Associate Professor Columbia University, United States
Introduction: Central venous access is a common and necessary procedure in the pediatric intensive care unit (PICU) for which parental consent is usually sought. Parents of critically ill children experience substantial stress and must make decisions with unfamiliar and variable information. Studies show parental recall of details of procedural consent are lacking and worse when stressed. Visual aids can improve comprehension and retention and may mitigate anxiety, but have not been studied for this procedure.
Methods: We performed an exploratory, single-site, unblinded, randomized trial of a novel visual aid during procedural consent for non-emergent central venous access in the PICU. English and Spanish-speaking parents of children requiring a central venous line or peripherally inserted central catheter were eligible. Parents were consented to the study but were not explicitly told of the aid or being randomized to receive procedural consent with or without it. Parents were compared by their understanding and anxiety regarding the procedure using modified validated scales (Decisional Conflict Scale-Low Literacy [DCS] and State-Trait Anxiety Inventory-Short [STAI-S]). Parental demographics and health literacy and patient medical information were collected. After data collection, all parents were able to review the visual aid.
Results: Since May 2023, a convenience sample of 9 parents (2 Spanish-speaking) have been enrolled. Six were missed due to research team unavailability, and one parent declined to participate. Six parents were randomized to consent with the aid and 3 without. There was no difference in parental health literacy or anxious traits. Patient illness severity was different between the two groups, but not baseline functional status. Parents consented with the aid reported significantly less anxiety about the procedure (STAI-S State Score 7.2 with, 11.3 without, p=0.035). There was no difference in parental understanding. Feedback on the visual aid was universally positive.
Conclusions: Using a visual aid during consent for central venous access may mitigate parental anxiety about the procedure and be a useful supplement to the consent process. Additional participants will help with more complete randomization and better delineate our findings.
