Objectives
This study aimed to compare elements discussed during the consent process for procedural sedation in the pediatric emergency department to documentation and parental recall before and after implementation of a standardized consent form.
Methods
This is a mixed-methods study combining retrospective electronic record review and cross-sectional surveys of providers and parents after consent for procedural sedation. Surveys were obtained before and after implementation of a precompleted consent form. Providers' survey responses were compared with consent documentation. Recall of consent elements discussed by linked parent-provider dyads were compared.
Results
Six hundred fifty-five encounters were reviewed. Pediatric emergency medicine fellows and pediatric emergency department-based pediatricians were more likely to document any benefit (odds ratio [OR], 1.5; 95% confidence interval [CI], 1.0–2.4) or alternative (OR, 2.7; 95% CI, 1.8–3.9) compared with PEM attendings. Providers were more likely to report discussion of failure to complete the procedure (OR, 7.3; 95% CI, 2.3–23.3) and parents were more likely to recall discussion of this risk (OR, 5.3; 95% CI, 1.0–27.8) in the postintervention group. Based on provider recall, using the precompleted consent form was associated with providers discussing at least 2 of the 3 benefits (84.0% vs 97.2%, P < 0.01), 5 of the 5 risks (31% vs 67.7%, P < 0.01), and improved parental recall of risks (5.7% vs 22.9%, P = 0.03). More providers reported taking less than 1 minute to complete the form in the postimplementation group (12.0% vs 43.7%, P < 0.01).
Conclusions
Implementing a precompleted consent form for procedural sedation was associated with providers reporting decreased time spent completing the consent form and better alignment of key consent elements between reported provider discussion and parental recall.