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DII - A Patient Engagement Workbook for Research Teams


Published on

August 2, 2017

Sarah Madrid
Co-Chair, HCSRN Patient Engagement in Research SIG
Institute for Health Research, Kaiser Permanente or Colorado

A presentation of the Southern California Regional Dissemination, Implementation and Improvement Science Webinar Series

Provided by the UCLA CTSI

Published in: Education
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DII - A Patient Engagement Workbook for Research Teams

  2. 2. o Scientific Interest Group since 2014 • Today: 117 members representing 13 HMORN member organizations, the VA, PCORI, and other academic research institutions o Mission of the SIG: Improve the HCSRN’s capacity to meaningfully engage patients as members of research teams to increase the value and applicability of research findings for patients, and to enable them to make informed healthcare decisions and achieve better health outcomes. [HCSRN: Healthcare Services Research Network]
  3. 3. o Develop a community of engagement practice among HMORN researchers, patients and other stakeholders o Conduct baseline and follow up assessments of engagement resources available in member organizations o Consult on building engagement infrastructure within member organizations o Consult on planning for and implementing patient engagement in all phases of research o Recruit patient partners as members of the SIG o Identify best practices for measuring the engagement of patient partners
  4. 4. Purposes of Survey: 1. Elicit engagement practices of HMORN research teams 2. Identify best practices in engagement 3. Develop a tool for research teams
  5. 5. o Roles and Stages of Engagement o Identification/Recruitment/ Screening o IRB Oversight o Organizational Support o Compensation/Contracting/Hiring o Training – Patient Partners and Research Team o Data Sharing o Feedback and Evaluation/Retention Results of survey used to create a user’s manual for researchers preparing to engage patients in research.
  6. 6. As a basis for customization to individual research teams or research shops Examples: o include organization-specific templates for contracting or hiring o add decision flows for determining appropriate compliance trainings depending on intensity or duration of engagement o incorporate organizational standards for compensation
  7. 7. I. Why Engage Patient Partners on This Study? OUTCOME: Reasons for engagement are clearly articulated Justify the need for engaging patients on the research team: Notes: Is engagement required for the study proposal? How will the patient perspective enhance the study? At what stages of the research process will patients be engaged? How much will it cost to engage patients on the study? (see following slides) Do the benefits of engagement outweigh the costs?
  8. 8. Estimating Costs of Engagement: How much time will it take to: Identify and recruit patient partner(s) Train patient partner(s) and research team Consult with IRB/Compliance Consult with HR, IT, Sponsored Projects, or Member Relations Evaluate the impacts of engagement on project and research team Other
  9. 9. Estimating Costs of Engagement (cont.): Consider costs of: Notes: Compensating patient partner(s) Reimbursing partner(s)’ expenses (transport, parking, mileage, etc) Travel for patient partner(s) to conference(s) to present study findings Other
  10. 10. II. Define the role(s) of patient partner(s) on the team: Outcome: Clear role statement(s) for patient partner(s) Roles # Stage(s) of Research Define the roles and list the responsibilities Investigator/Co- Investigator Consultant Advisory panel member Focus group member Research staff: who will have primary responsibility for communicating with patient partner(s)?
  11. 11. III. Engagement Logistics OUTCOME: Logistics are thought through; preparations begun For each patient partner to be engaged, answer the following: How often will s/he be needed and for how long? When will s/he be needed? Where will s/he need to go? How many weeks/months/years will s/he be needed? How much will s/he be compensated? In person or virtual participation? What kind of contract(s) will be needed?
  12. 12. Compensation Considerations List any limitations or compensation restrictions NB: Compensation should be proportional to the role(s) played by the patient partner(s) Organizational restrictions? Budget limitations? Equity with other team members? Other?
  13. 13. Compensation Considerations (cont.) Context? Contracting? • Adopt compensation rates used in other studies – adequate? • Any relevant organizational requirements? • Use the government consultant rate? (recommended by PCORI) • Volunteer basis (not recommended)? • Will you reimburse participant travel? (recommended by PCORI) • Consulting/service agreement? • Confidentiality issues?
  14. 14. IV. Identification & Recruitment of Patient Partners OUTCOME: Clear description of patient partner you want to target Define any inclusion or exclusion criteria for recruiting patients to the team according to the specific needs of the study: Disease burden/ health condition/ experience? Particular demographic or other characteristic(s)? Other inclusion or exclusion criteria?
