Abstract
BackgroundRecruitment is a necessary, yet challenging component to clinical trial implementation. Using intentional strategies to meet enrollment goals is important to ensure the recruited sample adequately reflects the intended study population. Outreach via electronic health record (EHR) patient portals is a promising strategy. While identifying potentially eligible individuals in the EHR is largely accepted as effective, little is known about the effectiveness of outreach via EHR compared to outreach via traditional electronic mail (email) communication given equivalent population identification strategies.MethodsThis study was conducted using recruitment data from one of four study locations participating in the LEAP study, a multi-site, double-blind, placebo-controlled trial studying the long-term use of phentermine on weight loss and blood pressure. Between May 2023 and February 2024, 17,989 potentially trial-eligible participants identified using EHR data were randomized to either portal or email recruitment communications. Outreach success was measured at six milestones between starting the self-screener and study randomization. Recruitment rates overall and by demographic subpopulation are reported at each milestone as a percent of total invited and as a percent of previous milestone completers. Multivariate analysis considers the moderating effect of demographics on the relative impact of communication type.ResultsOverall, 6.6% (n = 1191) completed the self-screener and 0.5% (n = 85) were randomized into the LEAP trial. Individuals randomized to patient portal communication were more likely to start the self-screener (Odds Ratio [OR]= 2.4 [2.12, 2.73], p < 0.0001) and complete the subsequent four steps, however there was no significant difference in the percent ultimately randomized into the study (OR = 1.43 [0.93, 2.21], p = 0.10). Moreover, when controlling for completion of the previous step, all subsequent milestone differences were no longer significant. Gender was the only significant moderating factor of all available participant characteristics, with women 2.92 ([2.48, 3.43], p < 0.001) and men 1.72 ([1.41, 2.12], p < 0.001) times more likely to respond to portal messages than email communications.ConclusionsInitial activation in study activities was higher in the patient portal group. Although this impact sustained itself across all but the final study milestone and resulted in absolute larger counts among those randomized to portal messages, there is no evidence that this choice will improve representation in biomedical research or the final study randomization rate overall. Therefore, these findings suggest using the portal strategy may lead to more effort without yield on interim steps by both the research team and the potential participants compared to email. Ultimately, the research team's approach may depend on organizational context and study topic, as some topics do not lend themselves to the less secure nature of email communications.