Community-Engaged
Practice Based
Research: The Mayo
Clinic Experience
Paul V. Targonski, MD, PhD
Director, Mayo Clinic Health System
Practice Based Research network
September 15, 2011
Brief Outline
• There is no such thing as
translational research
• Community engagement is a set of
universal principles beyond research
• Scientists can’t make the national
research enterprise successful
without some help
National Institutes of Health
• “The nation’s medical research agency”
• ~27 institutes and centers
• $30 billion annually
• Funds approximately
• 50,000 competitive grants
• 325,000 investigators
• 3000 universities, medical schools and
•
research institutions
6000 intramural scientists with 10% of budget
What is Translational Research?
• the conversion of basic research
advances into products that can be
tested on humans.
archives.who.int/prioritymeds/report/FinalRep/GlossaryREPFIN.doc
What is Translational Research?
• To improve human health, scientific discoveries must be translated into
practical applications. Such discoveries typically begin at “the bench”
with basic research — in which scientists study disease at a molecular
or cellular level — then progress to the clinical level, or the patient's
“bedside.”
Scientists are increasingly aware that this bench-tobedside approach to translational research is really a twoway street. Basic scientists provide clinicians with new
tools for use in patients and for assessment of their
impact, and clinical researchers make novel observations
about the nature and progression of disease that often
stimulate basic investigations.
http://nihroadmap.nih.gov/clinicalresearch/overview-translational.asp
The Traditional Biomedical Model
• 17 years from discovery to practice
• For the <15% of studies that actually
make it that far
• And only 5% are applied in practice with
their originally intended use
• Minoxidil and hair growth versus
blood pressure control
• Hence the federal support of translational
and practice-based research!
What is Translational Research?
• “Translational research includes two
areas of translation. One is the
process of applying discoveries
generated during research in the
laboratory, and in preclinical studies,
to the development of trials and
studies in humans. The second area of
translation concerns research aimed at
enhancing the adoption of best
practices in the community.”
http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-06-002.html
Institutional Clinical and Translational Science Award
Translational Research
• T1 seeks to move a basic discovery into a candidate health
application.
• T2 assesses the value of T1 application for health practice
leading to the development of evidence-based guidelines.
• T3 attempts to move evidence-based guidelines into health
practice, through delivery, dissemination, and diffusion
research.
• T4 seeks to evaluate the “real world” health outcomes of a T1
application in practice.
TRIP
Community Engagement?
http://medicalcenter.osu.edu/research/translational_research/Pages/index.aspx
What is practice based
research?
• Practice-based research is a systematic,
rigorous and collaborative inquiry by teams of
healthcare providers, community experts,
scientists and other stakeholders into the
systems, methods, policies, programmatic
applications and population-level outcomes of
health care practice in order to discover new
information, generate new ideas, and implement
innovative solutions to the existing paradigms of
care to further improve care to patients,
populations, and communities.
Why Practice-Based Research?
A Typical Month of Healthcare in the United States
Green LA et al: N Engl J Med 344(26):2021, 2001
Definitions
• Practice-based research network: “A group of ambulatory
practices devoted principally to the primary care of patients.
Typically, PBRNs draw on the experience and insight of
practicing clinicians to identify and frame research
questions whose answers can improve the practice of
primary care. By linking these questions with rigorous
research methods, the PBRN can produce research findings
that are immediately relevant to the clinician and, in theory,
more easily assimilated into everyday practice."
Agency for Healthcare Research and Quality,
http://www.ahrq.gov/research/pbrn/pbrnfact.htm, last accessed June 2, 2011
United States PBRN Environment
Networks
Medical
Dental
Nursing
Pharmacy
Public Health
Federal Funding:
NIH
AHRQ
CDC
MCHS PBRN
A large network of small affiliated/integrated
practices
~1150 providers, ~75 practices, 9 hospitals, ~650k
patients, in 3 states
• Vision: Healthier patients and communities
through the scholarship of health practice.
• Mission: Solving the problems of health care
practice to improve the health and health
equity of patients and communities.
The vision, mission and membership reflects our
definition of community and role.
