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Parental Enrollment Decision-Making for a Neonatal Clinical Trial
Elliott Mark Weiss1, Katherine F Guttmann2, Aleksandra E Olszewski1
1Treuman Katz Center for Pediatric Bioethics, Seattle Children's Research Institute, Seattle, WA; Department of Pediatrics, University of Washington School of Medicine, Seattle, WA.
The Journal of Pediatrics
|August 17, 2021
Summary
Parents
Area of Science:
- Neonatal Research
- Clinical Trial Recruitment
- Parental Experience
Background:
- Recruitment in neonatal clinical trials is complex.
- Understanding parental perspectives is crucial for successful enrollment.
- Differences exist between parents who enroll and those who decline.
Purpose of the Study:
- To describe the parental experience of recruitment in a neonatal clinical trial.
- To compare experiences between parents who enrolled their infants and those who declined.
- To identify factors influencing enrollment decisions.
Main Methods:
- A survey was conducted across 12 US neonatal intensive care units.
- Parents of infants in the High-dose Erythropoietin for Asphyxia and encephaLopathy (HEAL) trial were surveyed.
- Survey assessed interactions with staff, consent, study perceptions, decisional conflict, reasons for/against participation, and decision timing.
Main Results:
- Parents who declined enrollment preferred contact by clinical staff over research staff.
- Enrolled parents reported more positive initial impressions of the study.
- Decision-making timing and specific considerations varied by enrollment status.
Conclusions:
- Parental recruitment experiences differ significantly based on enrollment status.
- Findings highlight the need for tailored recruitment strategies in neonatal trials.
- Improving recruitment processes can enhance family participation and trial success.
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