Partnering with Patients and Families in Research:
A New Paradigm
Sponsored by the MGH Clinical Research Program, The John D.
Stoeckle Center for Primary Care Innovation and the MGH Office of
Patient Advocacy
Thier Conference Room, Thier Research Building @ MGH
October 7, 2013
Goals of the Program
Explore
– Discuss patients and families as
collaborators in research at MGH
– Explore MGH current environment for
engaging patients and families in research
– Identify and prioritize potential next steps
for MGH and the Clinical Research
Program
Patient And Family Partnerships
in Research
Susan Edgman-Levitan, PA
Executive Director
Stoeckle Center for Primary Care Innovation
Massachusetts General Hospital
October 7, 2013
The John D. Stoeckle Center
for Primary Care Innovation
What is Patient- and Family-Centered
Care?
“Health care that establishes a partnership among
practitioners, patients, and their families…to ensure
that decisions respect patients’ wants, needs, and
preferences and that patients have the education and
support they need to make decisions and participate
in their own care.”
Crossing the Quality Chasm: A New Health System for the
21st Century, Institute of Medicine, 2001 & The Picker
Institute
The John D. Stoeckle Center
for Primary Care Innovation
Figure 1. A Multidimensional Framework for Patient and Family Engagement in
Health and Health Care
Source: Carman et al., 2013; Scholle et al., 2010
The John D. Stoeckle Center
for Primary Care Innovation
Global Patient/Family
Partnerships and Engagement
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PCORI
Private Foundations
AHRQ/NIH
Gordon and Betty Moore Foundation Patient Care Program: $500M
for patient engagement research and implementation
MA, 2008 “An Act to Promote Cost Containment, Transparency and
Efficiency in the Delivery of Quality Health Care.”
World Innovation Symposium in Healthcare 2013: Patient
engagement recommendations for health, economic, and education
ministers around the world
Lucian Leape Institute: Safety is Personal Report
NHS Patient Constitution
WHO Patients for Patient Safety
The John D. Stoeckle Center
for Primary Care Innovation
The Value of Patient and FamilyCentered Care
• Patients are the only source of information about
many aspects of quality.
• The patient’s experience is linked to improved clinical
outcomes, reduced readmissions, reduced mortality,
and reduced malpractice risk, and improved ability to
manage chronic conditions.
• Partnering with patients and families brings a wealth
of knowledge to clinicians and staff that they do not
possess.
• Partnerships with patients and families inspire and
energize clinicians, staff, and leaders while grounding
them in reality, focused on the “right” solutions.
The John D. Stoeckle Center
for Primary Care Innovation
Patients &Families as Partners: the Benefits
Patients/Family
Clinicians/Staff
Organization
Opportunity to affect
change
Enhances
relationships with
patients/families
Improves quality of
services and programs
Improves clinical
outcomes
Improves clinical
outcomes
Keeps programs relevant
and realistic
Builds knowledge/skill
Develops knowledge
and skills
Brings creative solutions
Models empowerment Provides a reality
for others
check and fresh
perspective
Helps save money: 1040% reduction in costs
Network with others
Improves philanthropy
support and advocacy for
org/service.
Increases empathy
and understanding
The John D. Stoeckle Center
for Primary Care Innovation
Examples of Patient/Family Feedback at
PHS and Partners
• Identified positives and negatives about current practices and
where to save money.
– Electronic medical records
– Creation of patient/clinician compacts
– Insulin induction
– Colonoscopy results
– Design of Yawkey Building
• Identified issues in patient education materials, letters, and
marketing materials
– Diabetes
– End of life
– Pediatrics
– Transplant booklet
– Care team descriptions
The John D. Stoeckle Center
for Primary Care Innovation
Characteristics of Excellent
Patient/Family Partners
• The ability to share
personal experiences in
ways that others will listen
and learn from them.
• The ability to see the “big”
picture.
• Interested in more than one
issue.
• Interested in improving
health care or research.
• The ability to ask tough
questions constructively.
• The ability to connect with
people.
• A sense of humor.
• Representative of the
relevant
patients/families/conditions.
