1. 1 Engagement in Clinical Research: The PCORI Engagement Rubric Kim Bailey, Engagement Officer UVA Webinar October 10, 2014

2. Kim Bailey Engagement Officer

3. Session Objectives 1)Provide an overview of PCORI and engagement at PCORI 2)Discuss PCORI’s programmatic areas and merit review process 3)Walk through PCORI’s Engagement Rubric 4)Introduce additional funding opportunities at PCORI

4. About PCORI

5. Our Mission PCORI helps people make informed health care decisions, and improves health care delivery and outcomes, by producing and promoting high integrity, evidence-based information that comes from research guided by patients, caregivers and the broader health care community.

6. Our Strategic Goals Influence Research Funded by Others Speed the Implementation and Use of Evidence Increase Quantity, Quality and Timeliness of Research Information

7. Study Design/ Implementation Evaluation Topic Selection and Research Prioritization Merit Review We Engage Patients and Other Stakeholders at Every Step

8. PCORI Patient/ Stakeholder Community Patient/ Consumer Caregiver/ Family Member of Patient Clinician Patient/ Caregiver Advocacy Org Hospital/ Health System Training Institution Policy Maker Industry Payer Purchaser

9. Research We Support

10. PCORI National Priorities for Research Assessment of Prevention, Diagnosis, and Treatment Options Improving Healthcare Systems Communication & Dissemination Research Addressing Disparities Accelerating PCOR and Methodological Research

11. We Fund Research That… Studies the benefits and harms of interventions and strategies delivered in real-world settings Compares at least two alternative approaches Adheres to PCORI’s Methodology Standards Is based on health outcomes that are meaningful to the patient population Engages patients and other stakeholders at every stage Is likely to improve current clinical practices

12. We Focus Attention On… Conditions  Conditions that affect large numbers of people across a range of populations  Conditions that place a heavy burden on individuals, families, specific populations, and society  Rare diseases, which are difficult to study Populations  Racial and ethnic minorities  Older adults  Low-income and rural populations  Children

13. PCORI Merit Review Impact of the condition on the health of individuals/populations Potential for the study to improve healthcare and outcomes Technical merit Patient-centeredness Patient and stakeholder engagement Applications are reviewed against five criteria: Applications are reviewed by a panel of two scientists, one patient, and one other stakeholder. PCORI’s Board of Governors makes funding decisions based on merit review and staff recommendations.

14. Patient-Centeredness and Patient and Stakeholder Engagement Patient and Stakeholder Engagement Patients are partners in research, not just “subjects” Active and meaningful engagement between scientists, patients, and other stakeholders Community, patient, and caregiver involvement already in existence or a well-thought out plan Patient-Centeredness Does the project aim to answer questions or examine outcomes that matter to patients? Do research questions and outcomes reflect what is important to patients and caregivers?

15. The Engagement Rubric

16. The rubric is intended to provide guidance to applicants, merit reviewers, awardees, and engagement/program officers (for creating milestones and monitoring projects) regarding patient and family engagement in the conduct of research. It is divided into four segments: Planning the Study Conducting the Study Disseminating the Study Results PCOR Engagement Principles

17. Planning the Study

18. Potential Activities Include; Identifying the topic and developing the research question to be studied Creating the intervention Identifying the comparators Defining the characteristics of study participants

19. Planning the Study Real World Examples; Epilepsy study: The patients and parents of patients with epilepsy pose the question: Which anti-epileptic drugs best preserve sufficient cognition to go to work or school and to function normally, while still preventing seizures adequately? Diabetes study: Clinicians who reviewed the initial study design indicated that clinical practice is quite variable and suggested that a three-arm approach would be more appropriate for the study. The study design was revised accordingly. Cancer study: Patient partners determine that all women with breast cancer would be eligible versus only women who had completed active treatment.

20. Conducting the Study

21. Potential Activities Include; Participating in and monitoring the conduct of the project Assisting with the recruitment of study participants Assisting with data collection and data analysis Participating in the evaluation of patient and stakeholder engagement

22. Conducting the Study Real World Examples; Chronic pain study: The informed consent document is developed with patient partners to make it understandable to study participants. Depression study: Patient advocacy groups assist with recruitment through their patient networks—the “book club” model. Preeclampsia study: Study team will recruit via a national network of local health departments and community health centers, as well as a preeclampsia advocacy group’s website, and Facebook page.

23. Disseminating the Study Results

24. Potential Activities Include; Identifying partner organizations for dissemination Planning dissemination efforts Participating in dissemination efforts, such as the authoring of manuscripts and the presentation of study findings

25. Disseminating the Study Results Real World Examples; Chronic Trauma study: The research team will convene a policy summit with relevant professional societies during the third year of the study to focus on identifying ways to speed the implementation of findings into practice. Cardiac study: A Patient Dissemination Board is helping to craft the dissemination plan and advise the research team on how to best share study findings. Chronic pain study: Patient partners co-author manuscripts, present at scientific and lay conferences, and share study findings through their networks.

26. Engagement Principles

27. Reciprocal Relationships Co-learning Partnership Trust Transparency Honesty

28. Additional Funding Opportunities

29. Tier 1 Up to $15,000 Up to 9 month term Tier 2 Up to $25,000 Up to 12 month term Tier 3 Up to $50,000 Up to 12 month term PCORI Funding Announcement Researchers who unsuccessfully submitted a PFA and need to improve proposal Pipeline to Proposal Awards Or submissions to other PCOR/CER Funders

30. Tier I Pipeline Awards (Up to $15,000 for up to 9 months) Available to individuals, consumer/patient organizations, clinician(s), researcher(s) or a combination of the above to support:  Community building around an area of research interest to improve outcomes for patients  Creation of structure and communication strategies  Develop an understanding of PCORI, and “research done differently”

31. Tier II Pipeline Awards (Up to $25,000 for up to one year) Available to emerging research/non-research partnerships to support:  Data network and registry development  Development of infrastructure  Generation and refinement of research question through community events, town hall meetings, etc.

32. Tier III Pipeline Awards (Up to $50,000 for up to one year) Available to advanced research/non-research partnerships, including those who submitted PCORI proposals and were not funded, to support:  PCORI research proposal (re)submission focusing on development of engagement plan  Research partnership skill development

33. Additional Funding Opportunities Engagement Awards  Intended to strengthen the capacity of patients and other stakeholders to engage in the research process  Up to $250,000 and up to two years Research Meeting and Conference Support  Up to $50,000 for one-time awards  Up to $250,000 for multi-year, multi-event awards

34. Engagement Resources PCORI’s Engagement Rubric http://www.pcori.org/assets/2014/08/PCORI- Engagement-Rubric-with-Table.pdf Sample Engagement Plans http://www.pcori.org/assets/2013/11/PCORI-Sample- Engagement-Plans.pdf http://www.pcori.org/assets/2013/11/PCORI-Sample- Engagement-Plans.pdf Engagement in Research website page http://www.pcori.org/get-involved/what-is-engagement-in- research/ http://www.pcori.org/get-involved/what-is-engagement-in- research/ PCORI’s Methodology Standards PC-1 to PC-4 http://www.pcori.org/assets/PCORI-Methodology- Standards1.pdf http://www.pcori.org/assets/PCORI-Methodology- Standards1.pdf

35. Find Us Online www.pcori.org Kim Bailey, Engagement Officer kbailey@pcori.org