PCORnet and the Health eHeart Alliance

Mark J. Pletcher, MD, MPHEpidemiology and Biostatistics, and Medicine

UCSF

AHA Sessions, Nov 17th 2014

Disclosures

• None

Outline

• What is PCORnet?– Vision and approach

• Transforming the Health eHeart Study into a patient-powered research network

• Using PCORnet for cardiovascular research– Health eHeart’s role

PCORnet

• Patient-Centered Outcomes Research Network– PCORI’s nationwide network for conducting large-

scale, efficient, patient-centered comparative-effectiveness research

– Electronic health records: new resource– Engage patients from the beginning– Create a Learning Health System• Pragmatic trials integrated into healthcare delivery• Learn from every patient!

PCORnet

• Patient-Centered Outcomes Research Network– 11 Clinical Data Research Networks: CDRNs– 18 Patient-Powered Research Networks: PPRNs– 1 Coordinating Center– $100+ million dollars for 18 month Phase I– Highest-level support from NIH, AHRQ, CMS, and

big stakeholders (insurers, health plans, industry)

PCORnet

• CDRNs– Gather electronic health record (EHR) data from

networks of healthcare institutions (millions of records)

– Develop governance and IT required to USE that data

– Start engaging cohorts with particular conditions

PCORnet

• PPRNs– Patients with common condition– Motivated by their condition to:• Donate their data• Contribute research ideas• Participate in studies

– Patient governance

PCORnet

• Phase I – Build the Network– Create network policy– Engage patients– Distributed data analysis, common data model– “Research readiness” (Consent, IRB)– Two network demonstration research projects• Weight cohort• Aspirin dosing trial

Where does Health eHeart fit in?

The Health eHeart Alliance

• PCORnet’s cardiovascular-focused PPRN– Sophisticated data collection platform– Lots of data already– But can we really engage patients?

Health eHeart Alliance

• Recruited an Interim Steering Committee from patient groups and stakeholders– American Heart Association– StopAfib.org– Mended Hearts– Sudden Arrhythmia Death Syndromes Foundation

Health eHeart Alliance

• Invested heavily in developing patient governance– Building from scratch – pro’s and con’s– Help from “collaboration ninja” consultants– Create a culture of trust and mutual respect• “Radical transparency”• Real overlap of incentives• Create shared vision

Health eHeart Alliance

• Mission Statement– Pioneering new ways to empower patients in

proving research, care, and quality of life for heart patients

Health eHeart Alliance

• Patient-Powered Research Summit!– Nov 6/7 in San Francisco– Invited broadly• Health eHeart study participants• Patient-leader networks• Researchers at UCSF, potential collaborators, other

PCORnet networks

– Novel participatory process

Health eHeart Alliance

• Research study ideas– Triggers of MI– N of 1 toolkit for statin decliners CVD risk, satisfaction– N of 1 toolkit for paroxysmal afib QOL– Online support groups for newly diagnosed afib– Qualitative study of transitions in care, role of data– Activity monitors in CVD patients more activity– Sharing mental health issues with cardiologists– Improving “success in life” among young stroke patients

Health eHeart Alliance

• Research study ideas– Triggers of MI– N of 1 toolkit for statin decliners CVD risk, satisfaction– N of 1 toolkit for paroxysmal afib QOL– Online support groups for newly diagnosed afib– Qualitative study of transitions in care, role of data– Activity monitors in CVD patients more activity– Sharing mental health issues with cardiologists– Improving “success in life” among young stroke patients

Health eHeart Alliance

• Research study ideas– Triggers of MI– N of 1 toolkit for statin decliners CVD risk, satisfaction– N of 1 toolkit for paroxysmal afib QOL– Online support groups for newly diagnosed afib– Qualitative study of transitions in care, role of data– Activity monitors in CVD patients more activity– Sharing mental health issues with cardiologists– Improving “success in life” among young stroke patients

Health eHeart Alliance

• Research study ideas– Triggers of MI– N of 1 toolkit for statin decliners CVD risk, satisfaction– N of 1 toolkit for paroxysmal afib QOL– Online support groups for newly diagnosed afib– Qualitative study of transitions in care, role of data– Activity monitors in CVD patients more activity– Sharing mental health issues with cardiologists– Improving “success in life” among young stroke patients

Health eHeart Alliance

• Lessons learned so far– Patient-powered research design actually works• Patient stories are a rich source of material

– Researchers will come to the table• Motivated by PCORI funds?• Pleasantly surprised!

– Takes time• Setting expectations and culture• Everyone has a lot to say!

What comes next…

• Can we capitalize on Summit momentum?– Will any of these ideas move forward?– Who will do the work?– Can we replicate the Summit? Online equivalent?– Can we engage the wider research community?

(role here for AHA)

PCORnet is coming

• PCORnet will be a major resource for cardiovascular research– Trials that can use EHR data to identify patients

and track outcomes

• The Health eHeart Alliance can help you engage patients and access PCORnet…

Thanks to our team

• Greg Marcus• Jeff Olgin• Mellanie True-Hills• Debbe McCall• Melissa Moss• Alice Lara• Matt Siemionko• Marcia Baker• Katie Cataldo• Angela Loehr• Kristen Downing• Jesse Caruso

• Kristi Miller• Carol Maguire• Madelaine Faulkner• Ida Sim• Elliott Antman• Meighan Girgus• Heidi Dohse• Rebecca Petzel• Brooking Gatewood• Kathi Sigona• Larry Payne

CDRNs vs. PPRNs

CDRNs PPRNsStart with a massive source of data Start by engaging patientsPatients mostly not consented All patients consentedEHR data easy EHR data hardPROs hard PROs easyNatural reservoir for recruitment Natural receptacle for the recruitedNatural back-end data source Natural front end platform