The John D. Stoeckle Center
for Primary Care Innovation
Barriers: Clinician/Investigator Concerns
• Research issues are too technical for lay people to
understand
• Paternalism/loss of “expert” status
• Patients/families are too overwhelmed to participate
• Patients/families will see the “messy” side and problems
of medicine
• Patients/families will express feelings in a negative and
critical manner
• Unrealistic requests or expectations
The John D. Stoeckle Center
for Primary Care Innovation
Barriers: Patient and Family Concerns
• Don’t trust that clinicians/staff will listen
• Clinicians will underestimate the value of their
perspective
• Logistics
– No mechanism for providing child care
– Transportation is difficult or unavailable
– Meetings are only held during working hours
– Patients/families lose time/money from their
families/jobs
– Translator services
The John D. Stoeckle Center
for Primary Care Innovation
Barriers: System Issues
• Staff/patients/families have never participated in
research studies before
– Lack of knowledge of each other’s roles
– Use of jargon
– Addressing confidentiality issues
• Recruiting the right people
• No mechanism to reimburse or compensate
patients/families
• Lack of resources for training staff and families to work in
partnership
• Staff cannot be paid overtime for meetings after hours.
The John D. Stoeckle Center
for Primary Care Innovation
Barriers: Lack of Quantitative and
Qualitative Research Support
• Structured interviews: patients, families,
employees who have been patients
• Focus Groups
• Observations
• Ethnographies
• Surveys
The John D. Stoeckle Center
for Primary Care Innovation
Patient/Family Orientation Programs
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The mission, goals, and priorities
of the organization.
Who’s who in the organization
and/or on the project team and
how to contact other team
members.
Basic volunteer program
orientation and training.
HIPAA and the importance of
privacy and confidentiality.
Specific skills and knowledge
needed to be an effective team
member ,e.g., quality
improvement or research
methodologies.
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“Jargon 101.” While it is best to
reduce the amount of jargon used
in meetings, sometimes it is
impossible to completely eliminate
jargon. If there are terms that will
be used frequently, make sure
that advisors understand them.
How to prepare for a meeting:
appropriate attire, what to do
ahead of time, and what to bring.
How meetings are conducted:
format, agenda, minutes, roles
(e.g., facilitator, secretary,
timekeeper).
Technologies that will be used
(e.g., conference calls, web-based
tools).
The John D. Stoeckle Center
for Primary Care Innovation
Potential Models for Advanced
Patient/Family Training
The John D. Stoeckle Center
for Primary Care Innovation
National Breast Cancer Coalition Clinical
Trials Project LEAD®
• a four-day advanced course open to graduates of Project
LEAD® Basic Science and the Project LEAD® Institute.
The course focuses on understanding and improving
breast cancer clinical trials research. This course, part of
NBCC’s Clinical Trials Initiative, trains advocates to
participate in all levels of the clinical trials process from
evaluating trial design to serving on Institutional Review
Boards and Data Safety Monitoring Boards.
The John D. Stoeckle Center
for Primary Care Innovation
National Breast Cancer Coalition Project
LEAD® Institute
• Taught by a renowned research faculty, this is a five-day intensive
science course for breast cancer advocates covering the basics of
cancer biology, genetics, epidemiology, research design and
advocacy.
• Participants will:
– Learn the language and concepts of the science of breast cancer, including
cancer biology, genetics, genomics and proteomics, the roles of DNA, RNA, and
proteins, and the development of cancer at the molecular level;
– Distinguish between descriptive studies, analytic studies, clinical trials, and metaanalyses, and identify the extent to which each establishes causality;
– Acquire the skills to critically interpret scientific literature, and to become
educated about scientific aspects of breast cancer;
– Become familiar with the wide range of consumer advocacy opportunities, and
how breast cancer research decisions are made;
– Gain the necessary leadership and advocacy development skills to confidently
participate in the scientific community as a breast cancer advocate.
–
The John D. Stoeckle Center
for Primary Care Innovation
PCORI National Priorities for Research
Projects that address critical decisions that patients, their
caregivers, & clinicians face with too little information
The John D. Stoeckle Center
for Primary Care Innovation
PCORI: 5 Merit Review Criteria
1.Impact of the condition on the health of individuals
& population
2.Potential for improving care & outcomes
3.Technical merit
4.Patient-centeredness
5.Patient & stakeholder engagement in the
formulation of research questions, design,
implementation, monitoring, & reporting
The John D. Stoeckle Center
for Primary Care Innovation
“Honest criticism is hard to take,
particularly from relative, a
friend, an acquaintance, or a
stranger.”
