Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.

CER 2016 Hernandez patient engagement

338 views

Published on

CER 2016 Hernandez patient engagement

Published in: Healthcare
  • Be the first to comment

  • Be the first to like this

CER 2016 Hernandez patient engagement

  1. 1. Team Science: Partnering with Patients Adrian F. Hernandez, MD, MHS Director, Health Services and Outcomes Research Associate Director, DCRI
  2. 2. All Rights Reserved, Duke Medicine 2007 What problems are we trying to solve? 1
  3. 3. All Rights Reserved, Duke Medicine 2007 A Persistent Problem – Major Gaps in Evidence 3 Tricoci P et al. JAMA 2009;301:831-41
  4. 4. All Rights Reserved, Duke Medicine 2007 Level of Evidence A Current Guidelines* *Guidelines expressing*Guidelines expressing Level of EvidenceLevel of Evidence 11.7%11.7% 26.4%26.4% 15.3%15.3% 13.5%13.5% 12.0%12.0% 22.9%22.9% 6.4%6.4% 6.1%6.1% 23.6%23.6% 0.3%0.3% 9.7%9.7% 11.0%11.0% 19.0%19.0% 4.9%4.9% 4.8%4.8% 0%0% 10%10% 20%20% 30%30% AFAF Heart failureHeart failure PADPAD STEMISTEMI PerioperativePerioperative Secondary preventionSecondary prevention Stable anginaStable angina SV arrhythmiasSV arrhythmias UA/NSTEMIUA/NSTEMI Valvular diseaseValvular disease VA/SCDVA/SCD PCIPCI CABGCABG PacemakerPacemaker Radionuclide imagingRadionuclide imaging
  5. 5. All Rights Reserved, Duke Medicine 2007 Trial Hyperinflation Berndt E, Cockburn I. Monthly Labor Review, June 2014
  6. 6. All Rights Reserved, Duke Medicine 2007 The Driver is Complexity Berndt E, Cockburn I. Monthly Labor Review, June 2014
  7. 7. All Rights Reserved, Duke Medicine 2007 Surprisingly….. Less Participation Berndt E, Cockburn I. Monthly Labor Review, June 2014
  8. 8. All Rights Reserved, Duke Medicine 2007 How Can We Engage Patients (Participants)? 2
  9. 9. All Rights Reserved, Duke Medicine 2007 Post Approval Studies Create stud y proc edur e Implemen t the Stud y Monitor the stud y Analyze data and interpret results Dissemi- nate study infor matio n FDA Review and Approv al Develop the study conc ept Secure Funding Prepare the Stud y Proto col • Provide input on study design such as barriers to participation, study endpoints, and risk/benefit perception • Provide input on study design such as barriers to participation, study endpoints, and risk/benefit perception • Recruit study participants • Serve as a peer advocate during the informed consent procedure • Recruit study participants • Serve as a peer advocate during the informed consent procedure • Provide feedback on how the patient community will view results • Provide feedback on how the patient community will view results •Work with research team to ensure study participants get feedback from study •Write newsletter articles or blog about results • Co-present results with researcher at a conference or support group •Work with research team to ensure study participants get feedback from study •Write newsletter articles or blog about results • Co-present results with researcher at a conference or support group •Serve on a Data Safety Monitoring Board • Provide recommendations for revising study protocol if changes need to be made •Serve on a Data Safety Monitoring Board • Provide recommendations for revising study protocol if changes need to be made •Work with researcher to secure NIH, PCORI, AHRQ funding • DART & Halo Therapeutics, e.g. raise seed funding •Fundraise for own research •Work with researcher to secure NIH, PCORI, AHRQ funding • DART & Halo Therapeutics, e.g. raise seed funding •Fundraise for own research • Help finalize eligibility criteria within the study protocol • Assist in creating the informed consent form • Advise study recruitment • Help finalize eligibility criteria within the study protocol • Assist in creating the informed consent form • Advise study recruitment Across the continuum? • Provide information on unmet need aand therapeutic burden • Interest of research question to patient community • Provide information on unmet need aand therapeutic burden • Interest of research question to patient community • Serve on FDA advisory committees or post- market surveillance initiatves • Serve on FDA advisory committees or post- market surveillance initiatves Courtesy: Bray Patrick-Lake, MFS
  10. 10. All Rights Reserved, Duke Medicine 2007 Common problems with protocols from patient perspective • Exclusion/inclusion criteria so stringent that no “real” patients meet criteria • Study not feasible – Procedural burden too high – Unmanageable dosing regimen – Too many study appointments – Location not convenient – Pediatric patients needing to be seen during school hours Courtesy: Bray Patrick-Lake, MFS
  11. 11. All Rights Reserved, Duke Medicine 2007 Perspectives on Patient Engagement Per Investigator (Worries) • Single-minded focus on cures • Disrupt or delegitimize the peer review process • Bring an agenda or too much emotion • Lack sufficient experience to speak to essential issues of scientific merit Per Patient (Benefits) • Inspire scientists • Improve plans for recruitment, retention, outreach, follow up, dissemination • Provide “real life” perspectives on risk/benefits • Serve as reminder to ultimate end product of concrete health benefits rather than an ‘academic’ only product
