Stakeholder Engagement for Patient-Centered Outcomes Research

Vanessa Jacoby, MD, MAS Associate Professor

Obstetrics, Gynecology, and Reproductive SciencesUniversity of California, San Francisco

Change in Research Model

Design the Study

Conduct the Study

Disseminate and Implement

Results

ResearchersStakeholders

Who are the Key Stakeholders?

ResearchersPatients and their familiesHealth care providersDrug and device companiesHealth Insurers

Government agencies Disease Advocates/Foundations

Others?

Why include stakeholders in research?

Design the Study

Conduct the Study

Disseminate and Implement

Results

Support Funding

Help Enrollment

Diverse opinions strengthen design

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 ActPCORI 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 EngagementNo standard approachInclude stakeholders in all phases of researchExample 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 fibroidsCompare symptoms and fertility/ pregnancy outcomes among fibroid treatmentsFunded by PCORI and AHRQ (Agency for Healthcare Research and Quality)

Stakeholder Engagement

Patients representatives involved in grant developmentOne patient is voting member of Steering CommitteeStakeholder Advisory Group is key study committee (20 members)

Stakeholder Advisory Group

Health Insurers

Ob/Gyns

Fibroid Device and Drug Manufacturers Health Systems

Government and Nonprofit Agencies (e.g. ACOG)

Women with Fibroids

Stakeholders and Study Design

What are the most important outcomes of fibroid treatment?

STAKEHOLDER

Heavy Bleeding

Pregnancy and fertility

Treatment failure

Women with fibroids x x x

Ob/Gyns x x x

Device manufacturers x x

Health insurers x

Stakeholders and Study Design

What are the most important outcomes of fibroid treatment?

STAKEHOLDER

Heavy Bleeding

Pregnancy and fertility

Treatment failure

Sexual Function

and Mental health

Women with fibroids x x x xOb/Gyns x x x

Device manufacturers x x

Health insurers x

Stakeholders and Study Design

What are the most important outcomes of fibroid treatment?

STAKEHOLDER

Heavy Bleeding

Pregnancy and fertility

Treatment failure

Sexual Function and

Mental Health

Cost effectiveness

Women with fibroids x x x x

Ob/Gyns x x x

Device manufacturers x x

Health insurers x x

Stakeholders and Recruitment

How do we successfully enroll participants?

STAKEHOLDERClinical

encounters

Advertising Social media

Women with fibroids x

Ob/Gyns xDevice manufacturers x

Health insurers x

Challenges with Stakeholder Representatives

•Do stakeholders, especially patients, accurately represent their community?High health literacyGet along with researchersAble to attend meetings

Thousands of women with fibroids Input from

1 patient on Steering Committee

New approach to Stakeholder Engagement

Crowdsource participation in research

Thousands of women with fibroidsInput from

Thousands of women with fibroids

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 trustRespect privacySupport open discussionsMOSAIC

◦ Website open to public◦ Registration required to post

comments◦ Select identity settings

PCORI funded Community Engaged Network for AllPatient 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 researchReal time email/text message updates as research is conducted

Disseminate and Implement Results

Medical journals have limited audienceStakeholders engaged in their community

Stakeholders can support implementation of results---AMA changes guidelines---Blue Cross changes coverage decisions

Challenges with Mosaic

Need to connect to broader audience (e.g. text messaging)Need core study team with enthusiastic partners

Women who Access MosaicInput from

Thousands of women with fibroids

Stakeholder EngagementImproves and strengthens clinical researchInvolve stakeholders from the start of research Many approaches to engagement…more innovations soon!