting screening criteria for alcohol abuse will receive baseline, 3-, and 6-month assessments to evaluate SBIRT effectiveness.
Hierarchical Linear Modeling (HLM) techniques will be applied to data on practitioner and practice-level variables in combination with data from the
randomized trial to address the following Specific Aims: Aim 1: Identify practitioner and practice-level factors associated with agreement to adopt
SBIRT. Aim 2: Evaluate the effectiveness of SBIRT protocols (compared to assessment-only controls using a randomized controlled design) to assess
the reduction of alcohol use (quantity, frequency measures and frequency of binge drinking) and alcohol-related problems from baseline to 3- and 6month follow-up intervals. Aim 3: Identify practitioner and practice-level factors associated with fidelity of SBIRT implementation (using data from
audio-taped hygienist interventions coded for fidelity to motivational interviewing principles). Aim 4: Examine both direct and indirect effects of
practitioner and practice-level factors on the effectiveness of SBIRT protocols with regard to reducing alcohol use and related problems, specifically
considering the possible mediating role of implementation fidelity. We hypothesize that patients in the SBIRT condition will have greater reductions in
alcohol use and alcohol-related problems at both follow-up periods (Aim 2). From a multi-level perspective, it is hypothesized that practitioner level
(more recent training, more preventive orientation, greater professional familiarity with clinical practice guidelines and professional association
initiatives) and practice level (larger practices with greater resources, involvement in other preventive initiatives) variables will be positively associated
with SBIRT adoption (Aim 1), implementation fidelity (Aim 3), and effectiveness (Aim 4). The overall objective of the proposed Challenge Grant in
response to 05-DE-102 is both to demonstrate the effectiveness of dental practice based SBIRT as well as to identify contextual factors influencing
delivery and effectiveness. Ultimately, this will lead to a larger randomized trial to assess the effectiveness of SBIRT for improving the health, social,
and economic functioning of the population. Given estimates of the prevalence of alcohol abuse in the United States as high as 10 million people,
dental practice based SBIRT has great potential to improve the nation's health. Alcohol abuse is estimated to impact 10 million Americans with great
personal, familial, and social costs. Screening, Brief Intervention, Referral and Treatment (SBIRT) approaches been effective in both reducing alcohol
use and related problems in other health care settings, but have not been tested in dental practice. As a minimum of 60% of the U.S. population visits
a dental office each year, the present project to test the effectiveness of SBIRT in dentist's offices can have enormous public health significance.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Total Cost
$474,730
$133,815
Project Number
2
Project Title
Principal Investigator
DENTAL CARIES IN VLBW
INFANTS
Performing
Organization
RESERVE UNIVERSITY
Abstract
Total Cost
Students and Science Educators. DESCRIPTION (provided by applicant): This longitudinal study addresses the relationship between birth weight
and early childhood caries (ECC) in a cohort of pre-term very low birth weight (VLBW) and full-term normal birth weight (NBW) infants. VLBW and
ECC disproportionately affects poor and minority children costing Medicaid billions of dollars annually for treatment. The improved survival of VLBW
children has resulted in greater long-term disabilities and need for health services, thus classifying them as children with special health care needs.
The oral health needs of VLBW children have not been adequately studied. VLBW children are known to have a high prevalence of enamel defects in
the primary dentition, which in turn can lead to increased susceptibility to ECC. Socio- behavioral factors that can predispose some children to ECC
are unknown in VLBW children. Therefore the primary aims of the study are to (1) assess the incidence of ECC in VLBW and NBW infants; (2) assess
mediators such as the incidence of developmental enamel defects, S.mutans infection and the extent of oral health behaviors in VLBW and NEW
infants; (3) assess the indirect relationship between birth weight and ECC via mediators after controlling for independent moderating variables. A total
of 200 VLBW and 200 NBW infants will be followed at 8 and 18-20 months corrected age. The proposed study will collect data on caries (decayed and
filled surfaces), mediating biological variables (enamel hypoplasia and opacity, S.mutans levels) and infant oral health behavior (feeding, diet, oral
hygiene practices, and dental access), and independent variables (demographics, parent predisposing, enabling, need characteristics, dental
behavior, biological and child medical factors). Data analysis for testing aims 1 and 2 includes the generalized estimating equations (GEE) models,
and a two-stage structural equations model (SEM) for testing the role of mediators in aim 3. The sample size provide 85 to 99% power to compare the
two groups in terms of the three study aims. The results of this study will provide critical data to address the knowledge gaps in taking care of VLBW
children. The clinical implications include primary prevention, early diagnosis and treatment to prevent further susceptibility to dental decay. It is also of
public health interest since interventions to target knowledge, attitude, beliefs, and oral health practices can be implemented in programs for special
needs children, and there by improve both oral and systemic health.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
3R25DK078391-03S1
EXPLORING BIOMEDICAL
RESEARCH OPPORTUNITIES
(EBRO)
BARBOUR, SUZANNE E
VIRGINIA
COMMONWEALTH
UNIVERSITY
3K23DK070757-04S1
CLINICAL AND BEHAVIORAL
DETERMINANTS OF CKD
DISPARITIES
BOULWARE, LEIGH E
JOHNS HOPKINS
UNIVERSITY
3K23DK080952-02S1
ADDRESSING LITERACY AND
NUMERACY IN SELF-CARE &
CAVANAUGH, KERRI
VANDERBILT UNIVERSITY
38
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): The long-term objective of the EBRO (Exploring Biomedical Research
Opportunities) project is to improve the provision of health care by increasing the number of underrepresented populations with research careers
addressing diabetes, endocrinology, metabolism, nutrition, obesity, and digestive, liver, urologic, kidney, and hematological diseases. By focusing the
program on diabetes, digestive, and kidney diseases, we hope to increase representation in these important areas that have significant impact on the
health of minority individuals. A secondary aim is to enhance the diversity of the pipeline of qualified minority students in graduate programs in the
School of Medicine of Virginia Commonwealth University (VCU). The EBRO project is line with VCU's mission to serve the people of the state and the
nation by providing a fertile and stimulating environment for learning, teaching, research, creative expression, and public service. The EBRO project
will provide a 10-week summer research experiences for 25 underrepresented minority undergraduate students majoring in biology, chemistry,
biochemistry, and other related disciplines which will integrate didactic instruction with hands-on research experiences in the laboratories of a highly
collaborative, successful, and nurturing research faculty. The didactic curriculum will introduce students to the intellectual tools needed for a
successful career in research. Clinical research seminars will help EBRO students to put their basic science research into perspective and recognize
the relationships between their research projects and issues related to health disparities. The project will partner VCU with several in historically black
colleges and universities (HBCUs) as a means to expand the geographic diversity of the students who can participate in the program. By targeting
students who would not otherwise have considered careers in science and/ or have little or no access to research facilities, we hope to contribute to
the diversity of individuals pursuing careers in biomedical science. Together, we anticipate these activities not only provide EBRO students with
insights into career options in biomedical research, but will also inspire them to pursue these options. Given the importance of cultural sensitivity and
diversity in all aspects of health services, from the bedside to the laboratory, we believe that EBRO is poised to a make significant impact on minority
health disparities by contributing to the diversity of biomedical researchers for the 21st century.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): Dr. L. Ebony Boulware is a junior faculty member in the Department of
Medicine and the Welch Center for Prevention, Epidemiology and Clinical Research at the Johns Hopkins School of Medicine who recently trained in
Internal Medicine at University of Maryland Medical Center and completed a fellowship in General Internal Medicine at Johns Hopkins. She seeks this
Mentored Clinical Scientist Award to study why the health burden of CKD is magnified among ethnic/racial minorities. Ethnic/racial disparities in the
incidence and prevalence of CKD are striking, with African Americans suffering rates of CKD 4 to 6 times greater than their White counterparts. While
some of the excess incidence of ESRD in high-risk populations can be explained by sociodemographic, lifestyle, and clinical factors, much of the
excess risk of progression toward ESRD for ethnic minorities remains unexplained. Building on research experience and skills attained during her
fellowship, Dr. Boulware aims to assess potential attitudinal, behavioral, and clinical mechanisms (awareness and perceived susceptibility to disease,
adherence, trust and perceived discrimination, patient-physician communication) through which previously unexplained ethnic/racial disparities in CKD
could be explained. She will conduct cross-sectional and longitudinal studies of participants in a multi-center study (Atherosclerosis Risk in
Communities Study), high-risk African Americans (Jackson Heart Study), and high-risk patients in urban clinical settings (collecting data in her
proposed ancillary study to an ongoing NIH/NHLBI-funded randomized controlled trial of persons with hypertension and diabetes in Maryland). Data
include medical history, behavioral measures, physical examination measures, and laboratory studies. Analytic methods will include logistic
regression, survival analysis, analysis of clustered data, and other longitudinal data analysis techniques. In addition to experience in the conduct of
these studies, Dr. Boulware will enhance her research knowledge and skills through advanced coursework, research team meetings, conferences, and
seminars in the supportive and multidisciplinary environment of the Welch Center. This award will provide Dr. Boulware with a foundation to launch her
independent research career devoted to understanding the reasons behind ethnic/racial disparities in chronic kidney disease (CKD) progression, and
in reducing ethnic/racial disparities in CKD.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): The influence of patient literacy or numeracy (math) skill on the
$134,929
$50,000
$53,946
Project Number
2
Project Title
Principal Investigator
Performing
Organization
CLINICAL OUTCOMES IN ESRD
3P60DK079626-02S1
UAB DIABETES RESEARCH AND
TRAINING CENTER
GARVEY, W TIMOTHY
UNIVERSITY OF ALABAMA
AT BIRMINGHAM
1RC1DK086178-01
FAILURE TO UTILIZE DIABETES
HEALTH SERVICES FOLLOWING
A REFERRAL
KARTER, ANDREW JOHN
KAISER FOUNDATION
RESEARCH INSTITUTE
39
Abstract
implementation of clinical self-care recommendations in patients with end-stage renal disease is not known. Large knowledge gaps exist in
understanding the basic mechanisms by which patients incorporate, interpret and apply health-related information in the daily care of complex chronic
diseases. My primary long term goals are : 1). to explore the determinants and barriers of self-care behaviors in patients with kidney disease,
specifically the role of literacy/numeracy and 2). to systematically develop and evaluate educational interventions targeted for low literacy/numeracy
patients to increase participation in self-care and improve clinical outcomes. End-stage renal disease requires intensive management by both provider
and patient. In chronic hemodialysis (CHD), patient self-care behaviors include adherence to dietary and fluid restrictions, obtaining prescribed dialysis
therapy, vascular access care, adherence to complex medication regimes and management of comorbid diseases. Participation in self-care by CHD
patients is often low and has been associated with an increased mortality risk. Low health literacy is common affecting over 90 million people in the
U.S., and has been associated with lower knowledge of chronic disease and lower adherence. We hypothesize that literacy and numeracy are
important determinants of self-care behaviors and clinical outcomes in CHD patients. The primary research goals of this application are: 1). to develop
methods to describe literacy and numeracy skills and associated characteristics of CHD patients, 2). to determine the association of low
literacy/numeracy with knowledge, self-efficacy, and participation in CHD self-care behaviors and clinical outcomes, and 3). to evaluate the impact of a
provider intervention, targeted to patients with low literacy, on self-care behaviors and clinical outcomes. The proposed research will result in
fundamental knowledge and new methodology to identify and measure mechanisms and barriers of self-care in CHD patients, which will enable the
design and implementation of patient-centered, educational, and adaptive interventions to improve adherence to self-care recommendations.
Importantly, this experience will provide the candidate with a new and advanced methods skill-set that will enable her to develop into a successful
independent investigator well equipped for significant contributions to improving the care of patients with kidney disease.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION, OVERALL (provided by applicant): This proposal will establish a new Diabetes Research and
Training Center (DRTC) at the University of Alabama at Birmingham (UAB). The immediate goal of the center is to promote excellence in diabetes
research. Through these efforts, the center ultimately endeavors to decrease morbidity/mortality and increase quality of life for our diabetes patients,
and to provide an outstanding environment for student training and for faculty career development in diabetes research. Our specific aims are to: 1.
Facilitate and enhance diabetes research by establishing core technologies expressly required by our investigator base. These technologies will be
effectively provided by three biomedical resource cores, Bioanalytical Redox Biology, Animal Physiology, and Human Biology Cores, and two
Prevention & Control cores, the Metrics & Health Services Research and Community Engagement Cores. 2. Augment diabetes research via a pilot &
feasibility grant program that will emphasize innovation, translation, and career development of highly promising junior investigators. 3. Promote a
cohesive intellectual environment for an outstanding multi-disciplinary investigator base, which will enhance learning, collaboration, collegiality, and
innovation. 4. Develop and evaluate new models of diabetes patient care that incorporate multi-disciplinary health care teams to improve patient
outcomes, provide venues for clinical training, and create laboratories for translational and health services delivery research. 5. Leverage the resolve
of UAB leadership, substantial institutional commitments, and generous philanthropy from our community to impel the development of a pre-eminent
center of diabetes research excellence in the heart of the deep south. A new DRTC will have a high impact for diabetes research at UAB for several
reasons including (i) our patients who have the highest rates of diabetes in the US, (ii) the collaborative and nurturing environment afforded research
centers at UAB, and, most importantly, (iii) an outstanding investigator base with diabetes research excellence in human physiology, animal
physiology, free radical biology and oxidative stress, inflammation, vascular biology, health disparities, health services, and community based
research. Diabetes is both a metabolic and vascular disease, and one strategy employed by the DRTC is to unite metabolic and vascular researchers
around these common themes to achieve a better understanding of the mechanisms, prevention, and control of diabetes, diabetes complications, and
cardiometabolic risk.
DESCRIPTION (provided by investigator): This application addresses broad Challenge Area (01) Behavior, Behavioral Change, and Prevention and
specific Challenge Topic, 01-DK-103 Improved understanding of behavioral and social factors related to non- Adherence in people with diabetes. We
propose to study patterns and predictors of diabetes patients' failure to utilize referred health services (e.g., standard lab tests, specialty visits, health
education). These preventive health services are particularly important in the care of diabetes given the disease complexity, need for continual
monitoring, and frequent intensification. This project will inform policy in two areas of importance to the NIH: (1) how to address poor adherence
among patients with diabetes and (2) how to reduce health disparities. Findings will help us better understand the potentially high-cost patients who do
not adhere to their diabetes treatment plan despite full access to integrated, pre-paid health care and allow identification of barriers to care. The
project uses data from an NIH funded study, The Diabetes Study of Northern California (DISTANCE) plus new data captured from the Kaiser
Permanente electronic health record (EHR). The study has immediate and longer-term public health implications, given that repeated non-utilization
('persistent non-utilization') may adversely affect continuity of care, and increase the risk for serious and costly events. This study is feasible within the
two-year time frame of the challenge grant award. The investigator team has demonstrated productivity, combines expertise in adherence and
diabetes health services research, and is highly experienced in acquiring and analyzing the data involved. ABSTRACT Poor adherence to a medical
treatment plan is a serious public health problem in diabetes. While some aspects of adherence, particularly adherence to medications, have been
studied extensively, much less is known about adherence to (utilization of) referrals for health services (e.g., standard lab tests, specialty visits, health
education). These health services are vital in the care of diabetes given the disease complexity, need for continual monitoring, and frequent
intensification. Up until now, quality of and access to care have been traditionally assessed from utilization records. An important limitation of such
data is that it cannot differentiate between two causes of non-utilization: 1) the healthcare provider did not offer the care (by prescription or referral)
versus 2) non-utilization of offered care. While healthcare providers may assume that their patients will use a health service following a referral, it is
virtually unknown to what extent patients fail to do so. Under- utilization in certain subgroups, particularly among minority and socioeconomically
disadvantaged patients, has been largely attributed to social disparities in access rather than under-utilization of offered care (i.e., inadequate
adherence). While resources are needed to increase access for vulnerable populations, we must consider that there is also sub-optimal uptake of
offered services even where access is not at issue. In this study, we take advantage of the electronic health record (EHR) system which captures
Total Cost
$786,000
$250,040
Project Number
2
Project Title
Principal Investigator
Performing
Organization
Abstract
Total Cost
electronic referral and prescribing within a large, integrated health care delivery system (Kaiser Permanente). The EHR enables us to investigate nonutilization of referred health services. This potentially has great public health importance given that repeated non-utilization ('persistent non-utilization')
may adversely affect continuity of care, and increase the risk for serious and costly events. Understanding the prevalence, social patterns, patient-,
provider- and system-level predictors of non-utilization and persistent non-utilization will allow the design of interventions aimed at reducing this form
of non-adherence. Findings will also inform a more accurate and valid definition of quality of care and access, and have important applications for our
understanding of social disparities in the quality of care. Study subjects will include members of the Kaiser Permanente Northern California Diabetes
Registry, a large, well-characterized, ethnically diverse, insured population of managed care patients with diabetes mellitus. Socially disadvantaged
patients are well represented in this study population, which has relatively uniform access to and quality of care, unlike most population-based
samples. Given that 92 per cent of Americans with diabetes have health insurance, findings from this insured population should have broad public
health relevance. Moreover, we will benefit from the rich patient-level data provided by the 20,188 diabetic patients in the DISTANCE cohort. Given
this will be the first, large epidemiological study to assess non- utilization of referred care, it will provide a more comprehensive understanding of how
nonadherence impacts health and may inform the design of future interventions aimed at reducing health disparities. We have evidence that a small
proportion of patients with diabetes within an integrated health plan fail to utilize care following a referral for covered health services (e.g., standard lab
tests, specialty visits, health education). These non-utilizing patients lack continuity of care, are at high risk of adverse events, and may end up costing
the healthcare systems much more than patients who utilize offered care. PUBLIC HEALTH RELEVANCE: In this study, we will evaluate the
prevalence of non-utilization and persistent (repeated) non-utilization for referred health services for diabetes. We will then evaluate social disparities
and other patient-, provider- and system-level predictors of non-utilization. Understanding non-utilization will facilitate the design interventions aimed at
reducing this form of non-adherence. Findings will also inform a more accurate and valid definition of quality of care and access, and have important
application for our understanding of social disparities in the quality of care. This project will help us better understand patients who are 'falling through
the cracks' despite full access to integrated health care, and allow healthcare delivery systems to modify their programs to better serve their
membership.
3U01DK061021-09S1
LIMITED COMPETITION:
CHRONIC RENAL
INSUFFICIENCY COHORT (CRIC)
STUDY
RAHMAN, MAHBOOB
CASE WESTERN
RESERVE UNIVERSITY
3U01DK060984-09S1
PROSPECTIVE RENAL
INSUFFICIENCY COHORT
EVALUATION: PRICE
TOWNSEND, RAYMOND R
UNIVERSITY OF
PENNSYLVANIA
1R01DK081335-01A1
UNDERSTANDING DISPARITIES
IN OBESITY AND ITS
COMORBIDITIES IN THE US
WANG, YOUFA
JOHNS HOPKINS
UNIVERSITY
40
No abstract available.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): Between 2003-2007, the prospective Chronic Renal Insufficiency Cohort
(CRIC) Study enrolled >3400 adults with chronic kidney disease to address overarching goals of identifying predictors of rapid progression of kidney
disease and clarifying the relationship between kidney dysfunction and the risks of subclinical and clinical cardiovascular events, death, and resource
utilization through an initial 5-year follow-up. The proposed CRIC-2 extended follow-up through 2013 offers a unique opportunity to leverage the
existing effort and success of CRIC-1 to establish a cohort of participants with chronic kidney disease who have long-term prospective follow-up on
progression of kidney disease and a variety of different outcomes. This unparalleled resource will also expand the science related to chronic kidney
disease natural history as well as the impact on cardiovascular disease and other adverse events. Specific Aims to be addressed by the University of
Pennsyvania Clinical Center are: 1. To re-enroll a high percentage of CRIC Phase 1 participants into Phase 2 of CRIC 2. To collect exposure and
outcome data per the CRIC Phase 1 and 2 protocols 3. To maintain high levels of retention in the study 4. To investigate self-reported clinical events
and obtain supporting medical records and documentation. 5. To enter data and process/ship biological specimens. 6. To implement local quality
assurance and quality control procedures as a means to obtain standardized, high quality measurements 7. To monitor data collection, data entry, and
follow-up rates 8. To participate in governance and oversight of the CRIC study through study wide subcommittees and activities 9. To publish and
present findings from the CRIC Study 10. To promote and support the conduct of ancillary studies in CRIC, including collaboration with the broader
nephrology research community. In this application we will outline how our site has fulfilled its obligation in phase 1, how it has contributed in particular
to ancillary studies in CRIC.
DESCRIPTION (provided by applicant): Understanding Disparities in Obesity and Its Comorbidities in the U.S. Obesity/overweight has become a
public health crisis in the U.S., and currently affects 2/3 of adults and 1/3 of children. Obesity can serve as a good indicator of unhealthy lifestyles such
as unhealthy diet and inadequate physical activity (PA), two key modifiable risk factors for many chronic diseases including Type 2 diabetes (T2D) and
hypertension (HBP). National data show large ethnic/SES disparities in obesity, T2D, HBP and healthcare. Obesity is believed as the result of a large
number of biological, behavioral, social, environmental and economic factors and the complex interactions between them that promote a positive
energy balance. The determinants of these disparities are still poorly understood. Many speculations have been made regarding the major contributors
based on a growing body of literature, which has focused largely on individual factors such as SES, body image, and lifestyle factors and in some
recent studies regarding selected community characteristics. Our understanding of the relative contribution of these factors, the interplay between
them, and the social, economic and environmental context on individual-level behaviors is limited. Our proposed 3-year study is a systematic
investigation based on data collected from national surveys, large cohort studies and other sources and aims to understand the causes of ethnic/SES
disparities in obesity and its co-morbidities (T2D and HBP) as well as the related health care in the U.S., both adults and children. We will use an
interdisciplinary approach to study the determinants at the individual-, family-, and community- level using several sophisticated statistical methods:
Aim 1: To study the modifiable determinants of ethnicity/SES disparities in obesity and main co-morbidities. We will study the contributions (in absolute
and relative terms) of risk factors at the individual-, family-, and community-level, including psychosocial, behavioral, environmental, economic, and
policy factors. Aim 1a: Study the contribution of individual-level (e.g., diet, PA, SES, social support, psychosocial factors), and family-level variables
(e.g., SES, participation in food assistance programs, resemblance between parents and their children in diet, PA, and weight status); Aim 1b: Study
the contribution of social context factors (e.g., food outlets, fitness facilities, food prices, community characteristics, school PE and recess policies,
$120,472
$143,136
$574,167
Project Number
2
Project Title
Principal Investigator
Performing
Organization
Abstract
Total Cost
school food service). Aim 1c: Consider all related factors at multi-levels simultaneously to study their relative contributions. Aim 1d: Using similar
approaches study T2D and HBP. Aim 1e: Conduct ecological/ aggregated analysis to study the underlying causes of the disparities at the state and
metropolitan statistical area (MSA) levels. Aim 2: To study the influence of primary healthcare on the disparities of obesity and the causes of health
care (related to obesity) disparities. Aim 3: To conduct simulation analyses using systems analysis approaches to examine the effects of potential
interventions and scenarios for helping eliminate the ethnicity/SES disparities. Findings of this study will help achieve several of the objectives
specified in the NIH PAR, and help direct future interventions to eliminate health disparities. PUBLIC HEALTH RELEVANCE: The proposed 3-year
study is a systematic investigation based on data from national surveys and other sources to understand the individual-, family-, and community-level
causes of ethnic/SES disparities in obesity and its co-morbidities including type 2 diabetes and hypertension as well as the related health care in the
U.S. using an interdisciplinary approach.
National Institute of Environmental Health Sciences (NIEHS)
1RC1ES018120-01
AFRICAN AMERICANS AND
ENVIRONMENTAL CANCERS:
SHARING HISTORIES TO BUILD
TRUST
MIRANDA, MARIE LYNN
DUKE UNIVERSITY
DESCRIPTION (provided by applicant): This proposal responds to the (09) Health Disparities broad challenge area and the specific challenge topic:
Building Trust Between Researchers and Communities Through Capacity Building in Environmental Public Health (09-ES-101*). African Americans
have the highest overall cancer death rate and shortest survival of any racial and ethnic group in the US. These disparities are accentuated in the
American South. For example, the US breast cancer death rate is 23.0 (per 100,000) for Caucasian women, as compared to 34.3 for African American
women. The NC breast cancer death rate is 27.2 and 38.0 for Caucasian and African American women, respectively; and in our study area, Durham
County, the breast cancer death rate is 27.5 for Caucasians and 42.0 for African Americans. The causes of these inequalities are complex, but arise,
at least in part, from disparities in income, education, nutrition, and access to healthcare. These factors all increase the likelihood of exposure to
environmental carcinogens, which may contribute to increased cancer mortality among African Americans. The central objective of this proposal is to
advance the partnership between the Sisters Network and Duke to address community concerns regarding environmental contributors to cancer
health disparities among high-risk African American families. Our specific aims are to: 1) develop a team and a framework for understanding the
community dynamics in Durham County, NC as they relate to environmental contributors to cancer as a health endpoint; 2) deploy community health
workers to inventory the exposure, diet, residential, and social history among 300 high-risk African American families; and 3) develop family-based
models of environmental public health action directed at cancer health endpoints. This project leverages and promotes ongoing relationships between
Duke University and the Triangle Chapter of Sisters Network, Inc. The proposal brings together the expertise of oncologists, environmental scientists,
geographers, patient navigators, and community organizations. This approach holds promise for addressing environmental public health concerns
regarding breast and other cancers locally and in other geographic regions. In addition, the proposal will build trust between the African American
community and the health care system through a collaborative model of listening, learning, and outreach. The proposed work is reflective of Duke’s
commitment to work collaboratively with the community to place knowledge in service of society and to foster strong interdisciplinary research
programs in environmental health sciences and health care systems.
$484,137
BROWN UNIVERSITY
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): The IMSD Scholars Program in Brown University's Division of Biology and
Medicine will significantly increase the number of underrepresented minority (URM) Ph.D. students trained for careers in basic biomedical and public
health research. Efforts already initiated have doubled our percentage of URM students in the past three years. This IMSD Program is projected to
again double (to 20%) the URM population in the Division's 10 doctoral programs. The IMSD grant will fund 5-7 doctoral students per year for up to
two years. First year students will be appointed via a selective process and provided with the necessary support, advising, mentoring, and
developmental tools to overcome deficiencies in academic preparation or other disadvantages and successfully attain a PhD. The PIs will oversee
continuous and detailed evaluation with internal and external oversight to permit assessment of progress toward goals, the ability to adjust strategy as
needed, and provide incentives for advancing a culture of diversity within Ph.D. training. Three specific aims are proposed. (1) Enhance and expand
strategic partnerships with institutions that are minority-serving or train large numbers of URM students. In addition to new partnerships, we will
improve our long-standing relationships with the Leadership Alliance and Brown-Tougaloo Program, and develop relationships with professional
organizations serving the academic interests of URM students. (2) Implement a Multifaceted Personalized Educational Program for IMSD Scholars
that provides a continuous-to-degree advising and support structure empowering students to develop their full potential. The program core is a menu
of training modules designed specifically for IMSD Scholars. Seminars, advising meetings, IMSD Scholar-faculty functions, a peer mentor network,
student-faculty compacts, an interactive program website, and an annual retreat with external and internal advisors provide integration and continuity
within the program. All IMSD faculty trainers have federal funding and a record of successfully mentoring URM trainees. (3) Improve divisional
diversity practices in Ph.D. training by raising awareness of the benefits faculty mentors and their research programs derive from investments in this
area and by providing an institutional structure that sets expectations for diversity and rewards achievement. As faculty beyond the initial group of
mentors observe the successes of this group and seek out IMSD Scholars for their own labs, they will receive incentives. The eventual outcomes of
this aim will be measured by increases in the number of (a) URM students overall, (b) individual doctoral programs with a critical mass of URM
students, and (c) faculty labs with URM students doing thesis research. The IMSD's administrative home in the Dean's office provides the leadership
and accountability to effect positive change and advance the institutional culture. In percent terms, the number of underrepresented minorities
(URM) earning Ph.D.s in biological and health sciences falls far below their percentage of the overall U.S. population. This is a major problem because
contrasted to the majority population, URM populations in the U.S. have significant disparities in access to health care and outcomes related to
personal health. To overcome these biases, large numbers of qualified URM Ph.D.s must be produced. The proposed IMSD program will double the
number of URM students entering Ph.D. training in biology and public health at Brown University through proven training, retention/advising and
assessment strategies that involve strong leadership, internal and external advisory oversight, and strong institutional commitment.
