OBJECTIVE The objective of this study was to determine the feasibility of a clinical trial to study a novel central venous access visual tool’s impact on anxiety and decisional comfort in surrogate decision-makers during procedural consent. METHODS This was a single-site, randomized pilot study. English- and Spanish-speaking parents of children requiring nonemergent central venous access in 1 of 3 pediatric intensive care units in an urban academic children’s hospital were eligible. Parents were randomized 1:1 to central venous access procedural consent with or without the tool. Parents’ and patients’ characteristics were queried, including parental health literacy and anxious traits. Their anxiety and decisional comfort surrounding the procedure for their child were measured using modified validated scales (Low Literacy Decisional Conflict Scale, Amsterdam Preoperative Anxiety and Information Scale, and State-Trait Anxiety Inventory-Short). After data collection, all parents reviewed the tool, and feedback was elicited. Feasibility measures included enrollment/retention, randomization, and parental acceptability. RESULTS A total of 28 parents (4 Spanish-speaking) were enrolled (20% of those eligible, 90% of those approached) and were well randomized to each intervention group. Parents found the tool and trial overwhelmingly acceptable. There was no difference in parental state anxiety or decisional comfort metrics. CONCLUSIONS This randomized pilot study demonstrated feasibility in enrollment/retention, randomization, and parental acceptability, but not preliminary efficacy in decreasing parental anxiety or decisional discomfort.
Spence et al. (Fri,) studied this question.