JMIR Publications

ABSTRACT

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 noninferior 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 their adolescent child 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. Noninferiority was established if the 95% Confidence Interval (CI) upper bound of the difference in scores (conventional format minus web-based) was less than the noninferiority 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 noninferior 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. Clinical Trial: ClinicalTrials.gov NCT02061280, NCT01437995