Enrollment strategies in the era of digital revolution: Experience from a remote health management program (Preprint)

Abstract

Remote or decentralized clinical studies allow innovative outreach opportunities, but whether that will result in improved enrollment remains unknown.

We report our experience in identifying potential participants from various sources and testing diverse outreach and enrollment strategies within a decentralized clinical trial framework.

We employed multiple screening and outreach methods to identify and enroll patients into an entirely remote implementation study for guideline-directed care in patients with type 2 diabetes at high risk of cardio-renal complications, within the Mass General Brigham health network. Eligible patients were identified by querying the Electronic Data Warehouse (EDW) and invited by either individualized Electronic Health Record (EHR)-portal messages, emails, or bulk EHR-portal invitations. Traditional outreach included reviewing upcoming clinic visits, accepting provider referrals, and mailing invitation letters. All patients who received the program invitation also received enrollment phone calls.

Of the 200 enrolled participants, 190 (95%) were identified via the EDW, 2 (1%) were identified from upcoming clinic visits, and 8 (4%) resulted from direct provider referrals. Of patients identified through the EDW queries, the rates of enrollment were: 0/3666 (0%) through bulk EHR-portal messages, 49/191 (25%) by an individualized EHR-portal message, 61/657 (9%) by e-mail and 80/588 (13%) by mailed letter . Clinic-based enrollment resulted in a 2% (2/102) enrollment rate from upcoming visits and 22% (8/36) from provider referrals. In total, traditional methods (mailed letters or clinic-based approaches) accounted for 45% (90/200) of enrollments, while electronic methods contributed to 55% (110/200).

Remote clinical research is feasible through less-personalized enrollment methods; however, enrollment remains labor and resource-intensive. Database queries can be used to identify many potentially eligible candidates, but electronic communications generated a low yield of interested participants, and traditional individualized approaches, including manual screening, mailed letters, and provider referrals, were required to achieve enrollment targets. To enhance the enrollment process, innovative and scalable patient engagement strategies must be developed and integrated, aiming to reduce effort and maximize efficiency.