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Am J Perinatol
DOI: 10.1055/a-1863-2141
Original Article

Video-Assisted Informed Consent in a Clinical Trial of Resuscitation of Extremely Preterm Infants: Lessons Learned

Namrita J. Odackal 
1   Department of Neonatology, North Denver Envision Group, Arvada, Colorado
,
Catherine G. Caruso 
2   Department of Pediatrics, Oregon Health and Science University, Portland, Oregon
,
Melissa Klitzman
3   Division of Neonatal-Perinatal Medicine, Indiana University School of Medicine, Indianapolis, Indiana
,
Monica Rincon
4   Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland, Oregon
,
Bobbi J. Byrne
3   Division of Neonatal-Perinatal Medicine, Indiana University School of Medicine, Indianapolis, Indiana
,
Jameel Winter 
5   Division of Neonatology, University of Minnesota Medical School, Minneapolis, Minnesota
,
Gina R. Petroni
6   Department of Public Health Sciences, University of Virginia, Charlottesville, Virginia
,
Karen D. Fairchild
7   Division of Neonatology, University of Virginia School of Medicine, Charlottesville, Virginia
,
Jamie B. Warren
2   Department of Pediatrics, Oregon Health and Science University, Portland, Oregon
› Author Affiliations Funding The primary VentFirst trial is funded by National Institutes of Health (grant no.: HD087413).
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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

  • Informed consent in acute clinical contexts is difficult.

  • Videos offer an alternative communication tool.

  • Continued research is necessary to optimize the consent process.

Keywords

informed consent - video - neonatology - resuscitation

Authors' Contributions

N.J.O. designed this study and is primary author of this manuscript. J.B.W. created the consent video. M.R. did the Spanish video translation. N.J.O., C.G.C., M.K., M.R., B.J.B., K.D.F., and J.B.W. recruited and surveyed participants for the study. All authors were involved in editing the manuscript.




Publication History

Accepted Manuscript online:
26 May 2022

Article published online:
30 June 2022

© 2022. Thieme. All rights reserved.

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