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TRANSCRIPT
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
2
Lisa Stewart, MA
Engagement Officer
Public & Patient
Engagement
PCORI Staff Introductions
3
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
1
• Engagement integration through working group formation, drafting study goals, and meeting facilitation/discussion guide
2
• 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 [email protected]
Thank You!
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