Electronic health records (EHRs) have transformed the way clinical care is recorded and reimbursed, and now their promise for reaching across large populations is making them a key resource for cardiovascular research.
One example of the use of EHRs in research is the pragmatic ADAPTABLE (Aspirin Dosing: A Patient-centric Trial Assessing Benefits and Long-term Effectiveness) study, which recently enrolled its 1,000th participant. The key to its successful launch has been the major effort to connect the research community to share perspectives and formulate a shared purpose (Curr Cardiol Rep 2016;18:81).
Aimed at enrolling 20,000 patients at high risk for cardiac events from a network of 35 U.S. health systems, ADAPTABLE was designed to assess whether low- or standard-dose aspirin is better for preventing heart attacks and stroke in patients with coronary artery disease. It is the first randomized clinical trial conducted using PCORnet, the National Patient-Centered Clinical Research Network, and serves as a vanguard of the network’s scope and capabilities.
PCORnet created a structured data platform that ADAPTABLE will use to organize EHR and associated data from hospitals and health systems into a consistent, usable format. The study will identify, recruit and follow patients electronically.
One of the important aims of ADAPTABLE is to engage patients, their healthcare providers and trial investigators in leveraging the PCORnet infrastructure. In ADAPTABLE, the patient’s role has shifted from participant to partner. Adaptors are patient representatives who have been involved in ADAPTABLE since the inception of the research question. Adaptors provided input on the protocol, consent form, study portal and materials.
They will be integral in disseminating study updates and results to other patients and in the community.
The secret sauce is shared purpose
The successful launch of ADAPTABLE depended on effective strategies for bringing the diverse members of the research community together. Approaches have included broad initiatives to frame a shared purpose for the trial in interesting and engaging terms. This included building partnerships around clinical, quantitative and informatics perspectives, and taking into account both the “big picture” and the fine detail. The shared purpose was then disseminated and refined through inclusive, early-phase strategy meetings held long before implementation began. This new paradigm of using a formal, decentralized approach was part of the “secret sauce” for project success, connecting people to share perspectives and formulating a shared purpose and program.
Lessons for EHRs in research
Five substantive sessions were held in as many months, with an average of 42 attendees per session. The initial session began with 31 people invited; the final invitation was distributed to 124 email addresses. Knowledge sharing occurred beyond meeting attendance via slide sharing and online recordings.
Key learnings included the fact that using EHRs for research is more complicated than might be expected. Suggestions:
- Question and re-examine assumptions about the persectives of various segments of the research community.
- Frame strategy to get everyone on the same page. It can take a great deal of energy but is integral for achieving results together.
- When developing strategy and tactics, ask what works for participants and learn from their responses.
EHR systems are still relatively new, so all available individual and institutional knowledge must be considered.
W. Schuyler Jones, MD, is an assistant professor of medicine at Duke University and Duke Clinical Research Institute. Shelley Rusincovitch is an informatics architect at the Duke Clinical and Translational Science Institute.