Franklin P. Jones
The Saturday Evening Post
The John D. Stoeckle Center
for Primary Care Innovation
Those who say
it cannot be
done should not
interrupt the
person doing it.
-Chinese
Proverb
The John D. Stoeckle Center
for Primary Care Innovation
References & Resources
•
Barry MJ, Levitan SE. Shared Decision Making—the Pinnacle of
Patient-Centered Care. N Engl J Med 2012; 366:780-781.
•
Gerteis M, Edgman-Levitan S, Daley J, Delbanco TL, editors. Through
the Patient’s Eyes. San Francisco: Jossey-Bass Publishers, Inc.; 1993.
•
Edgman-Levitan S, Shaller D, McInnes K, Joyce R, Coltin K, Cleary P.
The CAHPS Improvement Guide: Practical Strategies for Improving the
Patient Care Experience. CMS, Baltimore, MD; 2003
•
Delbanco T, Berwick D, Boufford JI, Edgman-Levitan S, Ollenschlager
G, Plamping D,Rockefeller RG. Healthcare in a Land Called
PeoplePower: Nothing About Me Without Me. Health Expectations,
2001 Sep; 4 (3): 144-50.
The John D. Stoeckle Center
for Primary Care Innovation
References & Resources
• William Boulding, PhD; Seth W. Glickman, MD, MBA; Matthew P.
Manary, MSE; Kevin A. Schulman, MD; and Richard Staelin, PhD.
Relationship Between Patient Satisfaction With Inpatient Care and
Hospital Readmission Within 30 Days - Page 2 (Am J Manag Care.
2011;17(1):41-48)
• Luxford K. What does the patient know about quality? International
Journal for Quality in Health Care 2012; Volume 0, Number 0: pp. 1–2
• Greaves F, Pape UJ, King D, Darzi A, Majeed A, Wachter RM, Millett C.
Associations between web-based patient ratings and objective measures of
hospital quality. Arch Intern Med. 2012 Mar 12;172(5):435-6. Epub 2012
Feb 13.
• Isaac T, Zaslavsky AM, Cleary PD, Landon BE. The relationship between
patients' perception of care and measures of hospital quality and safety.
Health Services Res 2010;45(4):1024-1040.
The John D. Stoeckle Center
for Primary Care Innovation
References & Resources
•
Sorra J, Khanna K, Dyer N, Mardon R, Famolaro T. Exploring
relationships between patient safety culture and patients' assessments of
hospital care. J Patient Saf. 2012 Sep;8(3):131-9.
•
Lehrman WG, Elliott MN, Goldstein E, Beckett MK, Klein DJ, Giordano
LA. (2010). Characteristics of Hospitals Demonstrating Superior
Perfomance in Patient Experience and Clinical Process Measures of Care.
Medical Care Research and Review, 67(1):38-55.
•
Fremont AM, Hargraves JL, Rowe RM, Jacobson NB, Ayanian JZ.
Patient-Centered Processes of Care and Longterm Outcomes of
Myocardial Infarction. JGIM, 2001:16:800-808.
•
Cleary PD. A Hospitalization from Hell: A Patient’s Perspective on
Quality. Ann Intern Med. 2003 Jan 7;138(1):33-9.
The John D. Stoeckle Center
for Primary Care Innovation
References & Resources
• Webster, PD, Johnson, B. Developing and Sustaining a
Patient and Family Advisory Council, Institute for FamilyCentered Care, 2000.
• Johnson, B., Abraham, M., Conway, J., Simmons, L.,
Edgman-Levitan, S., Sodomka, P., Schlucter, J., & Ford, D.