$161,464
National Institute of General Medical Sciences (NIGMS)
3R25GM083270-02S1
41
ADVANCING THE CULTURE OF
PHD LEARNING AND
SCHOLARSHIP IN BIOLOGY AND
HEALTH SCIEN
CAMPBELL, ANDREW
GARRETT ;THOMPSON,
NANCY L.;
Project Number
2
Project Title
Principal Investigator
Performing
Organization
3SC3GM083780-02S1
UNDERSTANDING FEMALE
PARTNERS OF BISEXUAL MEN:
IMPLICATIONS FOR HIV/STD
RISK
HARAWA, NINA THAWATA
CHARLES R. DREW
UNIVERSITY OF MED &
SCI
3K23GM076652-04S1
RANDOMIZED CLINICAL TRIAL
OF A LESS-INVASIVE
RESUSCITATION PROTOCOL
FOR SEPSIS
JONES, ALAN E
CAROLINAS MEDICAL
CENTER
Abstract
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): In the United States, the reported rates of new HIV diagnoses among
black and Hispanic women are, respectively, 20 and 5.4 times that of white women. A greater tendency toward bisexual behavior and non-gay
identification among black and Hispanic men who have sex with men (MSM) than among white MSM is thought to contribute to the large racial/ethnic
disparities in HIV/AIDS observed among women; however, nearly nothing is known about the female partners of behaviorally bisexual men.
Furthermore, many HIV-infected women are considered 'heterosexual unidentified risk' because they do not fit into an HIV transmission category other
than sex with a male of unidentified risk. We propose a two-phase study to better understand HIV risk among women of color by identifying predictors
of sex with bisexual and unidentified risk men and exploring psychosocial issues surrounding and correlates of these sexual partnerships. This
research will be carried out among African-American and Latina females recently tested for HIV in publicly funded test sites in Los Angeles County.
In Phase I, a matched case-control analysis will be carried out using secondary data to identify predictors of having had sex with a bisexual man or of
being diagnosed HIV-antibody positive with unidentified heterosexual risk. In Phase II, recently tested women will be recruited and interviewed,
including 30 who report bisexual male partners and 20 HIV-infected women with unidentified sexual risk. The in-depth semi-structured interview will
examine psychosocial factors surrounding sexual relationships with men, including known bisexual, potentially bisexual, and presumed heterosexual
men and explore (1) the range of relationship types characterizing women's relationships with these men; (2) attitudes regarding gender roles and
desired partner traits; (3) how and when participants became aware of their partners' bisexual behavior and how this awareness influenced their HIV
risk perception; (4) how HIV-antibody positive women with unidentified sexual risk perceive they and their partners were infected; and (5) participant's
attitudes and behaviors regarding health-related research, health care, and STD/HIV prevention. Interview transcripts will be analyzed using a
consensual qualitative research approach to identify major themes and generate hypotheses and survey items for a larger quantitative interview study
comparing women reporting sex with a bisexual male to women who do not believe that they have had sex with a bisexual man. They will also help
direct prevention resources and guide HIV prevention intervention approaches among women of color.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): This proposal details a structured mentored training program in patientoriented clinical research. The PI has completed a residency in emergency medicine and a clinical research fellowship and is seeking this award to
complete an intensive experience of mentored research training and research didactic education to achieve the career goals of 1) achieving
independent research funding for the purpose of 2) conducting significant investigations in the area of emergency department (ED) treatment of
severe sepsis and septic shock. This project includes a 5 year curriculum with three distinct phases of training including: 1) Mentoring - Dr. Jeffrey
Kline is the project mentor. He is an NIH-funded investigator who will ensure timely and effective application of the knowledge gained through
coursework and research experience. Other mentors include a career development mentor, an external project mentor, and a statistical mentor; 2)
Didactics - A Masters of Science in Clinical Epidemiology and Health Services Research will be obtained and this degree will significantly enrich the
methodological knowledge base and research skills initiated in the Pi's research fellowship; 3) Investigation - The research program in this award
seeks to test the hypothesis that a less- invasive goal-directed resuscitation protocol is equivalent to a fully invasive goal-directed resuscitation
protocol in ED patients with severe sepsis and septic shock. Sepsis is a major public health crisis whose incidence is increasing by 1.5% per annum,
results in 215,000 deaths per year and costs the United States $16.7 billion dollars in health care resources per year. Previous work has suggested
that fully invasive goal- directed resuscitation in the ED could substantially reduce the in-hospital mortality and hospital resources in severe sepsis and
septic shock. Unfortunately the protocol is complicated, invasive and expensive. In a randomized clinical trial we will compare for hospital mortality
equivalence this fully invasive protocol to a less-invasive protocol by replacing central venous oximetry measurements with lactate clearance
measurements. The relevance of this project lies in its benefit to public health of providing a less-invasive resuscitation protocol that will be simpler,
cheaper and thus more accepted and applied to clinical practice. This will potentially result in saving thousands of lives per year and reduce the cost of
care for septic patients.
Total Cost
$96,575
$101,430
National Institute of Mental Health (NIMH)
1R21MH085792-01
42
IDAHO PARTNERSHIP FOR
HISPANIC MENTAL HEALTH
AISENBERG, EUGENE
;DWIGHT-JOHNSON,
MEGAN ;POWELL, LINDA
G;
MOUNTAIN STATES
GROUP, INC.
DESCRIPTION (provided by applicant): The primary goal of the Idaho Partnership for Hispanic Mental Health phase one planning project is to reduce
disparities in mental health treatment among Hispanics in southwest Idaho, who are primarily an immigrant population of Mexican origin. The project's
first step will be to conduct a community assessment which will: 1) further knowledge about Hispanics' perceptions and beliefs about mental illness,
and behaviors and preferences regarding mental health treatment, and 2) assess southwest Idaho's mental health provider organizations' knowledge,
attitudes, and practices regarding their services to Hispanic individuals, and gaps in service access and provision for Hispanics. As barriers to
Hispanics access and use of mental health services are already well-documented, the purpose of this community assessment will be to inform the
improvement of mental health service delivery. The project will use a community-based participatory research approach. Project partners include
Mountain States Group, the University of Washington, Centro de Comunidad y Justicia, Dr. Al Sanchez (Hispanic mental health consultant), and an
existing Hispanic Health Community Advisory Board. Strong equitable partnerships between the research organizations and the Hispanic community
have already been established. All have participated in formulating the proposal's research design, which includes semi-structured interviews with 240
adult Hispanics residing in southwest Idaho, and open-ended interviews with 35 southwest Idaho mental health services providers. The project's data
findings, supplemented by secondary data research, will be used to prioritize infrastructure development and capacity building actions to respond to
Hispanics' mental health service needs. The research and community partners will form two specific action plans, one for implementing communitybased and culturally appropriate mental health services interventions, and a second for conducting mental health service provider training to improve
their understanding, skills, policies, and practices in working with the Hispanic community. Phase one activities will lead to the submission of a full
research proposal to implement the recommendations. PUBLIC HEALTH RELEVANCE: To work effectively, health care providers need to
understand the differences in how various populations in the United States perceive mental health and mental illness and treatment services (Healthy
People 2010). The Idaho Partnership for Hispanic Mental Health will contribute to the understanding of Hispanics' perceptions and beliefs about
mental illness and mental health treatment. Findings will be used to improve the cultural relevance, responsiveness, and accessibility of community-
$177,839
Project Number
2
Project Title
Principal Investigator
Performing
Organization
Abstract
Total Cost
based mental health services for southwest Idaho Hispanics.
3R24MH077192-02S1
CATALAC: COMMUNITYACADEMIC TREATMENT &
ASSESSMENT FOR LOW-INCOME
AGED CONSUMERS
AREAN, PATRICIA A.
UNIVERSITY OF
CALIFORNIA SAN
FRANCISCO
3P20MH068662-05S1
BIPOLAR ILLNESS
INTERVENTION IN HISPANIC
COMMUNITIES
BOWDEN, CHARLES LEE
UNIVERSITY OF TEXAS
HLTH SCI CTR SAN ANT
3R01MH082425-02S1
EFFECTIVENESS OF A
DEPRESSION CARE
MANAGEMENT INITIATIVE IN
HOME HEALTHCARE
BRUCE, MARTHA L.
WEILL MEDICAL COLLEGE
OF CORNELL UNIV
43
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators.DESCRIPTION (provided by applicant): Evidence-based assessment and treatment of mental illness in older adults
are rarely available to poor older adults of color. Community agencies and academic centers rarely partner to provide these services to underserved
populations and very rarely work collaboratively on research. The Collaborative Alliance for Treatment and Assessment of Low-income Aging
Consumers (CATALAC) project, a partnership between the Over-60 Research Program at the University of California, San Francisco (UCSF) and the
Family Service Agency of San Francisco (FSA), seeks funding to develop a community-academic research partnership to develop a shared an
mutually designed research infrastructure to assess FSA's success and mission in providing evidence-based mental health for diverse populations of
low-income older adults. The activities we propose are designed to simultaneously enhance the clinical and research infrastructure at FSA, so that
evidence-based interventions can be both implemented and evaluated, and to develop procedures and practices that can be generalized to other
FSASF programs as well as to other community agencies. Over the past four years, FSA and UCSF, as the CATALAC team, have worked to facilitate
organizational and provider readiness for adopting both EBPs and research at FSA. Activities include the creation of an IRB within FSA; participation
of two FSA clinicians in the CARTA program; Mr. Bennett's strategy of involving respected, key clinicians in the development of EBP training and
integration of assessment into practice; the creation of the Felton Institute for transmitting EBPs; and Dr. Arean's continued membership on FSA's
board of directors. Our aims are to (1) Test and refine an assessment toolkit for mentally ill older adults that is practical and portable in English and
Cantonese (2) Implement a web-based electronic clinical and research case identification and outcome monitoring system, (3) Implement and
evaluate Problem Solving Therapy for older adults with depression and mild cognitive impairment and (4) Develop a research-training program in
community-based clinical outcomes research. The partnership process and activities will be evaluated by Dr. Karen Linkins of the Lewin Group. A
successful community and academic collaboration must be beneficial to both partners and both partners must contribute to the process. FSASF and
UCSF-OS have already begun such a partnership, which thus far is proving to be a fruitful enterprise. Both parties now wish to enhance this
partnership and move it to the next level, by creating tools and methods that can be emulated and easily available to other partnerships of this nature.
Our partnership also addresses county and state- level initiatives to move EBPs and integrate evaluation into mental health services. This partnership
will have substantial impact not only in the field of geriatric mental health, but in policy related to community- academic partnerships.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators.DESCRIPTION (provided by applicant): This program seeks to establish a Developing Center for Interventions and
Service Research (DCISR) that will forge an academic-community partnership to conduct interdisciplinary interventions research that will improve care
of bipolar disorders, study moderators and mediators in the community that affect outcomes and participation in clinical research, and be of particular
relevance to Hispanic Americans. The DCISR will enable the applicants to expand and develop their research capabilities, and contribute to greater
alignment of research outcomes with community needs. With the DCISR infrastructure, the applicants will increase community involvement in study
planning and management, and develop study designs better able to improve community-relevant interventions and the generalizability of results.
These accomplishments will be greatly enriched by the opportunity to study in a comparative effort the Hispanic population that constitutes 55% of the
population of the ninth largest city in the U.S. The DCISR brings together a multidisciplinary group of investigators with differing research foci around
a central area of interventions and public health study on BD. The DCISR will develop a scale that provides an aggregate measure of
psychopathology in BD, as well as sub-scale measurement of the full scope of depressive and manic symptomatology and will integrate data on
clinical, treatment, neuroimaging, and genetic research in bipolar subjects into one central database. The training components of the Center will
capitalize on the interdisciplinary model, with its potential for training beyond a primary focus of interest and access a broader group of mentors with
relevant expertise to interventions research in BD. The scientific theme of the DCISR will be to provide a focal point for BD research in the UTHSCSA
and the San Antonio area. Administration of the Center will be led by an Operations Committee that will have responsibility for the evaluation of
intervention studies, linking research staff and objectives of the DCISR with the community and community stakeholders, oversight of data
management and statistical operations, infrastructure development, training, program planning and insuring that the Center goals and vision are
inculcated in all its activities. The committee will work to integrate the efforts of diverse faculty participating in the DCISR, meet with and solicit the
input of the Community Advisory Committee, and convey the DCISR accomplishments within the Center and beyond. The OC will oversee
maintenance of DCISR resources and relationships, and monitor all DCISR studies. The strategic plan of the Center emphasizes facilitating
interdisciplinary investigation, forging alliances with the community, and incorporating the information learned from study of the community into
modification of designs of intervention studies, recruitment efforts, and translational efforts back to community caregivers and patients with BD. These
infrastructure developments will then support two developmental projects and additional pilot studies.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators.DESCRIPTION (provided by applicant): The goal of this research is to improve depression treatment and outcomes
among elderly home healthcare patients. Homecare nursing is a major source of health care for a large and growing number of medically ill or injured
older adults who are homebound by illness or disability. We1 and others2 have documented that clinically significant depression is twice as prevalent
in this patient population compared to similarly aged primary care patients. Depression can be effectively treated in older adults, and treatment
guidelines have been developed to help physicians make treatment decisions for their depressed older patients. However, medical home healthcare
patients rarely receive guideline-consistent treatment for depression. This application request funds to test the effectiveness of an intervention,
'Homecare Depression Care path' (CAREPATH), on two outcomes: 1. Depression treatment (i.e., initiate treatment or have a change in treatment that
is consistent with guidelines), and 2. Depressive symptoms (i.e., reduction in depressive symptoms over time). The CAREPATH protocol was
designed in partnership with home healthcare providers. It includes the major elements of depression care management models that have proven
effective in primary care but restructures these elements to fit the clinical needs of home healthcare patients and for consistency with home healthcare
practice. The intervention itself is designed to be ecologically sensitive to maximize the feasibility and generalizability of the program. The CAREPATH
Intervention will be tested within and among five homecare agencies located in Iowa, Michigan, New York City, Oklahoma and Upstate New York. The
$142,777
$256,820
$172,655
Project Number
2
Project Title
Principal Investigator
Performing
Organization
1R34MH082043-01A1
LATINO MEN AND DEPRESSION:
AN EXPLORATORY STUDY OF
HELP-SEEKING BEHAVIOR
CARDEMIL, ESTEBAN
CLARK UNIVERSITY
(WORCESTER, MA)
1R01MH082813-01A1
MODELING OFFICER-LEVEL
EFFECTS OF CRISIS
INTERVENTION TEAM (CIT)
TRAINING
COMPTON, MICHAEL T
EMORY UNIVERSITY
44
Abstract
five participating home healthcare agencies have demonstrated commitment to this research partnership and have already trained their staff in
Cornell's 'Training in the Assessment of Depression' (TRIAD). A total of 100 nurses will be randomized by pre-existing teams to CAREPATH or usual
care. The impact of CAREPATH on Depression Treatment will be tested with all eligible patients (N~1,000) using data collected routinely by all
agencies as these are the kinds of data that agencies typically use for quality assurance. Depressive Symptoms outcomes will be tested using the
Hamilton Depression Rating Scale (HDRS) collected by researcher staff from (N=500) patients who consent to in-person baseline and telephone
follow-up interviews at 12 and 24 weeks. If effective, the CAREPATH intervention could reduce the rates of unaddressed depression among elders
who use homecare. At the agency level, CAREPATH could be sustained by the participating agencies and disseminated to other interested homecare
agencies nation-wide. Project Narrative: This clinical services research will test the effectiveness of a homecare depression intervention
(CAREPATH)to improve depression treatment and outcomes among medically compromised older adults (age>65). If effective, the intervention could
reduce the rates of untreated depression among elders who use homecare. In addition, the CAREPATH intervention could be sustained by the
participating homecare agencies and disseminated nation-wide.
DESCRIPTION (provided by applicant): Depression is one of the most prevalent and disabling psychiatric disorders, and evidence suggests that lowincome Latinos may be at particularly high risk for experiencing the disorder. However, utilization of formal mental health services is very low in this
population, especially among less acculturated or recent immigrants. Latino men may be especially at risk for underutilizing services, due to both their
minority status and the impact of masculine gender norms that proscribe seeking help for problems in living. Given the rapidly increasing growth in the
Latino population in the US, it is critical for researchers to clarify barriers to treatment utilization in Latino men. To date, no research has examined the
cultural and gender-related variables that predict attitudes towards mental health treatment and treatment-seeking behavior in this population. We
propose to conduct the first systematic investigation of the culture- and gender-based psychological variables underlying the underutilization of
depression treatment by low-income, Latino men. The long-term goal of this research is to identify specific ways in which current treatments can be
modified or enhanced to make them more appealing and relevant to Latino men, ultimately improving the use of care by these men. This study will
utilize quantitative and qualitative methodology and will target a sample of low-income Latino men experiencing clinically significant symptoms of
depression. The quantitative portion will consist of 120 Latino men (60 who are currently in treatment, and 60 who are not) who will complete interview
and self-report assessments at two time points measuring a variety of predictors of treatment-seeking behavior, including attitudes toward mental
health treatment, stigma, and perceived barriers to care. In addition, a central focus of the quantitative portion will be to measure culture- and genderbased psychological variables that we predict will be associated with the more proximal predictors of treatment-seeking behavior. The qualitative
portion will consist of individual interviews with approximately 24 Latino men and will focus on understanding the processes by which decisions to seek
treatment for depression are made, and the role that culture and gender play in the treatment-seeking process. The specific research aims of this
investigation are: (1) To understand how low-income Latino men conceptualize depression, coping with depression, and depression treatment (2)
To identify and understand the facilitative factors and barriers that low-income Latino men experience when considering seeking treatment for
depression (3) To explore the ways that specific culturally-based and gender-based psychological variables influence depression treatment-seeking
in low-income Latino men (4) To develop a preliminary model of how culture and gender-related variables influence the ways in which low-income
Latino men interpret depressive symptoms and choose to seek or not seek treatment. Depression is one of the most prevalent and disabling
psychiatric disorders, yet treatment utilization rates remain very low, especially among low-income minorities. Latino men are at a particularly
heightened risk for not seeking mental health services when needed. This study is designed to clarify reasons why many low-income Latino men do
not seek help when they are depressed, thus providing the groundwork for improved services for this high risk group.
DESCRIPTION (provided by applicant): In Crisis Intervention Team (CIT) training, police officers participate in 40 hours of specialized training
provided by local mental health professionals, family members/advocates, and mental health consumer groups. Upon completion of the training, these
officers serve as specialized first-line responders for calls involving people with serious mental illnesses (SMI). The CIT model also supports
partnerships between psychiatric emergency services and police departments, increasing the likelihood that people in psychiatric crisis will be taken to
medical facilities rather than jails. The proposed study was developed in response to a prominent dearth of research on CIT, even though it is being
implemented widely in numerous municipalities across the U.S. This research, which will build on the PI's ongoing CIT research, will examine the ways
in which CIT training may ultimately lead to improved patient- and system-level outcomes by addressing the crucial issue of officer-level outcomes of
CIT. This research will be a first step toward understanding how this collaborative model works and will set the stage for research that could have
major implications for people with SMI who often interact with law enforcement/criminal justice systems. This project will compare CIT and non-CIT
officers and test two complementary models of effects of CIT-the Theory of Planned Behavior (TPB) and the novel Model of Officer-Level Effects of
CIT (MOLEC). The specific aims of the research are: Aim 1: To design, adapt, and study the psychometric properties (i.e., reliability, validity) of a
number of measures developed specifically for use with police officers; Aim 2: To evaluate the utility of the TPB, the exploratory MOLEC model, and a
combined model, in explaining intentions to facilitate mental health referrals and de-escalation skills of 250 CIT vs. 250 non-CIT officers; and Aim 3: To
examine the effectiveness of the CIT program in facilitating actual mental health referrals by comparing reports of encounters with individuals with
suspected SMI and appropriateness of referrals in CIT vs. non-CIT officers over 6 weeks. Months 1-6 will be dedicated to careful instrument
development/adaptation, engagement of police departments, preparation for recruitment and data collection, and testing of instrument
reliability/validity. Months 7-30 will include in-depth cross-sectional and 6- week longitudinal data collection, database development, and data entry.
Months 31-36 will involve data analysis and dissemination of findings to various relevant audiences. Ultimately, this research may elucidate how the
mental health and law enforcement communities can collaborate to improve the health of individuals living with SMI by reducing criminalization and
enhancing access to mental health services. PUBLIC HEALTH RELEVANCE: The public health importance of the proposed research is substantial
given the nationwide problem of criminalization of mental illnesses resulting in incarceration of people with serious mental illnesses for minor
infractions, which delays or precludes the provision of recovery-oriented mental health services. By studying officer-level effects of Crisis Intervention
Team (CIT) training, collaborations between law enforcement and mental health can be enhanced and people with serious mental illnesses may be
able to lead safer, healthier lives supported by mental health treatment services rather than being entangled in the criminal justice system.
Total Cost
$298,434
$772,136
Project Number
2
Project Title
Principal Investigator
Performing
Organization
1R21MH083088-01A1
USING A COMMUNITY BASED
PARTICIPATORY RESEARCH
APPROACH TO EXAMINE FAMILY
SUPPORT
COOK, JAMES R ;KILMER,
RYAN P;
UNIVERSITY OF NORTH
CAROLINA CHARLOTTE
1RC1MH088454-01
THEORY-DRIVEN MIXEDMETHODS EVALUATION OF
PTSD TREATMENT
IMPLEMENTATION IN VA RES
COOK, JOAN M
YALE UNIVERSITY
3R01MH08191601A1S1
DETECTION AND CARE FOR
DEPRESSION IN THE
PERIPARTUM
COYNE, JAMES C
UNIVERSITY OF
PENNSYLVANIA
45
Abstract
DESCRIPTION (provided by applicant): The long-range objectives of this project are to improve family functioning and reduce disparities in mental
health services and outcomes through the development of a sustainable research partnership among family support providers and university
researchers. Building upon existing partnerships among community agencies and university faculty in a developing System of Care (SOC) for children
with severe emotional disturbance (SED) and their families and for families in the child welfare system, this project will build the capacity of family
support programs to collect and manage data, enabling research to document the impact of family support activities. This research can inform practice
and reduce disparities in access to and receipt of services among underserved groups, and help build an evidence base for family support, particularly
when provided by paraprofessionals. It has strong potential for expanding to examine a wide array of family support programs offered by schools,
faith-based organizations, and nonprofits. Family support programs have been found to have modest effects on children and families (Layzer et al.,
2001). Since these programs continue to be encouraged as components of SOC initiatives supported through both SAMHSA and the Children's
Bureau, knowledge of their impact on children and families is critically important. A community-based participatory research (CBPR) approach will be
used to study family support, and local organizations will develop the capacity to identify research questions, collect and manage reliable and valid
data about service provision and outcomes, implement program elements consistently, analyze and interpret results, and translate information gained
via research into action. This project builds upon existing university-community partnerships to accomplish the following specific aims: 1. Strengthen
local infrastructure to support family support organizations and family members' active involvement in CBPR. The partnership will build upon existing
local resources to facilitate CBPR examining family support. 2. Examine the impact of family support on child and family team (CFT) meeting
processes and child and family functioning. Within both mental health and child welfare contexts, two multi-method pilot studies will examine the
impact of family support activities within a community SOC initiative, assessing the effects of family mentoring and support on the implementation of
CFT meetings, the plans developed in them, the services received by families, and the impact of family support programming on child and family wellbeing. PUBLIC HEALTH RELEVANCE: Relevance to Public Health Although family support programs have become important components of
Systems of Care, within both public mental health and child welfare systems, these programs, particularly when run by paraprofessionals, have been
relatively understudied. It is important to identify the characteristics and components of family support programs that can best benefit families. This
project will evaluate the impact of these programs to help build an evidence base that can inform and improve practice and, crucially, address
disparities in mental health services and outcomes.
DESCRIPTION (provided by applicant): This application addresses broad Challenge Area (15) Translational Science and specific Challenge Topic
(15-MH-105) Strategies to Support Uptake of Interventions within Clinical Community and Settings. Implementation of evidence-based treatments into
mental health service settings is a major priority for improving the quality of services and outcomes for patients. Studies of strategies to promote
evidence-based practices among VA PTSD treatment providers are an urgent necessity due to influx of over a million soldiers returning from wars in
Iraq and Afghanistan and a recent unexpected flood of Vietnam Veterans entering treatment. If inadequately treated, PTSD can become a chronic
disorder contributing to substantial psychological and physical impairments, as well as social and occupational disabilities. This application proposes
to evaluate two national roll- outs of evidence-based treatments in Department of Veterans Affairs (VA) residential Posttraumatic Stress Disorder
(PTSD) treatment programs (N= 40) within a theory-driven, empirically-based, multi-level dissemination and implementation framework. The
overarching goal is to characterize and assess the implementation process of the two evidenced-based psychotherapies for PTSD, Prolonged
Exposure (PE) and Cognitive Processing Therapy (CPT). The investigation will measure contextual factors likely to impact implementation, with
particular emphasis placed on clinicians' perceived characteristics of the therapies, environmental support, social networks and peer opinion leaders.
The proposed study will be conducted in partnership with the Northeast Program Evaluation Program (NEPEC), which monitors all VA mental health
programming nationwide, and the National Center for PTSD (NC-PTSD), which oversees the dissemination of PE and CPT nationally among VA
providers. We plan to extend the dissemination program evaluation efforts of the NC-PTSD by adding quantitative and qualitative assessments of over
250 mental health providers in residential PTSD treatment settings through online self-administered questionnaires, semi-structured interviews and onsite observation. Implementation outcomes will include full, partial and modified adoption by programs and individual providers, as well as patient
outcomes. Capitalizing on existing NEPEC patient outcome monitoring, the effect of implementation of PE and CPT can be examined in terms of
Veterans' PTSD symptoms, substance abuse, violent behavior, employment and satisfaction with treatment. This application proposes to examine rollouts of two evidence-based psychotherapies, Prolonged Exposure and Cognitive Processing Therapy, in Department of Veterans Affairs (VA)
residential Posttraumatic Stress Disorder (PTSD) treatment programs (N= 40) within a theory-driven, empirically-based, multi-level dissemination and
implementation framework. The VA is the nation's largest health care organization. Studying the process and outcome of PE and CPT implementation
in VA practice is an urgent public health necessity and likely has the potential to advance knowledge about effective implementation strategies for
improving the uptake of evidence-based treatments in other federally-funded mental health systems.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): Detection and Care for Depression in the Perinatal Period Major depressive
disorder (MDD) among women in pregnancy and the postpartum can have profoundly negative implications for women; fetal, infant, and child
development; and the larger family. This mixed method study examines the detection and treatment of depression in a sample of high-risk women
recruited during their first prenatal visit at one of two prenatal care sites chosen for diversity. One site serves a predominately white, married, insured
population and the other a predominately African-American, unmarried, Medicaid population. The overarching goal is to identify influences on access
and barriers to care for MDD in pregnancy and postpartum. Such influences include not only institutional, financial, provider, and practical issues, but
often overlooked factors such as personal and cultural attitudes about depression, engagement with the medical system, competing priorities, and
difficulties maintaining a focus on personal mental health during pregnancy and early motherhood, particularly for disadvantaged women. The
research involves identifying a group of approximately 1600 women at high risk for MDD based on history of MDD, treatment for MDD, or current
depressive symptomatology. These women will be assessed twice in pregnancy and twice postpartum for emergence of MDD. When these women
meet criteria for MDD, they will be entered into a treatment monitoring protocol. This protocol involves systematically assessing symptom level,
evidence of help-seeking, the detection of depression and offering of treatment by health providers, interactions with the health system, and the
Total Cost
$216,000
$426,438
$51,912
Project Number
2
Project Title
Principal Investigator
Performing
Organization
3K01MH079343-03S1
PTSD AND DUAL DISORDERS AT
THE INTERFACE OF THE MH AND
CJ SYSTEMS
CUSACK, KAREN J
UNIVERSITY OF NORTH
CAROLINA CHAPEL HILL
1RC1MH089757-01
MENTAL HEALTH FIRST AID FOR
COLLEGE STUDENTS: A MULTICAMPUS RANDOMIZED
CONTROL T
EISENBERG, DANIEL
;SPEER, NICOLE K ;
WESTERN INTERSTATE
COMMISSION HIGHER ED
1R34MH082804-01A2
ENGAGING HOMELESS YOUTH
IN VOCATIONAL TRAINING TO
MEET THEIR MENTAL HEALTH
NEEDS
FERGUSON, KRISTIN M.