Network Provider Comparison with MN/WI State
Providers
Provider
Characteristics
Chi-Square
df
p-value
Age group
2.27
3
0.519
Gender
5.33
1
0.021
Years in practice
4.12
4
0.390
Specialty
15.46
8
0.051
MHS PBRN Survey: Participatory and
Educational Research Interest
Topical Areas
Records Based Disease Specific Studies
Pt oriented Disease Specific Studies
HC Quality/Outcomes
HC Access/Delivery
HC Cost/Financing
Clinical Trials
0
Participatory Interest (%)
20
40
60
80 100
Skills Development Interest (%)
Respondent Interest in Participation in PracticeBased and Translational Research
Research Type
% of respondents
somewhat
very
interested
interested
Clinical Trials
57%
26%
Research that examines the cost
or financing of health care
36%
24%
Research that examines access to
and use/delivery of health care
41%
27%
Research that examines health care
quality and health care outcomes
38%
40%
Disease-specific studies involving
direct human subjects testing
46%
29%
Disease-specific studies involving
chart review (no direct subject contact)
45%
20%
Review proposals and
provide feedback
41
MHS PBRN Survey:Recruit participants for ongoing
63.9
studies other than my own
Interest in
Research Roles
Among
Respondents
Develop research ideas to share or
for others to implement
65.3
Participate in others’ studies
71.7
Run an occasional study in an area that
interests me
Run a sustainable
program of research
0
10
20
30
74.1
45.1
40
50
Percent Somewhat or Very Interested in Role
60
70
80
MHS PBRN Survey: Previous Research
Experience Among Respondents
Helped recruit participants to
clinical research studies
Collaborated or served as a co-investigator
In clinical research studies
Led studies
(PI)
Examples of “Other”
Experiences:
59.4
• REP Studies
• Direct data collection
• Developed project but
56.6
couldn’t get it funded
16.7
• Master’s thesis
• WREN office-based
10.8
Other
research participant
• Basic science research with
NIH/AHA support
0
10
20
30
40
50
Percent with Previous Experience
60
70
• Ran the PROS network for
North Dakota
• IRB approved project, not
taking off because of lack of
funds
Motivation = Interest + Relevance
• “I'd be very interested in clinical
effectiveness trials of various treatments,
approaches, drugs, et cetera.”
• “If there was an interesting study being
conducted. I probably would be able to
find some time to participate.”
• “I think for me it would have to be
meaningful and have to have come
clinical aspect to it, whether it's at the
evaluation stage or during.”
Research – Value to Practice
• Both the Administrators and Providers spoke
of the value of research to the Health System
• “You know value is often defined here as quality
over cost and if it increases quality it increases
value. If it decreases costs it increases values.
So if we can find things to do to good treatments
and therapy cheaper you know we're enhancing
value.” [Administrator]
• “We definitely see interest in the physicians
primarily where it relates to practice innovations
in clinical trials.” [Administrator]
• “If we look at clinical excellence as being a part of
the mission, that could certainly help promote
clinical excellence.” [Provider]
Research - Value to Practice
• “…I think that [research] actually helps to
stimulate the people that are involved in it
in the organization because it keeps us
involved in thinking and trying to innovate
and interested in improving care for our
patients and for our system.”
• “I think it's beneficial to me because I
believe it gives me an opportunity to
provide some input into the organization
and the way we operate and our degree of
success…”
Levels of Research Engagement
Level 0... no involvement in research – but an
expectation that one would support
colleagues involved in research
Level 1... being aware of studies open at
one’s site and willing to identify
patients who may be appropriate
for participation/ enrollment
Level 2... level 1 involvement plus
willingness to be involved in data
collection
Level 3... being a PI or co-PI on one or more
studies
Level 4... greater involvement in research,
+
e.g., site research leadership role
-
Time
What is Community Engagement?
Definitions
• Community: A community can be described as a group of
people who share some or all of the following:
geographic boundaries; a sense of membership; culture
and language; common norms, interests, or values; and
common health risks or conditions (IOM, 1995; Jewkes
and Murcott, 1996; Ruderman, 2000; Ricketts, 2001).
Members of communities typically experience the shared
reality of living or working in the same location or
environment and so are in a position to influence and be
influenced by the social, economic, and physical risk
factors in that environment (Roussos and Fawcett, 2000;
Kreuter et al., 2001). IOM, The Public’s Health in the 21st
Century, 2002, pp178-179
What is Community Engagement?
Community engagement is a dimension of Public Participation.
In research, community engagement is a process of inclusive
participation that supports mutual respect of values, strategies,
and actions for authentic partnership of people affiliated with or
self-identified by geographic proximity, special interest, or similar
situations to address issues affecting the well-being of the
community of focus.
Community engagement is a core element of any research effort
involving communities. It requires academic members to become
part of the community and community members to become part
of the research team, thereby creating a unique working and
learning environment before, during, and after the research.
NIH Council of Public Representatives
http://copr.nih.gov/reports/Definitions_of_CE_and_PP_Revised_508.pdf
Definitions
• Community Engagement: Applying institutional resources (e.g.,
knowledge and expertise of students, faculty and staff, political
position, buildings and land) to address and solve challenges
facing communities through collaboration with these
communities. The methods for community engagement of
academic institutions include community service, service-learning,
community-based participatory research, training and technical
assistance, capacity-building and economic development.
