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Engagement in Clinical Research: The PCORI Engagement Rubric

Kim Bailey, Engagement OfficerUVA WebinarOctober 10, 2014

Kim BaileyEngagement Officer

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

About PCORI

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 researchguided by patients,caregivers and the broader health care community.

Our Strategic Goals

Influence Research Funded by Others

Speed the Implementation and Use of Evidence

Increase Quantity, Quality and Timeliness of Research Information

Study Design/ Implementation

Evaluation

Topic Selection and

Research Prioritization

Merit Review

We Engage Patients and Other Stakeholders at Every Step

PCORIPatient/

Stakeholder Community

Patient/ Consumer

Caregiver/Family

Member of Patient

Clinician

Patient/ Caregiver Advocacy

Org

Hospital/ Health System

Training Institution

Policy Maker

Industry

Payer

Purchaser

Research We Support

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

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

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

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.

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?

The Engagement Rubric

The Engagement Rubric

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

Planning the Study

Planning the Study

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

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.

Conducting the Study

Conducting the Study

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

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.

Disseminating the Study Results

Disseminating the Study Results

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

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.

Engagement Principles

Engagement Principles

• Reciprocal Relationships• Co-learning• Partnership• Trust• Transparency• Honesty

Additional Funding Opportunities

Tier 1Up to $15,000

Up to 9 month term

Tier 2Up to $25,000

Up to 12 month term

Tier 3Up 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

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”

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.

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

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

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

Engagement in Research website page 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

Find Us Online

www.pcori.orgKim Bailey, Engagement Officerkbailey@pcori.org