Workshop: Engaging Patients in the Research Process Monday, September 23 rd, 2:30-4:30 PM Shapiro Board Room
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1 Workshop: Engaging Patients in the Research Process Monday, September 23 rd, 2:30-4:30 PM Shapiro Board Room Danielle Lavallee, PhD, PharmD Developing Patient-Centered Research Also Featuring: Maureen Fagan, DNP, MHA, and Dena Salzberg, BSN Register Online on the BWH Event Calendar or
2 Next Seminar Mon, October 21, 4 pm 5 pm Anne Beal, MD, MPH Deputy Executive Director and Chief Officer for Engagement, Patient-Centered Outcomes Research Institute PCERC Contact Information: Daniel Solomon, PCERC Co-Director (dsolomon@partners.org) Joel Weissman, PCERC Co-Director (jweissman@partners.org) Joshua Di Frances, Biomedical Research Institute Project Manager (jdifrances@partners.org)
3 2013 BRIght Futures Prize Join us and be part of this unique opportunity to help shape the future of research and patient care by watching each of the three 2013 finalists videos below, reading the Q & A with each finalist and voting for your favorite project! The project with the most number of votes will be awarded $100,000 at BWH Research Day on Thursday, November 21, Anyone can vote, but you may only vote once, so remember to share the BRIght Futures Prize link with your friends, family and colleagues and encourage them to vote as well! Vote at:
4 Enhancing Research through Patient Engagement Patient and Stakeholder Engagement Workshop Brigham & Women s Hospital Patient-Centered Comparative Effectiveness Research Center September 23, 2013 Danielle Lavallee, PharmD, PhD Surgical Outcomes and Research Center University of Washington, Department of Surgery lavallee@uw.edu
5 Improving Healthcare 5
6 Patient-Centered Outcomes Research Helps people and their caregivers communicate and make informed health care decisions, allowing their voices to be heard in assessing the value of health care options. This research answers patient-centered questions such as: Given my personal characteristics, conditions and preferences, what should I expect will happen to me? What are my options and what are the potential benefits and harms of those options? What can I do to improve the outcomes that are most important to me? How can clinicians and the care delivery systems they work in help me make the best decisions about my health and healthcare? 6
7 Improving Healthcare 7
8 8
9 Mullins CD et al. Continuous Patient Engagement in Comparative Effectiveness Research. JAMA 2012;307(15):
10 Experience from CERTAIN Patients: Provide an insiders perspective Articulate the most pressing questions and concerns Help us think through what information should be relayed and how 10
11 Patient Advisory Board Quarterly meetings to advise on general or one-off issues in CERTAIN. Assist in developing network. Provide mentorship to new Patient Advisors. Participate in other opportunities as interested. Patient Network Community Ad hoc participation in research activities Research Partners Partners in research project development, implementation, and communication of results
12 CERTAIN Patient Advisory Board 7 current patient advisors Quarterly in-person meetings Active input on: Current initiatives PRO questionnaires Making data transparent to patients
13 Patient-Reported Outcomes Are the outcomes relevant to patients? Is the timeframe reasonable? What modes of administration are feasible?
14 As Co-investigators Lumbar Epidural Steroid Injections for Spinal Stenosis (LESS) Study Provide perspective on outcomes of importance to patients Inform material development Recruitment Focus group materials Report development Participate in meetings Ask challenging questions!
15 Lessons Learned Patient involvement in research is a new concept for researchers AND for patients Clearly articulate the need and expectation for involvement Develop resources for facilitating involvement (or use existing ones!) Document, document, document! It is personal make it personal
16 Acknowledgements CERTAIN Core Leadership The Surgical Care and Outcomes Assessment Program (SCOAP) is a Coordinated Quality Improvement Program of the Foundation for Health Care Quality. CERTAIN is a program of the University of Washington, the academic research and development partner of SCOAP. Personnel contributing to this study: Centers for Comparative and Health Systems Effectiveness (CHASE Alliance), University of Washington, Seattle, WA: David R. Flum, MD, MPH; Rafael Alfonso-Cristancho, MD, MSc, PhD; Alexander Clowes, MD; Beth Devine, PharmD, MBA, PhD; Todd Edwards, PhD, MA; Farhood Farjah, MD, MPH; John Gore, MD, MS; Larry Kessler, ScD; Danielle Lavallee, PharmD, PhD; Mark Meissner, MD; Donald Patrick, PhD, MSPH; Sean D. Sullivan, PhD; Peter Tarczy-Hornoch, MD; Erik Van Eaton, MD; Thomas Varghese, MD; Jonathan Wright, MD; N. David Yanez III, PhD; Meliha Yetisgen-Yildiz, PhD, MSc; Allison Devlin, MS.
