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 postconsent survey, we sought to describe the impact of the video
on patient recruitment, satisfaction with the consent process, and knowledge about
the study.
Study Design This is a descriptive survey-based substudy.
Results Of the sites participating in the VentFirst trial that obtained institutional review
board (IRB) approval to allow use of the video to supplement the standard informed
consent process, three elected to participate in the survey substudy. From February
2018 to January 2021, 82 women at these three sites were offered the video and completed
the postconsent 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 five knowledge questions about
the study was 63 to 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 substudy. The ways in which audiovisual
tools might modify the traditional informed consent process deserve further study.
Key Points
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Informed consent in acute clinical contexts is difficult.
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Videos offer an alternative communication tool.
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Continued research is necessary to optimize the consent process.
Keywords
informed consent - video - neonatology - resuscitation