  15. 15. V. Recruitment: assess options and needs of study OUTCOME: Recruitment strategy(ies) that best fits study needs Options: Options: Existing patient panels or patient support groups Social media Referrals from clinicians/providers Internal patient registry Health system broadcast communications to members Online “matching” registry Flyers in clinics Flyers at disease specific fundraisers/community events Referrals from/network with community organizations Local media advertising
  16. 16. VI. IRB/Compliance OUTCOME: Clear guidelines to meet any IRB oversight requirements, or to receive formalized exemption Review recruitment and engagement plans with IRB: Notes: Does IRB require oversight or review of patient engagement? What documentation is required by IRB for patient partners on your research team? Are you accessing PHI in your identification or recruitment processes? What are the potential risks – and benefits - to the patient(s) in joining the research team?
  17. 17. Focus Group Stakeholder Advisory Panel SCOPE OF WORK? Research Team Collaborator: - data collection - instrument development - community gatekeeper - data analysis review and/or interpretation - dissemination activities - research question generation -conference attendance and/ or presentation - manuscript development/ report writing FREQUENCY of PARTICIPATION? One Time Episodic On-going Intense On-going Gift card Confidentiality agreement if needed MoU or 1 Day Service Agreement Stipend or Gift card Independent Contractor Service Agreement [ICSA] Stipend COMPENSATION? C o n t i n u u m o f E n g a g e m e n t INPUT? DATA Advice/Opinion/ Guidance/Perspective USE of INPUT? Conduct Research I.e., analyze, publish data Design, Interpretation and Improvement of Processes
  18. 18. VII. Other Departments OUTCOME: Organizational approvals in hand, and cooperation in preparing for patient partners Review the implications of your recruitment and engagement plans with: Sponsored Projects office Human Resources IT Governance or Member Relations
  19. 19. VIII. Prepare to Screen Promising Candidates Note: Characteristics of the ideal candidate(s) will depend on specifics of your study. Over-recruit to accommodate attrition during screening. OUTCOME: Prepared to select best candidate(s) for positions Select screening method(s): Personal interviews (phone or in- person) Survey or questionnaire administered remotely Previous participation on a study Prepare screening questions:
  20. 20. IX. Screening Practices (1/2) Guidelines to Avoid Bias: Comments: Patient(s) shows ease expressing self, including when opposing views are aired No apparent desire for a platform to communicate dissatisfaction Previous experience in a similar capacity (e.g., in a school, faith community, etc.) Isn’t already “savvy” about negotiating the health system (depends on role(s) – not necessarily a disadvantage) Is the study topic controversial? If so, determine whether patient holds extreme views for or against the topic. If so, how will that affect her/his participation?
  21. 21. Screening Practices (2/2) Communicate Logistics: Role on study Expectations for participation Study timeline Time requirements Compensation Training Ground rules Answer patient(s)’ questions; give her/him time to consider participation. OUTCOME: confirmed patient partner(s) who understand all aspects and expectations of participation.
  22. 22. X. Research Team Training OUTCOME: research team is prepared to work respectfully and effectively with patient partners. Train current research team members in preparation for working with patient team members Review goals of engagement and role requirements for patient(s) Clarify expectations for patient(s) engagement Review any institutional restrictions (e.g., on information sharing) Emphasize the rules of engagement; the patient(s)’ expertise is her/his experience as a patient
  23. 23. 6 Meta-Criteria for successful engagement: 1. TRUST 2. RESPECT 3. ACCOUNTABILITY 4. LEGITIMACY 5. FAIRNESS 6. COMPETENCE Lavallee DC et al., “Stakeholder engagement in CER: how will we measure success?” JCER, 1(5), 1-11 (2012)
  24. 24. XI. Formalize OUTCOME: patient partner(s) is assured that her/his participation is official, and integration into research team is initiated. Complete on-boarding formalities with patient partner(s): Collect information for initiating the compensation mechanism Execute any contractual mechanism(s), including confidentiality agreements Provide organizational employee information as needed, including email address and password(s) Establish data sharing protocols
  25. 25. XII. Train Patient Partner(s) OUTCOME: Patient partner(s) can be fully engaged in the study, feel useful and valued, and share her/his expertise willingly Conduct as needed for your particular study: IRB/HIPAA/Human Subject training Health plan or organizational information; required health system training(s) Develop ground rules for participation, including grounds for termination Specifics of study; context, background, design, etc. Specific role(s) on the study and responsibilities for both research staff and patient partner(s) Timeline and logistics of participation: when, where, how long, how often Value of patient(s)’ perspective, importance of speaking up, especially in disagreement or when unclear on an aspect of the study Training materials: glossary, acronym list, study abstract (if available), other Organizational policies (dress code, etc.)
