Tools for Building Research
Infrastructure at Health Centers
Jonathan N. Tobin, PhD
Clinical Directors Network (CDN)
The Rockefeller University
Center for Clinical & Translational Science (CCTS)
JNTobin@CDNetwork.org
www.CDNetwork.org/Rockefeller
www.Rockefeller.edu/ccts/communityengagement
Presented at NACHC – CHI
August 22, 2013 Chicago IL
CDN:
Past, Present & Future
• An informal network of clinical leaders who practice as
primary care clinicians in low-income and minority
communities
• A research and educational organization
• A means to translate clinical research into clinical practice
Primary Activities
 Practice-based Research




 Clinical Leadership & Sustained Clinician Engagement
 Early & Significant Community Engagement
Education and Training
Quality Improvement
Professional Development
PBRN Research Infrastructure
www.CDNetwork.org
2
Practice-based Research Network (PBRN)
Primary Health Care Safety-net Practices
& Center of Excellence
AHRQ Designated “Center of Excellence” (P30)
For Practice-based Research and Learning (2012)
US Department of Health & Human Services
Regional Health Administrator’s Award
“Outstanding Contribution Toward the
Elimination of Racial and Ethnic
Disparities in Health” (2001)
NIH Roadmap Initiative Designated “Best Practice”
Clinical Research Network (2006)
3
Accelerating
Research Translation
Funded in part by
AHRQ Grant #1 P30-HS-021667
NIH-National Center for Advancing Translational Sciences to The Rockefeller University
(NIH-NCATS Grant #8 UL1 TR000043)
CTSA Administrative Supplement Award (2011) to
The Rockefeller University Center for Clinical and Translational Science (CCTS)
and Clinical Directors Network (CDN)
and by HRSA (CHARN)
www.CDNetwork.org
4
CDN N2-PRN Building a Network of
Safety Net PBRNs
A collaboration among:
Access Community Health Network (ACCESS)
Alliance of Chicago (ALLIANCE)
Association of Asian Pacific Community Health Organization (AAPCHO)
Center for Community Health Education Research and Service (CCHERS)
Clinical Directors Network (CDN)
Community Health Applied Research Network (CHARN)
Fenway Institute (FENWAY)
New York City Research and Improvement Group (NYCRING)
Oregon Community Health Information Network (OCHIN)
Funded by AHRQ Grant: P30 HS 021667
Principal Investigator: Jonathan N. Tobin, PhD
Project Officer: Rebecca A. Roper, MS, MPH
Director, AHRQ PBRN Initiative
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2
N LEARNING COLLABORATIVE
Monthly Webcast Series
 Review Best Practices
 PBRN/CRM Innovations
 Research Methods Trainings
 Design rapid tests and implement pilots (PDSAs)
 Evaluate
 Adopt, Implement, Spread
 Share
Accelerate!
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2
N LEARNING COLLABORATIVE
TRACKS
1.
PBRN Research Management Innovations (for PBRN Senior Staff)
2.
PBRN Methods (for PBRN Senior Staff & Academic Collaborators)
3.
Introduction to Research (for CHC Nodes Staff & New PBRN Staff)
4.
PBRN Study Results (for CHC Nodes, CHC Partners, PBRN Senior
Leadership & Staff, Academic Partners)
933 online viewers to date
Visit: www.CDNetwork.org
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CDN N2-PBRN LEARNING COLLABORATIVE TRACK:
PBRN INTRODUCTION TO RESEARCH
Social Determinants of Health: Important Considerations for Medically Underserved
Community Health Center Patients
Featured PBRN: Association of Asian Pacific Community Health Organizations (AAPCHO)
An Update on Community-Based HIV Prevention Research and Applications
Featured PBRN: The Fenway Institute, Boston MA
Integrating Patient Reported Outcomes into Clinical Care: HIV as a Case Study
Featured PBRN: The Fenway Institute, Boston MA
Introduction to Collaborative Community-based Research
Featured PBRN: National Association of Community Health Centers (NACHC) and
Lutheran Family Health Center (Incubator PBRNs) and Clinical Directors Network Inc.,