17 Thank you! Danielle Lavallee, PharmD, PhD Surgical Outcomes and Research Center University of Washington, Department of Surgery
18 Successful Strategies: Incorporating Patient Advisors and Stakeholders to Research Teams Maureen Fagan, DNP, MHA, WHNP-BC, FNP-BC Dena Salzberg BSN, Patient Advisor
19 AIMS AND AGENDA Welcome and Introductions Understanding Patient and Family Centered- Care and why its beneficial Recognizing the opportunities for research involvement Recruiting, training and supporting the Patient and family advisors
20 PATIENT FAMILY CENTERED CARE Patient and Family Centered Care is working WITH patient and families, rather then doing something TO or FOR them.
21 PATIENT AND FAMILY CENTERED CARE CORE CONCEPTS People are treated with respect and dignity Health care providers communicate and share complete and unbiased information with patients and families in ways that are affirming and useful Individuals and families build on their strengths through participation in experiences that enhance control and independence Collaboration among patients, families and providers occurs in policy and program development and professional education as well as in the delivery of care.
22 WHY INVOLVE PATIENTS AND FAMILIES AS ADVISORS Bring important perspectives Teach how the system really works Inspire and energize researchers Keep researchers honest and grounded in reality Provide timely feedback and ideas Lessen the burden on researchers to create the aims and research question.. Researchers don t have to have all the questions Bring connection with the researcher s scientific focus Offers an opportunity to give back to science
23 ELEMENTS OF COLLABORATION Mutual respect for skills and knowledge Honest and clear communication Understanding and empathy Mutually agreed upon goals Shared planning and decision-making Open and two way sharing of information Accessibility and responsiveness Joint evaluation of progress Absence of labeling and blaming
24 BWH PFAC COUNCIL CHART Steering Committee (9 Patient/Family Advisors) Existing Launching Preparing NICU (4 Patient/Family Advisors) Neuro CIC (2 Patient/Family Advisors) South Huntington Medical Home (4 Patient/Family Advisors) Patient & Family Nursing Education Committee (1 Patient/ Family Advisor) Perioperative BWH Violence Prevention Committee Oncology CIC (3 Patient/Family Advisors) Continuum of Care (2 Patient/Family Advisor) Neuroscience Brigham Research Institute Ambulatory Council (2 Patient/Family Advisors) Shapiro (18 Patient/Family Advisors) Psychiatry (Seasonal Affective Disorder) Ortho CIC (1 Patient/Family Advisor) OB (4 Patient/Family Advisors) ED (3 Patient/Family Advisors)
25 SHAPIRO PATIENT AND FAMILY ADVISORS
26
27
28 FORM RESEARCH PARTNERSHIPS
29 BRI OPPORTUNITY 1. Inventoried subject matter of the BWH/Researchers 2. Match the BWH/advisor s narratives with the research content 3. Introduce the researcher-advisor pair and explored how the advisor would enhance the study 4. Facilitate the pair/council to build the study together
30 BWH RESEARCH ADVISOR METHOD Create a BRI Council Tutor the advisors in Scientific Method Tutor the researchers in PFCC patient experience of care Designed, implemented and facilitated the first PCORI grants
31 PRE- FRAMEWORK MEETINGS Meet and Greet meeting to hear narratives Scientific presentation of the research project Further discussion with large patient group to identify appropriate advisors for research Final meeting to test the current hypothesis for patient and family validation
32 BWH PATIENT ADVISOR FRAMEWORK Researcher Hypothesis Specific Aim Methods Measures Results Recommendations Summary What is the research question? Patient centered aims Qualitative & Quantitative From the researcher and patient advisor perspectives From the researcher and patient advisor perspectives Dissemination framework in the patient advisors and researchers voice Patient
33 PATIENT CENTEREDNESS Are patients and clinicians asking for this research Is there a need for new research Research format: design, implementation, dissemination Think about a dissemination framework Will this research make a difference to patients and clinicians Patients positioned to lead the translation committees Create transparency, efficiency, and enable collaboration between patients and researchers Will the research still be valid after the report is published
34 RESEARCH AIMED AT: Asking the question: what do patients and their families need to know? What research can change practice ( knowing that transparency and openness in during the process and dissemination helps with adoption ) Removing the power gradient between patients and providers
35 PATIENT/STAKEHOLDER ADVISORS INVOLVEMENT Participate in the formation of the research questions Collect the patients perceptions of the data/problem Understand what are patients the experts in Patients will report their own outcomes How would patients design the dissemination? Create a sustainable culture of deep collaboration among patient advisors and researchers
36 EMBRACE THE OPPORTUNITY TO DO RESEARCH DIFFERENTLY JOE SELBY MD, MHP
37 Developing Patient-Centered Research Brigham & Women s Hospital Patient-Centered Comparative Effectiveness Research Center September 23, 2013 Danielle Lavallee, PharmD, PhD Surgical Outcomes and Research Center University of Washington, Department of Surgery lavallee@uw.edu
