This document summarizes the Health eHeart Alliance, a patient-powered research network (PPRN) within PCORnet for cardiovascular health. Some key points: 1) The Health eHeart Alliance grew out of the Health eHeart Study, which collects various health data from participants online and through devices. 2) Through a Patient-Powered Research Summit, patients and researchers worked together to develop ideas for new studies, such as on triggers of heart attacks or improving quality of life for those with irregular heartbeats. 3) The Alliance aims to engage patients in research by having them help design studies and participate. The next steps are pursuing the ideas generated and engaging more participants and researchers.

1. Engaging Patients in Big
Data Networks
PCORnet and the Health eHeart Alliance
Mark J. Pletcher, MD, MPH
Epidemiology and Biostatistics, and Medicine
UCSF
AHA Sessions, Nov 17th 2014

2. Disclosures
• None

3. Patient-Powered Research Networks
(PPRNs)
• PCORI’s vision for PPRNs:
– Patients are in charge
– Patients are motivated by their condition to:
• Donate their data
• Contribute research ideas
• Participate in studies
– PPRNs work together with CDRNs in PCORnet to
do large, efficient, patient-centered research
projects

4. CDRNs vs. PPRNs
CDRNs PPRNs
Start with a massive source of data Start by engaging patients
Patients mostly not consented All patients consented
EHR data easy EHR data hard
PROs hard PROs (and other data) easy
Natural reservoir for recruitment Natural receptacle for the recruited
Natural back-end data source Natural front end platform

5. A PPRN for cardiovascular health
• The Health eHeart Alliance
– PCORnet’s PPRN for cardiovascular health
– Unique strengths, and some weaknesses
– Major challenge: turning a “Study” into a PPRN
• Today:
– The Health eHeart Study
– Engaging patients and harnessing patient power
– How will PCORnet use the Health eHeart Alliance?

7. The Health eHeart Study
• An “eCohort” designed to:
– Approach, consent, enroll over the internet
– Use online surveys for self-reported data
– Capitalize on emerging technology for novel,
efficient data collection
• Wearable sensors, apps, social networks, EHR
• …and a platform for CVD research

8. The Health eHeart Study
• Overarching Goal:
– Do research that improves cardiovascular health
• Approach:
– Collect “big data”
– Keep marginal costs low
– Support ancillary studies, including RCTs

9. Health eHeart Study

11. Integrated
devices and
apps

14. Measurements collected
• 141,720 surveys completed (many PROs)
• 248,811,840 ppt-minutes of step data!
• 76,514 weights from Fitbit, Withings, iHealth
• 18,054 blood pressures
• 43,523 Oxygen saturation + heart rates
• 18,657 EKGs from Alivecor
• 39,696 days of Ginger.io-derived
movement/communication patterns
• 2,429 possible hospitalizations from 179 hospitals

15. Health eHeart Study
• Lots of data
• Variable engagement
• Lots of possibilities as a research platform

16. Health eHeart Study
• Lots of data
• Variable engagement
• Lots of possibilities as a research platform
Can we turn the Health
eHeart Study into a PPRN?

17. 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

18. 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

19. Health eHeart Alliance
• Mission Statement
– Pioneering new ways to empower patients in
proving research, care, and quality of life for heart
patients

20. Health eHeart Alliance
• “Prototyped” patient-powered research design
– Our investigators worked with Interim Steering
Committee groups to brainstorm and co-design
research ideas

21. Health eHeart Alliance
• Patient-Powered Research Summit!
– Nov 6/7 in San Francisco
– Invited broadly
• Health eHeart participants
• Patient-leader networks
• Researchers at UCSF, potential collaborators, other
PCORnet networks
– Novel participatory process
• Organic topic suggestions, grouping, “vote with feet”
• Spend the day co-brainstorming research

30. 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

31. 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

32. 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

33. 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

34. 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!

35. What comes next…
• Can we capitalize on our 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!)
• Will this translate into Health eHeart STUDY
engagement (recruitment and retention)?

36. What comes next?
• How will PCORnet use our PPRN?
– Just another recruitment source?
– Co-enrollment with CDRNs, and a complementary
data source?
– Front-end for CVD-related PCORnet studies?

37. 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