(CDN), NY, NY
Funded by: AHRQ; Grant No. 1 P30-HS-021667
Stakeholder Feedback on Community Engaged Research in the CTSA Program
Featured PBRN: Center for Community Health Education, Research and Service (CCHERS)
Friday, August 9, 2013, 2:00-3:00pm EDT
Young African American Men and HIV: An Interactive Response to a Community Health
Issue
Featured PBRN: Access Community Health Network, Chicago, IL
Thursday, June 27, 2013, 12:00-1:00pm EDT
The Bronx Ongoing Pediatric Screening (BOPS) Initiative: Lessons Learned from a Large
Scale Initiative to Enhance Screening in Urban Primary Care
Featured PBRN: New York City Research and Improvement Group (NYC RING)
From Bench to Bedroom: Testing and Translating Behavioral Interventions from
Research into Practice
Featured PBRN: National Association of Community Health Centers (NACHC) (Incubator
PBRN) and Clinical Directors Network Inc., (CDN), NY, NY
Funded by: AHRQ; Grant No. 1 P30-HS-021667
Patient-Centered Medical Home: Using the EMR to facilitate PCMH Transformation
Featured PBRN: Alliance of Chicago Community Health Services
Thursday, Sept 12, 2013, 1:00-2:00pm EDT
Preparing for Meaningful Use Stage 2
Featured PBRN: Alliance of Chicago Community Health Services
Tuesday, July 30, 2013, 2:00-3:00pm EDT
The Research Potential of an EHR-Based Network: Lessons from the OCHIN PBRN
Featured PBRN: Oregon Community Health Information Network (OCHIN)
Funded by: AHRQ; Grant No. 1 P30-HS-021667
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CDN N2-PBRN
Clinical Directors
Network
(CDN)
Lutheran Family
Health Centers
(LFHCs)
Incubator PBRN
+
Community Health Centers
Hospitals
Hudson Brookdale Open Urban
River
Family
Door Health
Health
Care
Family Plan
Care
Center
Health
Center
+
Park
Slope
LFHC
Manhattan
Physician’s
Group –
95th Street
Access Community
Health Network
(ACCESS)
Manhattan
Physician’s
Group 125th Street
Family
Physician
LFHC
South Texas
Ambulatory
Research Network
(STARNet)
+
Kling
Adult
Medicine
Madison
Family
Health
4 PBRNs
12 CHCs
159 Patients
318 Specimens
Trevino
Family
Clinic
University
Health
System
DC Research Collaborative
• National Association of
Community Health Centers (NACHC)
• Clinical and Translational Science
Institute at Children’s National
• George Washington University (GWU)
• Clinical Directors Network (CDN)
• Alexandria Neighborhood
Health Services
• Mission Life Center
• Mary's Center for
Maternal and Child Care
• Unity Health Care
Lutheran Family Health Center (LFHC)
Brooklyn, NY
Research Training for Clinical Leaders
Epidemiology and Statistics
Study Design and Implementation
Grant Writing and IRB
Team Intervention Projects:
• Hepatitis C/HIV Screening
• Childhood and Teen Obesity
• Teen Pregnancy and Contraception
• Diabetes Type II
Lutheran Medical Center
Clinical Directors Network, Inc.
RESEARCH TRAINING FOR CLINICAL LEADERS 2012-2013
Goals:
• To enable practicing clinicians to develop their research interests and skills, through didactics on
the scientific and statistical aspects of study design (quantitative and qualitative) as well as
through hands-on experience in preparing and implementing a research project
• To provide technical assistance in grant-writing and identifying potential funding sources,
including training exercises and assistance in developing budgets, staffing plans, work-scopes,
and timelines
• To develop and provide oral and written research dissemination/presentation skills (scientific,
clinical and lay) at local, regional and national forums
• Co-Directors: Nonkulie Dladla, MD, MS
Lutheran Family HealthCare
Jonathan N. Tobin, PhD
CDN /The Rockefeller University
Center for Clinical & Translational Science
• Facilitator: Maria Dziok, PhD, Clinical Directors Network, Inc. (CDN)
Research Training for
Clinicians Course Goals
• Study Design and Implementation