UNIVERSITY OF
SOUTHERN CALIFORNIA
46
Abstract
initiation of treatment and follow up care for depression. A targeted and purposively selected subsample of these women will also receive qualitative
interviews to provide a more nuanced, comprehensive understanding of their responses to the quantitative assessments. Finally, a sample of maternal
care providers will be interviewed to understand the provider's perspective on the process of identifying and obtaining treatment of depression. Results
will show how design, implementation, and uptake and effective use of enhancements of care for depression in the perinatal period must be based on
a realistic understanding of the full range of factors affecting the accessibility and acceptability of care and how these factors vary with the
circumstances of women. This project examines the rates of detection of depression, quality of treatment received and outcomes achieved, and
moderating factors of these in more than 1600 high-risk women recruited during their first prenatal visit. Results will show how design, implementation,
and, importantly, uptake and effective use of enhancements of care for depression in the peripartum must be based on a more realistic understanding
of the full range of factors affecting the accessibility and acceptability of care and how these factors vary with the circumstances of women.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): This K01 application presents a career development plan for research on
posttraumatic stress disorder (PTSD) and comorbid substance use disorder (SUD) and serious mental illness (SMI) for individuals involved in the
criminal justice system. There is an increasing demand for programs that can effectively address the needs of mentally ill persons who cycle in and out
of the criminal justice system, yet little is known about the comprehensive needs of these clients and how to intervene in a way that balances costs
and benefits. A growing body of research identifies PTSD and comorbid SUD as highly prevalent yet largely overlooked problems among people with
SMI served in the mental health system. Although limited research suggests a higher prevalence of traumatic victimization and SUD in jail populations,
research exploring the prevalence of PTSD/SUD and its relationship to other mental health and criminal justice outcomes is currently lacking. The
proposed training plan complements the candidate's background in mental health services for PTSD by providing hew skills in core areas of criminal
justice systems and populations, randomized clinical trials, economic and advanced statistical analysis, and substance abuse. The research plan will
use these newly acquired skills to address policy-relevant questions regarding the treatment of individuals with dual disorders in the criminal justice
system. Two studies will be undertaken: (1) assessing the prevalence of PTSD/SUD among people with SMI in criminal justice diversion programs and
testing whether PTSD is a primary mechanism responsible for the association between trauma, substance abuse, and SMI; and (2) carrying out a pilot
feasibility study in a local jail diversion program using a modified CBT treatment for PTSD/SUD with mentally ill offenders. Based on findings from
these two preliminary studies a R01 application will be developed to test the treatment-effectiveness and cost-effectiveness of an integrated
intervention in a large sample, randomized study design with individuals diverted from jail who have comorbid PTSD/SUD. These training and
research experiences will provide the necessary foundation for career success as an independent investigator exploring PTSD and dual disorders at
the interface of the mental health and criminal justice systems.
DESCRIPTION (provided by applicant): This application addresses broad Challenge Area (15): Translational Research Challenge Area, and specific
Challenge Topic (15-MH-106): Mental Health Programs Designed for College Students with Mental Illness. Most college students with mental
disorders do not receive treatment, and over 80% of those who die by suicide have never made contact with campus mental health services.
Knowledge, stigma, and other health beliefs represent significant barriers to help-seeking for many of these students. However, there have been no
large-scale intervention studies for reducing these barriers to mental health treatment on college campuses. This project will fill this gap by determining
whether a community mental health education program, Mental Health First Aid (MHFA), is an effective method to increase number of students who
seek mental health services on college campuses. MHFA is an international, 12-hour training program that has been shown to increase knowledge of
mental illnesses and their treatments, decrease stigma, and increase helping behaviors in community members. However, it has not been tested in a
college setting in the United States. To determine the effectiveness of MHFA in US colleges, the proposed project will involve a randomized control
trial of the MHFA training program on 32 campuses representing a range of higher education institutions, from community colleges in rural areas to
research universities in large, urban areas. The MHFA training program will be administered to peer supports such as residential advisors.
Administrative data from campus mental health services and pre- and post-intervention surveys will be used to collect outcome data on service
utilization, knowledge, attitudes, and other measures. Data analyses will focus on identifying changes in students' behaviors, knowledge, and attitudes
toward mental illnesses that can be attributed to the MHFA training. In addition to testing a novel and timely mental health intervention for college
students, this project will result in improved data collection measures for college populations, and will lay the foundation for stronger connections and
future collaborations between diverse campus communities. If the MHFA program is successful in reducing stigma and increasing general on-campus
awareness and early treatment of emerging mental health problems, then it may provide a cost-effective means for enabling more students to seek
early treatments for developing mental health problems.
DESCRIPTION (provided by applicant): More than 2 million children and youth in the U.S. are homeless at some time each year. Once on the streets,
homeless youth frequently rely on high-risk survival behaviors to meet their basic needs. Compounding these high-risk behaviors, these youth also
have histories of depression, low self-esteem, trauma, substance abuse, and physical and sexual abuse. Despite the myriad mental health issues
homeless youth confront, their rates of engagement in existing services are limited. To date, the field also lacks a recruitment protocol for engaging
and retaining homeless, street youth in vocational and mental health services. The overall goal of this PAR-06-248 R34 proposal is to enhance the
engagement and retention of homeless youth with mental illness in our previously piloted and refined Social Enterprise Intervention (SEI), a vocational
intervention integrated with clinical services, specifically designed for homeless, street youth with mental illness, high-risk behaviors and limited
service engagement. The SEI seeks to improve street youths' engagement and retention in vocational and mental health services, and to increase
their social support, life satisfaction, service utilization, and mental health and functional status through peer mentoring, job training, clinical services
and harm-reduction strategies. The specific aims of our study are to: 1) develop and implement a peer-based service engagement protocol with
homeless youth; 2) develop strategies for increasing their retention in vocational and clinical services; 3) revise and finalize a manualized version of
the SEI to include the engagement protocol, retention strategies, and fidelity and sustainability measures for future model replication; and 4) conduct a
pilot study of the revised SEI manual and engagement protocol with 72 homeless youth (36 intervention and 36 control-group youth) to assess the
intervention's impact on various treatment outcomes. We propose a randomized experimental design with repeated outcome measurements at
Total Cost
$103,474
$493,989
$338,546
Project Number
2
Project Title
Principal Investigator
Performing
Organization
3R01MH076908-04S1
TELEMEDICINE-BASED
COLLABORATIVE CARE TO
REDUCE RURAL HEALTH
DISPARITIES
FORTNEY, JOHN C
UNIVERSITY OF
ARKANSAS MED SCIS LTL
ROCK
1RC1MH088329-01
PARENTS' ADHERENCE TO
TREATMENT
RECOMMENDATIONS: DO IT FOR
THE CHILDREN
GARBER, JUDY
VANDERBILT UNIVERSITY
1RC1MH088716-01
EVALUATING EFFECTIVENESS
OF A STATEWIDE PUBLIC
MENTAL HEALTH RE-ENTRY
PROGRAM
HARTWELL, STEPHANIE
UNIVERSITY OF
MASSACHUSETTS
BOSTON
47
Abstract
baseline and at 8- and 14-month follow-ups. Building upon the 5-year partnership between the USC School of Social Work and the host agency, My
Friend's Place, this study addresses the fundamental issue around identifying effective vocational programs for street youth within agency settings.
Presently, there are limited examples of community-based participatory research endeavors that involve the practice community in the design,
implementation and evaluation of interventions. As such, this study supports one of NIMH's key research priorities to expedite evidence-based
practices into clinical settings. Several products will be available from this study: 1) a revised SEI treatment manual that will include engagement and
retention protocols, fidelity measures and sustainability strategies; 2) baseline information of sample characteristics and variable distributions to help
plan our large-scale, randomized intervention trial; 3) pilot data on subject recruitment, randomization, data collection and SEI implementation
processes for our future randomized trial; and 4) an R01 application to test the effectiveness of the SEI in a subsequent randomized clinical trial.
PUBLIC HEALTH RELEVANCE: More than 2 million children and youth in the U.S. are homeless at some time each year. Major depression, posttraumatic stress disorder, and conduct disorder are found to be three times higher in homeless youth than in youth who have not left home. Given their
low service utilization, combined with high-risk street behaviors and mental health problems, these youth are at risk for developing new and
exacerbating existing mental health illnesses as well as for chronic homelessness. The proposed study responds to this pressing public health need
by developing strategies for engagement and retention of homeless youth with mental illness in a comprehensive vocational intervention integrated
with clinical services (the Social Enterprise Intervention), designed to enhance the youths' mental health, behavioral, social and functional outcomes.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. Rural individuals with depression face substantial barriers to care, seldom receive evidence-based treatment, and
experience poor outcomes. Collaborative care has been documented to improve outcomes in large urban Primary Care (PC) clinics. Implementing
collaborative care in small rural practices presents a unique challenge because it is not feasible to employ on-site multidisciplinary care teams
dedicated to depression treatment. No published studies have documented the effectiveness of collaborative care in small rural PC clinics. In fact, one
recent collaborative care effectiveness study conducted in both rural and urban practices found that outcomes were significantly improved in urban
clinics, but not rural clinics. Results from our current VA study demonstrate that telemedicine-based collaborative care is effective in small rural PC
clinics. Telemedicine-based collaborative care was provided to rural clinics by an off-site depression care team using telephones, emails, interactive
video, and a shared electronic medical record. A critical question for the field is whether it is more effective for small rural clinics to provide
collaborative care services on-site (practice-based collaborative care model) or to contract with an off-site care team that specializes in providing
collaborative care to multiple clinics from a centralized location using telemedicine technologies (telemedicine-based model). We propose to compare
the effectiveness/cost-effectiveness of telemedicine-based collaborative care to practice-based collaborative care in six Community Health
Center(CMC) systems in rural Arkansas. In 2003, 890 federally-funded CHCs served over 12 million poor, ethnically diverse patients living in medically
underserved areas. CHCs are in the process of re-engineering clinics to provide practice-based collaborative care as a part of the Health Disparities
Collaboratives. The proposed research has the potential to have a major public health impact because the results should be generalizable to the
hundreds of rural CHCs across the country. CHCs represent one of the largest and fasting growing PC systems in the nation, and thus results should
be applicable to a large number of providers and patients across the nation. In addition, CHCs serve predominantly low income minority populations
living in medically underserved areas. This population is at high risk for experiencing health disparities and thus, interventions targeting this population
have the potential to have a major impact.
DESCRIPTION (provided by applicant): This proposal is in response to Challenge Area (06): Enabling Technologies and Specific Challenge Topic, 06OD(OBSSR)-101* Using new technologies to improve or measure adherence. The primary aim of this research is to develop and test a method for
increasing adherence to treatment recommendations for mothers of children with emotional or behavior problems. Parental psychopathology is a
serious risk factor for psychiatric problems in children, yet most parents of children receiving mental health services do not get treatment for their own
problems. Such parental psychopathology, particularly maternal depression, places a burden on society through lost wages, increased marital strain,
and serious maladjustment in their offspring. The specific aim of the proposed research is to increase depressed mothers' adherence to
recommendations for treatment. Participants will be 200 mothers of children (7-17 years old) receiving psychiatric treatment in a community mental
health center. Mothers will be randomly assigned to either the Enhanced Motivation Intervention (EMI) or an information only control group. The EMI is
a modified version of the program developed by Swartz, Zuckoff, and colleagues who combined motivational and ethnographic interviewing into a brief
intervention that (a) elicits the mother's 'story' and her understanding of her central problems; (b) provides psycho education about their disorder; (c)
describes the effects of depression on children and the potential link between improvements in mothers' and children's symptoms; (d) obtains their
prior treatment history, hopes, and concerns about the recommended treatment; (e) identifies potential practical (e.g., child care) and psychological
(e.g., stigma) barriers to treatment seeking; and (f) elicits a commitment to take the next step (i.e., make an appointment). Evaluations at baseline and
8-weeks and 6-months post intervention, will assess mothers' psychiatric disorders, symptoms, functioning, and service utilization. Children's
symptoms, disorders, and functioning also will be measured. We hypothesize that adherence to treatment recommendations will be significantly
greater for mothers in the EM intervention group compared to mothers in the information only control group. The impact of the EM intervention on
changes in mothers' and children's psychopathology also will be examined. The public health implications of this research are that more individuals in
need of mental health services will receive and adhere to them, possibly resulting in a positive effect on their children's adjustment. Consistent with the
goals of the Recovery Act, the project would immediately create three new full-time jobs. If the intervention is successful, then a longer-term benefit
could be an increase in the demand for the services of mental health care providers, thereby expanding the work force.
DESCRIPTION (provided by applicant): This application addresses broad Challenge Area (09) Health Disparities and specific Challenge Topic, 09MH-101: Validating Models of Community Re-entry Programs for Prisoners with Mental Disorders. Abstract The purpose of this study is to combine
existing administrative databases to evaluate the effectiveness of a statewide re-entry program for people with mental illness exiting corrections. The
Massachusetts Department of Mental Health (DMH) Forensic Transition Team (FTT), a case management based re-entry program, has been in
existence for over 10 years. Although there have been descriptive studies documenting favorable short-term outcomes, a rigorous scientific evaluation
of the FTT program using matched controls has not been done. The goals of the proposed study are two-fold: (1) to evaluate the effectiveness of the
Total Cost
$28,670
$338,615
$411,072
Project Number
2
Project Title
Principal Investigator
Performing
Organization
1R21MH086136-01A1
CBPR ON ACTIVE LIVING AND
RECOVERY FOR RACIAL/ETHNIC
GROUPS WITH MENTAL ILLNESS
IWASAKI, YOSHITAKA
TEMPLE UNIVERSITY
1R21MH082712-01A1
IMPLEMENTATION STRATEGY
FOR DELIVERING A SCHOOLBASED MENTAL HEALTH
PROGRAM
KATAOKA, SHERYL H
UNIVERSITY OF
CALIFORNIA LOS
ANGELES
48
Abstract
FTT program in reducing recidivism, and (2) to assess whether the program's benefits are likely to outweigh the costs using a comparative economic
analysis. The study design is retrospective with the comparative analysis based on a case-control framework. Individuals with serious mental illness
who re-entered the community after incarceration but were not eligible for FTT program form the control group. The controls are matched based on
propensity scores selected from demographic, mental health and criminal history variables. We will conduct both 'between' and 'within' group analysis
of the FTT program to understand disparities in community re-entry outcomes. To accomplish the objectives of the study we will merge existing
administrative data for the years 2007 - 2010 from state agencies with which FTT clients have significant contact. These agencies include the
Department of Mental Health, Department of Correction, Hamden and Suffolk County Houses of Correction, Department of Public Health Bureau of
Substance Abuse Services providing substance abuse services, and publicly available data from the Criminal Offender Record Information system,
the state's official electronic arrest record repository. Major strengths and innovations of the proposed application are: (a) existing databases which
can be harmonized to answer research questions; (b) evaluation of a unique state-wide re-entry program serving voluntary participants that has been
in existence for over 10 years; and (c) the use of comparative economics. This application addresses the emerging public mental health crisis of
truncated continuity of care for individuals with severe mental illness involved in the criminal justice system in general and exiting corrections in
particular. Project Title: Evaluating Effectiveness of a Statewide Public Mental Health Reentry Program 1. Challenge Area and Specific Challenge
Topic This application addresses broad Challenge Area (09) Health Disparities and Challenge Topic 09-MH-101:'Validating Programs of Community
Re-entry Programs for Prisoners with Mental Disorders.' We propose to evaluate the effectiveness of a comprehensive re-entry intervention for
individuals with severe mental illness (SMI), both in terms of post-incarceration outcomes and comparative economics. To achieve our objectives we
undertake a interagency collaboration to harmonize existing administrative databases to compare individuals receiving re-entry services in comparison
to released prisoners with SMI who have not. Such analysis is needed to inform policy regarding the important issue of released prisoners with SMI
that impacts both public health and public safety.
DESCRIPTION (provided by applicant): This project uses community-based participatory research (CBPR) to examine the pathways of active living
toward recovery and the promotion of health and life quality for urban-dwelling culturally diverse groups of people with mental illness (CDGPMI). Our
pre-application community-based work has led to a formal partnership agreement with various community partners representing mental health
advocacy, mental health care and research, and mental health policy-making at local, regional, or national levels. Based on the CBPR principle, we
will maintain: (a) mutual respect and trust; (b) team-work and equitable participation; (c) co- learning and collective capacity-building; (d) powersharing and co-ownership of research; (e) a community- oriented bottom-up approach (rather than a top/university-down approach); (f) the integration
and synthesis of expertise and resources of CBPR team members; (g) the sustainable development of partnership; (h) a trans- disciplinary and crossdomain approach that overrides the academic-community-practice boundaries; and (i) collective empowerment and proactive actions toward social
change. This partnership, along with our Advisory Council including other stakeholders (e.g., culture and mental health advocates), will guide our team
to conduct mixed-method studies. First, we will conduct a pilot survey study with CDGPMI (n = 112) to collect preliminary baseline data on the
association of leisure behavior (as a context for active living) with recovery, health, and life quality. Then, we will conduct an in-depth multiple case
study, using periodical interviews and photo voice with African, Hispanic, Asian, and Caucasian Americans with mental illness (n = 40) who are
purposefully chosen based on the survey study findings. This case study will give voices to those individuals about recovery-oriented health and lifequality promotion through active living (with emphasis on actively engaged leisure) from a holistic and ecological perspective, by recognizing cultural,
environmental, and mental health care factors, as well as secondary conditions (e.g., social isolation, obesity). Interviews with primary support/caregivers for these individuals will also be conducted to gain additional outsider perspectives. The case-study findings will guide us to develop a CBPRinformed and evidence-based conceptual framework that identifies key personal, social, cultural, and environmental (including mental health care
systems) pathways through which active living mediates the processes toward recovery and the promotion of health and life quality for CDGPMI
(particularly, through enjoyable and meaningful leisure behavior). This R21 project will lead to our R01 to develop and test/evaluate a recoveryfocused active-living and health/life-quality-promotion intervention program for CDGPMI. Our overall research program is relevant to the National
Institute of Mental Health (NIMH)'s mission to reduce the burden of mental illness through improving health behaviors and daily functioning of persons
with mental disorders (with emphasis on active living and its role in promoting recovery, health, and life quality), and deliver more effective
personalized mental health care across diverse populations. PUBLIC HEALTH RELEVANCE: A major contribution of this research is that the project
will generate rich and in-depth data/evidence from a culturally diverse sample of urban-dwelling individuals with mental illness based on their lived
experiences and perspectives to better conceptualize the roles of active living (particularly, active leisure involvements) in the processes toward their
recovery and the promotion of health and life quality. This new data/evidence will extend and advance the existing knowledge in the literature about
recovery and health/life-quality promotion among individuals with mental illness by better articulating the mediating roles of active living in the
pathways toward recovery-oriented health/life-quality promotion. Importantly, our overall research program links and integrates the domain of recovery
and mental health/illness research with the domain of active living and health/life-quality promotion research conceptually, methodologically, and
practically. The knowledge/evidence generated from our research will be translated to person-centered, holistic, and strengths-based mental health
care practices in communities through the form of a recovery-focused active-living, health-promotion, and life- quality-enhancement intervention
program.
DESCRIPTION (provided by applicant): ABSTRACT Despite the growing number of evidence-based mental health treatments for youth being
developed, few are effectively practiced routinely in community settings. One reason may be the lack of attention paid to how these treatments are
implemented in the context of the organization providing the services to youth, whether it is in a clinic, social service agency, or school. This
application proposes to take a conceptual framework from the management literature and modify it for evaluating implementation effectiveness of a
mental health intervention in the school system. These concepts will be applied to the development of an implementation strategy for a school-based
trauma intervention, the Cognitive Behavioral Intervention for Trauma in Schools (CBITS) program. CBITS has been found to be effective in
decreasing trauma-related symptoms and now has been delivered in a number of U.S. sites. However, continued use of the intervention has varied.
One implementation strategy that has been used in the health care sector to improve medical care quality and was recently piloted with CBITS is the
Total Cost
$187,500
$262,125
Project Number
2
Project Title
Principal Investigator
Performing
Organization
1R01MH089466-01
MEASURING QUALITY ADJUSTED
LIFE YEARS IN CHILDREN WITH
AUTISM SPECTRUM DISORDERS
KUHLTHAU, KAREN
A;TILFORD, JOHN M ;
ARKANSAS CHILDREN'S
HOSPITAL RES INST
1RC1MH088732-01
DISSEMINATION OF EFFECTIVE
MH SERVICES IN FOSTER CARE
LEATHERS, SONYA J
UNIVERSITY OF ILLINOIS
AT CHICAGO
49
Abstract
Learning Collaborative (LC) approach. The LC encourages stakeholders across organizations to share how they have resolved barriers to
implementation. The specific aims of this application are: 1) to further refine a CBITS implementation strategy, based on the Learning Collaborative
approach, that addresses the key constructs for implementation effectiveness, 2) to adapt and pilot organizational management measures of
implementation factors and implementation effectiveness for use in assessing the implementation of CBITS in schools, and 3) to compare a CBITS
Learning Collaborative implementation strategy to a CBITS Implementation as Usual strategy for feasibility and acceptability. For Aim 1, the
modifications of the CBITS LC strategy will be informed by semi-structured interviews with a sample of clinicians who have participated in a CBITS LC
from sites across the country. In Aim 2, we plan to adapt measures from the management literature and then pilot them with 80 CBITS clinicians from
U.S. sites. Finally Aim 3 will be achieved by randomly assigning three schools in Los Angeles to receive the CBITS LC implementation strategy and
three schools to receive implementation as usual. The evaluation will consist of survey data that will inform semi-structured interviews with key
stakeholders in each participating school at two time points: Time 1 (Month 12) and Time 2 (Month 21). Findings from this exploratory pilot will provide
the necessary data to conduct a larger evaluation of CBITS implementation in schools. The long-term objectives of this work are to identify key
strategies to improve the implementation of school-based mental health treatments generally and to determine how implementation can best be
accomplished within the school system and structure. PUBLIC HEALTH RELEVANCE: This application is relevant to public health in that it will provide
preliminary evidence for improving the way in which evidence-based treatments are delivered in schools. This is highly relevant to addressing the
substantial unmet need for mental health services in children given that it has been documented that the school system is the most common place that
children and adolescents gain access mental health services.
DESCRIPTION (provided by applicant): Autism is a behavioral condition defined by deficient social interaction, language and communication, and
play. Children with autism can exhibit a number of behaviors including severe tantrums, noncompliance, destructiveness, and self-injury. They may
require less sleep and have frequent awakenings during the night. Successful interventions to treat the symptoms of ASD can improve the quality of
life of children with ASDs as well as their family members. Early behavioral interventions have the most potential to improve symptoms in children with
ASDs, yet are costly with considerable uncertainty regarding their cost-effectiveness. Research to measure the cost-effectiveness of interventions for
the treatment of children with ASDs is lacking. The primary goal of this proposal is to investigate methods for measuring quality adjusted life years
(QALYS) for cost-effectiveness analysis of interventions to treat children with ASDs. In particular, we are interested in whether generic instruments for
describing QALYS as proposed by the Public Health Service can capture these effects. Our primary hypothesis is that generic instruments for
measuring QALYS will be sensitive to variations in ASD-related symptoms among children with ASDs. We also examine whether family effects can be
measured with generic QALY instruments. Failure to include family QALYS in cost-effectiveness analyses of interventions to treat children with ASDs
can bias cost-effectiveness ratios. We plan to test our hypotheses using a sample of children with ASDs participating in two sites of the Autism
Treatment Network. The investigators for this proposal have developed a research agenda to quantify child and caregiver health in relation to child
disabilities. We seek to further this research agenda by i) Evaluating the sensitivity of alternative generic instruments for preference-weighting health
outcomes (measuring QALYS) in children with ASDs; ii) Determining whether caregiver QALYS should be incorporated into cost-effectiveness
evaluations of interventions to treat children with ASDs; and iii) Evaluating the psychometric properties of generic instruments for measuring QALYS in
children with ASDs using qualitative and quantitative methods. Findings from the study will improve methods to accurately assess the costeffectiveness of interventions to treat children with ASDs and assist in the translation of experimental findings into evidence-based policy for decision
making. PUBLIC HEALTH RELEVANCE: Autism spectrum disorders (ASDs) are characterized by impairments in social skills, communication, and
cognitive and behavioral functioning. Successful interventions for children with ASDs thus have the potential to not only affect outcomes of the child,
but may include substantial health benefits for the family. Guidelines for evaluating the cost-effectiveness of services recommend using the cost per
quality adjusted life year (QALY) gained. To date, no studies have attempted to evaluate whether instruments to measure QALYS in children with
ASDs are sensitive to the condition. In addition, research is needed to account for family effects in cost- effectiveness analysis. Despite the potential
for informing resource allocation to treatment of children with ASDs, methods and data for measuring QALYS in this population are lacking.
DESCRIPTION (provided by applicant): This application addresses broad Challenge Area (15) Translational Science and Specific Challenge Topic 15MH-105, Strategies to support uptake of interventions within clinical and community settings. This application will study an innovative approach to
implementing mental health services in child welfare settings to reduce foster children's behavior problems and improve school outcomes. This work
will address two critical needs in child mental health services research: (1) the need for empirically-based strategies to successfully implement
evidence-based services in urban service settings and (2) the particularly urgent need to implement effective mental health services for foster children,
who experience three to four times the rate of mental health problems than in the general population of children (Burns et al., 2004; Leslie et al.,
2005). The intervention to be disseminated includes parent management training integrated with structured support of learning at home and in school.
