Assessing Equitable Recruitment in a Digital Health Trial for Asthma.

Abstract

To assess a multi-pronged strategy using primarily digital methods to equitably recruit asthma patients into a clinical trial of a digital health intervention. We approached eligible patients using at least one of eight recruitment strategies. We recorded approach dates and the strategy that led to completion of a web-based eligibility questionnaire that was reported during the verbal consent phone call. Study team members conducted monthly sessions using a structured guide to identify recruitment barriers and facilitators. The proportion of participants who reported being recruited by a portal or non-portal strategy was measured as our outcomes. We used Fisher's Exact test to compare outcomes by equity variable, and multivariable logistic regression to control for each covariate and adjust effect size estimates. Using grounded theory, we coded and extracted themes regarding recruitment barriers and facilitators. The majority (84.4%) of patients who met study inclusion criteria were patient portal enrollees. Of 6366 eligible patients who were approached, 627 completed the eligibility questionnaire and were less frequently Hispanic, less frequently Spanish-speaking, and more frequently patient portal enrollees. Of 445 patients who consented to participate, 241 (54.2%) reported completing the eligibility questionnaire after being contacted by a patient portal message. In adjusted analysis, only race (OR 0.46 [(0.28, 0.77)], p=0.003) and college education (OR 0.60, 95% CI [0.39, 0.91], p = 0.016) remained significant. Key recruitment barriers included technology issues (e.g., lack of email access) and facilitators included bilingual study staff, Spanish-language recruitment materials, targeted phone calls, and clinician-initiated "1-click" referrals. A primarily digital strategy to recruit patients into a digital health trial is unlikely to achieve equitable participation, even in a population overrepresented by patient portal enrollees. Non-digital recruitment methods that address racial and educational disparities and less active portal enrollees are necessary to ensure equity in clinical trial enrollment.