38 PATIENT-CENTERED OUTCOMES RESEARCH Who gets to say what s patient-centered? (Hint: the one who s IN the center) ~ e-patient Dave
39 A RESEARCHER S PERSPECTIVE What characterizes Patient-Centered research How patients inform research How to frame patient-involvement
40 CER PCOR
41 CER PCOR Generates evidence to inform healthcare decisions Incorporates patient-reported outcome Compare different prevention, treatment, diagnostic strategies Incorporates patient-reported outcome
42 CER PCOR
43 HIGHLIGHTS OF PATIENT-CENTERED APPROACHES United States 1993 CARRA United Kingdom 1995 Cochrane Consumer Network 1996 INVOLVE 2004
44 LEVELS OF INVOLVEMENT/ENGAGEMENT
45 LEVELS OF INVOLVEMENT/ENGAGEMENT
46 LEVELS OF INVOLVEMENT/ENGAGEMENT
47 Engage Use Patient- patient Reported informants, Outcomes when persons patients or people representative risk of of a the condition population are the of best interest, source in all of phases information. of PCOR Public comment draft report of the Patient- Centered Outcomes Research Institute (PCORI) ~Draft report Methodology of Patient-Centered Committee Outcomes July 23, Research 2012 Institute (PCORI) Methodology Committee Mullins CD et al. Continuous Patient Engagement in Comparative Effectiveness Research. JAMA
48 PATIENT-CENTERED APPROACHES: CASE STUDIES
49 TOPIC PRIORITIZATION
50
51 DEVELOPING GUIDANCE FOR RESEARCH Are the outcomes relevant to patients? Is the timeframe reasonable? What modes of administration are feasible?
52 PROS IN ONCOLOGY Center for Medical Technology Policy. Effectiveness Guidance Document: Recommendations for incorporating patient-reported outcomes into clinical comparative effectiveness research in adult oncology
53 PATIENTSLIKEME DISRUPTING RESEARCH Wicks P, Vaughan TE, Massagli MP, Heywood J. Accelerated clinical discovery using self-reported patient data collected online and a patient-matching algorithm. Nat Biotechnol May;29(5): Epub 2011 Apr 24.
54 SOCIAL NETWORKING AND RESEARCH ADVANCEMENT Speed Traditional Clinical Trial About a year and a half to design and recruit. Additional time to analyze data Social Network ALS lithium trial Nine months to design, recruit and present preliminary results Recruitment Patients are recruited via doctors, usually at specialist centers in urban areas Patients self-select through the Internet, regardless of where they live Control Group Data Openness Patients randomly selected to receive placebo Group data are published Patients selected by closeness in historical progression of the disease Group and individual data are made available online ALS Study Shows Social Media's Value as Research Tool, Wall Street Journal, April 25, 2011
55 PATIENT-CENTERED OUTCOMES RESEARCH INSTITUTE (PCORI) Building knowledge in PCOR and patient involvement Setting standards for methodolgy Actively evaluating patient involvement to advance best practices Rapid dissemination of information Webinars Town Halls Newsletters
56 APPROACHING PATIENT ENGAGEMENT FOR RESEARCH
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58
59 WHY? Why am I planning to engage patients in my research? Do I want help prioritizing research? Do I want to understand what outcomes are important? Do I want to understand how patients seek/use information? What are the risks and opportunities for engagement? Is this a contentious topic? What are the risks of not engaging patients? Why not?
60 WHO? Who should be represented? Consider diversity in both populations represented & opinions present Consider patients, caregivers, family members Note: to answer the first two questions ask patients! Who is best to engage? Which one(s) - advocates versus patients/caregivers versus consumers? What role/position does the person hold? Does the person need decision-making power within an organization?
61 WHAT? What do we wish to accomplish? What should patients expect? What are the goals of involvement? What is the time frame and commitment? What support is provided? What techniques should we use for broadly engaging patients? Interviews Surveys Focus groups
62 WHEN AND WHERE? When will patient engagement occur in the process? One-time engagement vs. engagement throughout the life of a project For long-term activities considers approaches to sustain and maintain involvement Where will activities be conducted? Consider location of patients (and all stakeholders) Consider needs of patients
63 HOW? How will engagement be evaluated? What criteria will be used? How will evaluations occur (survey, interview, etc) How will findings inform future work? How will patients and the research team be informed of evaluation results?
64 A FEW RECOMMENDATIONS Patient engagement plans should link to the research plan Allot appropriate time for planning and involve patient partners in the process Evaluate the process from both the patient and research team s perspective Build relationships collaboration becomes easier when you know your partners Involve a facilitator when needed communication & communication management is key
65 FUTURE RESEARCH NEEDS The effect of patient involvement on the research process Understanding the most effecting methods for engagement The effect of patient involvement on health outcomes through: Better evidence? More informed decision-making?
66 FINAL THOUGHTS Collaborate Evaluate Document & Report
67 THANK YOU! DANIELLE LAVALLEE, PHARMD, PHD SURGICAL OUTCOMES AND RESEARCH CENTER UNIVERSITY OF WASHINGTON, DEPARTMENT OF SURGERY
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