The enhanced implementation model proposed in this application uses an adaptation of Rogers' (2003) diffusion of innovation theory, which suggests
that intervention uptake is improved by using a structured implementation process and, in particular, using highly influential early adopters of the
intervention in efforts for dissemination (Atkins et al., 2008; Rogers, 2003). The caseworkers and clinical social workers ('providers') of 160 foster
children with emotional and behavior problems will be randomized to experimental and control conditions. The intervention group will include key
opinion leader social workers and foster parent advocates who will target uptake of the intervention at two levels: child welfare providers and foster
parents. A key hypothesis of this study is that targeting uptake of interventions through an experimental implementation process will improve
intervention uptake and lead to lessened child behavior and school problems relative to a 'training as usual' implementation process. All hypotheses
will be tested using social network analysis and random effects regression models. This application builds on previous intervention research in child
welfare settings that has found that parent management interventions with foster parents volunteering to attend groups are effective in reducing foster
children's child behavior problems (e.g., Price et al., 2008; Chamberlain, 2002). In addition, in our recently completed pilot study (NIMH K01 070580)
in which we adapted Chamberlain's parent management training materials for use with primarily inner city, African American foster parents, we found
that foster parents in an intent-to-treat intervention group reported significantly fewer child behavior problems over time relative to control group foster
parents receiving services as usual. In this pilot project, we were able to reach 80% of our selected sample by providing services in both community-
Total Cost
$441,724
$486,435
Project Number
2
Project Title
Principal Investigator
Performing
Organization
1RC1MH088349-01
ECONOMIC PRODUCTION
FUNCTIONS OF SCHIZOPHRENIA
TREATMENT
LESLIE, DOUGLAS L.
PENNSYLVANIA STATE
UNIV HERSHEY MED CTR
1R01MH089607-01
BEHAVIORAL TREATMENT FOR
AUTISM IN COMMUNITY
SETTINGS USING A TELEHEALTH
NETWORK
LINDGREN, SCOTT DAVID
;WACKER, DAVID P;
UNIVERSITY OF IOWA
50
Abstract
based settings and foster homes. Despite the positive outcomes of the intervention and strong foster parent interest, however, little uptake of the
intervention occurred by existing bachelor's level providers following our training and in vivo coaching phase. This striking contrast in foster parents'
and agency providers' responses to the intervention has created the perfect opportunity to study an innovative implementation process in a short,
intense project with the goal of addressing a critical implementation problem in high-need service systems. This application specifically addresses
intervention uptake and sustainability by comparing intervention use, fidelity, and child outcomes for an experimental receiving an enhanced
implementation strategy vs. a control group receiving standard training. The experimental implementation process will occur in three phases and be
examined across 5 time points. In the first 3-month phase of the research, project-hired MSWs and foster parent advocates ('change agents') will be
infused into existing agency social work teams to conjointly provide groups and home visits, with shared training and supervision from the research
project and agency supervisors and a particular focus on increasing knowledge, exposure, and communication with potential adopters of the
intervention. In the second phase, active transfer of the intervention to existing providers will occur, with a particular focus on training key opinion
leader providers (KOLs) in effective dissemination of the intervention. In the third phase, agency staff will provide services, with consultation provided
only as requested by agency providers. The over 500,000 foster children in the U.S. are among the most vulnerable members of our society. They
have significant risks for mental health problems that lead to an extraordinarily high risk for outcomes such as incarceration (27% of boys and 10% of
girls) and homelessness (12% of all youth) in young adulthood (Courtney, et al., 2001). The significance of strategies to disseminate effective
interventions that interrupt this trajectory is enormous, given the extreme vulnerability of this population and the critical need to change their life
chances. PUBLIC HEALTH SIGNIFICANCE: The proposed research will study an innovative approach to implementing mental health services in
child welfare settings to reduce foster children's behavior problems and improve school outcomes. This work will address two critical needs in child
mental health services research: (1) the need for empirically-based strategies to successfully implement evidence-based services in urban service
settings and (2) the particularly urgent need to implement effective mental health services for foster children, who experience three to four times the
rate of mental health problems than in the general population of children. This application specifically addresses intervention uptake and sustainability
by comparing intervention use, fidelity, and child outcomes for an experimental group receiving an enhanced implementation strategy vs. a control
group receiving standard training. The experimental implementation process will occur in three phases and be examined across 5 time points
(baseline and 3, 6, 9, and 18 months). The implementation model is based on Rogers' (2003) diffusion of innovation theory, which suggests that
intervention uptake is improved by using a structured implementation process and, in particular, using highly influential early adopters of the
intervention in dissemination efforts.
DESCRIPTION (provided by applicant): Treatment for schizophrenia involves both behavioral and rehabilitation interventions and pharmacotherapy.
A number of studies have documented the effectiveness of various interventions and treatments for schizophrenia, but these studies fail to consider
how these treatments should be incorporated into an overall program of care. For example, a finding that patients who receive cognitive behavioral
therapy are 8 times more likely to have a 50% improvement in psychotic symptoms than patients who receive routine care suggests that patients with
schizophrenia should have access to these services, but does not say how cognitive behavioral therapy should be combined with other treatments to
provide the maximum level of improvement for the least cost. The goal of this study is to develop a production function model for the treatment of
schizophrenia, so that the marginal contributions of different types of care to improvements in patient symptoms or functioning can be modeled
simultaneously as they are used in actual practice settings. Shifts in patterns of care over time (from the inpatient to outpatient setting, or from
behavioral therapy to pharmacotherapy) will be evaluated in the context of the production function framework to determine whether the mix of services
can be altered to increase the benefit to patients for the same (or lower) cost. Using data from the NIMH Clinical Antipsychotic Trials of Intervention
Effectiveness (CATIE), the Medicaid programs of 42 states, and a large private-sector health care claims database, the aims of the project are: 1) to
estimate a production function for the treatment of schizophrenia and calculate marginal products associated with different types of services; 2) to
determine market prices for services used to treat schizophrenia and construct ratios of marginal product to price for these services; and 3) to identify
changes in patterns of care for schizophrenia from 2003 to 2007 and determine whether they are consistent with the efficient provision of care. The
implications of the study are considerable. Information about the technology of care for schizophrenia and marginal products associated with different
services can help inform policies on many levels, such as developing and refining treatment recommendations and guidelines, implementing utilization
review and case management programs, structuring insurance benefit plans, and allocating resources in public mental health systems. A number of
studies have documented the effectiveness of various interventions and treatments for schizophrenia, but these studies fail to consider how these
treatments should be incorporated into an overall program of care. Using data from the NIMH Clinical Antipsychotic Trials of Intervention Effectiveness
(CATIE), the Medicaid programs of 42 states, and a large private-sector health care claims database, the goal of this study is to develop a production
function model for the treatment of schizophrenia, so that the marginal contributions of different types of care to improvements in patient symptoms or
functioning can be modeled simultaneously as they are used in actual practice settings. Shifts in patterns of care over time (from the inpatient to
outpatient setting, or from behavioral therapy to pharmacotherapy) will be evaluated in the context of the production function framework to determine
whether the mix of services can be altered to increase the benefit to patients for the same (or lower) cost.
DESCRIPTION (provided by applicant): This study is designed to improve access to appropriate behavioral services for young children (ages 1 to 6
years) with autism spectrum disorders. The major research goal is to evaluate the effectiveness and efficiency of conducting behavioral treatment for
autism through a telehealth network to reach underserved areas of a rural state. Our prior research has demonstrated that parents can be successfully
trained to conduct functional behavior analysis (FA) and functional communication training (FCT) to reduce the disruptive behavior of young children
with autism and other developmental disabilities. The current proposal evaluates a service delivery model in which telehealth is used by behavioral
specialists to 'coach' staff and parents at regional health centers across a rural state to assess and treat the disruptive behaviors displayed by young
children with autism. The specific aims of this study focus on testing whether functional analysis and functional communication training, conducted
through telehealth coaching, is effective in reducing disruptive behavior and increasing positive social behaviors in young children with autism
spectrum disorders. Providing greater local access to behavioral procedures with expert consultation from a remote site should increase families'
opportunities to obtain behavioral services in a cost-effective and timely manner, which is an urgent public health need in rural states that face a
Total Cost
$496,384
$374,649
Project Number
2
Project Title
Principal Investigator
Performing
Organization
3R01MH077000-03S1
INTERSTATE VARIATION IN
HEALTHCARE UTILIZATION
AMONG CHILDREN WITH ASD
MANDELL, DAVID S
UNIVERSITY OF
PENNSYLVANIA
3K23MH082641-02S1
ADHERENCE TO HIV CARE:
ADVANCING THE SCIENCE
MUGAVERO, MICHAEL J
UNIVERSITY OF ALABAMA
AT BIRMINGHAM
3K23MH075964-03S1
SUPPORTIVE LISTENING WITH
DEPRESSED LOW-INCOME
MOTHERS
SEGRE, LISA SHARON
UNIVERSITY OF IOWA
51
Abstract
scarcity of trained behavioral specialists. The current project thus represents an investment in the statewide infrastructure needed to more effectively
serve children with autism and their families. PUBLIC HEALTH RELEVANCE: Autism is a neurodevelopmental disorder that results in marked
difficulties in social interaction, communication, and repetitive behavior. With a prevalence as high as 1 in 150 children (Centers for Disease Control
and Prevention, 2007), autism spectrum disorders represent a serious public health challenge. The proposed research will study the effectiveness of
delivering behavioral treatment for autism through telehealth methodology, which has the potential to overcome barriers that limit access to care in
rural and other underserved areas. The results of the proposed study should provide an evidence base on which to expand behavioral treatment
options for families of children with autism spectrum disorders.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): This R01 application seeks support to conduct a large national study that
will comprehensively identify the impact of state level autism-related policies on the publicly funded healthcare utilization of children with autism
spectrum disorders (ASD). The three primary aims of the study are to 1) conduct an intensive examination of state policies and practices that may
affect Medicaid-reimbursed healthcare delivery to children with ASD; 2) provide accurate national and state-level estimates of publicly-funded
healthcare utilization among children with ASD; and 3) examine the relative contribution of demographic, clinical and system-of-care characteristics on
the types, intensity and patterns of related service use. To accomplish these aims, we will review and code all relevant state-level policy documents to
define the publicly funded healthcare service delivery system for ASD in each state. We will supplement this census through interviews with state
administrators responsible for ASD-related health services. This most recent year of available Medicaid claims will be used to measure service
utilization and associated expenditures at the national and state levels. We will then examine the independent associations of state policies, and
school district, family and child characteristics with service utilization. These findings will provide critical information to states as they develop
appropriate standards of care and related policies for the growing number of children diagnosed with ASD, and will potentially lead to policy models
that improve care. This study will set the stage for future studies in which service utilization data from other systems and primary data about families'
experiences and outcomes are linked to data on healthcare. The study also will provide a baseline against which to measure the effects of future
system-level interventions. Finally, the results will provide evidence for a conceptual framework for understanding how states address the needs of
children with chronic disabilities in which the best course of treatment and expected outcomes are uncertain.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): Missed outpatient clinic appointments are common among HIV-infected
patients engaged in clinical care. Compounding the negative health consequences for individual patients, missed appointments have important
implications for HIV transmission, including spread of resistant virus, a serious public health consideration. Adherence to outpatient HIV clinic
appointments has been notably understudied. The goals of this proposal are to provide insight on barriers to HIV appointment adherence in an
underserved population, to generate knowledge regarding the impact of missed appointments on clinical outcomes, and to develop a clinical tool to
identify patients at high risk for future missed visits. Collectively, this research will provide a framework that will inform a theory-based intervention to
improve HIV appointment adherence, as well as a foundation for a sustainable research program dedicated to studying HIV health services utilization
and adherence to care. The research plan is driven by a unified conceptual model, linked with explicit measurement instruments, and a detailed
analysis plan. The specific aims for this proposal are to: Specific aim 1: Determine barriers and facilitators to outpatient HIV clinic appointment
adherence among African American patients lacking private health insurance; Specific aim 2: Derive and internally validate a novel, point-of-care
prediction rule to identify patients at high risk for outpatient HIV clinic appointment non- adherence and; Specific aim 3: Evaluate potential doseresponse relationships between non-adherence to outpatient HIV clinic appointments and important clinical outcomes. Specific aim 1 will be
accomplished through qualitative methods, specifically Nominal Group Technique. The 2nd and 3rd specific aims will be accomplished through a
prospective cohort study at the DAB 1917 HIV/AIDS Clinic. This research will expand upon the Principal Investigator's past training and research by
taking advantage of an outstanding mentoring and research environment, allowing him to acquire new skills in the conduct of patient-oriented HIV
research, so that he will become an independent investigator improving the health of people with HIV. Lay statement: Among persons with HIV,
missed clinic visits are common and may contribute to the spread of HIV to others. This research seeks to better understand reasons that HIV patients
miss clinic visits.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): The final resubmission of a Mentored Patient-Oriented Career
Development Award Application (K23) to support Dr. Lisa Segre's development as an academic research scientist with expertise in the development of
perinatal depression treatments for low-income and ethnic minority women. Dr. Segre intends to obtain additional training through formal coursework,
directed readings under supervision of her mentor, and direct interactions with members of her external advisory panel while pursuing a program of
research to develop new treatments for perinatal depression. Perinatal depression is a serious disorder affecting approximately 13% of new mothers,
with low-income and African-American women particularly at risk. Depression also has a pervasive and long-lasting impact on the physical, socialemotional, and cognitive development of children of depressed mothers. Dr. Segre's research will focus on the implementation and subsequent
evaluation of supportive listening/problem solving (SUPS), a treatment with established effectiveness in the United Kingdom. This treatment is
provided by non-threatening professionals, delivered in the home, and conveys an important sense of mutual respect. Dr. Segre intends to import,
implement, and evaluate the effectiveness of this treatment for depressed low- income and ethnic minority women who are unlikely, unwilling, or
unable to seek more traditional treatment from mental health professionals. A special emphasis will be placed on adapting the treatment to the context
of the US mental health and social service system, as well as evaluating the treatment's effectiveness. The central hypotheses of the Phase II
treatment evaluation trial are (1) that supportive listening/problem solving (SL/PS) will be significantly more effective than standard enhanced case
management in reducing depressive symptoms at the end of treatment and follow-up, (2) SL/PS will be significantly more effective than standard
enhanced case management in improving social adjustment at the end of treatment and follow-up, (3) clients and case managers will find SL/PS to be
an acceptable treatment, and (4) participation in SL/PS will be associated with significantly more use of professional mental health services than
Total Cost
$171,947
$107,239
$107,853
Project Number
2
Project Title
Principal Investigator
Performing
Organization
Abstract
Total Cost
participation in standard enhanced case management.
3K23MH074079-04S1
MATERNAL DEPRESSION AND
EARLY HEAD START
SILVERSTEIN, MICHAEL
BOSTON MEDICAL
CENTER
1R01MH089474-01
AUTISM IN URBAN CONTEXT:
LINKING HETEROGENEITY WITH
HEALTH AND SERVICE
DISPARITIE
SOLOMON, OLGA
UNIVERSITY OF
SOUTHERN CALIFORNIA
1R01MH081098-01A2
MENTAL HEALTH
COMMUNICATION IN ELDERLY
PRIMARY CARE VISITS AND
ECONOMIC OUTCOMES
TAI-SEALE, MING
TEXAS A&M UNIVERSITY
HEALTH SCIENCE CTR
52
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by candidate): Maternal depression is a source for substantial morbidity for both mother
and child. This K23 application outlines a mentored 5-year education and research plan, devoted to developing and studying a self- management
support system for maternal depression in Early Head Start (EHS), a federally funded early child development program for low income families. The
intervention, based on the Chronic Care Model, will involve the identification of mothers with depressive symptoms through standardized instruments,
and a case-management system that involves motivational enhancement and problem solving therapy. Through these strategies-the latter of which is
an evidence-based treatment for depression in and of itself-EHS caseworkers will link mothers to further evidence-based mental health services, such
cognitive behavioral therapy and medication management, and provide subsequent ongoing support and reassessment. The specific aims of the
research plan are to: 1. conduct qualitative interviews with EHS mothers to determine the range of attitudes to having their own mental health
addressed as part of their children's preschool experience; 2. conduct focus groups with EHS caseworkers to learn the personal and institutional
barriers to participating in this type of case-management system; 3. develop, through a 9-month pilot intervention, the details of the case-management
protocol; 4. conduct a quasi-experimental study of the system to test its effect on EHS mothers' receipt of services for depression, depressive
symptoms, social functioning, quality of maternal teaching interactions with their children, and child health care utilization. The candidate will gain
experience in qualitative and quantitative research methods, behavioral intervention design, systems approaches to mental health promotion, and
analysis of parent-child interaction. Information and experience gained from this project will be used to design a longitudinal randomized controlled trial
to study the effect of this system on both mothers' depressive symptoms and their children's developmental outcomes.
DESCRIPTION (provided by applicant): Although heterogeneity inherent in Autism Spectrum Disorders (ASDs) has long been recognized, little is
known about ways in which race, gender, socio-economic status, family culture and communication during clinical encounters affect the acquisition of
diagnosis and related services. Considered a barrier to more rapid advancements in autism research, heterogeneity within ASDs has never been
examined as a socio- cultural phenomenon where interpretation of atypical behavior is itself examined against socio-cultural expectations of normative
development under default socio-economic circumstances. We propose to examine heterogeneity in ASDs as a socio-culturally based phenomenon in
relation to three domains: 1) patterns of communication among African American caregivers and practitioners during clinical encounters that are vital
for developing partnerships and that are vulnerable to misunderstanding; 2) structural barriers to and opportunities for African American children
receiving timely and accurate diagnosis and appropriate services; and 3) African American caregivers' knowledge about ASDs and the social networks
relevant to information about diagnostic evaluations, interventions and services. We know from population-level demographic studies that there is an
unprecedented scale of health and service disparities in autism diagnosis for African American children. The picture that emerges from these studies
is of systematic delays in diagnosis and challenges to secure appropriate services once the diagnosis is received (Mandell, 2005, Mandell et al. 2007,
Stahmer & Mandell 2007). In a significant number of children, ASDs are identified late in childhood or missed altogether (California Legislative Blue
Ribbon Commission on Autism, 2005, 2007). This troubling picture repeats the pattern of healthcare and service disparities for African Americans
across illness categories. Following recommendations of the Institute of Medicine to address health disparities at two levels, interactional and
structural, (IOM, 1999), this two-year urban, multi-method ethnographic study examines disparities in diagnostic processes and service delivery
related to acquisition of ASDs diagnosis, and communication during clinical encounters for a cohort of African American children living in the Los
Angeles metropolitan area. We propose a novel combination of methods, urban ethnography (Lawlor, 2004; Mattingly & Lawlor, 2003) and social
networks analysis (Valente, 1995, 2002; Valente, Paredes & Poppe, 1998) to follow a cohort of African American children diagnosed with ASDs, their
primary caregivers and the practitioners who serve them, to document the children's' pathways to an ASDs diagnosis and services. The importance of
early identification and intervention (Dawson & Osterling, 1997) and delayed diagnosis among economically disadvantaged populations (Mandell et
al., 2007) make this study a critical step towards decreasing health and service disparities for African American children with autism in urban context
and facilitating practitioner-family partnership in clinical encounters. PUBLIC HEALTH RELEVANCE: The project examines disparities in ASDs
diagnosis and services for African American children in urban setting. Results of the project will help caregivers and practitioners to better
communicate and partner during clinical encounters. The project will facilitate earlier diagnosis and services for African American children with ASDs
which will help improve their developmental outcomes.
The medical office visit is the foundation of medical care and one of the most important professional activities of primary care physicians who are often
the only source of mental health services for older adults. Evidence continues to show that the gap between science and clinical practice remains
wide: as many as one half of older adults with a recognized mental disorder fail to receive any mental health services, and even fewer receive
evidence-based treatments. Racial minority patients fare even worse. It is an urgent public health concern that such a high proportion of patients
needing mental health services are without access to evidence-based care and that racial disparities in access to quality mental health care persist
despite advancements in efficacious treatments for mental illnesses. Direct observation of how patients and physicians interact has led to research
findings that are straightforward and easily understood by the public and policymakers. It offers a new perspective to study physicians' work and
patients' contributions with potentially important new insights. We propose to leverage the infrastructure and data afforded by an ongoing NIH- funded
study which is audio-recording 800 annual physical exam visits (checkups designed for physicians to comprehensively review their patients' health)
among socioeconomically diverse older adults in a large integrated delivery system, the Henry Ford Health System, in Detroit Michigan and its
surrounding suburbs. The proposed study is within the scope of the economics of mental health. We plan to apply mixed methods approach and
combine perspectives from mental health services research with behavioral economics, communication research, and statistics. We will use data from
audio-recordings, administrative benefits, medication dispensing, claims and encounter records, and surveys of patients and physicians to address the
Specific Aims of our study: Aim 1: Examine the productivity of physician-patient communication by linking elements of quality of communication on
mental health in the context of busy clinics and competing demands from co-morbidities in routine annual checkups with intermediate outcomes such
as patient's satisfaction and treatment adherence and distal clinical and economic outcomes including service use and costs. Aim 2: Testing for racial
disparities in communication content and time using the definition proposed by the Institute of Medicine in Unequal Treatment. We will first qualitatively
$85,500
$634,898
$497,013
Project Number
2
1R21MH079984-01A1
Project Title
A RANDOMIZED EXPLORATORY
STUDY OF TELEPSYCHIATRY
OUTCOMES IN RURAL YOUTH
Principal Investigator
WINTERS, NANCY CLAIRE
Performing
Organization
OREGON HEALTH AND
SCIENCE UNIVERSITY
Abstract
compare the content and time devoted to mental health and physical health communications between racially concordant and discordant patientphysician pairs. We will assess the contribution of factors that are germane to the practice environment and malleable to policy, e.g., length of visit, colocation of mental and physical health providers to observed disparities. At the completion of the study, we seek to formulate concrete
recommendations about specific organizational or clinical interventions that can address these national priorities: translating evidence to practice and
eliminating disparities.
DESCRIPTION (provided by applicant): This proposal is a substantial revision of application 1 R21 MH079984-01 which was reviewed October 11,
2006 by the Mental Health Services in Non- Specialty Settings review group. Goals, specific aims, and hypotheses have been clarified to be consistent
with a study of the equivalence between outcomes of known child psychiatric treatments for ADHD delivered via telepsychiatry as compared with faceto-face treatment. To address the concerns about small sample size and distribution of cases between ADHD and depression, the revised study will
include only youths with ADHD. The revised study also makes use of qualitative analysis methods to address other important issues of equivalence
concerning acceptability and burden of the technology. The assessment batteries have been simplified to reduce respondent burden. The research
team has been strengthened by increasing the percent effort of the PI and the co-investigator and the latter's role will involve regular oversight of the
project. An expert in qualitative analysis, Carla Green, PhD, MPH, has been added as a research consultant. The motivation for the project is to
establish feasibility of a larger multi- state randomized controlled study that would demonstrate equivalent outcomes for telepsychiatry and face-to-face
treatment of ADHD in rural youth. This research will strengthen the evidence base on outcomes of telepsychiatry in children, which is needed to justify
large scale investment in telepsychiatry as a means of improving rural youths' access to specialty child psychiatry services. The proposed subsequent
multi-state study has been described in greater detail.
Total Cost
$217,249
National Institute of Neurological Disorders and Stroke (NINDS)
3U54NS057405-02S1
STROKE DISPARITIES PROGRAM
KIDWELL, CHELSEA M
GEORGETOWN
UNIVERSITY
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (abstract): Acute stroke is the third leading cause of death and the leading cause of adult disability
in the US. A disproportionate amount of morbidity and mortality falls on underserved populations. Reduction of health disparities has become a
significant public health challenge and is a major goal of the Healthy People 2010 initiative. The programmatic goal of this proposal is to identify
biological and socioeconomic factors contributing to ethnic disparities and to develop innovative approaches to reduce these disparities for ischemic
and hemorrhagic stroke. Three research projects are proposed. Project 1, Acute Stroke Program of Interventions addressing Racial and Ethnic
disparities (ASPIRE), is an intervention study designed to investigate whether implementation of a multilevel intervention can significantly increase the
number of ischemic stroke patients appropriately treated with intravenous tissue plasminogen activator (IV tPA) in a predominantly underserved
community. The primary outcome measure will be the percentage of all ischemic stroke patients appropriately treated with IV tPA. Project 2,
Preventing Recurrence of Thromboembolic Events through Coordinated Treatment in the District of Columbia (PROTECT DC) is a randomized phase
II clinical trial of the PROTECT DC intervention (hospital-based initiation of aggressive secondary prevention combined with navigator case
management) vs. standard management in ischemic stroke patients from two underserved hospitals in the District of Columbia. The primary aims are
1) to refine the PROTECT DC design in preparation for a phase INI trial and, 2) to assess the effect of the intervention on 4 medication goals as
defined by normalization of objective measures of secondary risk factor control. Project 3, DiffErenCes in the Imaging of Primary Hemorrhage based
on Ethnicity or Race (DECIPHER) is a longitudinal, MR imaging, prospective, observational, cohort study designed to evaluate the prevalence and
significance by race/ethnicity of chronic cerebral microbleeds in patients with primary intracerebral hemorrhage. Three cores will support the projects:
A) Administration B) Participant Recruitment, Retention, Intervention and Outcomes, and C) Biostatistics / Data Management. This application is
designed not only to define factors leading to racial/ethnic disparities in stroke treatment and outcomes, but also to demonstrate the efficacy of
programs specifically designed to reduce these disparities. Project 1: Acute Stroke Program of Interventions Addressing Racial and Ethnic
Disparities (ASPIRE) PI: Amie Hsia DESCRIPTION: Stroke, the third leading cause of death and the leading cause of adult disability in the United
States, has a disproportionate impact on underserved populations that is reflected in higher incidence and mortality rates in these groups. Several
studies have suggested that blacks are less likely than whites to receive intravenous tissue plasminogen activator (IV tPA), the only FDA-approved
acute ischemic stroke therapy. Efforts are needed to elucidate factors contributing to racial/ethnic disparities in access to acute stroke care and to
develop programs to overcome these barriers. The specific aims of this intervention project are: A) to identify previously unrecognized sociocultural
and environmental barriers to acute stroke treatment in an underserved, urban population; B) to investigate whether implementation of a multilevel
intervention designed to address these barriers can significantly increase the number of ischemic stroke patients appropriately treated with
intravenous tissue plasminogen activator (IV tPA); and C) to perform program evaluation of the methods used in the intervention to determine which
efforts are the most effective. The investigators will assist each of 6 hospitals in the District of Columbia to develop a team of Stroke Champions to
implement educational programs and standardized procedures designed to improve acute stroke care. Five Baltimore hospitals will serve as the
control group. Essential design features of this project include: 1) a focus on underserved populations to identify community-specific barriers and then
tailor existing stroke education materials to increase health literacy and decrease delays in seeking treatment; 2) implementation of interventions to
address educational, attitudinal, and structural barriers at the public, paramedic and hospital levels; and 3) assignment of a dedicated research
coordinator to each hospital who will also serve as a Stroke Champion. The long term objective of the trial is to identify systematic, reproducible,
effective methods for improving the delivery of acute stroke therapies in underserved areas that can be implemented in a broader arena. The only way
to definitively affect outcomes for underserved stroke patients is to elucidate the complex issues related to access to treatment, and the District of
Columbia is the ideal city in which to perform these investigations.