Community engagement is not necessarily scholarship.
Gelmon SB, Seifer SD, Kauper-Brown J and Mikkelsen M. (2005) Building Capacity for Community
Engagement: Institutional Self-Assessment. Seattle, WA: Community-Campus Partnerships for
Health. http://www.ccph.info
• Community Placed Research: Research that involves study
procedures conducted in an organized community setting (outside
an academic medical center). Involves a one time or short-term
relationship between the investigator and the community, with
limited community involvement beyond being a venue for
recruiting research participants or for implementing research
procedures. (U of MN)
Performance of Community Based Research,
http://www.ctsi.umn.edu/community/assets/CommunityBasedResearchGuidance.pdf, last
accessed June 2, 2011
Principles of Community Engagement
• Investigators and communities understand what community engagement in
research means
•
•
•
•
•
•
•
•
•
•
•
•
Strong community/investigator partnership
Communities and investigators share power and responsibility equitably
Equitable inclusion of diverse perspectives and populations
Clear and relevant research goals
Mutual benefit
Capacity building
Respect and recognition
Continuous communications
Transparent monitoring and evaluation process
Appropriate policies regarding ownership and dissemination of results
Translation of research findings into policies, interventions, or programs
Sustain the relationship and the research outcomes
NIH Council of Public Representatives
http://copr.nih.gov/reports/Definitions_of_CE_and_PP_Revised_508.pdf
“How” is NIH community
engagement?
• NIH Director’s Council of Public
Representatives
• NIH National Center of Research
Resources?
• Clinical and Translational Science
Awards
• Community Based Participatory
Research
• Practice Based Research Networks
NIH: Values for Investigators Who Want to
Engage Communities in Their Research
• Investigators and
communities understand what
community engagement in
research means
• Strong communityinvestigator partnership
• Communities and
investigators share power and
responsibility equitably
• Equitable inclusion of diverse
perspectives and populations
• Clear and relevant research
goals
• Mutual benefit
•
•
•
•
Capacity building
Respect and recognition
Continuous communications
Transparent monitoring and
evaluation process
• Appropriate policies regarding
ownership and dissemination
of results
• Translation of research
findings into policies,
interventions and programs
• Sustain the relationship and
the research outcomes
NIH COPR: Community Engagement Framework for Development of Education/Training For Researchers
Challenges of Community Engagement
• Scientists
•Engagement and
Collaborative Skills
•Community Expectations
•Academic
•Institutional
•Funder
•Local partner
•Incentives/Professionalism
•Resources
•Partners?
•Funds
•Methodologies
• Communities
•Engagement Skills
•Collaboration
•Organization
•Fund of Research
Knowledge
•Interest
•Incentives
•Resources
•Partners?
•Time
Challenges for “CEPBR”
• IRB issues (coverage, others)
• FWA support and community protections
• Many providers and many sites (many
potential CBO contacts to manage)
• Geographic dispersion complicates
communication and relationship-building
• Representativeness of networks and
network CBO partnerships for
generalization of results
• Disparity of expectations for timing and
rigor
Challenges of Community Engagement
Approaches
• Bottom-up capacity for community
idea generation
• Inventory of academic technical skills
• Offer to communities as a
resource for project and program
evaluation
• Community advisory boards
• Communication mechanism to solicit
and provide feedback from
communities
Approaches (cont)
• Identify network member champions
who are engaged with community
• Clear mission/vision that involves
work outside the medical practice
• Establishing network values and
principles that promote and
respect community partnership
(COPR)
• PRINS-like inventory of communities
Example of Community Partnered Practice-Based
Research: Community Health Workers in the
Advanced Transdisciplinary Health Care Home
Intended to explore how coordination of medical team models with community
services could reduce health disparities
Improvements in preventive service and chronic disease management outcomes
directly impacted practice modification
•
•
•
•
•
Partnerships with Community
Skills/Methods Development
Staff Career Development
Community Capacity
Expansion to other practices
and grants
•
•
•
•
•
•
Improved Practice Outcomes
Team Care Best Practices
HCH Certification Support
State Policy Impact
National Exposure
Direct Impact on Practice and
Community Health
Practice-Based Research Network
Take home messages
• The translational research process is a
paradigm shift
• But one that really can enhance
moving discoveries into practice
• Community engagement can and should
occur and add value to all research
• Incentives and resources must better
align if community engagement is to
improve the translation of research into
practice
“Many people say that it is the intellect
which makes a great scientist.
They are wrong: it is character.”
- Albert Einstein
Thank You!