– To enable practicing clinicians to develop their research interests
and skills, through didactics on the scientific and statistical
aspects of study design as well as through hands-on experience in
preparing and implementing a research project
• Epidemiology and Biostatistics
– To develop and provide oral and written research
dissemination/presentation skills at local, regional and national
forums
• IRB/Human Subjects Protection
– IRB Application
– Informed Consent
• Grant Writing
– To provide technical assistance in grant-writing and identifying
potential funding sources, including training exercises and
assistance in developing budgets, staffing plans, work-scopes, and
timelines
• 60 CME/CNE/CDE Credits for Participation
Study Design and
Implementation
• Developing study questions and interventions
• Calculating sample size
• Identifying dependent and independent variables,
and covariates
•
•
•
•
•
• Patient-centered, clinical, laboratory, public health
Recruiting and retaining patients
Health disparities and cultural competence
Intervention and Fidelity Monitoring
Engaging Stakeholders
Interactive Experiences
• Participated in qualitative research/focus groups
• Participated in the informed consent process
Epidemiology and Biostatistics
•
•
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•
•
•
•
Prevalence and Incidence
Odds Ratio (OR), Relative Risk or Risk Ratio (RR)
Significance Testing, p-values, Confidence Intervals
Validity and Reliability
Bias and Confounding
Types of Analysis
Power, Sample Size, and Effect Size
Sensitivity and Specificity
Using Statistical Software (CDC EpiInfo)
A Review of Types of Study Designs
•
•
•
•
•
•
•
Prevalence/Surveys
Cross-sectional
Retrospective
Case Control
Prospective Cohort
Historical Cohort
Randomized Controlled Trial (RCT)
• Site level (Cluster RCT) vs. patient level
• Comparative Effectiveness Research (CER)
• Patient Centered Outcomes Research (PCOR)
• Qualitative/Focus Group
• Mixed Methods (Qualitative/Quantitative)
A Review of Study Designs
http://sph.bu.edu/otlt/MPHModules/EP/EP713_AnalyticOverview/EP713_AnalyticOverview7.html
Biomedical Informatics
Biomedical Informatics Methods,
Techniques, and Theories
Basic
Research
Applied
Research
Bioinformatics
Molecular
and Cellular
Processes
Imaging
Informatics
Tissues and
Organs
Clinical
Informatics
Individuals
(Patients)
Public Health
Informatics
Populations
and Society
Human Subjects Protection
& IRBs
• Writing an Informed Consent Form
• Conducting Informed Consent Interview (role play)
• Preparing an IRB Application
Grant Writing
•
•
•
•
•
•
Literature searches using PubMed
Patient Centered Outcomes Research Institute (PCORI)
Biosketch development
Drafting Specific Aims, Hypotheses, Analysis Plans
Identifying Funders – Using Foundation Center Resources
Grant development and submission
Primary Text:Recommended
Texts
SB Hulley, SR Cummings et al., Designing Clinical Research:
An Epidemiologic Approach (NY: Lippincott Williams & Wilkins; 2nd Ed.
2001)
Additional/Supplemental Texts & Resources:
• Leon Gordis Epidemiology (Philadelphia PA: Saunders Elsevier, 2009 4th Ed)
• N Krieger Epidemiology for the People (New York NY: Oxford, 2010)
• RS Greenberg, SR Daniels, WD Flanders, JW Eley, JR Boring III Medical
Epidemiology (4th Ed) (New York NY: Lange/McGraw Hill, 2005)
• RM Merrill Introduction to Epidemiology (Boston MA: Jones and Bartlett,
2010, 5th Ed)
• Univ of Pittsburgh - Epidemiology Super Course www.pitt.edu/~super1
• Univ of North Carolina – Epidemiology eText
www.epidemiolog.net
• CDN Clinical Research Track
www.CDNetwork.org
• Rockefeller Webcasts
www.CDNetwork.org/Rockefeller
Building a Stronger Science of Community Engaged Research
Guest Editors:
• Milton Eder, PhD
(ACCESS Community
Health Network)
• Michelle Proser, MPP
(NACHC)
• Peter Shin, PhD
(GWU)
• Jonathan N. Tobin, PhD
(CDN/Rockefeller Univ.)
