1. Parental Enrollment Decision-Making for a Neonatal Clinical Trial.
- Author
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Weiss EM, Guttmann KF, Olszewski AE, Magnus BE, Li S, Kim SYH, Shah AR, Juul SE, Wu YW, Ahmad KA, Bendel-Stenzel E, Isaza NA, Lampland AL, Mathur AM, Rao R, Riley D, Russell DG, Salih ZNI, Torr CB, Weitkamp JH, Anani UE, Chang T, Dudley J, Flibotte J, Havrilla EM, O'Kane AC, Perez K, Stanley BJ, Shah SK, and Wilfond BS
- Subjects
- Cross-Sectional Studies, Humans, Infant, Infant, Newborn, Intensive Care Units, Neonatal statistics & numerical data, Randomized Controlled Trials as Topic, Surveys and Questionnaires, Decision Making, Parents psychology, Patient Selection
- Abstract
Objective: To describe the parental experience of recruitment and assess differences between parents who participated and those who declined to enroll in a neonatal clinical trial., Study Design: This was a survey conducted at 12 US neonatal intensive care units of parents of infants who enrolled in the High-dose Erythropoietin for Asphyxia and encephaLopathy (HEAL) trial or who were eligible but declined enrollment. Questions assessed 6 factors of the parental experience of recruitment: (1) interactions with research staff; (2) the consent experience; (3) perceptions of the study; (4) decisional conflict; (5) reasons for/against participation; and (6) timing of making the enrollment decision., Results: In total, 269 of 387 eligible parents, including 183 of 242 (75.6%) of those who enrolled their children in HEAL and 86 of 145 (59.3%) parents who declined to enroll their children in HEAL, were included in analysis. Parents who declined to enroll more preferred to be approached by clinical team members rather than by research team members (72.9% vs 49.2%, P = .005). Enrolled parents more frequently reported positive initial impressions (54.9% vs 10.5%, P < .001). Many parents in both groups made their decision early in the recruitment process. Considerations of reasons for/against participation differed by enrollment status., Conclusions: Understanding how parents experience recruitment, and how this differs by enrollment status, may help researchers improve recruitment processes for families and increase enrollment. The parental experience of recruitment varied by enrollment status. These findings can guide future work aiming to inform optimal recruitment strategies for neonatal clinical trials., (Copyright © 2021 Elsevier Inc. All rights reserved.)
- Published
- 2021
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