Abstract
BACKGROUND: Enrollment and retention difficulties remain major barriers to conducting clinical trials. Financial incentives may promote clinical trial enrollment, however delivery methods to maximize enrollment, maximize retention, and minimize cost remains uncertain. METHODS: We conducted a single-blind, web-based randomized controlled trial of five financial incentive strategies on enrollment and retention rates in a longitudinal study of advance directives among community-dwelling older adults. Participants were eligible to receive a fixed total financial incentive, but the disbursement amounts at each study timepoint (baseline, 2-weeks, 4-weeks, and 6-weeks) differed between study arms. At each timepoint, participants completed a different advance directive. We conducted an intention-to-treat analysis for the primary and secondary outcomes of enrollment and retention. RESULTS: 1803 adults were randomized to one of five incentive strategies: constant n = 361; increasing n = 357; U-shaped n = 361; surprise n = 360; self-select n = 364. Overall, 989 (54.9%) participants elected to enroll in the advance directive study. There were no differences in enrollment rates between the control (constant 53.5%) and any of the four intervention study arms (increasing 54.3%, p = 0.81; U-shaped 57.3%, p = 0.30; surprise 56.9%, p = 0.35; and self-select 52.2%, p = 0.73). There were no differences in retention rates between the control (constant 2.1%) and any of the four intervention study arms (increasing 5.2%, p = 0.09; U-shaped 3.9%, p = 0.23; surprise 2.4%, p = 0.54; self-select 2.1%, p = 0.63). CONCLUSIONS: Financial incentive programs for trial enrollment informed by behavioral economic insights were no more effective than a constant-payment approach in this web-based pilot study.