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PCORI funded the development of PCORnet^®, the National Patient-Centered Clinical Research Network, to make it easier and more efficient to conduct research. PCORnet is made up of Partner Networks that harness the power of large amounts of health data and patient partnerships.

Patient-Powered Research Networks (PPRNs) are networks operated and governed by patients, families, caregivers, and community members in close collaboration with clinical researchers, with the goal of shaping and conducting research to better serve their communities and improve their health outcomes. Several PPRNs, including the Health eHeart Alliance, participated as Partner Networks in PCORnet.

PCORI funded the Health eHeart Alliance’s participation in PCORnet from 2015 to 2019. This report outlines the Health eHeart Alliance’s achievements in building its research infrastructure capacity to

1. Create ways to involve patients, families, and caregivers in decision making about the network
2. Create a way to collect and share data reported by patients for research
3. Involve patients, caregivers, families, and communities in the research process, including recruiting people to participate in research studies
4. Lead or join in research studies that focus on the community’s priorities

Network at a glance

The Health eHeart Alliance is a PPRN dedicated to preventing and managing conditions affecting the heart. The University of California San Francisco leads the Alliance, with support from heart-related advocacy organizations including the American Heart Association, Mended Hearts, the National Blood Clot Alliance, StopAfib.org, and the Sudden Arrhythmia Death Syndromes Foundation. In addition, a research study called the Health eHeart Study helps the network collect and manage data. The Alliance collected data for more than 200,000 patients interested in contributing to research on conditions affecting the heart.

How does the network operate?

The Health eHeart Alliance had a steering committee that included representatives from each of its partner organizations and nine patients. In addition, the Alliance included three working groups:

• The governance group developed processes for the network’s work and created structures for tracking new projects and keeping the steering committee informed.
• The engagement group managed the network’s work with patients, including working with someone tasked with overseeing patient participation and reviewing the network’s patient newsletter.
• The patient-centered review group made sure the network’s partners were working with patients throughout their research.

How did the network involve patients and other partners?

Patients helped lead and make decisions for the three Alliance working groups, the executive team, and other task forces. The Alliance invited patients to join in all research projects. To make it easier for patients to participate, the Alliance allowed patients to take part in meetings by phone, instead of having to meet in person. The Alliance also offered one-on-one phone calls with patients to help orient and prepare them for the different kinds of work being done. The Alliance built an online discussion board where patients could interact with one another about research topics that mattered to them. As of June 24, 2019, this discussion board had more than 10,700 participating patients. The Alliance also hosted an in-person research meeting led by patients that focused on conditions affecting the heart.

Who is in the network?

The Alliance had 219,046 participants who had expressed interest in heart-related research as of June 24, 2019. It started recruiting patients on the internet in 2013. The Alliance collected patient information through surveys, patient self-reports, electronic health records, fitness trackers, and medical samples. The Alliance electronically linked this patient information and stored the data online.

While a Partner Network in PCORnet, the Alliance participated in nine studies. The Alliance also formed close collaborations with other PPRNs and Clinical Data Research Networks (CDRNs). CDRNs are operated by healthcare systems, like hospitals, and are focused on standardizing patient care data across the participating health systems.

How does the network support future research?

Study patients continue to use the Alliance’s online forum to interact with each other. PPRNs follow PCORI standards to enhance the sustainability of the network, including fostering patient and clinician engagement at all stages of the research process, participating in multi-network PCORnet research, and building external collaborations. The Health eHeart Alliance has rebranded itself as the Heart Research Alliance.

Glossary

Clinical Data Research Networks (CDRN): CDRNs are networks that originate in healthcare systems, such as hospitals, health plans, or practice-based networks, and securely collect health information during the routine course of patient care.

Institutional Review Board (IRB): A group that follows federal regulations, state laws, and institutional policy to review, monitor, and approve research in order to protect the ethical rights and privacy of the subjects involved.

Patient-Powered Research Networks (PPRN): PPRNs are operated and governed by patient groups and their partners and are focused on particular conditions or populations.

PCORnet: PCORnet is a network of networks that brings together patients, clinicians, researchers, and healthcare systems to share information and participate in research.

