Transcript Stakeholder Engagement for Patient-Centered

Stakeholder Engagement for
Patient-Centered Outcomes Research
Vanessa Jacoby, MD, MAS
Associate Professor
Obstetrics, Gynecology, and Reproductive Sciences
University of California, San Francisco
Change in Research Model
Stakeholders
Researchers
Design
the Study
Conduct
the Study
Disseminate and
Implement
Results
Who are the Key Stakeholders?
Researchers
Patients and their families
Health care providers
Drug and device companies
Health Insurers
Disease Advocates/Foundations
Government agencies
Others?
Why include stakeholders in research?
Help Enrollment
Diverse opinions
strengthen design
Design
the Study
Conduct
the Study
Disseminate
and Implement
Results
Support Funding
Broaden impact of results
Deliver message effectively
Why include stakeholders in research?
Required by
Patient Centered Outcomes Research Institute
Authorized by Congress in 2010 as part of the Affordable Care Act
PCORI supports “research that addresses the questions and concerns most
relevant to patients, and we involve patients, caregivers, clinicians, and other
healthcare stakeholders, along with researchers, throughout the process”.
Stakeholder Engagement
No standard approach
Include stakeholders in all phases of research
Example of common stakeholder engagement strategy
COMPARING OPTIONS FOR MANAGEMENT:
PATIENT-CENTERED RESULTS FOR UTERINE FIBROIDS
Nationwide prospective cohort study
10,000 women undergoing treatment for uterine fibroids
Compare symptoms and fertility/ pregnancy outcomes among fibroid treatments
Funded by PCORI and AHRQ (Agency for Healthcare Research and Quality)
Stakeholder Engagement
Patients representatives involved in grant development
One patient is voting member of Steering Committee
Stakeholder Advisory Group is key study committee (20 members)
Stakeholder Advisory Group
Women with Fibroids
Government and Nonprofit Agencies
(e.g. ACOG)
Fibroid Device and Drug
Manufacturers
Ob/Gyns
Health Insurers
Health Systems
Stakeholders and Study Design
What are the most important outcomes of fibroid treatment?
Heavy
Bleeding
Pregnancy
and fertility
Treatment
failure
Women with
fibroids
x
x
x
Ob/Gyns
x
x
x
STAKEHOLDER
Device
manufacturers
Health
insurers
x
x
x
Stakeholders and Study Design
What are the most important outcomes of fibroid treatment?
Heavy
Bleeding
Pregnancy
and fertility
Treatment
failure
Sexual
Function
and Mental
health
Women with
fibroids
x
x
x
x
Ob/Gyns
x
x
x
STAKEHOLDER
Device
manufacturers
Health
insurers
x
x
x
Stakeholders and Study Design
What are the most important outcomes of fibroid treatment?
Heavy
Bleeding
Pregnancy
and fertility
Treatment
failure
Women with
fibroids
x
x
x
Ob/Gyns
x
x
x
Device
manufacturers
x
STAKEHOLDER
Health insurers
Sexual
Cost
Function and effectiveness
Mental
Health
x
x
x
x
Stakeholders and Recruitment
How do we successfully enroll participants?
STAKEHOLDER
Clinical
encounters
Advertising
Women with
fibroids
Ob/Gyns
Social media
x
x
Device
manufacturers
x
Health insurers
x
Challenges with Stakeholder Representatives
Thousands of women
with fibroids
Input from
1 patient on
Steering Committee
• Do stakeholders, especially patients, accurately represent their
community?
High health literacy
Get along with researchers
Able to attend meetings
New approach to Stakeholder Engagement
Thousands of women
with fibroids
Input from
Crowdsource
Thousands of women
with fibroids
participation in research
Create online platform for stakeholder collaboration
Proposals developed, discussed, and revised online
Academic medical center faculty and staff only
Crowdsourcing Research to Diverse Stakeholders
• Welcome all perspectives: “Research is stronger
when all voices are heard and valued”
Build trust
Respect privacy
Support open discussions
MOSAIC
◦ Website open to public
◦ Registration required to post
comments
◦ Select identity settings
PCORI funded Community Engaged Network for All
Patient Powered Research Network (PPRN)
Joubert Syndrome and Related Disorders Foundation
(JSRDF) plan for research protocol
Brainstorming Research Ideas
Discussing the Study Protocol
Maintaining Engagement
Opportunity to “follow” the research
Real time email/text message updates as research is conducted
Disseminate and Implement Results
Medical journals have limited audience
Stakeholders engaged in their community
Stakeholders can support implementation of results
---AMA changes guidelines
---Blue Cross changes coverage decisions
Challenges with Mosaic
Thousands of women
with fibroids
Input from
Women who Access
Mosaic
Need to connect to broader audience (e.g. text messaging)
Need core study team with enthusiastic partners
Stakeholder Engagement
Improves and strengthens clinical research
Involve stakeholders from the start of research
Many approaches to engagement…more innovations soon!