(2008). Partnering with patients and families to design a
patient-and family-centered health care system:
Recommendations and promising practices. Bethesda, MD:
Institute for Family-Centered Care. Available from
http://www.ipfcc.org/ resources/index.html
• Patient-Centered Care: What Does It Take? Dale Shaller
www.pickerinstitute.org/Research/shaller.pdf
The John D. Stoeckle Center
for Primary Care Innovation
Resources
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www.stoecklecenter.org
www.pcori.org
www.nbcc.org
www.ifpcc.org
www.npsf.org
www.ahrq.gov
www.hospitalcompare.hhs.gov
www.ihi.org
www.planetree.org
The John D. Stoeckle Center
for Primary Care Innovation
Thank You!
Susan Edgman-Levitan, PA
Executive Director
sedgmanlevitan@partners.org
617-643-3931
John D. Stoeckle Center for Primary Care Innovation
Massachusetts General Hospital
Boston, MA
The John D. Stoeckle Center
for Primary Care Innovation
Partnering with Patients and
Families in Research:
A New Paradigm
October 7th, 2013
Susan Sheridan, MBA MIM
Laura Forsyth, PhD MPH
29
PCORI
An independent non-profit funder of clinical
comparative effectiveness research.
Authorized by Congress as part of the 2010 Patient
Protection and Affordable Care Act (ACA).
30
A New Paradigm
31
Why PCORI?
Research has not answered
many questions patients face
People want to know which
treatment is right for them
Patients need information they
can understand and use
Research has not answered
many questions patients face
People want to know which
treatment is right for them
Patients need information they
can understand and use
32
Our Mission
PCORI helps people make informed health care
decisions, and improves health care delivery and
outcomes, by producing and promoting high integrity,
evidence-based information
that comes from research
guided by patients,
caregivers and the
broader health care
community.
Pictured: PCORI Board of Governors (March 2012)
33
Our National Priorities for Research
Assessment of Prevention,
Diagnosis, and Treatment
Options
Improving Healthcare
Systems
Communication &
Dissemination Research
Accelerating PCOR and
Methodological Research
Addressing Disparities
34
Our Growing Research Portfolio
Total number of research
projects awarded to date:
197
Total funds committed to
date:
$273.5 million
Number of states where we
are funding research:
36 states (including the District of Columbia)
Minimum research
commitment in 2013:
$400 million
35
“Research Done Differently”
Patient engagement as a path to rigorous research
Tell us what PCORI
should study
Help determine what
we fund
Engagement
Tell us how we are
doing
Help us share
research findings
Partner in the
conduct of
research
Tell us what PCORI Should Study
Submit your questions:
• online: www.pcori.org/questions
• Workshops
• Roundtables
• Engagement Awards
• Ambassador program
I want to know which blood
glucose testing approach is
best for me to manage my
diabetes.
Tell us what PCORI
should study
Engagement
I want to know which asthma
management tool will help my
child’s asthma
Which Anti Epileptic Drug (AED)
will have less long term impact
on my child’s cognition
Which support group
intervention is best for Latina
breast cancer survivors and
their caregivers?
Help determine what we fund
Advisory Panels &
Working Groups
PCORI Reviewers
Help determine what
we fund
Engagement
38
Participate as a “Patient Partner” in PCORI
funded research
Tell us what PCORI
should study
Help determine what
we fund
Engagement
Tell us how we are
doing
Help us share
research findings
Partner in the
conduct of
research
PCORI Merit Review Criteria
Criterion 1. Impact of the condition on the health of individuals
and populations
Criterion 2. Potential for the study to improve health care
and outcomes
Criterion 3. Technical merit
Criterion 4. Patient-centeredness
Criterion 5. Patient and stakeholder engagement
40
Patient-centered requirements for funding
(Review criteria)
Patient and
Stakeholder
Engagement
Patient-Centeredness
41
Methodology Standards Associated with
Patient-Centeredness
PC-1 Engage people representing the population of
interest and other relevant stakeholders in ways that are
appropriate and necessary in a given research context.
Stakeholders can be engaged in the processes of:
 Formulating research questions;
 Defining essential characteristics of study participants, comparators, and
outcomes;
 Identifying and selecting outcomes that the population of interest notices
and cares about (e.g., survival, function, symptoms, health-related quality
of life) and that inform decision making relevant to the research topic;
 Monitoring study conduct and progress; and
 Designing/suggesting plans for dissemination and implementation
activities.
