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Assessing Equitable Recruitment in a Digital Health Trial for AsthmaFunding This project was supported by grant numbers R18HS026432 and R18HS026432–02S1 from the Agency for Healthcare Research and Quality. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or Agency for Healthcare Research and Quality.
Objective This study aimed to assess a multipronged strategy using primarily digital methods to equitably recruit asthma patients into a clinical trial of a digital health intervention.
Methods 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 nonportal 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.
Results The majority (84.4%) of patients who met study inclusion criteria were patient portal enrollees. Of 6,366 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 (odds ratio [OR]: 0.46, 95% confidence interval [CI]: 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.
Conclusion 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. Nondigital recruitment methods that address racial and educational disparities and less active portal enrollees are necessary to ensure equity in clinical trial enrollment.
Protection of Human and Animal Subjects
The study was reviewed and performed in compliance with the Massachusetts General Brigham Institutional Review Board.
Received: 16 November 2022
Accepted: 06 May 2023
Accepted Manuscript online:
10 May 2023
Article published online:
09 August 2023
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