  26. 26. Retention of Patient Partner(s) Honesty, Transparency, and Respect Communication = the key to retention Establish and maintain close relationships with the patient partner(s) Send regular updates on project progress unless patient partner(s) attends frequent, regular meetings with the rest of the research team Ask patient partner(s) what you can do for them to enhance the benefits to them of participation. Maintain good partner relationships throughout lifetime of study, from pre-proposal through closeout and beyond. Hold team buildings to enhance communication and relationships among all team members (FOOD helps!)
  27. 27. XIII. Monitoring and Evaluation OUTCOME: Patient partner(s) feels heard and respected as valued study team member(s) Schedule a regular opportunity for patient partner(s) to provide feedback on their experiences. Should be a “safe” space for truthful feedback Establish clear ground rules for facilitated group discussions Online or written evaluation Provide feedback to patient partner(s) on her/his participation Respond to patient partner concerns or issues End the patient partner’s participation if necessary At the final evaluation, ask patient(s)’ preferences for being contacted again in the future for information updates or possible participation in other studies
  28. 28. Assessing Impact of Patient Engagement in Research: effects on the research process COREComponentsby ResearchStage Overarching Principles(common toALLstages) DesiredOutcomesby ResearchStage IMPACTFLOW Stage 1: developing the research question - measurable Stage 2: developing the research proposal - Balance of scientific rigor and incorporation of partner suggestions Stage 3: administrative pre-launch - shared responsibilities Stage 4: recruitment and data collection - methods implemented with integrity -adaptability - meet pts where they are - ensure truly “informed” consent Stage 5: data analysis - timeliness - examine real world implications Stage 6: dissemination and implementation: Diverse methods used; timely dissemination, translation and adoption; Legitimacy of results; relationships with partners sustained Question reflects, is relevant, meaningful and impactful to the community and its stakeholders, and is understood by all Scientific rigor, including plans for data sharing, dissemination & implementation , and assessment of impact Appropriate training; shared responsibility for ethics/protections; shared development of IRB, HR, training, and budget; transparent consent forms/language Anticipates participant issues; methods are feasible for participants and respect diversity; Clear, engaging, transparent materials, messaging, methods for recruitment that foster fair, ethical, and informed consent; tailored incentives; unbiased methods ensure diverse sampling Share data and information iteratively with partners; incorporate partner interpretations on data, solicit potential community stigmas; community relevance; protect/respect community Timely, far-reaching messaging done thru multiple channels; process AND results disseminated; translated/ adopted appropriately; sustained partner relationships; partners as advocates/ champions; no undue evaluation burden on partners Patient Centeredness – reflects/respects patient needs, preferences, experiences Plain Language – all information is accessible to all partners “Teamness” - shared responsibility for study; partner insights validated/incorporated Check assumptions: researchers and partners Outcomes have meaning/value to partners and community Capacity Building – partners gain skills and knowledge through experience and/or training Relevant question Improved study design Relevant proposal More effective methods Better and sustained recruitment Higher quality data Improved data interpretation More legitimate results Higher chance of translation/adoption Results communicated more broadly/ effectively Improved clinical practice and health outcomes
  29. 29. XIV. Closure: End of Study OUTCOME: Opportunity for all team members to reflect on value of study and relationships developed Sun-setting suggestions: Share study results if patient partner(s) hasn’t been involved in later stages of study Make a formal expression of gratitude for patient partner(s)’ contributions, e.g., provide a certificate of participation for patient partner(s) Hold a team gathering to debrief on successes/challenges, and to celebrate a job well done Ask partner to provide a summary of her/his experience, including high and low points, motivation for participating, and value of it personally and for the research.
  30. 30. Acknowledgements: • Ellis Dillon, Leah Tuzzio: co-chairs of the HCSRN Patient Engagement in Research Scientific Interest Group (PER SIG) • PER SIG membership (to join this listserv, contact • Note: Flow diagram on p.17 is a product of collaboration with Borsika Rabin. • Note: Flow diagram on p.28 is a product of the HCSRN Impact Assessment Workshop, Oct. 26-28, 2016. We thank Ellis Dillon, Bob Greenlee, Jacquetta Hinton, Deb Multerer, Gina Napolitano, Heather Olden, Mary Schramke, Ursula Salas, Leah Tuzzio, and Neely Williams for their collaboration on the workshop and the flow diagram.
  31. 31. Sarah Madrid Sr. Project Manager, Institute for Health Research, Kaiser Permanente of Colorado 303-614-1358 (T) Plan_Field/HMORNPatientEngagementWorkbook.pdf