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Impact of Using a Precompleted Consent Form for Procedural Sedation in the Pediatric Emergency Department
Nichole McCollum, Olivia Silva1, Laura Sigman
1George Washington School of Medicine and Health Sciences, Washington, DC.
Insights
A standardized consent form for pediatric procedural sedation improved documentation and parental recall of risks and benefits. This led to better alignment between provider discussions and patient understanding, while reducing completion time.
Area of Science:
- Pediatric Emergency Medicine
- Informed Consent
- Patient Safety
Background:
- Informed consent is crucial for procedural sedation in pediatric emergency departments.
- Variability in consent discussions can impact parental understanding and recall.
- Standardized tools may improve the quality of the consent process.
Purpose of the Study:
- To compare elements discussed during procedural sedation consent in a pediatric emergency department.
- To evaluate documentation and parental recall before and after implementing a standardized consent form.
- To assess the impact of a precompleted consent form on provider efficiency and consent quality.
Main Methods:
- Mixed-methods study: retrospective electronic record review and cross-sectional surveys.
- Surveys administered to providers and parents pre- and post-implementation of a standardized consent form.
- Comparison of provider survey responses with consent documentation and linked parent-provider recall.
Main Results:
- A precompleted consent form was associated with improved documentation of benefits and alternatives by providers.
- Providers were more likely to discuss procedure failure, and parents recalled this risk more often post-implementation.
- Parental recall of risks significantly improved with the standardized form (5.7% vs 22.9%).
- Provider time to complete the form decreased significantly post-implementation (12.0% vs 43.7%).
Conclusions:
- Implementing a precompleted consent form enhances procedural sedation consent in pediatric emergency settings.
- The standardized form improves alignment between provider discussions and parental recall of key consent elements.
- This intervention streamlines the consent process, reducing provider completion time.
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.
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