Overview

PCORI funded the development of PCORnet^®, the National Patient-Centered Clinical Research Network, to make it easier and more efficient to conduct research. PCORnet is made up of Partner Networks that harness the power of large amounts of health data and patient partnerships.

Patient-Powered Research Networks (PPRNs) are networks operated and governed by patients, families, caregivers, and community members in close collaboration with clinical researchers, with the goal of shaping and conducting research to better serve their communities and improve their health outcomes. Several PPRNs, including the Health eHeart Alliance, participated as Partner Networks in PCORnet.

PCORI funded the Health eHeart Alliance’s participation in PCORnet from 2015 to 2019. This report outlines Health eHeart Alliance’s achievements toward the PPRN goals of developing and optimizing research and engagement infrastructure capacity to

• Establish a governance structure that fully engages patients and other stakeholders for the purposes of contributing to research
• Create a data infrastructure conducive to the ongoing collection of patient-reported data
• Meaningfully engage patients, caregivers, families, and community members in the research process, including identifying and recruiting participants for clinical trials and other research studies
• Lead or partner in the conduct of comparative effectiveness studies responsive to the research priorities of their communities

Network Infrastructure

The Health eHeart Alliance is a PPRN dedicated to preventing and managing cardiovascular disease. The University of California San Francisco (UCSF) leads the Alliance with the support of a coalition of heart-related advocacy organizations including the American Heart Association (AHA), Mended Hearts, the National Blood Clot Alliance, StopAfib.org, and the Sudden Arrhythmia Death Syndromes (SADS) Foundation. In addition, the Alliance is supported by the Health eHeart Study, which provides an infrastructure for data collection and study management. The Alliance collected data for more than 200,000 patients interested in contributing to research on cardiovascular disease.

Network Governance and Operations

The Alliance’s steering committee included representatives from each of the five partner organizations as well as nine patient partners. The network included three working groups:

• The governance group developed formal decision-making processes for the network and created structures for tracking projects and keeping the steering committee informed.
• The engagement group oversaw the network’s general engagement efforts, including working with paid patient engagement officers on outreach and planning and reviewing the Alliance’s patient-facing newsletter.
• The patient-centered review group ensured the network’s collaborators were meeting the Alliance’s criteria for research partnerships.

Stakeholder Engagement

Patient partners served in leadership and decision-making roles in all Alliance working groups, task forces, and the executive team. The network invited patient partners to take part in all work and supported patient partners throughout the research process. This support included one-on-one phone calls to help orient and prepare patient partners for various aspects of the work. Patient partners could participate in all meetings remotely. To support engagement, the Alliance built an online forum, which was primarily used by study participants to interact with one another to discuss research that mattered to them. As of June 24, 2019, this forum had more than 10,700 users. The network also hosted two patient-powered research summits that focused on patient-prioritized cardiac health research ideas.

Demographics and Research Capacity

As of June 24, 2019, the Alliance counted 219,046 members who had expressed interest in cardiovascular research, either through consenting for the Health eHeart Study, which started in 2013, or otherwise. The Alliance collected information via Health eHeart Study surveys, patient-reported outcome measures, electronic health records, mobile health devices, and biospecimens and linked these data online.

While a Partner Network in PCORnet, Health eHeart Alliance participated in nine research studies, including randomized controlled trials, a methods study, comparative effectiveness research studies, and two N-of-1 trials. The Alliance led the development of the Cardiovascular Health Collaborative Research Group (CVH CRG) with OneFlorida and LHSnet. Through these collaborations, the Alliance also formed close collaborations with other PPRNs and Clinical Data Research Networks (CDRNs). CDRNs are operated by healthcare systems and are focused on standardizing patient care data across the participating health systems.

Future Opportunities

Study patients continue to use the Alliance’s online forum to interact with one another. PPRNs follow PCORI standards to enhance the sustainability of the network, including fostering patient and clinician engagement at all stages of the research process, participating in multi-network PCORnet research, and building external collaborations. The Health eHeart Alliance has formally rebranded itself as the Heart Research Alliance.