  12. 12. All Rights Reserved, Duke Medicine 2007 Meaningful Patient Engagement is often a foreign language Engagement Worst to Best • Online reports & anecdotes • Patient visits • The sign off • Survey • Focus group • Patient Stakeholders • Co-investigators Translation to Researchers •隨機雙盲對照研究 • 察性研究观 •病例對照研究 •病例對照研究 •案例系列 •病例報告 •想法,意見 Courtesy: Bray Patrick-Lake, MFS
  13. 13. All Rights Reserved, Duke Medicine 2007 Patient Advocate Review of Research • Why is this study important? • Who does this study benefit? • Do patients agree that clinical equipoise exists? • Will this change the standard of care? • Who’s eligible for the study? Are they representative of the patient population? • Are there other similar trials? • Does this fill a gap in research? • Will patients be interested in enrolling? • Is the study feasible? • Is the informed consent readable and clear? • How will study results be communicated? Earp, J.L., French, E.A, and Gilkey, M.B. (2008) Research Advocacy in Traditional Settings: Questions of Influence and Legitimacy. In Patient Advocacy for Health Care Quality: Strategies for Achieving Patient-Centered Care (pp. 445- 478). Sudbury, MA: Jones and Bartlett Publishers.
  14. 14. All Rights Reserved, Duke Medicine 2007 Can Patient (Participant) Engagement Matter? 3
  15. 15. All Rights Reserved, Duke Medicine 2007 What is PROSPER? • Patient-centered Research into Outcomes Stroke Patients prefer and Effectiveness Research • Above all, PROSPER is a research collaboration – Patients – Doctors – Caregivers – Researchers • Multiple perspectives and experiences = better understanding!
  16. 16. All Rights Reserved, Duke Medicine 2007 Patient-Centered Research into Outcomes Stroke Patients Prefer and Effectiveness Research
  17. 17. All Rights Reserved, Duke Medicine 2007 Real, live patients and what they say… “The worse doctor was a… cardiologist” “The doctors didn’t give me the clot-buster because I was on coumadin” “Doctors didn’t listen to what I needed” PROSPER Interview with Lesley Maisch http://www.youtube.com/watch?v=KubuT1_6Lrw
  18. 18. All Rights Reserved, Duke Medicine 2007 A Few Questions… Will statins be as good for me as someone younger? And what dose? Will statins be as good for me as someone younger? And what dose? What are the tradeoffs between long-term health and potential negative effects of my medications? What are the tradeoffs between long-term health and potential negative effects of my medications? I’ve had a stroke and worry about falls. Will blood thinners hurt me? Which one is better? I’ve had a stroke and worry about falls. Will blood thinners hurt me? Which one is better? How do the new anticoagulants affect my likelihood of having another stroke? How do the new anticoagulants affect my likelihood of having another stroke? Can antidepressants improve my quality of life after stroke? Can antidepressants improve my quality of life after stroke?
  19. 19. All Rights Reserved, Duke Medicine 2007 What outcomes are we addressing? – Days alive and at home (“home-time”) – Any fatigue or depression experienced as a result of the stroke – Quality of life – Mobility – Whether patient can complete normal activities like dressing, eating, shopping – How well patients are tolerating their medications/any side effects they are experiencing
  20. 20. All Rights Reserved, Duke Medicine 2007 PROSPER: Personalized Decisions http://www.prosper-stroke.org/
  21. 21. All Rights Reserved, Duke Medicine 2007 Can we do Even better? 4
  22. 22. All Rights Reserved, Duke Medicine 2007 75m+ http://www.cdc.gov/nchs/fastats/hospital.htm Patients walk through the doors of hospitals and clinics each year with questions about their health and their care. How do we study their experiences to find answers and create solutions that change care and improve outcomes??
  23. 23. A United Network: PCORnet PCORnet is a network of patients, clinicians, researchers, health systems and health plans united to efficiently generate evidence to improve patient-centered outcomes “Research Infrastructure Done Differently” “Research Infrastructure Done Differently”
  24. 24. Hallmarks of PCORnet 1. Highly engaged patients, clinicians, health systems, researchers and other partners 2. A collaborative community supported by robust governance 3. Analysis-ready standardized data with strong privacy protections 4. Oversight that protects patients, supports the timely conduct of research, and builds trust in the research enterprise 5. Research that is sustainably integrated into care settings and with communities of patients
  25. 25. Enabling Pragmatic Research: eScreening, eEnrollment and eFollowup 25 4 12 16 30 DCRI FOLLOW-UP •Patient Reported Outcomes •Medication use •Health outcomes Baseline Data ADAPTABLE Enrollee 8 20 …. OR CMS & Payer Virtual Data Warehouse FOLLOW-UP • Longitudinal health outcomes Portal FOLLOW-UP •Patient Reported Outcomes •Medication use •Health outcomes PCORNet Coordinating Center FOLLOW-UP • Via Common Data Model • Longitudinal health outcomes
  26. 26. All Rights Reserved, Duke Medicine 2007 Conclusions  Patients are a driving force in improving care and will be for the research enterprise.  Meaningful engagement of patient stakeholders across the research continuum will improve quality, efficiency and translation of research.  Patient engagement requires an investment of time and resources just like any component of research  Engaging patients as partners for research is inspirational and fun!
  27. 27. All Rights Reserved, Duke Medicine 2007 Thanks! Trials Trial s N

×