Audiovisual Augmentation of Electronic Consent to Improve Consent Rates and Comprehension: A Randomized Clinical Trial.

IMPORTANCE

The use of audiovisual aids in the consent process may improve comprehension and willingness to participate in research. However, data supporting this hypothesis are lacking.

OBJECTIVE

To determine the impact of audiovisual augmentation of the consent process on willingness to participate in research and on consent comprehension.

DESIGN, SETTING, AND

PARTICIPANTS

The Personalizing Cardiovascular Health: A Population Approach to Promoting Cardiovascular Disease Resistance and Resilience Among Individuals With Obesity (RESILIENCE) nonrandomized cohort study embedded this multiarm randomized clinical trial to test different participant consent modalities. RESILIENCE recruited participants between September 2019 and March 2022, with the analysis for this randomized substudy conducted from July to December 2025. No follow-up was undertaken for this study. This component of the study was conducted exclusively virtually and completed online within a single large US academic health system.

INTERVENTIONS: Potential participants were randomized for this trial in a 1:1:1:1 allocation to receive consent information via (1) text-only (2) text and physician-featured video, (3) text and patient-featured video, or (4) text and animated video.

MAIN OUTCOMES AND MEASURES: The primary outcome was provision of consent to participate in the cohort clinical study. The secondary outcome was consent comprehension, based on a score of at least 5 of 7 on a follow-up comprehension survey. Robust log-linear Poisson regression was used to determine the relative risks (RRs) of outcomes in comparison with the text-only arm. Analyses were conducted with the evaluable population.

RESULTS

Of 1535 participants (968 [63.1%] female; 658 [42.9%] ≥60 years of age; 380 randomized to text-only, 386 to text and physician-featured video, 383 to text and patient-featured video, and 386 to text and animated video) who began the consent process, 888 (57.9%) overall gave consent to participate in the study. Patient consent rates were similar across the 4 consent delivery strategies (text only [comparator], 221 of 380 [58.2%]; text and physician video, 241 of 386 [62.4%]; RR, 1.07 [96% CI, 0.95-1.21]; text and patient video, 203 of 383 [53.0%]; RR, 0.91 [96% CI, 0.8-1.04]; and text and animated video, 223 of 386 [57.8%]; RR, 0.99 [96% CI, 0.88-1.13]). Among 884 individuals who consented and completed the consent comprehension survey, the rate of comprehension of the consent process was high 86.4% (n = 764) and did not vary among the intervention delivery strategies (text only, 193 of 221 [87.3%]; text and physician video, 207 of 241 [85.9%]; text and patient video, 177 of 203 [87.2%]; and text and animated video, 187 of 223 [83.9%]). Compared with the text-only arm, the RRs of consent comprehension were not different for the text and physician-featured video arm (RR, 1.00; [95% CI, 0.93-1.07]), the text and patient-featured video arm (RR, 1.00 [95% CI, 0.93-1.07]) and the text and animated video arm (RR, 0.96 [95% CI, 0.89-1.04]).

CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of virtual consent delivery, the rates of patient consent and consent comprehension were similar regardless of whether they were delivered by text only or text augmented by physician, patient, or animated videos. Further evaluation of these consent delivery processes across different study types and patient populations is suggested to optimize the recruitment of diverse, informed populations.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04551872.