Engaging Patients in Big Data Networks

PCORnet and the Health eHeart Alliance

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

UCSF

AHA Sessions, Nov 17th 2014

Disclosures

• None

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

CDRNs vs. PPRNs

CDRNs PPRNsStart 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

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?

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

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

Health eHeart Study

Integrated devices and apps

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

Health eHeart Study

• Lots of data

• Variable engagement

• Lots of possibilities as a research platform

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?

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

• “Prototyped” patient-powered research design

– Our investigators worked with Interim Steering Committee groups to brainstorm and co-design research ideas

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

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!

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)?

What comes next?

• How will PCORnet use our PPRN?

– Just another recruitment source?

– Co-enrollment with CDRNs, and a complementarydata source?

– Front-end for CVD-related PCORnet studies?

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