42
PCOR Engagement Principles
Honesty
Partnerships
Reciprocal
Relationships
Trust
Transparency
Incorporates the Engagement Principles* and
conceptual framework of patient engagement in
research developed by PCORI’s scientific team
(Source: Curtis, P, Slaughter-Mason, S, Thielke, A,
Gordon, C, Pettinari, C, Ryan, K, Church, B, King,
V(2012). PCORI Expert Interviews Project)
Co-learning
43
Participate as a “Patient Partner” in PCORI
funded research
 Help determine what needs
to be researched
 Help recruit participants
 Help create the intervention to
be studied
 Evaluate the engagement
throughout the life of the
project
 Define outcomes important to
patients
 Disseminate research results
to advocacy organizations and
community
 Help write proposal
 Participate as Co-PI,
consultant or advisory
committee member
 Help determine methods and
processes of research study
44
Conceptual Model for PCOR
Outcomes
Outcomes
•
Culture of patientcenteredness in research
•
Meaningful & effective
partnerships
Near-term
•
Research relevant to
patients/other stakeholders
•
Use of research results in
health decisions
Actions
•
Initiate and maintain partnerships
between researchers and stakeholders
•
Facilitate cross-communication
among research stakeholders
Foundational Elements
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Awareness of methods for PCOR
•
Valuing of the patient perspective
•
Interest in PCOR
•
Ways for patients and researchers to
partner
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Resources and infrastructure
•
Policies/governance
•
Capture, use and optimize patient
perspective across phases of
research
•
Ensure meaningful influence on
research
•
Train for partnering
•
Share and use learnings
•
Quality health decisions
•
Satisfaction with health care
experiences
•
Optimal health outcomes
Intermedia
Long-term
PCOR Principles
Trust, Co-learning, Transparency, Respect
Conceptual Model of PCOR:
Foundational Elements
Awareness of methods for PCOR
Valuing of the patient perspective
Interest in PCOR
Ways for patients and researchers to partner
Resources and infrastructure
Policies/governance
Conceptual Model of PCOR:
Actions
Initiate and maintain partnerships between
researchers and stakeholders
Facilitate cross-communication among research
stakeholders
Capture, use and optimize patient perspective
across phases of research
Ensure meaningful influence on research
Train for partnering
Sharing and use of learnings
Conceptual Model of PCOR:
Outcomes
Near term outcomes
 Culture of patient-centeredness in research
 Meaningful & effective partnerships
Intermediate outcomes




Research relevant to patients/other stakeholders
Use of research results in health decisions
Quality health decisions
Satisfaction with health care experiences
Long term outcomes
 Optimal health outcomes
Patient engagement in research
 Improved research recruitment and retention rates
(Edwards et al. 2011)
 Enhanced trust between researchers and participants
(Decker et al. 2010; Edwards et al. 2011; Staniszewska et al . 2007)
 Improved content and construct validity of measures
(Cashman et al. 2008; Cotterell 2008)
 Improved patient understanding of results
(Chalmers 1995; McCauley et al. 2001; Doyle 2010)
 Increased relevance of research results to patients
(summarized in Nass et al. 2012)
PCORI Pilot Projects Program
50 projects in 24 states and Washington, DC
$31 million (over two years)
50
PCORI Pilot Projects: Stakeholder
Engagement
0
Patient(s)/Consumer(s)
Caregiver(s)/Family Member(s)/ of Patient
Patient/Consumer/Caregiver Advocacy Organization(s)
Clinician(s)
Clinic/Hospital/Health System Representative(s)
Purchaser(s)
Payer(s)
Industry Representative(s)
Policy Maker(s)
Other
10
Percent Reporting Engagement
20
30
40
50
60
70
80
90
100
Patient Engagement: Stages of the
Research Process
0
Topic solicitation/agenda setting
Question development/framing
Proposal development
Methods/study design
Data collection
Data analysis
Results review/interpretation/translation
Dissemination
10
20
30
40
%
50
60
70
80
90
100
Facilitators for Engagement
Not at all Somewhat
Critically
Important
Important Important
Important
Remuneration (e.g., honoraria,
travel support)
16%
28%
40%
16%
24%
16%
44%
16%
13%
29%
42%
17%
Communications strategies
7%
7%
33%
52%
Shared leadership strategies
8%
21%
21%
50%
Training/education of stakeholders
Training/education of researchers
Most Significant Contributions To-Date (~6
months into funding)
Changes to project methods, outcomes, or goals
Modifications to interventions
Helps open doors to clinical settings/ access to
clinical professionals
Refinement of instruments and interview questions
Contribute to interpretation of qualitative findings
Ways to improve the ease of data collection for
patients and providers, should speed data
collection
Inform dissemination strategies
Pilot Projects: Lessons Learned
Seek genuine partnership
Strategic selection of stakeholders
Continuous involvement of stakeholders
Adapt to the practical needs of stakeholders
Define expectations and roles
Building relationships requires in-person contact
A New Paradigm
56
Example - Nueva Vida Intervention: Improving QOL in
Latina Breast Cancer Survivors and their Caregivers
Intervention itself was developed by breast cancer survivors
Patient/stakeholder partners include clinicians (also cancer
survivors), patient survivors, caregivers and patient advocacy
organizations from diverse locations of the United States
including Washington DC area, New York and California.
