Guidance for Completing PCORI's Updated Engagement Plan for New Awardees and Future Applicants

June 19, 2018

PCORI in Practice Webinar Series

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Your Participation

Housekeeping: Attendee Participation

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Lisa Stewart, MA

Engagement Officer

Public & Patient

Engagement

PCORI Staff Introductions

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Julie Kennedy Lesch, MPAEngagement Officer

Public & Patient Engagement

Krista Woodward, MPH, MSW

Senior Program Associate

Public & Patient Engagement

• Engagement Plan: From Research Application to Implementation

• Discussion of the Updated Engagement Plan Template sections

• Research Team Reactions and “Lessons Learned”

– Dr. Annette M. Totten and Angela Combe

• Discussion / Q&A Session

Today’s Agenda

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Engagement Plan:

From Research Application to

Implementation

About Us

• An independent research institute authorized by Congress in 2010 and governed by a 21-member Board of Governors representing the entire healthcare community

• Funds comparative clinical effectiveness research (CER) that engages patients and other stakeholders throughout the research process

• Seeks answers to real-world questions about what works best for patients based on their circumstances and concerns

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We Fund Research That…

Meets these criteria:

1. Potential for the study to fill critical gaps in evidenceAddresses a clinical uncertainty or decisional dilemma experienced by patients and other stakeholders

2. 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 outcomes3. Scientific merit (Research design, analysis, and outcomes)

Has a research design of sufficient technical merit to ensure that the study goals will be met4. 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)

5. Patient-centerednessFocuses on improving patient-centered outcomes and employs a patient-centered research design

6. Patient and stakeholder engagementIncludes patients and other stakeholders as partners throughout the entire research process

Updated Engagement Plan

Template

• Guide the study team in refining the original engagement plan that was submitted as part of the application. The study’s updated engagement plan should serve as a useful resource that aids the team in fulfilling the objectives of a patient- and stakeholder-engaged clinical research project.

• Assist PCORI in documenting engagement activities at the project level to explore the influence and impact of engagement on study outcomes

• Better respond to awardee and partner support and training needs

Updated Engagement Plan Template Purpose

Updated Engagement Plan Template Components

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Background Information

GoalsEngagement

Structure

Proposed

Meeting & Key Activity

Timeline

Partner & Team

Preparation

Recruitment & Retention

Partner Roster, Bios,

and Roles

Process & Outcomes

Monitoring

Principal Investigator(s)

Project Title

Contract ID Number

Groups Engaged

Background Information

Engagement Component 1:

Engagement Goals- Study

Aligned Engagement Approaches

Engagement Goals-

Partners

Partner Motivation

Goals

Engagement Component 2:

Engagement Goals- Conversation Starters

What are your engagement goals and what are the key activities that align with those goals? In other words, what does your study team hope to accomplish through engagement and how?

What is motivating their involvement, their goals, and the benefits they hope to achieve?

What are your partners’ goals? In other words, what do they hope to gain from participating?

Advisory Panel Members

Roster

Short Biosketches

Research Team Member

ContributionsOverall Partner Roles

Partner Roster, Bios,

& Roles

Engagement Component 3:

Study Team Governance

Decision-Making

Processes Communication & Information

Pathways

Engagement Leadership

Engagement Structure

Engagement Component 4:

• One size does not fit all!

• Ranges from simple to complex

– Can consist of single advisory board or multiple advisory boards

– Complexity does not necessarily result in better engagement

• Should reflect lines of communication, information flows, and decision making authority

• Shows how engagement is represented in study governance

• Engagement oversight

– PI, Study Coordinator, Patient Co-I, Consultant

Engagement Structure Models

Example 1: Multi-Partner Advisory Board Model

Research Team

Clinician Advisory

Board

Policy Advisory

BoardParent/Caregiver

Advisory Board

Youth Advisory

Board

Example 2: “Hub & Spoke” National Model

National Advisory Board

Research Team

Local Advisory

Board

Local Advisory

Board

Local Advisory

Board

Type of Meeting or

ActivityFrequency

Setting

Purpose or Intent

Proposed Meeting &

Key Activity Timeline

Engagement Component 5:

Proposed Meeting and Key Activity Timeline Table

Resource: Proposed Meeting & Activity Timeline

Orientation to PCORI-funded

study

Roles & Expectations

Lay Communication

Study Team Training

Partner & Team Preparation

Engagement Component 6:

Partner Preparation - Conversation Starters

What are your research team members doing, if anything, to learn

best practices for working with partners of diverse background and

limited research knowledge?Have partners received

guidance on how to approach study staff with concerns? If

yes, how?