Sponsors:
• AHRQ
• CDN
• GWU
• NACHC
• RCHN
• HENRY SCHEIN
http://muse.jhu.edu/journals/progress_in_community_health_partnerships_research_education_and_action/toc/cpr.6.3.html
NATIONAL CENTER FOR HEALTH STATISTICS (NCHS)
•
•
•
•
•
•
www.cdc.gov/DataStatistics
www.cdc.gov/nchs/data_access/ftp_data.htm
www.cdc.gov/nchs/dhcs/dhcs_surveys.htm
NATIONAL HOSPITAL DISCHARGE SURVEY (NHDS)
www.cdc.gov/nchs/nhds.htm
NATIONAL AMBULATORY MEDICAL CARE SURVEY (NAMCS)
www.cdc.gov/nchs/ahcd.htm
NATIONAL HEALTH EXAMINATION & NUTRITION SURVEY
(NHANES)
www.cdc.gov/nchs/nhanes.htm
NATIONAL HEALTH INTERVIEW SURVEY (NHIS)
www.cdc.gov/nchs/nhis.htm
BEHAVIORAL RISK FACTOR SURVEILLANCE SYSTEM (BRFSS)
YOUTH BEHAVIORAL RISK FACTOR SURVEILLANCE SYSTEM
(YBRFSS)
www.cdc.gov/brfss
www.CDNetwork.org
www.hrsa.gov/data.htm
http://datawarehouse.hrsa.gov
http://quickfacts.census.gov/qfd/states/00000lk.html
www.CDNetwork.org/
CME accredited through AAFP
CDE accredited through AGD
CDN Webcast Series
• Health Care Acquired Infection Prevention for
Ambulatory Surgical Centers
• Train-the-Trainer Workshop in Infection Prevention for
Ambulatory Surgical Centers
• www.CDNetwork.org/HAI
• The Rockefeller University Center for Clinical and
Translational Science (CCTS) Series
• www.CDNetwork.org/Rockefeller
• Howard University College of Medicine AIDS Education
and Training Center-National Multicultural Center
Cultural Competence Series
• www.CDNetwork.org/AETCNMC
• RCHN Community Health Foundation
• www.CDNetwork.org/RCHN
CDN Resource Libraries & Toolkits
• Improving Colorectal Cancer Screening Rates among NYC
Russian Speaking Communities
• Sponsored by: NYC Dept. of Health and Mental Hygiene
• www.CDNetwork.org/RussianCRC
• Online Guidelines & Clinical Decision Support Tools
• Sponsored by: NYC Dept. of Health and Mental Hygiene
• eClinician.org
• Research Training Catalog for Federally Qualified
Health Centers (FQHCs)
• Sponsored by: NACHC, GWU, Children’s CTSI
• www.CDNetwork.org/NACHC
www.CDNetwork.org
www.CDNetwork.org/NACHC
Step 1:
Getting Started
www.CDNetwork.org/NACHC
Step 3:
Asking the
Right
Questions
www.CDNetwork.org/NACHC
www.CDNetwork.org
www.eClinician.org
36
Types of T2 T3 T4 Research
• CER
• PCOR
• CEnR
• CBPR
• PBRN
Comparative Effectiveness Research
Patient Centered Outcomes Research
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Community-Engaged Research
Community-based Participatory Research
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Practice-based Research Networks
Models of Practice-Based Research
• Top-Down
– Researcher-focused
– Funder-focused
• Bottom-up
– Clinician-focused (PBRN)
– Patient-focused (CBPR)
• Mixed Model (Bi-directional)
Clinician
Researcher
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 A common aim behind Comparative Effectiveness Research (CER) and Practicebased Research Network (PBRN)-conducted research is to produce new evidencebased medical knowledge that fills gaps between primary care practice realities
and findings produced by academic/tertiary-care research and clinical trials
CHALLENGES FOR PBRNS
 Less control over
Patient characteristics
Variability in practice clinical and research capacity
Multiple IRBs
Significant resource problems that impede research
 Other challenges include:
selecting studies that meet network goals and objectives
working within an adequate and sufficient budget
developing study teams and agreements among team members
training practice staff for participation
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Translational Research & NIH “Blue Highways”
T4
Public
Health
Impact
SOURCE: Westfall, et al., “Practice-Based Research—“Blue Highways’ on the NIH Roadmap”
JAMA 2007; 297: 403-406
Stages of CBPR vs. Key Steps in PCTs
CBPR
1. Selecting a research question
PCTs (MacPherson)
1. Appropriate research question
2. Defining the patient group
2. Designing the study
3. Identify a comparison group
4. Defining the treatment protocol
5. Ensuring adequate sample size
3. Recruiting patients
6. Referral, recruitment and
randomisation
4. Conducting the study
7. Outcomes
5. Analyzing the data
8. Analysis
6. Publishing, presenting, and
disseminating the results
7. Spread and sustainability
9. Reporting and dissemination
MacPherson H. Pragmatic clinical trials. Complementary Therapies in Medicine. 2004. 12:136-140.
Pragmatic-Explanatory Continuum
Indicator Summary (PRECIS) Tool
Thorpe KE et al. A pragmatic-explanatory continuum indicator summary tool (PRECIS): a tool to help trial
designers. CMAJ 2009; 180(10):E47-57.
Four-Stage Model of CommunityEngaged Research
One
Persons consulted
by the researchers
are at the
periphery of the
community.
Two
Researchers
retain total
control of the
project. There is
community
involvement, but
it is passive.
Three
Community
leaders are asked
not only for
endorsement of
the project, but
for guidance in
hiring community
residents to serve
as interviewers,
outreach workers,
etc.
Four
Community
members are
first among
equals in
defining the
research agenda.
1. Hatch J, Moss N, Saran A et al. Community research: Partnership in Black communities. American Journal of Preventive Medicine. 1993 NovDec;9(6 Suppl):27-31; discussion 32-34.