Patient advocacy organizations and patients/caregiver research
partners are compensated sub contractors and consultants in
project
Patient advocacy research partners helped develop choice of
comparator, eligibility criteria (all women with breast cancer would
be eligible vs. only women who had completed active treatment)
57
Example - Nueva Vida Intervention: Improving QOL in
Latina Breast Cancer Survivors and their Caregivers
Interventionist training provided by patient advocacy organization,
patient/survivor and clinician/caregiver
Frequent opportunities for check-ins/meeting across all project
partners (“early and often”)
Research team including patient/stakeholder partners involved in
discussion of study implementation, Institutional Review Board
protocols, recruitment, participant tracking, intervention delivery,
and outcomes assessment.
Patient Partners to share results through outreach to 150+ local
and national groups that provide care and support to tens of
thousands of Latino families facing cancer as well as participation
in Biennial National Latino Cancer Summit.
58
Example - Cognitive AED Outcomes in Pediatric
Localization Related Epilepsy (COPE)
The purpose of this project is to identify the AED that maximally preserves
cognitive function in children with Epilepsy
Patient Partners include a patient advocate, the National Epilepsy Foundation
and treating Clinicians
The patient advocate has epilepsy and a grassroots website
(myepilepsystory.org) connecting others with Epilepsy who reviewed early drafts
of the research design and endorsed the design.
Patient advocate partner originated the idea of a survey tool for the children
and helped craft survey language
59
Example - Cognitive AED Outcomes in Pediatric
Localization Related Epilepsy (COPE)
Patient advocate partner serves on the Research Executive Committee
is compensated as a consultant and participates in the investigator
meetings as well as all teleconferences during the study to contribute to
the conduct and study progress
Patient Partner will post study description on monthly updates on her
website and include final study results. She will collaborate with the
Epilepsy Foundation and media to share the importance of this study.
The National Epilepsy Foundation will be the primary source of sharing the
results of the study to the American Epilepsy Society and to patients and
their families including a patient friendly video of the PI of study results.
Clinicians and site PIs who are responsible for medical management of
pediatric LRE will serve on the Executive Committee as well.
60
Example - Addressing Mental Health Needs of
Rural African Americans
Patient Partner is a Tri County Rural Health Network and their
community members
Patient Partner helped write the proposal with their community members
involved in a deliberative democracy process that incorporates
decision-making directly by lay citizens, (instead of focus groups)
Patient Partner created a community advisory board that advised on
patient friendly informed consent forms, procedures and recruitment
Patient Partner re-framed the research question, application and
interview guide on a “wellness perspective” instead of a mental health
angle to be more culturally accepted
61
Example - Addressing Mental Health Needs
of Rural African Americans
Mental Health vs. Emotional Wellness
No one is going to talk to you about mental
health. When people hear mental health they
think of crazy. Ain’t nobody going to talk to you
about being crazy. I ain’t crazy, I don’t know
how to help you help crazy people
If you want my expertise, you have to ask me
about t
62
Tips - Promising Practices of Meaningful
Engagement in the Conduct of Research
Patient Partners involved in:
 identifying a priority topic and developing the research
question to be studied
 creating the intervention to be studied (if applicable )
 identifying the comparators to be used in the study
 identifying the goals or outcomes of the interventions to
be studied
63
Tips - Promising Practices of Meaningful
Engagement in the Conduct of Research
The Patient Partners co-develop methods and processes
for the research project as appropriate.
