Community-Engaged Practice Based Research: The Mayo Clinic Experience

1. 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

2. 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

3. 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

4. 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

5. 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-to-bedside approach to translational research is really a two-way 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

6. 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!

7. 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

8. 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

9. 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.

10. Why Practice-Based Research?A Typical Month of Healthcare in the United States Green LA et al: N Engl J Med344(26):2021, 2001

11. 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

12. United States PBRN Environment Networks Medical Dental Nursing Pharmacy Public Health Federal Funding: NIH AHRQ CDC

13. 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.

14. Network Provider Comparison with MN/WI State Providers

15. MHS PBRN Survey: Participatory and Educational Research Interest

16. Respondent Interest in Participation in Practice-Based and Translational Research Research Type % of respondents somewhat very interestedinterested 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%

17. MHS PBRN Survey: Interest in Research Roles Among Respondents Review proposals and provide feedback Recruit participants for ongoing studies other than my own Develop research ideas to share or for others to implement Participate in others’ studies Run an occasional study in an area that interests me Run a sustainable program of research

18. MHS PBRN Survey: Previous Research Experience Among Respondents Helped recruit participants to clinical research studies • Examples of “Other” Experiences: • REP Studies • Direct data collection • Developed project but couldn’t get it funded • Master’s thesis • WREN office-based research participant • Basic science research with NIH/AHA support • Ran the PROS network for North Dakota • IRB approved project, not taking off because of lack of funds • Airborne allergens in Middle East Collaborated or served as a co-investigator In clinical research studies Led studies (PI) Other

19. 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.”

20. 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]

21. 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…”

22. 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

23. What is Community Engagement?

24. 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

25. 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

26. 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

27. 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

28. “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

29. 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 and programs Sustain the relationship and the research outcomes NIH: Values for Investigators Who Want to Engage Communities in Their Research NIH COPR: Community Engagement Framework for Development of Education/Training For Researchers

30. 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 of Community Engagement

31. 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

32. Challenges of Community Engagement

33. 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

34. 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

35. Example of Community Partnered Practice-Based Research: Community Health Workers in the Advanced Transdisciplinary Health Care Home Partnerships with Community Skills/Methods Development Staff Career Development Community Capacity Expansion to other practices and grants 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 • 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

36. 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

37. “Many people say that it is the intellect which makes a great scientist.They are wrong: it is character.”- Albert Einstein

38. Thank You!