The Duke Heart Center, the second highest enrolling site in the ADAPTABLE study, recently celebrated a milestone with more than 1,000 patients enrolled. In this article, the team shares how they leverage their electronic health record (EHR) system to streamline the screening process for this pragmatic study designed to answer what is the best daily dose of aspirin for patients with heart disease.
They start by designing a report based on ADAPTABLE’s eligibility criteria. From this customized report, study coordinators receive a list of patients who have been automatically screened for the upcoming clinic day. Designed to minimize coordinator effort in identifying eligible patients, study coordinators use the list to confirm eligibility, remove any patients who have previously declined, and take note of the patient’s clinic appointment time so that a “Golden Ticket” can be delivered to clinicians to pass on to their eligible patients. A golden ticket is in invitation to eligible study participants to further explore and enroll in ADAPTABLE.
How is this daily list created? The customized report is run against EHR data available at that moment (real time) to identify potential patients – as opposed to the previous process of querying the PCORnet Common Data Model (CDM), which is a much more static process of organizing EHR data. Once the EHR identifies the patients and associates them to the ADAPTABLE protocol, a rule is implemented and a new field named “ADAPTABLE” (see image to the right) is populated in the multi-provider schedule column that providers see. This column is effectively a flag so providers can readily recognize when a patient is eligible for ADAPTABLE. This is especially helpful since many providers use this screen as their clinic ‘home’ screen.
Leveraging the EHR in this way has provided research staff with a near real-time view of eligible patients in their clinic and has allowed for better communication with providers and support staff. Patients identified as potential participants by coordinators can be evaluated for appropriateness by providers before the clinic visit begins, and nurses can remind providers which patients to approach during the day. Using this process has been a successful strategy to identify a larger pool of potential participants as well as providing a more consistent approach to recruitment.
The ADAPTABLE Duke Heart Center team started implementing this process in October 2017. Since then the team has seen an increase in eligible patients on the daily clinic lists compared to the former CDM system. Between November 2017 and March 2018, 65% of patients enrolled were a result of this process. This number reflects both enrollments in clinic and patients self-enrolling from home.
Effectively using EHRs as a recruitment strategy requires transparency and communication with clinicians. Before implementing a new EHR study identification and recruitment process, the team recommends that clinicians are informed about the study and process. Although pragmatic studies are intended to reduce clinician and coordinator effort, the role of clinicians and research staff in ADAPTABLE remains critical. Patients want to hear about study opportunities from their doctors and doctors welcome the opportunity to discuss participation in research with their patients.
Finding ways to make research more practical is what ADAPTABLE and pragmatic clinical research is all about. Using EHRs in ADAPTABLE integrates conversations about participation into the clinical work flow, helping both clinicians and patients become more aware of the research question, and better understand if participation is the right choice.