The Patient Partners co-deliver research methods/activities
as appropriate.
The research team, including Patient Partners, actively
evaluates engagement throughout life of the project
64
Tips - Promising Practices of Meaningful
Engagement in the Conduct of Research
Patient Partners are involved in the dissemination of
findings to patient, stakeholder, and research audiences
and findings are communicated in understandable, usable
ways.
Findings of the research are communicated quickly and in a
meaningful way back to the patients and communities who
were participants in the research project.
The roles and decision-making authority of all research
partners, including the Patient Partners, were well defined
65
Tips - Promising Practices of Meaningful
Engagement in the Conduct of Research
Any forward-facing materials are provided in plain language
and developed by or with input from patient/patient
organization partners.
The time and contribution of patient/patient organization
partners is valued and demonstrated in fair financial
compensation as well as reasonable and thoughtful time
commitment requests.
66
Other Resources on Meaningful
Engagement in the Conduct of Research
Webinar: “Promising Practices on Meaningful Engagement in the
Conduct of Research”
http://www.pcori.org/events/promising-practices-of-meaningfulengagement-in-the-conduct-of-research
Engagement Awards/Pipeline to Proposals
http://www.pcori.org/blog/pcoris-engagement-awards-a-newopportunity-to-build-new-research-partnerships/
Systematic Review
http://www.pcori.org/assets/Eliciting-Patient-Perspective-in-PatientCentered-Outcomes-Research-A-Meta-Narrative-SystematicReview1.pdf
67
Facilitating patient partnership in research
Ambassadors
Pipeline to Proposals
68
Find Us Online
www.pcori.org
69
PCORI-Fostering Patient
Engagement-Patient/Family
Advisory Councils
Robin Lipkis-Orlando,RN - Director of Patient Advocacy
rlipkisorlando@partners.org
What are Patient/Family Advisory
Councils? (PFACs)
•
Collaboration between patients, families and clinicians
•
Populated by patients and family members
•
Supported and facilitated by hospital administration
•
Advisory to hospital leadership
•
Advance patient and family centeredness
•
Meet 8-10 times per year
•
Interface with many areas of the hospital
•
Regulated by DPH
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MGH’s Patient and Family Advisory Councils
•
MGH Hospital for Children (MGHfC) (1999)
•
MGH Cancer Center (2001)
•
•
MGH Heart Center (2007)
Institute Heart, Vascular, Stroke Care (2012)
•
The General PFAC (2011)
•
Ambulatory Practice of Future Care Alliance (2012)
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General Areas for PFAC Work
•
Program Development and Design
•
Influencing Models of Care
•
Collaborating on Research Initiatives
•
Designing Patient and Family Education
•
Building Design and Patient Environments
•
Influencing and Providing Staff/Clinical Education
•
Shaping Marketing Approaches
73
MGH PFAC Activities
•
Participate in Care redesign teams
•
Provide feedback on Innovation Unit program content
•
Influence Patient and Family Centered rounds
•
Present at national and local conferences
•
Revise Visitor Policy and develop Tips for Visiting
•
Serve on hospital wide and service specific committees
•
Provide feedback on PCORI proposals
•
Participate in the interview process and orientation of new staff
•
Participate in Lunder building design and art work selection for units
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Rationale: Benefits of PFACs
•
Patient/Family insights help to advance hospital mission of clinical care,
research, training and education, quality and safety.
•
•
Patient/family members are eager to contribute and integrate into
our organizational structure.
•
Over one thousand patient comments per week, letters and interactions
indicate the powerful voice of our patients.
•
Patient and Family satisfaction increases with engagement
•
Patient outcomes are improved as they are focused on what is most
meaningful to patients
•
Bring a perspective that reflects the diversity and cultural sensitivity of
the MGH community.
