Parental Enrollment Decision-Making for a Neonatal Clinical Trial

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.

Keywords: decisional conflict; enrollment decision-making; research participation.

Figure 1;

Reasons to Enroll and Reasons Not to Enroll among Parents Asked to Participate in the HEAL Trial Participants were asked the influence of fifteen items on their enrollment decision. For each they selected one of five responses to identify the influence of that item on their enrollment decision: “a lot less likely to join,” “somewhat less likely to join,” “no effect,” “somewhat more likely to join,” or “a lot more likely to join.” Responses of parents who enrolled their infant in HEAL are on the left; those of parents who declined HEAL enrollment are on the right. We included seven items (listed above) within three categories of reasons to enroll: potential benefit to child; potential benefit to others; and personal coping. We included eight items (listed above) within four categories of reasons not to enroll: potential harm to child; burden of research participation; insufficient time to decide; and personal coping.