BRIESACHER, BECKY A
UNIV OF
MASSACHUSETTS MED
SCH WORCESTER
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): Cost-related Medication Nonadherence and the Health of Older Adults
Becky Briesacher, Ph.D., is a health services researcher and Assistant Professor of Medicine in the Division of Geriatric Medicine at the University of
$242,939
$53,932
National Institute on Aging (NIA)
3K01AG031836-02S1
53
COST-RELATED UNDERUSE OF
MEDICATIONS AND THE HEALTH
OF OLDER ADULTS
Project Number
2
Project Title
Principal Investigator
Performing
Organization
1R21AG030166-01A2
A FEASIBILITY STUDY TO
IMPROVE OLDER PATIENT PHYSICIAN COMMUNICATION
DAALEMAN, TIMOTHY P
UNIVERSITY OF NORTH
CAROLINA CHAPEL HILL
1R01AG034073-01
MEALS ON WHEELS
VOLUNTEERS AS HEALTH
LITERACY COACHES FOR
OLDER ADULTS
FREIMUTH, VICKI S
UNIVERSITY OF GEORGIA
(UGA)
1R01AG034179-01
SELECTION AND THE QUALITY
IMPACT OF NURSING HOME
OWNERSHIP
GRABOWSKI, DAVID C
HARVARD UNIVERSITY
(MEDICAL SCHOOL)
54
Abstract
Massachusetts Medical School. Her long-term career goal is to become an independently-funded researcher supported by rich mentorship and fruitful
collaborations in the area of aging and drug policy. Dr. Briesacher seeks a Mentored Research Scientist Development Award (K01) to gain: (1) a
better understanding of cost-related medication nonadherence (CRN) and its effect on the health of older adults, and (2) research experience with
models that account for irrationality in health behaviors. The candidate proposes a career development plan that provides new training in behavioral
economics, targeted exposure to clinical geriatrics, and advanced statistical methods in longitudinal analyses. The research program includes: (1)
creating a unique, longitudinal dataset from two national health surveys of older adults, (2) describing the longitudinal course of CRN, including
identifying the predictors and potential consequences on patient health and health care expenditures, and (3) developing models of CRN in older
adults that incorporate principles from behavioral economics, particularly time-inconsistency. The advanced training and three-part research program
will provide the foundation for Dr. Briesacher's transition to an independent investigator in geriatric health services research. In addition, this research
program will inform issues central to Medicare Part D prescription drug program and its effects on the health and financial stability of older adults.
RELEVANCE (See instructions): Strong evidence shows that medication adherence decreases with higher cost-sharing, yet medication cost- sharing
is rising, most notably in Medicare Part D. Discovering how optimal cost-sharing may improve medication adherence has significant implications for
the health and welfare of an aging society that is increasingly dependent on medications.
DESCRIPTION (provided by applicant): Participatory and patient-centered interactions between older patients and their physicians directly and
positively impact important patient outcomes, such as health status and the use of health care services. Patient activation and other related
interventions have been demonstrated to enhance these interactions, but are time consuming and do not replicate to primary care settings where most
older adults receive their care. This study will determine the feasibility of implementing the Electronic Enhancement of Health Assessments in Clinical
Encounters (ENHANCE) system in primary care settings. A sample of 60 patients presenting for routine care, who are 50 years of age and older with a
self-identified serious chronic illness (e.g., congestive heart failure, chronic lung disease) will be identified and recruited into a feasibility study. Patients
will be recruited from four primary care practices, which participate in a primary care research network, and will be selected from counties in central
North Carolina over a 9-month period. All practices will receive the intervention (i.e., ENHANCE), consisting of a touchpad personal computer and
software that will gather and report patient health-related quality of life at the time of the encounter. Patient encounters will be audio-taped and
analyzed using the Roter Interaction Analysis System (RIAS). The evaluation of the intervention will be guided by the RE-AIM framework, using semistructured interviews of physician and staff members, analyses of RIAS codes, and direct observation of practice sites during the study. Public Health
Relevance: Participatory and patient-centered interactions between chronically ill older adults and their physicians directly and positively impact
important patient outcomes, such as health status and the use of health care services. This proposal evaluates feasibility of a novel health information
technology system, called ENHANCE (Electronic Enhancement of Health Assessments in Clinical Encounters), that promotes patient- physician
communication in primary care practices. The long-term goal of our research is to implement, assess, and disseminate an intervention that enhances
quality, patient-centered communication and point-of- care decision making among chronically ill older adults and their physicians.
The objective of this study is to examine a model of health literacy coaching wherein Meals on Wheels (MOW) volunteers work with older adults to
enhance patient communication skills. While considerable progress marks the studying of written health literacy, fewer efforts have addressed
interactional health literacy. Interactional factors are posited as mechanisms that link health literacy with health services utilization. Older adults are at
particular risk of poor interactional health literacy. Patient communication skills--such as those developed by the Ask-Me-3 program from the
Partnership for Clear Health Communication--may redress this problem. MOW volunteers are ideally suited to be health literacy coaches, since they
enjoy special status as intimate, welcome, and regular visitors to the otherwise difficult to reach homebound. Previous research affirms that MOW
volunteers can conduct health promotion during brief encounters with clients. Two hundred MOW volunteers from rural and urban Georgia will be
trained as health literacy coaches. Twelve hundred MOW clients will be randomly assigned to one of three treatments. Some clients will receive meals
as usual. For others, MOW volunteers will give clients materials pertaining to Ask-Me-3 and will show brief modeling videos. A third group will in
addition receive over the course of a year four coaching sessions prior to health care encounters. To test the generalizability of the intervention, a
small replication will be conducted in Portland, Oregon. It is hypothesized that MOW clients receiving intensive coaching will exceed those who just
view Ask-Me-3 materials, who in turn will exceed those in the control, in outcomes relating to (1) active participation in a health information context, (2)
satisfaction with providers, (3) health self-efficacy, and (4) health status. Furthermore, with each subsequent health literacy coaching session,
intensively coached clients will manifest improved (a) comprehension of the medical assessment and orders, (b) intention to comply with
recommendations and orders, and (c) fewer communication barriers. The MOW volunteers/health literacy coaches will likewise gain in (i) satisfaction
with providers, (ii) written health literacy, and (iii) satisfaction in their volunteerism. Findings will advance understanding of interactional health literacy.
DESCRIPTION (provided by applicant): The quality of care delivered to frail elders residing in nursing homes remains an important and perplexing
issue in American health policy. Given the preferential tax treatment afforded nonprofit firms, there has been much interest among policymakers and
researchers alike in examining whether the nonprofit sector provides higher quality relative to its for-profit counterpart. A large literature examines this
issue, but the vast majority of the existing studies have taken a cross-sectional approach to compare for-profit and nonprofit quality. However, the type
of consumer who chooses a nonprofit facility may be quite different in many unobserved ways from the consumer who selects a for-profit facility. If so,
simple comparisons of quality in for-profits and nonprofits, controlling for observable characteristics, may yield misleading estimates. By using
'differential distance' to the nearest nonprofit nursing home relative to the nearest for-profit nursing home, we can mimic randomization of residents
into more or less 'exposure' to nonprofit homes when estimating the effects of ownership on quality of care. Based on this methodology, the following
specific aims are proposed: Aim 1: To examine selection and access differences across for-profit and nonprofit nursing homes using a range of patient
characteristics, including payer type, acuity, demographics (race, gender and age), and socio- economic status (education; zip code level income).
Aim 2: To test the effect of differential distance to the nearest nonprofit nursing home relative to the nearest for-profit nursing home on likelihood of
entry into a nonprofit nursing home. Planned sub-analyses include an examination of the role of distance and ownership choice in the context of
urban/rural markets, discharges from hospitals with a sub-acute nursing home unit, and different subgroups of nursing home patients (e.g., is there
evidence of a weaker relationship among racial minorities or Medicaid recipients, which may be the case if those residents are more likely to have to
Total Cost
$156,753
$497,018
$293,340
Project Number
2
Project Title
Principal Investigator
Performing
Organization
1R01AG034056-01
RACIAL DISPARITIES IN OLDER
ADULTS: IMPACT OF MEDICARE
PART D
HANLON, JOSEPH T
UNIVERSITY OF
PITTSBURGH AT
PITTSBURGH
1RC1AG035616-01
TRACKING DISPARITIES IN THE
EFFECTIVE DELIVERY OF
HEALTH SERVICES
LIM, STEPHEN ;MURRAY,
CHRISTOPHER J.L. ;
UNIVERSITY OF
WASHINGTON
2T32AG023482-06
AGING HEALTH AND HEALTH
SERVICES RESEARCH TRAINING
MOR, VINCENT
BROWN UNIVERSITY
55
Abstract
bypass the nearest facility in order to gain access to care). Aim 3: To use instrumental variables analysis to examine the effect of ownership on riskadjusted, person-level short-stay measures of quality such as activities of daily living decline or 30-day re-hospitalization and risk- adjusted, personlevel long-stay measures of quality such as pressure ulcers or physical restraints. Significance: By examining the link between nursing home
ownership and quality of care, this study provides an opportunity to improve the quality of care for the millions of Americans receiving care in nursing
homes. This study will also provide long-term care researchers with a potential new approach to analyzing for-profit and nonprofit differences which
accounts for unobserved patient differences across ownership types, and which could also be applied to study the impact of other facility
characteristics such as chain ownership. Thus, the information derived from this study has the potential to make important research and policyrelevant contributions aimed at improving the quality of care for all nursing home residents. PUBLIC HEALTH RELEVANCE: There has been much
interest among policymakers and researchers alike in examining whether nonprofit nursing homes provide higher quality relative to their for-profit
counterparts. By examining this relationship using a novel empirical strategy, this study provides an opportunity to improve the quality of care for the
millions of Americans receiving care in the nursing home setting.
DESCRIPTION (provided by applicant): Both hypertension and ischemic heart disease (IHD which includes those with a history of myocardial
infarction [MI] or it's risk equivalent diabetes) are more common and more likely to be inadequately controlled in older African Americans when
compared to older Caucasians. One key pathway to these racial disparities is greater cost related medication non adherence in older African
Americans when compared to Caucasians. Medicare Part D which began January 2006 provides a drug benefit for those enrolled. The impact of this
health policy intervention on racial disparities in medication use and control of chronic diseases such as hypertension and ischemic heart disease is
unknown. The long-term objective of our proposed study is to reduce racial disparities in health outcomes by examining the impact of this policy
intervention of increasing prescription drug coverage among the elderly. Using a longitudinal design we will examine two objectives. Objective 1 is to
determine the impact of the Medicare Part D drug benefit intervention on racial differences in the use of antihypertensive medications in those with
hypertension and the use of lipid lowering medications in those with IHD (i.e., those with a history of MI and/or diabetes. One specific hypothesis to be
tested is that after the Medicare Part D implementation, older Africans Americans in this high risk group will receive more intense antihypertensive
regimens than older Caucasians. A second specific hypothesis to be tested is that the disparity in any lipid lowering medication use between
Caucasian and African American older adults in these high risk groups will be reduced after Medicare Part D implementation. Objective 2 is to
determine the impact of the Medicare Part D drug benefit intervention on racial disparities in the control of hypertension and IHD. One specific
hypothesis to be tested is that the disparity in uncontrolled blood pressure between Caucasian and African American older adults with hypertension
will be reduced after Medicare Part D implementation. A second specific hypothesis to be tested is that the disparity in uncontrolled lipid levels
between Caucasian and African American older adults with IHD will be reduced after Medicare Part D implementation. This study capitalizes on
longitudinal data from the ongoing 11 year Medicare population based National Institute on Aging (NIA) funded Health Aging and Body Composition
Study. Our multidisciplinary research team has extensive experience conducting health policy analyses, pharmaco-epidemiological studies with
geriatric populations, health disparities and cardiovascular disease research and is uniquely positioned to shed light on this critical policy issue.
Moreover, our proposed research is responsive to one of the three research action areas (public policy) outlined in PAR 07-379 entitled 'Behavioral
and Social Science Research on Understanding and Reducing Health Disparities' and will shed light upon the effectiveness of the Medicare Part D
intervention to reduce health disparities. This study is also consistent with the interests of the National Institute on Aging's Behavioral and Social
Research Program's Health Disparities Initiatives. PUBLIC HEALTH RELEVANCE: Both access to drug therapy treatment and chronic disease
guideline adherence are included as part of the recently released list by Centers for Medicare and Medicaid Services (CMS) entitled 'Evidentiary
Priorities for the Elderly Population'. This list provides clinical research topics for which there are significant knowledge gaps. If Medicare Part D
reduces racial disparities by increasing access to medication use which leads to better control of hypertension and IHD, then our study will inform
other initiatives to expand insurance coverage to other vulnerable populations.
DESCRIPTION (provided by applicant): The primary goal of the Tracking Disparities in the Effective Delivery of Health Services project is to develop,
apply and refine methods that enhance health agencies, policy-makers, researchers, and analysts' ability to track disparities in the effective delivery of
interventions to improve population health. The two specific aims towards achieving this goal are: (1) to use all available data to estimate the coverage
and effective coverage of a range of key health interventions for each of the 39 counties in the State of Washington over the period 2000 to 2008 and
(2) to develop a set of standardized training tools and protocols that can be used as a template for estimating effective coverage in other settings.
Statistical approaches will be used to determine the coverage, and where possible, the effective coverage of a range of key interventions for each of
the 39 counties in Washington State. Interventions will include both personal and non-personal interventions, including, for example, community-based
education to reduce population exposure to key risk factors such as tobacco, inpatient management of major disease such as myocardial infarction
and stroke as well as outpatient management of risk factors such as high blood pressure and lipids. Based on the methods used to estimate coverage
and effective coverage a suite of tools and training materials will be created to allow implementation of these approaches in other locations around the
world. Measuring not just aggregate levels of coverage, but disparities in coverage and effective coverage is the goal of this proposal. Stewards of
health systems can improve the health of their populations by delivering effective interventions. Measures of coverage and effective coverage of the
treatment of non-communicable disease and the associated risk factors, particularly in developed county settings, capture the population in need of an
intervention, the utilization of a health service by those in need, and the quality of the intervention being delivered by the health system.
DESCRIPTION (provided by applicant): The training grant 'Aging Health and Health Services Research' addresses all 4 of the major goals of the NIA
Strategic Plan for research, by educating well trained researchers, with multi-disciplinary experience and a broad understanding of the biological,
social, health, service and policy aspects of aging with special emphasis placed on trainees becoming highly skilled in the traditional and emerging
methodologies for analyzing the highly complex and nested data that characterize the new era of epidemiology. Training Program Specific Aims
1.Recruit high quality doctoral students into aging research; 2.Provide training in substantive topics relevant to health services research in aging;
3.Provide education in epidemiological methods & statistical approaches with applications to aging research; 4.Provide research experiences in
ongoing aging related epidemiological and health services research projects; 5.Prepare students for academic and research careers as independent
Total Cost
$227,250
$499,616
$132,000
Project Number
2
Project Title
Principal Investigator
Performing
Organization
1R21AG033862-01
EFFECT OF IMPLICIT RACIAL
BIAS ON RECOMMENDATION OF
PATIENTS FOR TOTAL KNEE
REPLA
OLIVER, MOHAMMED
NORMAN
UNIVERSITY OF VIRGINIA
CHARLOTTESVILLE
2U01AG022376-05A2
PHYSICAL EXERCISE TO
PREVENT DISABILITY
PAHOR, MARCO
UNIVERSITY OF FLORIDA
3R01AG025801-03S1
ACUTE CORONARY SYNDROME
OUTCOMES FOR MEDICARE
PATIENTS
STEARNS, SALLY CLARK
UNIVERSITY OF NORTH
CAROLINA CHAPEL HILL
56
Abstract
scientists. Description of the Training Program in Aging Health and Health Services Research. The training program builds on the existing graduate
programs in Epidemiology, Biostatistics and Health Services Research. It represents a combination of courses, seminars, symposia, inter-disciplinary
guided study and research experiences with a group of experienced and well-funded investigators doing research on aging and health. The training
program builds competencies in the substantive area of aging and the health care delivery system as well as in methodological skills. This is achieved
by a combination of course work, seminars, symposia,journal clubs and by exposing students to a rich researchenvironment as trainees participate in
faculty members' externally funded research. Training Program Competencies include: 1) aging related issues, from biology to clinical geriatrics to
socio- economic factors;2) methods relevant to aging related research. Understanding aging is divided into two segments: 1) the substantive areas of
biology, clinical medicine, psychology and sociology of aging; and 2) the system of preventive health and health care services with which the elderly
and disabled must interact. Methodological applications in aging research include: 1) ethical and regulatory issues in research conduct; 2) research
design and interpretation; and, 3) statistical and analytic techniques particularly the management and manipulation of complex, hierarchical and
longitudinal data sets linking administrative and primary data focused on the frail elderly and the health services and poliy environment in which they
live. RELEVANCE: We propose to train graduate students in Health Services Research, Epidemiology and Biostatistics in understanding the
biological, social, health, service and policy aspects of aging in order to prepare them for careers as independent scientists. We emphasize trainees
becoming highly skilled in the traditional and emerging methodologies for analyzing the highly complex and nested data that characterize the new era
of social science research and the epidemiology of aging.
DESCRIPTION (provided by applicant): Racial and ethnic health disparities abound, with decreased quality of health care in these underserved
communities. The reasons for these health inequities are complex and multi-layered. As noted by the Institute of Medicine, there are historic and
contemporary social inequities that have been embodied in these populations and in the health systems that care for them. In addition, racial biases of
health care providers also may play a role in the unequal treatment of minority populations. Racial stereotyping and bias have been identified as
factors in the delivery of cardiovascular disease care, pain management, and mental health care. Given the well-documented disparity in the receipt of
total knee replacements between African-American and white patients with severe osteoarthritis, research is sorely needed to better understand what
role racial stereotyping and bias plays in creating these inequities in the provision of this treatment. In the proposed research project, we will
objectively measure physicians' racial stereotyping and bias and evaluate its association with those physicians' recommendations of patients for TKR.
We also propose an innovative educational intervention aimed at reducing the effect of racial bias on clinical decision-making and will assess its
efficacy. Findings from this exploratory study will be used to develop a larger, more long-term study of racial stereotyping and bias in clinical decisionmaking and methods for intervening to mitigate their effects. Specific Aim 1 will test whether physicians express explicit racial bias, using a Web-based
survey instrument. Specific Aim 2 will test whether physicians show implicit racial bias, using Web-based Implicit Association Tests (IATs). Specific
Aim 3 will evaluate whether the magnitude of implicit bias predicts physician recommendation of TKR for African-American and white patients with
severe osteoarthritis. Specific Aim 4 will assess whether use of the Web-based IAT as an educational intervention decreases the effect of implicit
racial bias on physician recommendation of TKR. Public Health Relevance: The proposed research project tests an intervention to help physicians
manage and, perhaps, eliminate their racial bias. If this intervention proves effective, we will have a powerful tool to help reduce racial health
disparities.
DESCRIPTION (provided by applicant): As the life expectancy of older Americans increases, prevention of age-associated physical function decline
and disabilities has emerged as a major clinical and public health priority. A critical factor in an older person's ability to function independently is
mobility, the ability to move without assistance. Older people who lose mobility are also less likely to remain in the community, have higher rates of
morbidity, mortality, and hospitalizations and experience a poorer quality of life. While several studies suggest that physical exercise may prevent
physical disability, including mobility disability in healthy and frail older adults, definitive evidence is lacking. A Phase 3 randomized, controlled trial
(RCT) is needed to fill this evidence gap. Preliminary data to estimate sample size needs for such a trial, however, are currently insufficient, and
further feasibility data should be gathered before such a trial can be effectively designed and implemented. In response to specific guidance from the
NIA that relates to key trial design benchmarks (including sample size calculations to demonstrate the feasibility of a full-scale trial and
refining/developing recruitment, procedures, materials and organizational infrastructure), we propose to conduct a pilot, single-blind RCT involving
comparison of a physical exercise program of moderate intensity with a health education control. A total of 500 sedentary persons aged 70-85 years
who are at risk of disability will be followed at 6 sites for >1 year. We will assess the combined outcome of major mobility disability defined as
incapacity to walk 400 m, or death, which will be the primary outcome of the full-scale study. To our knowledge, this outcome has not been used in
previous RCTs, and therefore, a pilot study is needed to assess its incidence rate. Secondary outcomes will include ADL disability, major fall injuries
and cardiovascular events. We will explore the effects of the intervention on physical performance measures, cognitive function, health-related quality
of life, and use of health care services. In addition, we will perform cost-effectiveness analyses of the intervention. This pilot study will yield the
necessary preliminary data to design a definitive Phase 3 RCT. By providing a conclusive answer regarding whether physical exercise is effective for
preventing major mobility disability or death, the results of the full-scale trial wilt have relevant clinical and public health implications, and will fill an
important gap in knowledge for practicing evidence-based geriatric medicine.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): Coronary artery disease is the most frequent cause of death in the elderly.
The gold standard therapy for acute coronary syndrome (ACS) is early mechanical myocardial revascularization with either percutaneous intervention
with stents (PCIS) or coronary artery bypass grafting (CABG). Although studies suggest that elderly patients with ACS may benefit from myocardial
revascularization, these reports lack the power to determine optimum invasive myocardial strategy with respect to age, gender, race, comorbidities
and geography. Our long range goal is to identify an efficacious invasive treatment strategy for ACS in the elderly. The central hypothesis of the
proposed research is that surgical myocardial revascularization improves survival rates in ACS patients aged 65 and older with fewer reinterventions
and decreased resource utilization than the more frequently prescribed strategy of PCIS. The principal objectives of this project are to use national
Medicare hospital and physician claims from the Centers for Medicare & Medicaid Services to address four specific aims; 1) Identify the factors
Total Cost
$153,091
$11,918,679
$147,547
Project Number
2
1RC1AG036158-01
Project Title
EFFECT OF PRESCRIPTION
DRUG BENEFITS ON
CARDIOVASCULAR OUTCOMES
IN THE ELDERLY
Principal Investigator
TRIVEDI, AMAL NITIN
Performing
Organization
BROWN UNIVERSITY
Abstract
associated with diffusion of mechanical myocardial revascularization over the study period (2002-2006) in Medicare patients presenting with ACS; 2)
Determine the influence of age, comorbidity presence, race, gender, and geographic location on the selection of mechanical revascularization strategy
(PCIS or CABG); 3) Compare clinical outcomes and hospital/physician resource utilization with respect to the initial mechanism of mechanical
revascularization treatment; 4) Determine if age, comorbidity presence, race and/or gender are associated with disparate outcomes within the selected
treatment modality in Medicare ACS patients. We will use propensity score methods to control for mechanism of revascularization to reduce bias from
selection. Key outcome measures include rates of rehospitalization, reyascularization, nursing home use, morbidity, new onset delirium, mortality, and
Medicare hospital/physician expenditures over a four year follow-up period. A Markov model will be used to portray the relative effects of the two
procedures. These results will guide future study design for treatment of ACS in the elderly.
* Description of resources is excellent, including a detailed description of human subject confidentiality protection and of data sharing. * Briefly,
Harvard Medical School's Dept. of Health Care Policy has 114 faculty, staff, and trainees, 21,000 square feet of continuous space , and a state-of-theart server room with shared resources (14 Unix and Linux systems), and advanced data security systems. * Brown's Center is equally impressive,
with enviable space, extensive secured computer access in offices at the Brown University Center for Gerontology, and the Health Care Research
Facility. * There is no question that they can deliver the analyses proposed, and prepare publicized papers. Weaknesses * None.
Protections
for Human Subjects: Acceptable Risks and/or Adequate Protections Inclusion of Women, Minorities and Children: G1A - Both Genders, Acceptable
M1A - Minority and Non-minority, Acceptable C3A - No Children Included, Acceptable Budget and Period of Support: Recommended as
Requested * This is a very large budget; funds appear to be for the retention of existing faculty and staff, with the exception of a single new junior
person at Brown.
Total Cost
$498,387
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1R21AA018309-01
EXAMINING KEY ASSUMPTIONS:
PREVENTION OF ALCOHOL USE
FEINBERG, MARK ETHAN
PENNSYLVANIA STATE
UNIVERSITY-UNIV PARK
3R03AA017278-01S1
PREVENTING FASD: THE
IMPLEMENTATION AND IMPACT
OF STATE POLICIES
THOMAS, SUE
PACIFIC INSTITUTE FOR
RES AND EVALUATION
3R01AA013806-05S1
ALCOHOL TREATMENT &
HEALTH DISPARITY IN
AMERICAN INDIANS
WALKER, R. DALE
OREGON HEALTH AND
SCIENCE UNIVERSITY
57
DESCRIPTION (provided by applicant): The proposed pilot research project will examine the empirical validity of key assumptions regarding the
epidemiology of adolescent alcohol use that underlie current federal and state policies toward community- based prevention of alcohol use and other
problem behaviors. Communities are faced with a diverse array of dozens of identified risk factors and a confusing array of alcohol and other drug
(ATOD) prevention programs. To help provide a coordinated and planful community-based approach, policymakers have moved toward an emerging
best practices model we term 'Community Diagnosis' (C-Dx). In this model, communities systematically assess and identify risk factors that are
elevated compared to national and state norms, and then select preventive interventions targeting those elevated risk factors. The C-Dx approach is
being instantiated in communities through the policies of state and federal governments, as well as foundation initiatives. The C-Dx model is based on
research showing that a large number of risk/protective factors are linked to adolescent alcohol and other substance use and abuse. However, in most
cases to date, this linkage has only been made at the level of individuals, not communities. Such research provides a rationale for intervening to
enhance parenting in individual families to reduce early- onset adolescent alcohol use. However, what has not yet been demonstrated is that these
same relationships hold at the level of community, where decisions on actions are made. It is likely that individual-level epidemiology alone does not
provide a sufficient basis for community prevention decisions; there is a need for in-depth exploration of 'community level social epidemiology of youth
risk and outcomes.' There are at least five assumptions in the move from individual research to community prevention that have not been adequately
examined and may not be valid. The five assumptions will be examined through quantitative analyses of several large datasets that contain data on
youth risk and ATOD use across communities. The results of these analyses may enable us to recommend changes to the C-Dx model; however, it is
likely that this pilot project will set the stage for a more intensive line of work examining the community epidemiology of alcohol and other substance
use. PUBLIC HEALTH RELEVANCE: This project seeks to test five key assumptions in the application of individual epidemiology concerning
adolescent alcohol use to community-level decision-making. The validity of these assumptions has not been demonstrated previously. If these
assumptions are not valid, then the leading model for applying science to community-based prevention of alcohol and other problem behaviors may
need to be reformulated to maximize the effectiveness of prevention resources. Increasing the efficiency of the application of prevention resources
would have substantial public health benefits for youth, families, and society.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): This proposed exploratory study is the first step in a larger research
agenda to investigate the impact of two distinct types of state laws regarding alcohol use during pregnancy (public health-oriented or punitive) on
pregnant women's decisions to seek substance abuse treatment and prenatal health services. The relevance of this study is that FASD is a critical
health issue about which policy choices are being made without evidence based research about the impact of those choices on healthy fetuses,
healthy children, substance abuse-free women, and intact, stable families. The study's specific aims include: 1) To set the stage for the first study to
assess implementation impact across types of alcohol and pregnancy policy. In this pilot, we will test the adequacy of research design, data collection
instruments (especially those designed for use with women to whom the policies are targeted), and the feasibility of rigorous, systematic data
collection in one state, California, with a mixed set of alcohol and pregnancy policies. 2) To provide evidence-based guidance of the effects of public
health and punitive laws to policymakers who seek to improve birth outcomes in their states. 3) To employ an interdisciplinary research design that
relies on multiple methodologies, stages, and standpoints to reflect each element of the policymaking, policy implementation, and service delivery
systems. The stages of the proposed eighteen month study are as follows: 1) Update and expand the statutory, regulatory and case law in California.
2) Collect and analyze publicly-available national and county-level data and evaluate their adequacy to assess the need for services, the extent of
service provision, and the manner in which the services have been provided. 3) Identify and interview key personnel in California state and county
agencies and legislative committees who make policy for and interact with pregnant women substance abusers. 4) Using the key contacts in each of
three selected counties, conduct interviews and focus groups with a broad range of affected women.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators.DESCRIPTION (provided by applicant): This proposal is the third submission of application number R01 AA01380601 which was originally submitted in response to Request for Application Number AA02.002 ('Research on Alcohol Health Disparities') and most
recently reviewed February 13, 2003 by the National Institute on Alcohol Abuse and Alcoholism Health Services Research Review sub-committee
$189,000
$4,621
$154,000
Project Number
2
1R21AA018311-01
Project Title
A MODEL FOR PRIMARY CARE
MANAGEMENT OF ALCOHOL
USE DISORDERS AMONG
HOMELESS WOMEN
Principal Investigator
WEINREB, LINDA F
Performing
Organization
UNIV OF
MASSACHUSETTS MED
SCH WORCESTER
Abstract
(AA-2). The application has again been extensively revised in response to reviewer comments. Nonetheless, this health services research study
continues to be motivated by health disparities such as the high rates of morbidity and mortality related to alcohol use among American Indians.