What kind of training or education, if any, will be provided

to prepare partners for participation in your study’s

research process?

How will the research team ensure that partners clearly

understand the expectations of serving on a PCORI-funded

project?

R&R Strategies informed by

Partners

Culturally-Congruent

Recruitment Materials

[Study Participant] Recruitment &

Retention

Engagement Component 7:

• Partner Engagement during research subject recruitment and retention:

– Refining enrollment script

– Reviewing informed consent documents

– Selecting recruitment sites

– Training research subject enrollment coordinator

Recruitment & Retention

“ “Our Patient and Stakeholder Advisory Panels … help us craft recruitment messages, including radio and television ads, to maximize reach to the intended audience...and we have begun to see an increase in inquiries about the study.”

"Stakeholders have made specific recommendations to maximize subject enrollment and retention. For example, they highlighted that engaging the clinical teams in the study process would help them reinforce the importance of the study and adherence to study procedures.”

“

Effective engagement monitoring

“Course Correction”

Tool

Maximize partner

contributions

Engagement Sustainability

Process & Outcomes Monitoring

Engagement Component 8:

Outcomes Monitoring Publications

• The updated engagement plan is intended to be a tool

– A road map for executing engagement and optimizing the contribution of partners

– Enables Principal Investigators and engagement coordinators to frame up discussions with partners

• The updated engagement plan will allow PCORI Engagement Officers and Program Officers to provide targeted support to research teams

• PCORI staff will be able to collect richer data that will inform the field

Summary

Research Team:

Reactions & Lessons Learned

Research Team Members

Annette M. Totten, PhD, MPAPrincipal Investigator

Oregon Health & Science University

Angela Combe, MSEngagement Manager

Eastern Oregon Practice EnhancementOregon Health & Science

University

• “A Cluster-Randomized Trial Comparing Team-Based versus Primary Care Clinician-Focused Advance Care Planning in Practice-Based Research Networks”

• Summary Statement: This project proposes to test ways to align health care with patient goals and preferences for patients with serious illnesses (i.e., a prognosis off 1-2 years). The project team is trying to identify the best model for primary care practices to engage in advance care planning which includes developing patient-centered plans for care in patients’ last months and at the end of life. Patients, family members, and people who work in primary care will be involved in planning and conducting this study, connecting science to real life.

• Primary Outcomes: 1) How much time patients spend at home and not in the hospital, and 2) Whether care provided matches patient goals.

Link to Project Page

PCORI-Funded Project Details

Figure 1. Patient, Family and Partner

Engagement Structure and Partnerships*

Completing the Updated Engagement Plan Template

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• Engagement integration through working group formation, drafting study goals, and meeting facilitation/discussion guide

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• Incorporating engagement for developing and refining outcome and process measures

3• Conceptualizing that the template as a tool

Discussion / Q&A

• Which aspects of today’s webinar are most meaningful to you?

• What else would you like to learn about the updated Engagement Plan Template?

• How does today’s webinar resonate with your own work?

• How do you think the Engagement Plan Template could help your team better plan and conduct engagement throughout the lifetime of a research project?

Discussion

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General Engagement Resources

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https://www.ncbi.nlm.nih.gov/pubmed/28289118

PCORI Engagement Rubric

Info Sheet on Patient and Stakeholder Partner Roles

Budgeting for Engagement Activities

Compensation Framework for Engaged Research Partners

Sample Engagement Plans

Methodology Report

PCORI in Practice Webinar Series

Acknowledgements

• Dr. Annette M. Totten and Angela Combe

• Awardees and partners

• Following this event, the slides, a recording, and additional materials for this webinar will be posted to https://www.pcori.org/events/2018/guidance-completing-pcoris-updated-engagement-plan-new-awardees-and-future-applicants

• Send any questions or comments about today’s webinar to ppet@pcori.org

Thank You!

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