Using Pragmatic Decentralized Recruitment Strategies in Practice Based Research: The PREVENTABLE Study

Context: COVID-19 has severely impacted traditional approaches to Practice Based Research recruitment strategies. The Center for Primary Care Research at Atrium Health is actively enrolling participants as a site for PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr adults (PREVENTABLE), a multi-center, decentralized trial.

Objective: Pragmatic, decentralized trials are an effective way to reach individuals hesitant to come in-clinic as well as reducing study costs.

Study Design and Analysis: REDCap is used to review and sign informed e-consents. The PREVENTABLE website allows sites to directly enter data. The central study pharmacy mails a 90-day supply of study drug to participants. A call center staffed with personnel trained on study protocol, which includes a phone screen for cognitive function (TICS-M), performs follow up.

Settings or Dataset: PREVENTABLE is enrolling participants across 86 US based sites, including Veteran Affairs. We are recruiting from 77 primary care research practices across nearly 3,000 square miles. Participants are offered options for consenting and completing study related activities in clinic or via phone or video capable device.

Population Studied: Participants aged ≥75 years without dementia, disability, or clinically evident cardiovascular disease.

Intervention/Instrument: The number of participants who e-consent compared to those who do not.

Outcome Measures: The number of e-consents obtained is tracked through REDCap, while the length of virtual consents compared to in person consents is tracked via Atrium’s healthcare software.

Results: Currently, 12 of 53 participants e-consented, while the rest consented in-person. 5 patients were interested but did not participate due to limited internet or transportation access. Study drug order activity completed between site and central study pharmacy include more than 55 shipped and delivered orders. Based on check-in and out times in healthcare software, virtual visits take ^~1.25 hours with 1 study personnel and on-site visits take ^~2 hours with up to 3 study personnel.

Conclusion: The study design has allowed Atrium Health to recruit, enroll, and retain participants living 40+ miles away or those with alternate addresses. Study related time and effort are saved by site personnel.