Patient and Stakeholder Engagement in Research Chinenye Anyanwu, PharmD, MPH Engagement Officer Patient & Public Engagement P2P Tier A Training June 14, 2018

Discussion for Today What is PCORI? Better Research Through Engagement Facilitating patient and stakeholder engagement in research Q&A

What is PCORI?

PCORI’s Mission and Strategic Goals PCORI helps people make informed healthcare decisions, and improves healthcare delivery and outcomes, by producing and promoting high-integrity, evidence-based information that comes from research guided by patients, caregivers, and the broader healthcare community. Strategic Goals: Increase quantity, quality, and timeliness of useful, trustworthy research information available to support health decisions Speed the implementation and use of patient-centered outcomes research evidence Influence research funded by others to be more patient-centered

PCORI Funds Patient-Centered Outcomes Research PCOR is a relatively new form of CER that…. Considers patients’ needs and preferences, and the outcomes most important to them Investigates what works, for whom, under what circumstances Helps patients and other healthcare stakeholders make better-informed decisions

We Fund Research That… Meets these criteria: Potential for the study to fill critical gaps in evidence Addresses a clinical uncertainty or decisional dilemma experienced by patients and other stakeholders Potential for the study findings to be adopted into clinical practice and improve delivery of care Has the potential to lead to improvements in clinical practice and patient outcomes Scientific merit (Research design, analysis, and outcomes) Has a research design of sufficient technical merit to ensure that the study goals will be met Investigator(s) and environment The proposed project has a team with appropriate investigators (e.g. qualifications and experience), as well as an environment with sufficient capacity (e.g. resources, facilities, and equipment) Patient-centeredness Focuses on improving patient-centered outcomes and employs a patient-centered research design Patient and stakeholder engagement Includes patients and other stakeholders as partners throughout the entire research process

Engagement at PCORI

Better Research Through Engagement

Why Engage? To influence research to be patient-centered, relevant, and useful To establish trust and a sense of legitimacy in research findings To encourage successful uptake and use of research results

Engagement makes a Difference in PCORI Projects Better understanding of stakeholders’ personal perspectives (e.g., priorities, experiences) Refined study that is more patient-centered Research questions Interventions and/or comparators Outcomes and measures Data collection Recruitment/retention strategies Enhanced study participant enrollment rates Note: Key themes from project years 1 and 2 (N = 258 awardees, 254 partners) Themes mentioned in >10% of responses of both partners and awardees.

Most Common Effects of Engagement on Partners Established new relationships Improved personal health management Made a difference in the lives of others Personal growth or self-improvement Gained new knowledge and insights about research New professional opportunities Belief in patient/stakeholder representation in research “Understanding the various health disparities leading to diabetes, kidney disease has made me assess my personal life, my level of physical activity and my food intake. I have made changes in my lifestyle which include exercising 3 x per week and encouraging my family to take part in physical activities such as hiking, basketball and so forth… This was an eye opener.” –Other type of Stakeholder

What do we mean by Engagement?

Meaningful Partnerships

What We Mean by Engagement… Meaningful involvement of patients, caregivers, clinicians, and other healthcare stakeholders throughout the research process Detailed, well-thought-out, and creative engagement plan Diverse groups of stakeholders Engagement takes many shapes and sizes, not one size fits all!

Core Engagement Principles Reciprocal relationships Co-learning Partnership Trust, transparency, and honesty

Building Effective Partnerships Source: Schools in Partnership

Engagement Continuum Adapted from Hassan Murad et al. (2012). Eliciting Patient Perspective in Patient-Centered Outcomes Research: A Meta Narrative Systematic Review. Rochester, MN: Mayo Clinic. See also Arnstein SR. A ladder of citizen participation. Journal of the American Planning Association. 1969;35:216–24

Facilitating Patient and Stakeholder Engagement in Research

“Engagement is hard…” Relationship building, maintaining throughout and between projects Budgeting for engagement expenses Feasibility of incorporating feedback Training and skill development needs (for partners and researchers) Compensation Determining level and depth of engagement of stakeholders Engaging hard to reach and vulnerable populations

PCORI Engagement Rubric–A Valuable Resource Provides practical guidance to applicants, merit reviewers, awardees, and engagement/program officers on effective engagement in research Planning the Study: How patient and stakeholder partners will participate in study planning and design Conducting the Study: How patient and stakeholder partners will participate in the conduct of the study Disseminating the Study Results: How patient and stakeholder partners will be involved in plans to disseminate study findings and ensure that findings are communicated in understandable, usable ways PCOR Engagement Principles: Reciprocal relationships, co-learning, partnership, trust, transparency, honesty

Engagement Officers Support PCORI’s organizational engagement efforts Support active portfolio management by: Helping awardees to outline engagement milestones Participating in the awardee calls and/or separate calls with key patient and stakeholder partners Serving as a resource to troubleshoot engagement challenges and facilitating communication between awardees around engagement challenges Gathering promising engagement practices from the portfolio and linking awardees to opportunities to highlight promising practices in engagement

Updated Engagement Plan Background Information (Groups Engaged): Goals and/or Purpose Statement Partner Roster, Bios and Roles Dedicated Engagement Leadership Staff Engagement Structure Diagram Proposed Meeting and Key Activity Timeline Partner Preparation and Training Process and Outcomes Monitoring

Understanding The Science of Engagement 4/11/2016 Understanding The Science of Engagement What is happening? Build on existing sources of data to describe engagement in PCORI projects more deeply, including how partnerships are initiated and fostered Further explore the influence and impact of engagement on research – what are we learning about it and what is happening because of it. How is it happening & how is it influencing results? Explore how the influence is occurring, test associations between different types of engagement and specific impacts of engagement, better understand how people are making engagement happen. Practice-Based Knowledge Literature and Portfolio Analysis Knowledge & Information that PCORI translates into what people can use Undertaking a more systematic understanding of that in the IDIQ Identify facilitators of and challenges to research engagement

Support and Resources to Build Partnerships, Infrastructure, Capacity and Community Training and Tools: Engagement Development Funding: Networking,, Learning and Sharing

Engagement is hard….but not Impossible! Communication is KEY! Mistrust takes seconds to form and years to deconstruct Training, training, training! Engagement is relational, not transactional Create equity Mentorship Culture shift—Researchers are afraid of patients, patients are afraid of researchers

Engagement Resources PCORI’s Engagement Rubric: http://www.pcori.org/sites/default/files/Engagement-Rubric.pdf Sample Engagement Plans: http://www.pcori.org/sites/default/files/PCORI- Sample-Engagement-Plans.pdf   Compensation Framework: http://www.pcori.org/sites/default/files/PCORI- Compensation-Framework-for-Engaged-Research-Partners.pdf Engagement Budgeting: http://www.pcori.org/sites/default/files/PCORI- Budgeting-for-Engagement-Activities.pdf Engagement in Research Website: http://www.pcori.org/funding- opportunities/what-we-mean-engagement          Methodology Report: https://www.pcori.org/sites/default/files/PCORI- Methodology-Report.pdf PCORI In Practice Webinar Series: https://www.pcori.org/get- involved/participate-pcori-events/pcori-practice     

Additional Resources Community Campus Partnerships for Health https://ccph.memberclicks.net/resources INSPIRE Repository (Initiative to Support Patient Involvement in Research) http://www.inspireresearch.org/ Wisconsin Network for Research Support (WINRS) https://winrs.nursing.wisc.edu/

Thank You! Chinenye Anyanwu, PharmD, MPH Engagement Officer, Public and Patient Engagement canyanwu@pcori.org | www.pcori.org