Given these health disparities, it is worrisome that there have been few studies examining relationships between treatments and outcomes for natives
with alcohol problems. In particular, there is little or no research on services for urban Native Americans with alcohol abuse or dependence. This lack
of information is unfortunate since most American Indians now live in cities. The proposed project will examine processes of treatment and outcomes
among clients of programs focusing on American Indians in Seattle, Washington and Portland, Oregon. The Seattle Indian Health Board and the
Native American Rehabilitation Association in Portland, Oregon primarily serve urban American Indians, are closely connected with general medical
services, offer ancillary care such as family therapy, provide numerous treatment modalities for individuals with alcohol problems, and support ongoing
research projects. Both agencies serve members of several tribes and both have clients who spend part of the year in the city and part on
reservations. Both agencies have adapted for Native people and incorporated into their treatment programs standardized therapies including
Motivational Enhancement and Cognitive-Behavioral Treatment. The project will use an inception cohort design. Clients presenting for treatment of
alcohol problems at the study programs will be informed about the project. After informed consent is obtained, subjects will be interviewed using
instruments such as the Addiction Severity Index and the Project Match Form 90. Subjects will be interviewed again six months, 12, and 18 months
after baseline. Outcomes of interest will include abstinence, number of drinking days, alcohol-related problems, psychiatric problems, general medical
problems, and satisfaction with services. Interviews with clients and providers, observations of treatment sessions, and reviews of taped treatment
encounters will be employed to elicit details of treatment services received. Hierarchical linear models and structural equations models will be used
to relate treatments to outcomes. Predictors will include variables describing culturally specific treatments provided to the Native clients as well as
measures of clinician cultural competence. Administrative data will be used to compare outcomes for American Indians versus general population
clients. Information generated from the project will be useful in devising optimal treatment for indigenous people living in urban areas and in planning
randomized clinical trials. The research team (headed by a Cherokee psychiatrist and including members of several tribes) will disseminate results in
collaboration with the newly funded American Indian and Alaska Native National Resource Center on Substance Abuse Prevention and Treatment.
DESCRIPTION (provided by applicant): The proposed study will conduct a small randomized trial to test the effectiveness of the collaborate care
model (CCM) for homeless women with alcohol use disorders (AUD) and risky drinking in a large Health Care for the Homeless (HCH) primary care
setting. It is well documented that the CCM yields numerous benefits for primary care patients with chronic conditions, ranging from depression to
asthma and diabetes. Researchers and clinicians have argued that the CCM holds promise for individuals with significant AUD and co-occurring
problems. As yet however, this approach has not been adequately applied and studied for homeless populations. Our goal is to adapt and determine
the effectiveness of the CCM on improving AUD and risky drinking among homeless women. In keeping with recent developments in the substance
abuse treatment literature, we will also assess changes in a wide range of outcome measures, including: alcohol use and related problems, mental
health problems, functional status, housing status, and service utilization. We will also examine the effectiveness of the CCM on homeless women's
initiation, engagement, and retention in appropriate AUD treatment as compared to usual care. This study will contribute knowledge about the fit
between the CCM model and AUD and risky drinking treatment in primary care, and will provide substantive findings that point clinicians and
policymakers towards better ways to address the complex needs of a highly at-risk population. The CCM model is ideally suited to the complex, cooccurring problems of homeless women, who comprise one of the fastest growing segments of the homeless population. Alcohol use disorders alone
or combined with other drug use disorders has been reported in 60% of homeless women. Homeless women's substance abuse commonly co-occurs
with other problems including depression, posttraumatic stress disorder, poor physical health, victimization, high risk sexual practices, and difficulty
exiting homelessness. The CCM is one of the few evidence-based approaches that offers a strategy for coordinating care for patients with multiple comorbidities with documented effectiveness. The specific aims of the study are as follows: 1) To finalize an adaptation of the CCM for homeless women
with AUD and risky drinking, including a) preparation of a treatment protocol (manual, training, and tracking) and b) assessment of intervention
feasibility, acceptability, and fidelity; 2) To conduct a small randomized trial to determine the effectiveness of the CCM for homeless women with AUD
and risky drinking on increasing initiation, engagement, and retention in AUD treatment; and, 3) To establish preliminary outcomes and effect sizes for
the effectiveness of the CCM on AUD and risky drinking, alcohol use consequences, mental and physical functioning and housing outcomes among
homeless women to inform a larger scale RCT. PUBLIC HEALTH RELEVANCE: It is well documented that the collaborative care model (CCM)
yields numerous benefits for primary care patients with chronic conditions. As yet however, this approach has not been adequately applied and
studied for homeless populations. Our goal is to adapt and determine the effectiveness of the CCM on improving AUD and risky drinking among
homeless women in a large Health Care for the Homeless (HCH) primary care setting. This study will contribute knowledge about the fit between the
CCM model and treatment for AUD and risky drinking in primary care, and will provide substantive findings that point clinicians and policymakers
towards better ways to address the complex needs of a highly at-risk population.
Total Cost
$228,782
National Institute on Deafness and Other Communication Disorders (NIDCD)
3R01DC009560-01S1
58
MODERATORS AND OUTCOMES
IN CHILDREN WITH MILD TO
SEVERE HEARING IMPAIRMENT
MOELLER, MARY PAT
;TOMBLIN, JAMES BRUCE
UNIVERSITY OF IOWA
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators .ABSTRACT While previous studies have shown that children with mild-to-severe hearing loss are at risk for poorer
language, academic, social and psychological outcomes, these studies were conducted prior to the implementation of universal newborn hearing
screening and recent technological advances in amplification. Early identification of hearing loss, improved amplification technologies, and access to
quality early intervention programs have the potential to improve the performance of this group of children. The requisite clinical studies needed to
provide optimal intervention to this subgroup of children with hearing loss have not been conducted. The proposed research will address this gap.
Specifically, there is a critical need to examine outcomes in a large group of children who have benefited from these advances. Thus, the overall goal
of the proposed studies is to examine a range of longitudinal outcomes of this subgroup of children with hearing loss. Multi-center, multi-disciplinary
evaluations will be conducted in order to gain a comprehensive understanding of the impact of mild to severe hearing loss on these children and their
families. It is critical to determine the constellation of factors that support the early development of speech, language, cognitive, and psychosocial skills
as well as quality of life issues within the family. A comprehensive set of child outcomes (e.g., speech production and perception, language, academic,
$470,431
Project Number
2
1R21DC010926-01
Project Title
EARLY SOCIAL COMMUNICATION
CHARACTERISTICS OF ASD IN
DIVERSE CULTURES IN THE US
A
Principal Investigator
WETHERBY, AMY M
Performing
Organization
FLORIDA STATE
UNIVERSITY
Abstract
psychosocial, cognitive) and family outcomes (e.g., parenting, quality of life, and satisfaction with services) will be examined and compared to results
from normal-hearing children with similar backgrounds. One of the largest known contributors to outcomes in children with hearing loss is reduced
auditory/linguistic experience. Therefore, the focus of the proposed work will be on variations in receipt and effectiveness of early interventions (e.g.,
hearing aid use, educational programs) that are intended to enhance auditory/linguistic experiences. In so doing we believe that it is also important to
identify barriers to service access and other factors that influence intervention compliance. Educational service provision for children with mild to
severe hearing loss may vary in critical ways (e.g., accessibility, intensity and provider specialization). Further, it is likely that family (community of
residence, parenting, income) and child(temperament, communication skills, degree of hearing loss) factors will interact with intervention features to
influence outcomes. The planned recruitment of a large, representative sample will support the use of multivariate procedures, including Structural
Equation Modeling, to examine the ways in which child, home/community and intervention characteristics combine to affect outcomes. Moderators and
Functional Outcomes in Children with Mild to Severe Hearing Loss Narrative. This project will obtain critical information regarding the extent to which
mild to severe hearing loss in early childhood threatens the well-being of children. The project also will provide important insight into the effectiveness
of interventions concerned with mitigating the hearing loss and its negative consequences These data will, therefore, form the foundation for
evidenced based practice and policy for the clinical management of children with hearing loss.
There is a pressing need to improve early detection of Autism Spectrum Disorders (ASD) so that families can access intensive, appropriate
intervention services as early as possible. However, studies indicate that important racial and ethnic disparities exist in the identification and diagnosis
of children with ASD in the US, which impact access to services. Very little research is available on ASD from developing countries. This research
investigation is a foundational study of early social communication markers of ASD in children from two diverse cultures from two different countriesLatino immigrants in Southeastern US and the KwaZulu-Natal (KZN) province of South Africa. These two regions were selected to inform future
epidemiological research on ASD in diverse populations both in the US and other developing countries. Children in this study will range from 18 to 36
months of age. This study will use an observational case-control research design to compare early behavioral markers of ASD in 15 children who end
up with a confirmed diagnosis of ASD from a predominantly Latino immigrant population in Collier County, Florida in the southeastern US (ASD-US1),
15 young African children from KZN who end up with a clinical diagnosis of ASD (ASD-Africa), and matched control children from Leon County,
Florida, who have been diagnosed with ASD by the FIRST WORDS(R) Project (ASD-US2). The three groups of children with ASD will be compared to
groups of typically developing (TD) children from each site (TD-US1, TD-Africa, TD- US2). Children will be recruited with autism-specific screening
tools adapted for these low-resource settings. We will first conduct a series of focus groups to adapt the screening and diagnostic tools to be culturally
appropriate and to understand the influence of culture on expectations of children and understanding of disabilities including ASD. Social
communication markers of ASD will be compared during two different video recorded observation methods-structured observations using systematic
sampling procedures and naturalistic observations of everyday activities. A clinical diagnosis of ASD based on the DSM-IV diagnostic criteria will be
confirmed or ruled out by experienced clinicians using the Autism Diagnostic Observation Schedule. These findings will provide information about the
relationship between culture and ASD in order to advance science on the heterogeneity of ASD and have important implications for informing research
on genetic and environmental mechanisms of ASD. This research study is pivotal to our long term aims of adapting screening and diagnostic tools for
epidemiological research and strengthening in-country and global collaboration to build the capacity in low-resource settings for appropriate accessible
early intervention. PUBLIC HEALTH RELEVANCE: The expected outcomes of this study will have significance for the field by identifying behavioral
markers that distinguish young Latino children in the Southeastern US and African children from KwaZulu-Natal with Autism Spectrum Disorders
(ASD) from children with typical development from those cultures. It is important to investigate the relationship between culture and ASD in order to
advance science on the heterogeneity of ASD. Cultural differences may be evident in the behavioral phenotype of ASD, recognition and interpretation
of symptoms by caregivers, the decisions parents make regarding evaluation and treatment, and interactions between families and the healthcare
system. The results of this research will lead to culturally sensitive screening and evaluation methods that may decrease the age at which all children
with ASD are diagnosed.
Total Cost
$238,233
National Institute on Drug Abuse (NIDA)
1R24DA024868-01A2
59
DIDARP AT THE UNIVERSITY OF
PUERTO RICO SCHOOL OF
PUBLIC HEALTH
ALBIZU, CARMEN E
UNIVERSITY OF PUERTO
RICO MED SCIENCES
DESCRIPTION (provided by applicant): Our goal is to enhance our capacity to conduct drug abuse research with criminal justice populations from a
public health perspective, at the University of Puerto Rico, Graduate School of Public Health. Our research development strategy centers on
developing proficiency in research competencies in a critical mass of faculty that will cohesively pursue epidemiological and health services research
relevant to engaging and retaining in community drug treatment re-entering inmates with histories of a substance use disorder. The program will
provide as well opportunities to develop research capacity in students at different stages in their education and to encourage them to engage in drug
abuse research careers. The research projects submitted with this application will explore individual and drug treatment provider factors that may
predict entry and retention in community drug treatment for re-entering ex-offenders with a substance use problem. The proposed projects should
contribute to address the disproportionate prevalence of untreated substance use problems in incarcerated populations as well as the large proportion
of untreated ex-offenders that become re-addicted and who are re-incarcerated shortly after release The research projects include three pilot and one
developmental project that address NIDA research priorities such as the services needs of special populations and studies of service providers. We
expect MIDARP support to enhance our capacity to engage in NIH funded drug abuse research of relevance to addressing disparities borne by
Latinos with a substance use disorder. To reach our goal, we have established the following aims: 1) Provide leadership, support, and coordination to
increase the number of Latino faculty and students capable of successfully conducting drug abuse research relevant to a criminal justice context. 2)
Enhance institutional and extra- institutional resources that sustain the successful planning, financing, and conduct of drug abuse research. 3)
Disseminate research findings in a timely and effective fashion to the research community, to the academic programs, and to other stakeholders
involved in addressing the drug treatment needs of ex- offenders with a substance use problem. PUBLIC HEALTH RELEVANCE (See instructions):
We expect to build a synergestic cluster of faculty, students, and academic leaders that have expressed a growing interest in the public health impact
of problems associated with drug abuse in the criminal justice population.
$523,707
Project Number
2
Project Title
Principal Investigator
Performing
Organization
1R01DA024658-01A1
INTERNET AS SUPPLIER:
PREVENTING ADOLESCENT USE
OF NON-MEDICAL ADDICTIVE RX
ARRIA, AMELIA M
TREATMENT RESEARCH
INSTITUTE, INC. (TRI)
1R21DA027142-01
EXAMINING A TEXT MESSAGE
INTERVENTION FOR SMOKING
CESSATION
BOCK, BETH C
MIRIAM HOSPITAL
1R21DA025298-01A1
OLDER DRUG USERS: A LIFE
COURSE STUDY OF TURNING
POINTS IN DRUG USE AND
INJECTION
BOERI, MIRIAM W
KENNESAW STATE
UNIVERSITY
60
Abstract
DESCRIPTION (provided by applicant): Adolescent non-medical use of highly addictive prescription opioid drugs, such as Vicodin and Oxycontin; and
tranquilizers, such as Valium and Xanax, is increasing. Although the reasons for increasing adolescent non-medical use of addictive prescription drugs
are not known, we do know that they are widely advertised and sold over the internet without prescription. The Treatment Research Institute and Drug
Strategies have conducted research on internet drug sales for the past four years and we believe that 'non-prescription websites (NPWs)' may be one
important contributing factor to increasing adolescent use of these drugs. There has been no research on the role of the internet in supplying
prescription medications to adolescents without a prescription. This revised RO1 will continue our investigations of the use of internet and other
sources for drug purchase by high risk adolescents currently in residential treatment programs. We have a revised 30-minute data collection protocol
using well-validated items from the CASI (Meyers et al., 1995 - 2007) that will be administered via a well-tested and engaging web interface
(BubbleMonkey) to a purposive sample of 2000 adolescents (12 - 17) from 30 programs in a two-year data collection period. The data collection has
been designed to completely protect confidentiality. The study has three primary aims: 1. To determine whether internet purchase is a significant
source of drug availability for adolescents with serious substance abuse and addiction problems. We operationally define 'significant' as a prevalence
rate of 20 percent or higher in this sample. 2. To determine whether internet drug availability is associated with a significant proportion of relapses
following efforts to stop drug use. Again, we operationally define 'significant as a prevalence rate of 20 percent or higher. 3. To explore whether use of
internet websites and other sources, differs as a function of demographic and drug use characteristics among these high-risk adolescents. Information
is urgently needed about the relationship between rising rates of adolescent non- medical use of prescription drugs and internet websites that market
those drugs without a prescription. This study will be the first to obtain this information directly from adolescents about internet sources of drug supply.
PUBLIC HEALTH RELEVANCE: Adolescent non-medical use of highly addictive prescription opioid drugs, such as Vicodin and Oxycontin and
tranquilizers such as Valium and Xanax, continues at high levels. These substances are widely advertised and sold over the internet without
prescription, perhaps fostering adolescent use. This study will obtain information directly from adolescents about their use of the internet and other
sources to obtain drugs.
DESCRIPTION (provided by applicant): Most smokers want to quit and nearly half attempt to quit each year. However, few actually succeed. The
problem is particularly acute among young adult smokers who tend to under-utilize existing smoking cessation services, and have limited access to
health insurance and healthcare. New, innovative approaches are needed that can reach out to younger adult smokers and help them quit.
Intervention delivery modalities that can be inexpensively delivered in an appealing format with wide reach are particularly compelling for treating
younger smokers. For this project we will develop and test a theoretically driven, evidence-based smoking cessation counseling intervention that can
be delivered through SMS text messages. Text messaging is popular with younger adults (<35 years), over half of whom use text messaging, often
sending 50 or more messages per week. Text messaging can be used to provide advice and interactive support adapted from evidence-based
interventions for smoking cessation. However, thus far text messaging is an untapped medium and has been only rarely studied as an intervention
delivery tool. Existing studies have significant limitations which the proposed study will attempt to redress. This project consists of three sub-studies:
Initial Acceptance Testing, Prototype Evaluation, and initial Efficacy Testing. We will first develop a detailed presentation of the proposed intervention
system and conduct an initial test of the program's potential feasibility and acceptability using a series of 3-4 focus groups with 24 smokers from our
targeted demographic and conduct semi-structured interviews with key stakeholders. Information obtained from these interviews and focus groups will
be used to inform prototype development. Intervention programming and the content of intervention messages will be completed in month 9 of the
project period. We will then recruit a second sample of 24 adult smokers to use the program as a smoking cessation intervention for 7 weeks, and then
participate in focus groups to evaluate their experience with the system. We will also demonstrate the working prototype to key stakeholders and
conduct interviews to obtain their feedback. Based on these evaluations, we will refine the intervention. In year 2 we will recruit a sample of 40 adult
smokers from the target group and randomly assign them to receive either the text-message intervention (TXT) or a self- help intervention with contact
control (TXC). Outcomes at end-of-treatment and six-month follow up will be used to obtain effect size estimates needed for a larger trial. PUBLIC
HEALTH RELEVANCE: Younger adult smokers typically have limited access to healthcare and under-utilize smoking cessation services. This project
will develop an evidence-based, theoretically driven smoking cessation program delivered through text messaging, which is a popular form of
communication used by the majority of younger adults. This project has substantial public health significance in that successful dissemination of the
intervention could reach as many as 6.8 million smokers annually.
DESCRIPTION (provided by applicant): Although drug use and HIV rates among older drug users are increasing at alarming rates, knowledge on drug
use patterns and risk behaviors among this cohort as older adults is limited. National trend data show that adults who are 45 or older comprise the
fastest growing age group of drug users as well as new drug treatment admissions and new HIV/AIDS cases. The two-fold goal of this exploratory R21
application is to address the lack of current knowledge on older drug users and provide innovative mathematical models that have the potential to
inform future research on specific turning points in drug use and related health risks over the life course. In this mixed-methods study we use
quantitative methods to identify turning points in drug use and risk behaviors, qualitative methods to explore these turning points more thoroughly, and
mathematical analysis to build predictive models on turning points in drug trajectories. The community-based sample will consist of active users (n=50)
and former users (n=50) of heroin, cocaine, and methamphetamine age 45 and older. Data are collected using a quantitative matrix on drug history
and social roles and a qualitative in-depth interview. The study site is the metropolitan statistical area (MSA) of Atlanta that includes urban, suburban
and rural settings. The knowledge gained from an in-depth exploration of this sample will add to our understanding of an aging drug-using population,
inform future research on older drug users and provide innovative mathematical models on risk behaviors and drug use to be tested in future largesample studies. To accomplish this we propose three specific aims: (1) To identify turning points in the onset, continuation, and cessation of drug use
throughout the life course of a sample of older users; specifically how social roles, race, gender, age, social contexts, policies and historical events
influence turning points in drug use and drug- related HIV risk behaviors; (2) To thoroughly explore these turning points and transitions over the life
course, specifically changes in drug availability, risk behaviors, routes of administration, social roles, networks, support, policies, settings, and
geographic locations, imbedded in a life course perspective; (3) To build Dynamic Bayesian Networks that best model the static and dynamic aspects
found in our quantitative and qualitative data. In so doing we are able to identify not only statistical relationships between the variables but also the
Total Cost
$499,609
$204,000
$201,000
Project Number
2
Project Title
Principal Investigator
Performing
Organization
1RC1DA028428-01
A MOBILE ENABLING
TECHNOLOGY TO PROMOTE
ADHERENCE TO BEHAVIORAL
THERAPY
BOYER, EDWARD W
;PICARD, ROSALIND W
UNIV OF
MASSACHUSETTS MED
SCH WORCESTER
1F31DA025391-01A1
THE EXPERIENCE OF
BENZODIAZEPINE DEPENDENCE
AMONG OLDER WOMEN: A
CULTURAL ANALYSI
CANHAM, SARAH LOUISE
UNIVERSITY OF
MARYLAND BALT CO
CAMPUS
1R01DA022313-01A2
INDIVIDUAL DIFFERENCES IN
SMOKING EXPOSURE AND
NICOTINE DEPENDENCE
SENSITIVITY
DIERKER, LISA C
WESLEYAN UNIVERSITY
61
Abstract
influence and progression of these through time. Together these aims provide needed in-depth details on the lives of older drug users as well as
trajectory models that can be used to target treatment strategies on the turning points in drug use trajectories. The information and models provided by
this study can be used to develop better prevention, intervention and treatment programs by focusing on specific turning points in drug careers. This is
a unique and innovative exploration of methodologies that can lead to future studies. The models developed from this R21 exploratory research grant
will be used to propose a R01 grant to extend the predictive value of the models on turning points in drug trajectories throughout the life course.
PUBLIC HEALTH RELEVANCE: Recent health studies show an alarming increase in drug use and HIV/AIDS among older adults, a cohort composed
primarily of aging baby boomers. Retrospective life histories of older adult drug users allow an in- depth exploration how risk factors are influenced by
the social context of drug users over the life course and help to identify turning points in the drug trajectory. By applying what we learn from the lives of
older drug users in this sample, the findings will inform research and health initiatives for older as well as younger users, including prevention,
intervention and treatment programs.
DESCRIPTION (provided by applicant): This application addresses broad Challenge Area (06) Enabling Technologies, 06-DA-105: Improving health
through ICT/mobile technologies. The ultimate goal of this research is to fundamentally change the ways in which behavioral interventions are
delivered. We propose an innovative mobile Enabling Technology-iHeal-that recognizes stressors that threaten a patient's recovery and then delivers
evidence-based interventions exactly at the moment of greatest need. Our objective is to determine, within subjects, the extent to which physiologic
and affective changes detected by iHeal are predictive, within subjects, of posttraumatic stress or drug cues. The study team has considerable
expertise in technology development and in assessment of behavioral interventions in co-occurring disorders. We will study 25 subjects drawn from an
existing SAMHSA-funded investigation that utilizes intense case management to monitor progression of PTSD and substance abuse in returning
combat veterans. Our proposed investigation will share interventions with the SMAHSA study that are based upon a blending of Motivational
Interviewing and Cognitive Behavioral Therapy approaches for PTSD and substance abuse. Specific aims: 1) To evaluate the accuracy with which
iHeal characterizes physiological and affective phenomena as acute stress reactions related to PTSD and environmental drug cues; and 2) To
evaluate the effect of Motivational Interviewing-based interventions on acute stress reactions related to PTSD and environmental drug cues. This initial
proposal is extremely innovative. The proposed iHeal device will employ cutting-edge wireless technology to link wearable sensors to personal mobile
computing platforms (e.g., iPhone). This linkage will allow iHeal to detect co-occurring biological and behavioral processes, while embedded
computing in the mobile platform permits iHeal to deliver evidence-based empathetic interventions at the opportune moment. iHeal can learn to
intervene in ways that are most effective for the user, including scripted text-based dialogues modeled after brief interventions; use of motivating
images or messages from loved ones; playing a meaningful song; or contacting a counselor at the moment of greatest need. Ultimately, a wearable
wireless device that anticipates stressors and intervenes at a likely transition to risky activities has enormous potential in a variety of social, behavioral,
and biomedical research enterprises. Importantly, iHeal has immediate commercial applications that will encourage job growth in behavioral science,
biomedical, computer science, telecommunication, and electrical engineering enterprises. iHeal is an innovative device that uses wearable sensors to
detect pulse, skin conductance, and acceleration; the sensor array links wirelessly to an iPhone which has an app that identifies changes in the user's
physiology. Changes consistent with acute stress from PTSD exacerbations or drug use cues generate an empathetic conversation between the
iPhone and the user, who enters real-time data on social/behavioral/environmental contexts. The iPhone (which tracks time and GPS data) uses
predictive software to anticipate upcoming stressors and helps the user avoid them. The public health significance of this proposal is 1) iHeal will
detect co-occurring biological and behavioral processes in real time; 2) it will discern undiscovered behavioral states; 3) it will predict a behavior of
interest; and 4) it will deliver empathetic interventions to the user at the opportune moment for intervention. Because it is based on the union of
existing technology and has immediate commercial applications, iHeal will encourage job growth in behavioral science, biomedical, computer science,
telecommunication, and electrical engineering enterprises.
DESCRIPTION (provided by applicant): The proposed research is a qualitative inquiry which aims to understand the experience, meaning, and
interpretation of benzodiazepine (BZD) dependence in a sample of community-dwelling older women. A second aim is to determine whether culture
has a role in the experience of BZD dependence among women in later life. Key questions to be explored include: what are the theories that
individuals use to guide their understanding of their own dependency? How do informants construct their own life histories in relation to BZD
dependence? And, do older BZD abusers recognize symptoms of dependency in themselves, how do they understand them, and what actions do they
or do they not take? A study group of 20 women (10 European American and 10 African American) age 75 and older who self-report BZD dependence
and regular usefor 3 months or longer will participate in a life-line exercise and in-depth life history interviews. Interviews will be coded and analyzed
for thematic content. The overarching goal of the in-depth interviews will be to identify patterns in informant's life history, which dimensions are
important to informants, and how these are related to one another; the proposed open-ended qualitative interviews are the only way to gather this type
of information. PUBLIC HEALTH RELEVANCE: The study will provide important, previously unreported, insight into the everyday lives of older
women. This research will contribute to the empirical base of knowledge, will identify potential strategies for enhancing well-being in later life, and
perhaps will develop some conclusions that may help ameliorate dependency. This will be important for physicians and other providers interested in
enhancing and maintaining mental health and well-being in old age.
DESCRIPTION (provided by applicant): This application represents a request for support to conduct research integrating developmental theory
regarding nicotine exposure and sensitivity with state-of-the-art statistical methods aimed at defining unique population subgroups at risk for nicotine
dependence. To date, risk research focused on the role of depression and alcohol use in the emergence of smoking behavior and nicotine
dependence has largely been confined to efforts intended to evaluate increased probability of smoking exposure. A complimentary or alternate
explanation for the association is that depression and/or alcohol use may signal increased sensitivity to nicotine dependence at similar levels of use.