•
Endorsed by national bodies- IHI, AHRQ, Inst .for Patient/Family
Centered Care.
•
75
Lunch Activity
• At your tables, discuss the following question:
1.
How can patients and researchers work together as collaborators in
research for mutual benefit? What does successful collaboration look
like?
2.
What gaps or challenges do you see that limit MGH researchers from
collaborating with patients in research and competing for PCORI and
other funding opportunities in this realm?
• Please spend 15 minutes on each topic
– Suggestion: Go around the table so everyone has a chance to speak
• Designate a scribe to take notes and someone to report back to the
group at the end of lunch
MGH Clinical Research
Program
Partnering with Patients and
Families in Research: A New
Paradigm
Janet E. Hall, MD
Co director, CRP Education Unit
October 7, 2013
CRP: Who We Are
WF Crowley, Jr - Director
Genetics/
Genomics
S.Slaugenhaupt
Translational
M. Freeman
J.Smoller
IT
H. Chueh
CRP Admin
CER
J. Meigs
E. Campbell
C. Hong
T. Koretskaia
K. Ryan
Biostatistics
D. Finkelstein
Education
J. Hall
A. Nierenberg
CRSO
A. Nierenberg
Clinical Research Education Unit (CREU)
Co-Directors:
Unit supports:
Unit produces:
Drs. Janet Hall and Andrew Nierenberg
>6,000 attendees a year
>250 courses a year
Key Focus Groups:
Clinical Investigators
Biostatistics
Design and Conduct of Clinical Trials
Genetics
IRB
Research Tools
Data Management
Grant Writing
Scientific Communication
Clinical Research Staff
Project Manager Offerings
Research Nurse (RN) Offerings
Clinical Research Coordinator (CRC)
Clinical Skills Trainings
RN/CRC Continuing Education
RN/CRC Orientation
RN/CRC IRB Education
RN/CRC Mandatory Trainings
New focus area: PCORI grants support for Patients, Investigators and Research Staff
Potential Resources for Patient Engagement and PCORI
Funding at MGH
Clinical Research Education Program
– Development of targeted educational activities
Investigators
Study staff
Patients
– Courses
Short or long, introductory through more advanced
On-line
– Compendium of other Materials
Potential Resources for Patient Engagement and PCORI
Funding at MGH
Clinical Research Support Office (CRSO)
– Individual mentoring of investigators
– Help with funding
Sources of funding
Budgeting
Resource templates
Best practices for patient engagement
– Coordinators
– IRB support
Potential Resources for Patient Engagement and PCORI
Funding at MGH
Clinical Effectiveness Unit
– Individual mentoring of investigators
– High level review of grants
Potential approaches
Education Unit Activities
– Workshops/Courses for patients and researchers
Support linkages between researchers and patients
– Leverage existing PFACs
– Support creation of a research PFAC
– Adapt RSVP platform for patient “recruitment” as collaborators
Support Grant Applications
– Ongoing support from available CRP resources
– Boiler plate templates to support PCORI grants
– Review PCORI summary statements ->guidelines/recommendations
– Develop/Identify/Share resources
Address the uniqueness of PCOR research
– Advocate for interim support mechanisms
– Support specialized review processes with IRB
Acknowledgements
PCOR Program Planning Committee
Susan Edgmont-Levitan PA,
Executive Director of the MGH John D. Stoeckle Center for Primary Care Innovation.
Janet E, Hall, MD
Clinical Research Program (CRP) faculty member
Associate Physician in Medicine., Associate Chief of the Reproductive Endocrine Unit
and Co-Director of the CRP’s Education Unit,
Clemens S. Hong, MD, MPH
Clinical Research Program (CRP) faculty member,
Department of Medicine, Primary Care
Physician researcher in The John D. Stoeckle Center for Primary Care Innovation and
Primary Care Operations Improvement.
Robin Lipkis-Orlando, RN, MS
Director of the MGH Office of Patient Advocacy
Andrew A. Nierenberg, MD
Clinical Research Program (CRP) faculty member,
Department of Psychiatry
MGH Director, Bipolar Research Program, and Associate Director MGH Depression
Clinical and Research