Comprehension of Clinical Trial Information by Caregivers and Adolescents Delivered via Multimedia Video versus Conventional Practice: A Nonrandomized Controlled Trial (Preprint)

BACKGROUND Research participants often misunderstand the required elements of informed consent information whether provided in written or oral format. Informed consent instruments with embedded evidence-based learning theory principles administered by multimedia electronic formats may improve comprehension and retention. OBJECTIVE The objective was to determine if study information comprehension and retention using an interactive multimedia video consent process was non-inferior to comprehension and retention after an in-person face-to-face interaction with a conventional written consent document for caregivers and adolescents enrolling in a clinical trial. METHODS Participants were caregivers and children aged 12- to-17 years who were considering enrollment in a clinical trial of asthma treatments. Consent information was presented as a multimedia web-based video consent interaction or as a conventional written consent document with in-person interaction between prospective participants and the study staff. The trial was a parallel nonrandomized non-inferiority design comparing the two consent methods. Caregivers and adolescents completed a 17-item open-ended comprehension questionnaire (score range, 17-51) at enrollment and end of study 20 weeks later. Comprehension and retention were compared between consent formats. Non-inferiority was established if the 95% Confidence Interval (CI) upper bound of the difference in scores (conventional format minus web-based) was less than the non-inferiority margin of 2.4; superiority was established if the upper bound of the CI was less than zero. RESULTS Fifty-four caregivers and adolescents dyads completed the interactive multimedia web-based video consent and 25 dyads completed the conventional consent. Thirty-three percent of all adolescents were Black, 57% were male, and 61% had a household income less than $60,000/year. For caregivers, the interactive multimedia web-based format was non-inferior to the conventional format at enrollment (mean [95% CI]) differerence between conventional and web-based, -0.30 (-2.52, 1.92) and and was superior at end of study 20 weeks later, -2.20 (-3.9, -0.5). There was a loss of comprehension over 20 weeks of -1.65 (-3.1, -0.19) with the conventional, but not the multimedia web-based format 0.14 (-0.84, 1.12). For adolescents, non-inferiority of the multimedia web-based format was not established. CONCLUSIONS Consent information delivered through an interactive multimedia web-based platform that incorporates evidence-based learning theory principles is understood as well as a conventional consent discussion in caregivers considering enrolling their adolescent in an asthma clinical trial. Retention of study information over time was better with a multimedia format in caregivers. CLINICALTRIAL ClinicalTrials.gov NCT02061280, NCT01437995