Stimulated by findings obtained through current grant support, the goal for the next five years is to apply both traditional and state-of-the-art statistical
methods to the analysis of longitudinal data that includes assessment of DSM-IV nicotine dependence and the widest array of measures of smoking
exposure available. The following specific aims will be addressed: 1) Describe individual differences in the patterning (e.g. quantity, frequency, timing
and duration) of smoking behavior associated with the emergence of nicotine dependence. 2) Evaluate the role of depression and alcohol
Total Cost
$499,381
$32,069
$260,919
Project Number
2
Project Title
Principal Investigator
Performing
Organization
1R21DA024631-01
IMPLEMENTATION AND
DISSEMINATION OF TOBACCO
CESSATION STRATEGIES IN
FREE CLINICS
FOLEY, KRISTIE L
DAVIDSON COLLEGE
1RC1DA028284-01
DEVELOPMENT OF BEHAVIORAL
AND SOCIAL INTERVENTIONS
THAT REDUCE STIGMA AND
IMPROVE
FULLER, CRYSTAL M
COLUMBIA UNIVERSITY
HEALTH SCIENCES
62
Abstract
use/disorders in promoting increased exposure to smoking and /or increased sensitivity to nicotine at similar levels of use. 3) Identify prominent and
unique risk/exposure pathways that predict the emergence of nicotine dependence for population subgroups. 4) Determine the attributable risk
associated with each of the prominent risk/exposure pathways in order to evaluate the potential for reduction of smoking behavior in the population.
Existing data will be utilized including adolescent and young adult samples. Multiple statistical techniques for evaluating the presence of population
subgroups at risk for nicotine dependence at varying levels of exposure will be used including latent class analysis (LCA) and classification and
regression tree (CART) analysis. These group-based approaches will be complimented with traditional regression techniques and Receiver Operator
Characteristic (ROC) analysis in order to evaluate the unique and complimentary contributions of variable-centered and group-based methods for
evaluating individual variability in the etiology of nicotine dependence. We expect that the completion of the proposed studies will substantially
advance our understanding of smoking etiology that will inform the targets, timing and content of intervention for those individuals most sensitive to the
development of nicotine dependence. PUBLIC HEALTH RELEVANCE This research will provide a more detailed understanding of the nature and
onset of nicotine dependence in adolescents and young adults. The identification of individuals with high susceptibility to nicotine dependence will
inform more targeted efforts for further reducing smoking prevalence.
DESCRIPTION (provided by applicant): Individuals without health insurance are 1} times more likely to smoke than those insured through private
providers and are less likely to receive smoking cessation advice from a health professional. Limited access to smoking cessation programs among
the uninsured may contribute to their excess disease burden and poorer survival. The goal of this research is to provide formative data on the
implementation and dissemination of evidence-based tobacco cessation strategies in free clinics by achieving the following aims: (1) increasing free
clinics' organizational readiness to adopt the United States Public Health Service's Guidelines on Treating Tobacco Use and Dependence; (2)
evaluating the efficacy of the evidence-based strategies in promoting tobacco cessation behaviors among the clinics' health care volunteers and
uninsured patients; and (3) testing whether the North Carolina Association of Free Clinics has the capacity to disseminate the evidence-based tobacco
prevention and cessation strategies in absence of the university research team. These aims will be accomplished through a randomized, controlled
trial design to test the adoption, efficacy, and dissemination of clinic-based tobacco cessation strategies in six free clinics. These aims will be
evaluated using three data collection protocols including key informant interviews, environmental scans, and patient exit interviews. Free clinics serve
a critical role in health care delivery of America's uninsured population. They are non-profit private entities distinct from other safety net providers in
that they do not accept reimbursement from any third-party payors, do not charge patients for health care services, and rely extensively on volunteer
health care professionals. More than 300,000 patient visits occurred in North Carolina's free clinics in 2006. Of 55 free clinics in North Carolina
providing medical or dental care , only one out of four clinics offers any tobacco cessation services and only two have a comprehensive tobacco
cessation program onsite. The proposed research study responds to an unmet need for the successful implementation and dissemination of evidencebased tobacco cessation care for the uninsured. The overall intent of this research is to ultimately close the gap between research discovery and
program delivery in the area of tobacco control. PUBLIC HEALTH RELEVANCE: The scientific evidence demonstrates that comprehensive clinicbased interventions significantly improve quit rates among tobacco-using patients. The evidence is also compelling that individuals without health
insurance are less likely to receive tobacco cessation counseling, yet are more than 1 } times the general population to use tobacco. This study will
test the implementation and dissemination of evidence-based clinical practice guidelines in the free clinic setting, whereby having a significantly
positive impact on the health of the uninsured.
DESCRIPTION (provided by applicant): This application addresses the broad Challenge Area (01) Behavior, Behavioral Change, and Prevention and
the specific Challenge Topic, 01-DA-106: Development of behavioral and social interventions that reduce stigma and improve quality and accessibility
of health care services in low resource settings. We will evaluate a pharmacy-based pilot intervention that combines rapid HIV testing with other
preventive screening services including blood pressure, glucose, and cholesterol screening. This pilot targeted to injection drug users (IDUs) who
purchase syringes from pharmacies via the New York State Expanded Syringe Access Program (ESAP) - a program aimed at increasing sterile
syringe access to help reduce HIV transmission. By combining HIV testing with less stigmatizing screening services and offering testing to all
pharmacy patrons instead of singling out drug users, the likelihood of reducing HIV testing and drug use-associated stigma will increase. Although HIV
testing is increasingly accessible and new testing technologies are available, HIV testing rates are low in the black and Hispanic community, especially
among IDUs at risk for HIV and many other infectious and chronic diseases. Structural barriers (i.e., lack of health insurance) in the black and Hispanic
community, especially among IDUs may limit access to regular health care/ preventive services. Access barriers are compounded by stigma
associated with getting an HIV test that may identify an individual as a drug user and/or someone who engages in socially unacceptable behavior.
Thus, this proposed study aims to 1) qualitatively evaluate HIV testing and chronic disease screening in pharmacies, 2) compare/contrast correlates of
agreeing to a HIV test vs. not among IDU syringe customers and their peers and 3) qualitatively compare/contrast HIV testing with comprehensive
screening services pharmacy (intervention) vs. HIV testing only pharmacy (control). To accomplish these aims, we propose to conduct in-depth
interviews among key stakeholders to inform development of study materials, IDU/peer survey and pharmacy staff surveys. We will recruit 2 ESAPregistered Harlem pharmacies (1 intervention and 1 control) where our current work has developed the infrastructure to perform on-site screening
services. Among the intervention and control pharmacies, 798 (518 non-drug using, 70 drug-using +3 networks/ drug user) pharmacy customers will
be recruited. We will adapt a previously developed training module to train pharmacy personnel on how to engage pharmacy customers. Customers
from the intervention pharmacy will complete a brief attitude scale on attitudes toward HIV, IDUs and stigma, watch an educational video on the
importance of health screening (particularly HIV testing), participate in desired screening services and undergo a structured 20-minute ACASI that
repeats the attitudes scale. Customers in the control pharmacy will only undergo HIV testing and a structured 20-minute ACASI survey. Semistructured surveys will be administered to all pharmacy staff to ascertain impact of on-site prevention services on pharmacy personnel and business
flow. We will use standard qualitative analytic techniques and GEE to account for clustering in quantitative analyses. The proposed research is highly
significant in that it aims to explore a pilot intervention that involves expanding pharmacy services to include HIV testing and to determine if offering
HIV testing within a comprehensive prevention approach that includes less stigmatizing screening tests (i.e., blood pressure, glucose and cholesterol
screening) increases HIV testing among injection drug users who purchase syringes in pharmacies and their peers (drug-using and/or non-drug
Total Cost
$185,167
$499,884
Project Number
2
Project Title
Principal Investigator
Performing
Organization
1R01DA025600-01
IMPACT OF CORE
IMPLEMENTATION
COMPONENTS ON ADOPTION
GUYDISH, JOSEPH R
UNIVERSITY OF
CALIFORNIA SAN
FRANCISCO
1R01DA027414-01
PARITY, CHILD MENTAL HEALTH,
AND SUBSTANCE ABUSE
MEARA, ELLEN R
HARVARD UNIVERSITY
(MEDICAL SCHOOL)
1RC1DA028407-01
INTENSIVE OUTPATIENT V.
OUTPATIENT TREATMENT WITH
BUPRENORPHINE AMONG
AFRICAN AME
MITCHELL, SHANNON
GWIN
FRIENDS RESEARCH
INSTITUTE, INC.
63
Abstract
using). We will be using new HIV testing technologies and bringing technological innovations and treatment modalities to low-income communities in
New York City. If successful, this model can be duplicated not only throughout other high-risk neighborhoods in New York, but in several other cities
and states. If our findings are positive, broader public health impact could follow. Pharmacists can partner with clinicians and other health care
providers to offer an integrative approach to HIV testing to high-risk injection drug using populations and to other groups with limited access to health
care services such as the uninsured and undocumented immigrants. Adoption of this integrative approach to HIV testing on a larger scale could also
be implemented and reduce many of the access and stigmatization barriers experienced in marginalized populations for HIV testing while
simultaneously increasing and improving general health and well-being by targeting chronic disease outcomes that disproportionately affect
marginalized populations.
In recent years the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) has made significant gains in testing the effectiveness of
promising addiction treatments, and disseminating findings about those treatments to the field. At the same time, drug abuse treatment systems
nationwide face a trend toward the increasing use of evidence-based practices. In the context of these complimentary efforts and trends, the
translation of research findings to meet practice needs has gained prominence. A number of theoretical perspectives and constructs have been
advanced, yet establishing their usefulness offers singular challenge due to the range of factors thought to impact research translation, and the
number of programs and long time horizon needed to assess research translation outcomes. As a laboratory for translational research, where studies
are conducted in partnership with Ureal world' community clinics, the CTN allows observation of the process of effectiveness research over time, from
protocol conceptualization through implementation and into the post-study period. In collaboration with CTN protocol 0031 (Stimulant Abuser Groups
to Engage in 12Step:STAGE-12), this study will assess relationships relevant to the translation of research into practice: a)how the fidelity of STAGE12 implementation impacts client outcomes, b) whether commonly hypothesized counselor and organizational variables affect treatment fidelity, and c)
uptake of the STAGE 12 intervention in participating clinics after the trial ends. In exploratory analyses, the project will model these multiple
relationships for their impact on intervention adoption after the clinical trial ends. Although prior research has examined individual relationships among
these variables, this study will assessing multiple relationships in the context of a multi-site clinical trial, extending observation to encompass preimplementation, during implementation, and post implementation measures and constructs. The short term goal of the project is to assess key
relationships in a theoretically driven model of implementation, using the CTN STAGE-12 study asa research platform. The 16ng term goal is to speed
the translation of CTN research findings to implementation, so that clinics can more readily adopt research based interventions, and more effectively
treat the persons families, and communities they serve.
The recent passage of the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008, which requires private health
plans to provide equal coverage of behavioral and medical/surgical services, also known as parity, represents an important step in the expansion of
access to substance abuse and mental health treatment. The new law will create an opportunity for new funding for behavioral health services, and it
will likely launch a significant restructuring of private and public insurance coverage for behavioral health treatments. In fact, the new legislation may
have its largest public health impact through its indirect influence on the State Children's Health Insurance Program (SCHIP), public health insurance
coverage for children under 20 not income-eligible for Medicaid. SCHIP enrollees suffer behavioral health problems at higher rates than in the overall
child population, like their counterparts on Medicaid. However, SCHIP programs tend to limit coverage of behavioral health treatment through visit/day
limits, high co-payments, coinsurance, and deductibles in ways that Medicaid programs do not. Federal parity legislation is especially significant for
many SCHIP programs because these states meet federal SCHIP benefit requirements by benchmarking behavioral health benefits against private
insurance plans directly affected by the new law. Thus, the new legislation creates a natural experiment by effectively inducing changes in benefit
design, and likely changes in the management of behavioral health services in some SCHIP programs, while leaving other programs that do not
benchmark benefits in this way unchanged. The effect of this legislation on access to substance abuse and mental health services was further
strengthened by the reauthorization of SCHIP in February of 2009, both because it expands the scope of the program with additional funding, and
because it requires parity. We propose to exploit the variation created by new federal parity legislation to pursue three aims. 1) to examine how SCHIP
programs change behavioral health benefit design and management approaches in response to changes in benchmark plans induced by parity
legislation; and 2) to estimate changes in SCHIP coverage, utilization and out of pocket spending for child behavioral health services (Aim 2) among
likely SCHIP enrollees in affected states following the implementation of new federal parity legislation. We will pursue these aims with primary data
collection regarding benefit design and management features of state SCHIP programs before and after the law change (Aim 1). Second, we will
survey parents regarding substance abuse and mental health service use and related outcomes among children aged 3 to 17 before the law change
takes effect and 12 months after the law change (Aim 2). We will analyze these new data using appropriate panel data methods to account for
repeated observations on individuals, and using estimation strategies such as generalized Poisson or negative binomial models for count data and
generalized linear models to address spending data, which are often highly skewed.
DESCRIPTION (provided by applicant): This application addresses broad Challenge Area (05): Comparative Effectiveness Research, and specific
Challenge Topic (05-DA-104): Comparing Drug Treatment Effectiveness in Ethnic Minority Populations Background: Although there is relatively little
difference in illicit drug use rates between African Americans and Whites, there is are significant differences in terms of the collateral impact of opiate
use on these two communities and wide disparities in their access to treatment. Buprenorphine, a partial mu agonist approved for use the US in 2002
outside of strictly regulated opioid treatment programs, has the potential to reduce the disparity between demand for treatment and treatment access.
However it appears from early data on the implementation of buprenorphine in the US that the health disparities faced by African Americans are now
extending to this treatment. Indeed, according to SAMHSA over 90 percent of the patients receiving buprenorphine in their evaluation of this treatment
were White. Many African Americans in urban areas are unable to find or afford the kind of buprenorphine physician office-based treatment that the
approval of buprenorphine was intended to make possible. In Maryland and elsewhere, drug treatment agencies are responding to the disparities in
access to buprenorphine treatment by offering grants or contracts to drug treatment programs that have traditionally relied exclusively on psychosocial
approaches ('drug-free' outpatient programs) to treatment. This arrangement has potential to ameliorate the access problem for African Americans,
who in Baltimore make up about 80 percent of the city's heroin-using population. But this arrangement has also uncovered knowledge gaps that must
Total Cost
$389,925
$453,601
$498,748
Project Number
2
Project Title
Principal Investigator
Performing
Organization
1R01DA022341-01A2
IMPROVING CARE CONTINUITY
IN DRUG ABUSE TREATMENT
STITZER, MAXINE L
JOHNS HOPKINS
UNIVERSITY
3R01DA026091-02S1
COMPUTER VS THERAPISTDELIVERED BRIEF
INTERVENTION FOR DRUG
ABUSE IN PRIMARY CARE
SVIKIS, DACE S.
VIRGINIA
COMMONWEALTH
UNIVERSITY
64
Abstract
be filled to enable both access and optimal patient centered treatment for this population. One such gap concerns what level of psychosocial treatment
is appropriate for this population. Second, we need to understand how attitudes of staff at formerly abstinence-oriented programs affect the use of an
opioid agonist in terms of retention in treatment and outcomes. Design: This two-group randomized clinical trial will test the effectiveness of intensive
outpatient (IOP) v. standard outpatient (OP) treatment in 272 heroin-dependent African American adults receiving buprenorphine in 3 formerly 'drugfree' programs. Participants will be randomly assigned to one of the two treatment intensity conditions at intake and assessed at baseline, 3-, and 6months post-baseline to determine treatment retention, frequency and severity of heroin and cocaine use, self-reported HIV-risk, quality of life, and to
determine DSM-IV criteria for Full or Partial Remission of Opioid Dependence. Furthermore, patient factors potentially critical for treatment success
(e.g., attitudes towards buprenorphine and average buprenorphine dose while in treatment) will be examined to determine their importance in
influencing treatment outcomes. Moreover, both patient and staff attitudes and average buprenorphine dose will be evaluated to determine their
respective relationships to treatment experiences and treatment retention. Significance, Innovation and Public Health Impact: This study is significant
because it will examine the comparative effectiveness of two common counseling approaches offered with buprenorphine in clinics treating large
numbers of African Americans, a population with significant need and limited access to this type of effective treatment. Study findings may help to
expand the availability of buprenorphine to African Americans, inform providers and policymakers regarding the relative benefits of two levels of
intensity of counseling, and inform the field regarding factors associated with optimal buprenorphine utilization and program retention. The use of the
DSM-IV criteria for remission as a one of the outcome measures represents an important augmentation of the usual drug abuse research outcome
measures, which usually rely primarily upon urine testing results and self-reports of drug use as the primary outcome measure and do not take into
account drug- related reductions in clinically significant impairment or distress, despite some continued intermitted drug use. Public Health Statement
This study will examine the comparative effectiveness of two common counseling approaches offered with buprenorphine in clinics treating large
numbers of African Americans, a population with significant need and limited access to this type of effective treatment which reduces drug use and
HIV-risk. Study findings may help to expand the availability of buprenorphine to African Americans, inform providers and policymakers regarding the
relative benefits of two levels of intensity of counseling, and inform the field regarding factors associated with optimal buprenorphine utilization and
program retention.
Residential treatment is one of the most desirable modalities offered in any treatment system. Yet it is also one of the most costly, and its benefits are
limited if not followed reliably by continuing aftercare in an outpatient program. This services research project will examine the comparative
effectiveness of three evidence-based interventions for improving historically low rates of successful transition from residential to outpatient care. The
project takes place within the treatment service delivery system of Baltimore City and represents a collaboration between Johns Hopkins University
SOM, the Mid Atlantic Node of the National Drug Abuse Treatment Clinical Trials Network (CTN) and Baltimore Substance Abuse Systems (BSAS),
the Substance abuse authority for the City of Baltimore. The interventions to be examined are a) Transportation Escort that delivers residential clients
to the door of the outpatient referral program on the day of discharge, b) Client Transition Incentive that offers a financial incentive to clients who
successfully enroll in outpatient aftercare and c) Residential In-reach that arranges. orientation visits by outpatient staff who visit referral clients at the
residential program. These enhanced interventions will be compared with a usual care control condition in which no special intervention is in place.
Using a Latin Square cross-over design than maximizes external validity, treatment conditions will be in place during 6-week intervals of time in a predetermined sequence during the 2-year project. Primary outcome measure will be the percent of referred clients who are admitted to an outpatient
aftercare program within 30 days of residential discharge. Length of stay in the outpatient program will also be examined as a function of transition
interventions as a secondary outcome. Overall, the project will provide valuable new data that can be used by policy makers to select treatment
transition options that will maximize continuity of care within a drug abuse treatment services delivery system.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): To distinguish between the parent R01 grant and the competitive revision
(CS), information relevant to the parent grant is shown in standard text format. Information relevant to the competitive supplementary revision (CS) is
shown in italics. The current application is submitted in response to NOT-OD-09-058 ('NIH Announces the Availability of Recovery Act Funds for
Competitive Revision Applications'). The parent grant (R01DA026091-01; 'Computer vs. Therapist-Delivered Brief Intervention for Drug Abuse in
Primary Care') was funded 9/08 in response to DA 08-021 (SBIRT in medical settings). Briefly, the rationale and methods for the parent study are as
follows: The vast majority of persons with substance use disorders go undetected and untreated. Proactive screening, brief intervention, and referral
for treatment approaches (SBIRT) have tremendous potential for identifying and influencing undetected substance abuse, but efforts to incorporate
them in the community have met with substantial obstacles related to training, time, costs, and acceptance. Computer-delivered approaches, on the
other hand, are a promising alternative and merit serious consideration, as they have shown beneficial effects on substance use outcomes (e.g.,
Hester et al., 2005; Ondersma, Svikis & Schuster, 2007). These approaches also have tremendous advantages in terms of replicability, accessibility,
and cost. The parent R01 grant identifies primary care patients at risk for heavy/problem alcohol and drug use through a 15-minute, computerdelivered health screen (Health Cheq) that queries patients about nutrition, exercise, sleep and mood as well as alcohol, tobacco and other drug use.
Persons who screen at risk for heavy/problem substance use and provide informed consent (N=680) are randomized to one of 4 groups: computerdelivered health screen alone (standard care, SC), assessment only (CA), assessment plus computer-delivered brief motivational intervention (CACI),
or assessment plus therapist-delivered brief motivational intervention (CATI). Outcomes (substance use via self- report and urine toxicology) are
compared at 1, 3, and 6 months post-randomization. A sophisticated economic analysis will also be performed to compare costs for computer and
counselor-delivered interventions. The impetus and rationale for the competitive supplementary revision (CS) are as follows: While the computerdelivered Health Cheq screens for tobacco use, the parent grant does not specifically target cigarette smoking for intervention. This was disappointing
to clinicians in the target clinic who report that over one-third (35%) of their patients smoke cigarettes and little is currently being done to address this
problem. Smoking harms nearly every organ of the body, causing many diseases and reducing the health of smokers in general (Surgeon General's
Report, 2004). The 2008 Practice Guidelines for Treating Tobacco Dependence identifies the 5 A's (Ask, Advise, Assess, Assist, Arrange) as the most
promising practitioner-delivered intervention. As with SBIRT above, however, numerous barriers to incorporating the 5 A's intervention into routine
Total Cost
$479,911
$612,385
Project Number
2
1R01DA023091-01A2
Project Title
DRUG ABUSE, CRIMINAL
JUSTICE SYSTEM INVOLVEMENT
& HEALTH DISPARITIES IN
YOUTH
Principal Investigator
WU, PING
Performing
Organization
NEW YORK STATE
PSYCHIATRIC INSTITUTE
Abstract
clinical practice have been reported (Fiore et al., 2008). This competitive supplement (CS) makes convenient use of the infrastructure already in place
through the parent grant to collect benchmark data on the effectiveness of a computer-delivered 5A's intervention for cigarette smoking. The
computerized 5A's intervention already exists for prenatal smoking (R21, Ondersma & Svikis). With minor revisions it can be studied in the competitive
supplement project. Specifically, the proposed research will compare 1- and 3-month smoking cessation rates in medical patients (N=380) randomized
to the computer-delivered 5A intervention or a screening + resource information control group. The CS proposal will not only provide additional
employment opportunities for research assistants, it will also increase the rate and number of subjects recruited for the parent grant and provide
greater power for secondary analyses. Most importantly, it will inform the field about the efficacy of a computer-delivered 5 A's intervention with both
clinical and economic analyses. If outcomes are comparable to those reported in previous practitioner-delivered research, the practical and economic
implications of its use will be significant and should ultimately reduce tobacco mortality and morbidity rates in this country. PUBLIC HEALTH
RELEVANCE: Although a physician-delivered 5A's approach to smoking cessation is considered the 'gold standard' among researchers, the extent to
which this intervention has been adopted in routine practice settings is sadly lacking. This competitive supplement will collect benchmark data on
smoking cessation rates when the 5A's intervention is delivered entirely via computer-based technology. If outcomes are comparable to those reported
in the 2008 practice guidelines for tobacco cessation and better than those found in standard care, the findings would have major practical and
economic implications, ultimately assisting more patients in their efforts to stop smoking. This CS interfaces perfectly with the parent R01, which
targets heavy/problem alcohol and/or drug use and compares 2 greatly simplified, computer-based approaches to screening and brief intervention to a
more traditional, counselor-delivered MI intervention. If one or both of the computer-based approaches yields outcomes comparable to the usual
counselor-delivered approach, the simplicity of the computer-based technology would make treatment available to many more persons with drug or
alcohol problems as well.
DESCRIPTION (provided by applicant): The current application is the second revision of our application responding to Program Announcement PA07-114. Our proposed study will examine substance abuse, juvenile/criminal justice system involvement and health disparities in youth, focusing on
comparisons between African American and White youth. African Americans comprise about 12% of the US population, but they represented almost
half of the prison population in 2004. Increases in arrests for drug offenses have accounted for nearly one third of the growth of the African American
inmate population in recent decades. However, findings from national community surveys have shown that rates of substance use and abuse in
African Americans are similar to those of Whites. Also, studies have shown that African Americans are less likely to receive adequate treatment for
substance use related problems. There is a need to understand racial/ethnic disparities related to juvenile/criminal justice system involvement,
substance use and access to treatment for substance use related problems. The proposed project utilizes data from three nationally representative
surveys of youth: (1) a large community sample with information on criminal justice system involvement histories, substance use/abuse/dependence,
and use of substance treatment services; (2) a longitudinal (7-year) survey of youth covering substance use, delinquent behaviors, juvenile/criminal
justice system involvement and risk factors at the individual, family and community levels; and (3) a large, nationally representative sample of youth in
placement in Juvenile Justice facilities. Study aims: (1) To examine rates of Juvenile/Criminal Justice System involvement among youth, especially
among those with substance use or abuse/dependence, comparing African American and White youth, and identifying factors which may partially
explain the differences between the two groups; (2) Using longitudinal data, to examine racial/ethnic differences in the relationship between substance
use and juvenile/criminal justice involvement, including the role of substance use in pathways to criminal justice involvement from adolescence to
young adulthood, as well as the impact of criminal/juvenile justice system involvement on subsequent changes in patterns of substance use; and (3)
To examine differences in the types of treatment received for substance use related problems by African-American and White youth with
juvenile/criminal justice system involvement, and identify barriers to use of treatment services faced by African-American youth with juvenile justice
system involvement. Public Health Relevance: Given that African American youth are disproportionately represented among juvenile and adult
arrestees and prisoners/detainees, especially for drug offenses, and that treatment services for substance use related problems for people involved in
the criminal/juvenile justice system tend to be lacking or inadequate, there is a great need to understand the racial/ethnic disparities related to
juvenile/criminal justice system involvement, substance use and access to treatment for substance use related problems. The proposed study will
examine these racial/ethnic disparities in terms of the dynamic longitudinal relationship between substance use and juvenile/criminal justice system
involvement, and in terms of access to treatment services for substance use related problems, from a public health perspective.
Total Cost
$375,071
National Institute on Nursing Research (NINR)
3R01NR008800-04S1
65
A FAMILY PARTNERSHIP
INTERVENTION FOR HEART
FAILURE
DUNBAR, SANDRA B.
EMORY UNIVERSITY
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators.DESCRIPTION (provided by applicant): Self-management behaviors required for persons with heart failure (HF) are
multifaceted and include initiating and maintaining a reduced sodium diet and implementing a complex medication regimen. Adherence to these
behaviors is poor, and nonadherence accounts for a large percentage of HF hospital readmissions and health services use. Because performance of
these behaviors occurs in the family context and is influenced by family activities and habits, a family approach to improve self-management behaviors
has great promise. This study will evaluate the incremental effect of a family-focused intervention over a structured patient-family education program
and usual care for persons with heart failure. The study will examine whether adding a family partnership intervention (FPI) based on autonomy
support theory improves dietary and medication-taking self-management behaviors over a structured patient family education program or usual care. A
randomized three group repeated measures design will be used to enroll HF patient-family member dyads (n=262). The FPI Intervention will be
delivered in the outpatient setting in a group format, and patient-family education and data collection will occur in the General Clinical Research
Center. Patient variables and measures are dietary sodium (24-hour urinary sodium), medication adherence to HF drugs including angiotensin
converting enzyme inhibitors and diuretics (Medication Event Monitoring System), heart failure severity (brain natriuretic peptide levels), functional
ability (6 minute walk distance), HF patient depressive symptoms (Beck Depression Inventory II), and perceived quality of life (Minnesota Living with
Heart Failure Questionnaire). Data will be obtained at baseline, and 4 and 8 months. Family member variables include depressive symptoms (Beck
Depression Inventory-II) obtained at baseline, 4 and 8 months. Secondary aims will examine health resource utilization (hospitalizations, emergency
department or provider contacts) over the 8 months and patient and family member perceived autonomy support. Baseline measures of clinical (NYHA
$424
Project Number
2
Project Title
Principal Investigator
Performing
Organization
1R21NR011332-01
PPM-PREP: PEER-MENTORED
PREPAREDNESS FOR ADULTS
WITH DEVELOPMENTAL
DISABILITIES
EISENMAN, DAVID PAUL
UNIVERSITY OF
CALIFORNIA LOS
ANGELES
1RC1NR011710-01
A VISION OF HOPE:
INTEGRATION OF PALLIATIVE
CARE IN CHRONIC PEDIATRIC
DISEASES
GELLER, GAIL
;RUSHTON, CYNDA H.
