Video-assisted informed consent in a clinical trial of resuscitation of extremely preterm infants: Lessons learned

Abstract

OBJECTIVE: Obtaining informed consent for clinical trials is challenging in acute clinical settings. For the VentFirst randomized clinical trial (assisting ventilation during delayed cord clamping for infants <29 weeks’ gestation), we created an informational video that sites could choose to use to supplement the standard in-person verbal and written consent. Using a post-consent survey, we sought to describe the impact of the video on subject recruitment, satisfaction with the consent process, and knowledge about the study. STUDY DESIGN: Descriptive survey-based sub-study. RESULTS: Of the four sites participating in the VentFirst trial that chose to allow use of the video to supplement the standard informed consent process, three elected to participate in the survey sub study. From February 2018 to January 2021, 82 women at these three sites were offered the video and completed the post-consent survey. Overall, 73 of these 82 women (89%) consented to participate in the primary study, 78 (95%) indicated the study was explained to them very well or extremely well, and the range of correct answers on 5 knowledge questions about the study was 63%-98%. Forty-six (56%) of the 82 women offered the video chose to watch it. There were no major differences in study participation, satisfaction with the consent process, or knowledge about the study between the women who chose to watch or not watch the video. CONCLUSION: Watching an optional video to supplement the standard informed consent process did not have a major impact on outcomes in this small sub-study. The ways in which audiovisual tools might modify the traditional informed consent process deserve further study.