JOHNS HOPKINS
UNIVERSITY
66
Abstract
Class, left ventricular ejection fraction, comorbidities), sociodemographic, and general family functioning variables will be obtained for sample
description and use as covariates in hypothesis testing. Repeated measures models will be used to test the hypotheses of group differences in
adherence and quality of life, physical and psychological outcomes over time controlling for pertinent clinical and sociodemographic variables. This
study will test whether a cost-effective, theoretically-based, nurse managed autonomy support intervention provides an incremental effect over
structured patient-family teaching and usual care in improving patient and family outcomes. This study will provide data upon which future clinical
practice guidelines can be based and will establish priorities for patient care according to which interventions are linked to improved self-management
behaviors. Greater understanding of the relationships among family functioning, self management behaviors, psychological and physical outcomes,
and health resource utilization are important for future studies and evaluation of clinical practice with HF patients.
DESCRIPTION (provided by applicant): The overall goal of this proposed study is to develop and pilot test a disaster preparedness intervention
targeting adults with a developmental disability, such as mental retardation, epilepsy, cerebral palsy or autism, who are living independently in the
community (ADD). While this population is growing and increasingly relocating into the community, scant empirical research has been conducted to
reduce their disaster-related health consequences. A community-academic partnership between UCLA and the Westside Regional Center (WRC), an
LA based service provider for ADD, proposes a two-phase, community-based participatory research study. The aims are to: 1) identify barriers and
facilitators to disaster preparedness among ADD living independently in the community (Phase 1); and 2) pilot test a disaster-preparedness
intervention for ADD living independently in the community to determine feasibility and effect size (Phase 2). The intervention builds upon studies the
partners conducted on disaster preparedness and developmental disabilities. The Principal Investigator developed a disaster preparedness
intervention (PREP) and demonstrated its efficacy with Latino immigrants. WRC showed that peer mentors can effectively conduct health promotion
for ADD. In Phase I of the proposed study, findings from focus groups of ADD will be used to tailor PREP for ADD. In Phase 2, a health educator and
peer mentors will deliver the modified intervention, PM-PREP (Peer Mentored PREP) in six-11/2 hour sessions held at the WRC. PM-PREP will build
upon Social Cognitive Theory and the Theory of Planned Behavior. Pilot testing of PM-PREP will employ a two-group, pre-test/post-test design with a
sample of 40 ADD who receive the intervention and a wait-list control group (n=40). Participants will be evaluated at baseline and one-month postintervention. Data will be collected using a standard preparedness checklist modified for this population with pictures of each item. Data analysis will
include descriptive statistics for preparedness assessments, attendance rate, demonstrated knowledge and structured observation measures. Logistic
regressions will evaluate treatment effects for single preparedness items and linear regression will evaluate the treatment effect of a combined
preparedness score. This proposed study fills a gap in disaster preparedness and innovatively applies peer-mentored health promotion to the disaster
research field. The peer-mentor model is theoretically sound because consumers view peers as well equipped to provide support to those facing
similar life experiences and health barriers. Study results will guide development of a future RO1 proposal that could contribute knowledge about the
effectiveness of peer-mentor interventions with ADD generally, improve disaster preparedness with ADD specifically, and reduce disaster-related
disparities in this vulnerable population. This proposal responds to PA 06-452, 'Behavioral and Social Research on Disasters and Health' and NINR's
interest in 'interventions to enhance preparedness...in those with disability' and 'interventions to assist caregivers of ill and disabled persons to prepare
for...disaster situations.' PUBLIC HEALTH RELEVANCE: Persons living with a disability are a vulnerable group experiencing disproportionate risks
from disasters, disparities in access to preparedness, relief and response programs, and scarce empirical research to guide programs aiming to
reduce their disaster-related health consequences. This project will determine the feasibility and effect size of a peer mentored intervention to improve
disaster preparedness of adults with a developmental disability who are living independently in the community. Lessons learned will lend support for
rigorously testing this intervention in broader samples.
DESCRIPTION (provided by applicant): Under the broad challenge area (04) Clinical Research, this proposal is directly responsive to the following
specific challenge topic: 04-NR-102* Methods to Enhance Palliative Care and End-of-Life Research This initiative will develop and test interventions to
enhance the quality of care for persons with a life-threatening illness. This research will provide the foundation for the development of evidencedbased guidelines to standardize palliative and end-of-life care. Children, adolescents and young adults are not supposed to get seriously ill or die, but
when they do, their lives and their families are forever changed. In addition to the physical challenges faced by young people with chronic, lifethreatening diseases, the unpredictability and life- limiting nature of many of these diseases raise significant emotional, spiritual and social difficulties
for affected individuals and their families, and create special challenges for the health care team. Too often, a fragmented health care delivery system
and lack of support systems add to the distress. These challenges are particularly salient in the context of diseases that, at least currently, have no
curative treatments. The absence of a cure can result in a loss of hope. This proposal is designed to improve the quality of care, and instill a new
vision of hope, for adolescents, young adults and families affected by chronic, life-threatening diseases by integrating the principles and practices of
palliative care into the training of the clinicians who care for them. This project is specifically focused on two genetic conditions, Duchenne Muscular
Dystrophy (DMD) and Sickle Cell Disease (SCD). Although there are significant differences between these conditions, both are life-threatening and
life-limiting and are therefore highly amenable to palliative care. Improved technologic and medical interventions have significantly increased the life
expectancy of affected individuals but this has created new challenges with regard to transitioning patients from pediatric to adult care clinicians and
settings. The specific aims of our project are to (1) understand the lived experiences and unmet needs of adolescents and young adults with these
chronic, life-threatening diseases, and the impact of caring for these populations on interdisciplinary teams of clinicians; and (2) enhance the
integration of palliative care principles and practices through the training of interdisciplinary professionals, patients and families. We will accomplish
these aims in three phases. First, we will develop and/or modify documentary training videos based on interviews with patients, families and the
clinicians who care for them. Second, we will adapt an existing training program that incorporates palliative care principles in the delivery of care for
these two populations. Finally, we will compare/assess the efficacy of two different training interventions in improving clinician attitudes and behaviors,
and patient experiences, with respect to several components of palliative care. This project is likely to have significant impact on reducing the
attitudinal and systemic barriers to the integration of comprehensive palliative care. Our results will inform the refinement of educational and practice
guidelines with regard to the integration of palliative care principles into DMD and SCD care as well as its application to other life-limiting chronic
conditions, and result in long term improvements in the delivery of quality health care for young people with chronic disease. This proposal is designed
Total Cost
$150,091
$498,981
Project Number
2
Project Title
Principal Investigator
Performing
Organization
3R21NR011187-02S1
A PATIENT-CENTERED
STRATEGY TO REDUCE
DIABETES DISPARITIES IN
CHINESE AMERICANS
IVEY, SUSAN LEE
UNIVERSITY OF
CALIFORNIA BERKELEY
1RC1NR011647-01
COMMUNICATION IN LATESTAGE CANCER: EXPLORING
HOSPICE DECISION
WALDROP, DEBORAH
PEASE
STATE UNIVERSITY OF
NEW YORK AT BUFFALO
CROWLEY, REBECCA S
UNIVERSITY OF
PITTSBURGH AT
Abstract
to improve the quality of care, and instill a new vision of hope, for adolescents, young adults and families affected by Duchenne Muscular Dystrophy
(DMD) and Sickle Cell Disease (SCD), two of the most common chronic, inherited, life- threatening diseases, by integrating the principles and
practices of palliative care into the training of the clinicians who care for them.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. Project Summary/Abstract The number of adults with diagnosed diabetes in the US increased 61% from 1991 to
2001 and will double by 2050. Diabetes is the sixth most common cause of death, causing cardiovascular and kidney disease, blindness, and lower
limb amputations. Improved disease management can reduce morbidity and mortality from diabetes. Unfortunately, diabetes patients, especially
immigrants and minorities, often do not receive recommended levels of care, indicating a critical need for developing culturally-appropriate and
effective strategies that can be incorporated into existing medical practices. Diabetes has emerged as a new epidemic across the US and diabetes
rates are growing faster among Asian Americans and Pacific Islanders than in any other racial/ethnic group. In particular, diabetes rates for Chinese
are higher in the US than in native countries, and rates have been demonstrated to increase with acculturation. Approximately 15% of Chinese are
diagnosed with diabetes, ~ 2.5 times higher than in the general U.S. population (5.9%). Also, Chinese American diabetes rates are 5 to 7 times higher
than in their native countries. However, there continues to be alack of support for national, community and academic efforts to collect Chinese
diabetes data. This may be related to the relative lack of political influence and the model minority myth among Chinese Americans. This proposed
project is a community-academic collaboration between Asian Health Services (AHS), the Association of Asian Pacific Community Health
Organizations, and the University of Calilfornia, Berkeley that includes a Chinese American community advisory board consisting of Chinese diabetics,
family members, providers, and advocates that are engaged in all phases of the project. It will assess whether a multi-level pilot team care
intervention, incorporating culturally and linguistically-proficient clinical care, family education, and community promotion, is feasible, effective, and
affordable for improving diabetes care and outcomes compared with usual care model among underserved Chinese Americans at AHS. 74% of
patients at AHS are Chinese, 67% of patients are at or below 100% federal poverty level and 86% are best served in a language other than English.
Data will be analyzed using qualitative and quantitative techniques. A particular strength of this project is that it will build on an existing collaborative,
the Diabetes Care Initiative, that was started by Chinese patients and providers at AHS, a safety net federally qualified health center, in Alameda
County, California. This community-based collaborative seeks to increase patient-centered care and to promote healthy dietary and physical activity
behaviors in Chinese diabetics. Ultimately, it aims to promote healthy behaviors among Chinese diabetics, their family members, and the community
at-large to prevent adverse diabetes outcomes and prevent new diabetes cases in Alameda County and beyond. Project Narrative: This project was
started up by Chinese diabetes patients and doctors at a clinic, because diabetes has become a big issue for Chinese people. The clinic's patients,
their families, and doctors will work with local researchers to find ways to improve diabetes care in the clinic and to help educate patients and their
families.
DESCRIPTION (provided by applicant): Communication in Late-stage Cancer: Exploring Hospice Decisions This application addresses broad
Challenge Area (04): Clinical Research and specific Challenge Topic, 04-NR-103*: Methods to Enhance Palliative Care and End-of-Life Research.
Estimates indicate that 388,322 people over age 65 died from cancer in 2005 and that almost 60% of all newly diagnosed malignant tumors and 70%
of all cancer deaths occur in this age group.2,9 People who are age 65 or older are 10 times more likely to be diagnosed with cancer and 15 times
likely to die from it than are people under age 65.10 Cancer of the pancreas, stomach, rectum, lung, leukemia, non-Hodgkin's lymphoma, liver, kidney,
and ovarian cancers account for two-thirds to three-quarters of cancer deaths in older adults.10 Each cancer trajectory is unique and distinct, being
influenced by numerous factors which include: the type of cancer, its lethality and stage at diagnosis, the available treatment and its side effects, all
coexisting comorbid conditions, the person's age, and the nature of communication with providers and family members.11 Each type of cancer is
accompanied by different symptom clusters which shape and influence the lived experience of cancer and are likely to inform communication and
decision-making about the utilization of services such as home care and hospice. While 44% of all hospice patients have cancer and four out of five
are over age 65, many older cancer patients only utilize hospice for short periods of time or decline it altogether. The overall purpose of this study is to
explore and describe how, when and with whom, older cancer patients communicate their concerns and needs for care during the advanced stages of
the illness and compare the decision-making and service utilization of cancer patients who have enrolled in hospice with those who have not.
Specifically the study aims to: 1. Explore the factors that contribute to older cancer patients' decisions about service utilization and the timing of their
decisions; 2. Compare decision-making and service utilization patterns of older cancer patients who are enrolled in hospice with those who are not 3.
Determine how decision-making about service utilization is different relative to the type of cancer and its trajectory; 4. Explore family caregivers' roles
in decision-making. This exploratory descriptive study will employ a sequential mixed methods design involving multiple types of data which will be
linked for the purpose of developing complementarity between the overlapping perspectives of cancer patients and their caregivers. Data will be
collected through in-depth interviews which will include a combination of open-ended and categorical questions as well as standardized measures.34
The rationale for using mixed qualitative and quantitative data is to generate a deeper understanding of the complexities of hospice decision making.
The results will provide information about clinical decisions in 'real time' by gathering the experiences of cancer patients and their families in their own
words. Guided by a 7 stage framework of decision-making32, participants will be asked about how and when they chose the services they are using.
The resulting descriptive profile will contribute to a deeper understanding of how older people talk about and decide to seek care during in advanced
cancer. The results of this study are relevant to public health in three ways. (1) Understanding how older people comprehend, perceive and
experience advanced cancer and the availability of services at life's end has direct relevance to quality of life in advanced cancer. (2) Exploring
decision-making about hospice enrollment or declination and the timing of that decision will inform healthcare providers about communication with
older cancer patients and their families. (3) Understanding how end-of-life decisions are made is essential for the efficient planning and delivery of
comprehensive services for the growing number of adults who will die from cancer.
Total Cost
$18,374
$230,937
National Library of Medicine (NLM)
3T15LM007059-23S1
67
PITTSBURGH BIOMEDICAL
INFORMATICS TRAINING
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. The University of Pittsburgh proposes a five-year renewal of its training program in Biomedical Informatics. This
$1,041,647
Project Number
2
Project Title
Principal Investigator
PROGRAM
Performing
Organization
PITTSBURGH
3T15LM009462-03S1
SYSTEMS ENGINEERING FOCUS
ON CLINICAL INFORMATICS
GUERLAIN, STEPHANIE A
UNIVERSITY OF VIRGINIA
CHARLOTTESVILLE
1RC1LM010512-01
IMPROVING CHILDHOOD
IMMUNIZATION COMPLIANCE
USING ELECTRONIC HEALTH
RECORDS
MILLER, MARLENE
ROSEMARY
JOHNS HOPKINS
UNIVERSITY
1RC2LM010798-01
DEVELOPMENT OF A
STATEWIDE MASTER PERSON
INDEX
NARUS, SCOTT P
UNIVERSITY OF UTAH
68
Abstract
program has grown significantly since its inception in 1987. It currently has 40 trainees, 12 of whom are supported by the training grant. Trainees seek
academic degrees through one of two programs. The majority of students obtain degrees through the Biomedical Informatics (BMI) Training Program,
which is offered through the School of Medicine. Most trainees study in the general BMI degree track. In addition, the program has concentrations in
bioinformatics, dental informatics, health services research, library informatics, and public health surveillance for trainees with those special interests.
Students with a special interest in artificial intelligence in medicine can obtain degrees through the Biomedical Informatics track of the Intelligent
Systems Program (ISP). Both the BMI Training Program and the ISP offer M.S. and Ph.D. degrees. The BMI Training Program also offers a one-year
Certificate option. Since the BMI and ISP training programs are tightly linked and coordinated through their faculty and staff, for brevity we refer to
them as one program below. Graduates of the program are finding excellent employment opportunities. The program is supported by an
interdepartmental core faculty with 30 members, all of whom are experienced educators and active researchers. It is administered through the
University's Center for Biomedical Informatics (CBMI), which provides administrative support, space, and equipment for the trainees. A tightly knit
leadership/administrative group of two co-directors and three very experienced staff members supports the program director in the overall operation of
the program. We request 19full-time funded training positions per year for the period 2007-2012, which maintains the current number of library
informatics trainees at two, maintains the number of dental informatics trainees also at two, and increases the number of 'uncategorical' positions from
11 to 15. We are requesting this increase in positions in anticipation of CBMI becoming a Department of the Biomedical Informatics (DBMI) in
2006,leading to the hiring of five new faculty members over the next five years. The larger DBMI faculty will be able to provide mentoring for the
requested increase in NLM-funded trainees. We will continue to recruit students with a wide range of backgrounds and interests, with a special
emphasis on recruiting trainees from disadvantaged backgrounds.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. The goal of this training program is to bring systems engineering students and faculty into the healthcare field
through the discipline of clinical informatics, which we believe is a natural fit, and to break down the barriers between systems engineering and
healthcare research through close collaboration over common research goals. The National Academy of Engineering (NAE) and Institute of Medicine
(IOM) 2005 report entitled 'Building a Better Delivery System: A New Engineering/Health Care Partnership' identified system failures in current
healthcare delivery and recommended an interdisciplinary approach to solving these problems based on information technology and systems
engineering (SE). It identified key barriers to this strategy, including differences between the healthcare and engineering disciplines in 'methods,
metrics, values and mind-sets.' We propose a new strategy for research training in clinical informatics responding directly to the problems identified in
the report. This strategy builds on existing successful collaborations between the Department of Systems and Information Engineering in the School of
Engineering and Applied Science at the University of Virginia (UVa) and several units in UVa's School of Medicine, including the Division of Clinical
Informatics in the Department of Public Health Sciences. Our program creates PhD and postdoctoral training opportunities designed to attract students
and established researchers from other fields to address challenging clinical informatics questions. The program inherits a framework from the existing
substantial SE graduate program, with unique curricular and research components. The core curriculum includes formal introductions to clinical
informatics, SE, and the structure and operation of healthcare delivery systems. Subsequent alternative tracks for training include human-automation
interaction, computational statistics and simulation, risk and decision analysis, systems integration, and optimization and control. Research projects
are collaborative, with trainees having both healthcare and engineering mentors as they conduct research using systems engineering and medical
informatics approaches applicable to improved healthcare delivery and training. We anticipate that this collaborative approach to training will lead to
fundamental advances in clinical informatics with a trained set of researchers who will continue to develop the field, thereby addressing the needs
articulated by the NAE and IOM.
DESCRIPTION (provided by applicant): The title of this project is Improving Childhood Immunization Compliance Using Electronic Health Records.
This application addresses broad Challenge Area (05) Comparative Effectiveness Research and specific Challenge Topic, 05-LM-103: Improving
Compliance of School Children with Immunization Schedules. While immunizations are routinely cited as the most valuable pediatric preventive
service, fewer than half of children receive all recommended immunizations on time. In addition, the National Healthcare Disparities Report
consistently demonstrates substantial racial, ethnic, and socioeconomic disparities in childhood immunization delivery. The overall goal of the
proposed research is to improve the entire spectrum of school-aged childhood immunization rates among a predominantly African American, inner city
population, utilizing and comparing 2 interventions: 1. an automated Electronic Health Record-derived provider-specific performance feedback report,
and 2. automated Electronic Health Record-derived trigger alerts when patients in need of immunizations present to clinic. Successful completion of
this project will inform the National Institutes of Health, providers, patients, payers, policymakers and the public how to maximize the impact of
electronic health records to improve immunization rates among school-aged children. Results of this study will add important new knowledge to the
field regarding whether and how electronic health records can be used to improve immunization rates among school-aged children. These findings can
be applied to narrow the gap between evidence and practice in terms of completion rates for school-aged childhood immunizations. The overall goal of
the proposed research is to improve the entire spectrum of school-aged childhood immunization rates among a predominantly African American, inner
city population, utilizing and comparing 2 interventions: 1. an automated Electronic Health Record-derived provider-specific performance feedback
report, and 2. automated Electronic Health Record-derived trigger alerts when patients in need of immunizations present to clinic. Successful
completion of this project will inform the National Institutes of Health, providers, patients, payers, policymakers and the public how to maximize the
impact of electronic health records to improve immunization rates among school-aged children. .
DESCRIPTION (provided by applicant): Our goal is to create a Master Person Index (MPI) that unambiguously identifies each individual who receives
health care in the State of Utah. This index will enable qualified clinical and translational research to be performed in an environment with unique
attributes: (1) over 80% of all patient care in the State is supplied by three providers, and these encounters (ambulatory and in-patient) are recorded
electronically; and (2) extensive experience unmatched in other states of creating a research infrastructure (the Utah Population Database) that
provides a demographic and familial description for much of the population of Utah and that is linked to corresponding medical data. We propose to
create the technology and policies for a statewide MPI in order to satisfy the critical need to link records across disparate institutions. Each MPI entry
Total Cost
$350,890
$397,606
$1,302,194
Project Number
2
Project Title
Principal Investigator
Performing
Organization
Abstract
Total Cost
will contain only enough information to uniquely identify an individual and map that individual to original data sources. While the MPI will not contain
encounter-specific information, it will provide the capability for qualified investigators to link institutional records into patient-specific longitudinal health
histories. The outcome of this proposal will be a unique research infrastructure but with strategies and methodologies that can be adopted as a model
for other institutions. Its impact would have broad relevance to a variety of research interests supported by NIH Institutes and Centers. To address the
challenge of securely and confidentially linking records across disparate institutions, we will establish a statewide Master Person Index that includes a
master repository (database) of demographic information from the contributing institutions, and the services surrounding the repository to allow
authorized access. We will establish guidelines to ensure institutions the ability to contribute to, use, and safeguard the statewide MPI. We will
investigate and implement methods for matching and merging records. We will demonstrate the ability of health care and public health institutions to
add new records to the MPI, update existing records, and query the repository for links to corresponding person-records at other institutions. We will
utilize the State's health information exchange infrastructure to prove extensibility of the system to the statewide environment. We will develop a
governance and financing model that will ensure the long-term viability of the statewide MPI. The outcome of this proposal will be a unique research
infrastructure but with strategies and methodologies that can be adopted as a model for other institutions. PUBLIC HEALTH RELEVANCE: A
statewide MPI will satisfy the critical need to link records across disparate institutions in order to provide the capability for qualified investigators,
clinicians and public health officials to link institutional records into patient- specific longitudinal health histories. The development of this critical
resource will have a significant statewide impact on the entire population of the Utah for research, clinical and public health outcomes. We also
anticipate a national impact because of our goal to provide MPI guidelines and methodologies that could be adopted by other states and regions, and
because use of the MPI will facilitate studies with broader applicability of research results.
Office of the Director (OD)
3R01NR008800-04S1
A FAMILY PARTNERSHIP
INTERVENTION FOR HEART
FAILURE
DUNBAR, SANDRA B.
EMORY UNIVERSITY
3R21HL084528-03S1
EFFECT OF PARAMEDIC AIRWAY
EXPERIENCE ON PATIENT
OUTCOMES
WANG, HENRY E
UNIVERSITY OF ALABAMA
AT BIRMINGHAM
69
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators.DESCRIPTION (provided by applicant): Self-management behaviors required for persons with heart failure (HF) are
multifaceted and include initiating and maintaining a reduced sodium diet and implementing a complex medication regimen. Adherence to these
behaviors is poor, and nonadherence accounts for a large percentage of HF hospital readmissions and health services use. Because performance of
these behaviors occurs in the family context and is influenced by family activities and habits, a family approach to improve self-management behaviors
has great promise. This study will evaluate the incremental effect of a family-focused intervention over a structured patient-family education program
and usual care for persons with heart failure. The study will examine whether adding a family partnership intervention (FPI) based on autonomy
support theory improves dietary and medication-taking self-management behaviors over a structured patient family education program or usual care. A
randomized three group repeated measures design will be used to enroll HF patient-family member dyads (n=262). The FPI Intervention will be
delivered in the outpatient setting in a group format, and patient-family education and data collection will occur in the General Clinical Research
Center. Patient variables and measures are dietary sodium (24-hour urinary sodium), medication adherence to HF drugs including angiotensin
converting enzyme inhibitors and diuretics (Medication Event Monitoring System), heart failure severity (brain natriuretic peptide levels), functional
ability (6 minute walk distance), HF patient depressive symptoms (Beck Depression Inventory II), and perceived quality of life (Minnesota Living with
Heart Failure Questionnaire). Data will be obtained at baseline, and 4 and 8 months. Family member variables include depressive symptoms (Beck
Depression Inventory-II) obtained at baseline, 4 and 8 months. Secondary aims will examine health resource utilization (hospitalizations, emergency
department or provider contacts) over the 8 months and patient and family member perceived autonomy support. Baseline measures of clinical (NYHA
Class, left ventricular ejection fraction, comorbidities), sociodemographic, and general family functioning variables will be obtained for sample
description and use as covariates in hypothesis testing. Repeated measures models will be used to test the hypotheses of group differences in
adherence and quality of life, physical and psychological outcomes over time controlling for pertinent clinical and sociodemographic variables. This
study will test whether a cost-effective, theoretically-based, nurse managed autonomy support intervention provides an incremental effect over
structured patient-family teaching and usual care in improving patient and family outcomes. This study will provide data upon which future clinical
practice guidelines can be based and will establish priorities for patient care according to which interventions are linked to improved self-management
behaviors. Greater understanding of the relationships among family functioning, self management behaviors, psychological and physical outcomes,
and health resource utilization are important for future studies and evaluation of clinical practice with HF patients.
This award is issued in response to Notice OD-09-060, Recovery Act Administrative Supplements Providing Summer Research Experiences for
Students and Science Educators. DESCRIPTION (provided by applicant): This is a proposal for the NHLBI R21 Innovative Research Grant Program,
which encourages the analysis of existing data sets to explore new hypotheses. Endotracheal intubation (ETI) is the insertion of a plastic tube into the
trachea (throat) to assist the breathing of a patient with a critical illness such as cardiopulmonary arrest, heart failure, respiratory failure or major
trauma. While ETI is performed by physicians in the hospital, resuscitation usually begins in the out-of- hospital setting under the care of paramedics.
In many fields of clinical practice, medical errors are known to be associated with both practitioner procedural volume as well as patient outcome.
Many studies have found that paramedics commit errors when performing ETI. Furthermore in a preliminary study, we found that paramedics perform
ETI infrequently in clinical practice and at frequencies far below that needed to maintain procedural proficiency, safety and effectiveness. Few direct
links between the procedure, success and errors, and patients outcomes (including hospital course or resource utilization) exist. We posit that ETI
performed by paramedics with low procedural experience may adversely affect patient outcome and hospital course of care. The goal of this study is
to determine if paramedic (ETI) procedural experience is associated with patient outcomes and in-hospital course of care. In the proposed study we
will probabilistically link three publicly- available statewide administrative databases encompassing paramedic patient encounters, admitted inpatients
and deaths. We will apply multivariable regression to the linked data set to evaluate the connection between paramedic ETI procedural experience
(annual volume of ETI), outcomes (mortality and in-hospital adverse events) and in-hospital resource utilization. We propose a new collaboration
between research teams at the Universities of Pittsburgh and Utah, which have expertise in the areas of out-of-hospital care, health services research,
the analysis of large-scale data sets and probabilistic linkage. These findings may demonstrate that paramedic ETI experience directly impacts patient
outcome, and may promote major changes in the design and delivery of this life-saving out- of-hospital intervention. These findings would also confirm
$9,803
$4,234
Project Number
2
Project Title
Principal Investigator
Performing
Organization
Abstract
Total Cost
this linkage method as a new, powerful tool to evaluate the earliest portion of acute medical care - that begun in the out-of-hospital setting.
Notes
1
All of the ARRA awards listed in this table were obligated by NIH prior to September 30, 2010. In general this means that project period end dates will be no later than September 29, 2011.
However, all ARRA awards are subject to the standard terms of award as indicated in the NIH Grants Policy Statement, including the authority to extend the final budget period of a previously
approved project period for up to 12 months without additional funds.
2
Projects including a suffix with the letter ‘S’ (e.g. 3D43TW007784-04S1) are supplements, or continuation grants. Additional information regarding the current number or years of support is
available through RePORTER. For more information on the components and meaning of NIH grant numbers, please see: http://www.nimh.nih.gov/research-
funding/grants/research-funding-frequently-asked-questions-faqs.shtml#5
70