A video-assisted informed consent intervention will be implemented in the Dell Children’s Medical Center (DCMC) Emergency Department (ED). Parents whose children are recommended for LP will be randomly selected to receive either standard informed consent procedures or video-assisted informed consent. We plan to enroll 100 participants. The intervention group (n=50) will receive procedure information via a video and the control group (n=50) will receive standard procedure explanation. The 2-minute video (available in English or Spanish) will use animation to explain the neonatal LP procedure, benefits, and risks. All participants will complete brief knowledge surveys after the intervention and will be asked to provide feedback on their satisfaction with the informed consent process. Pediatric emergency medicine physicians at Dell Children’s collaborated to create the knowledge surveys using the Delphi method. The primary outcome to be assessed is the efficacy of the video intervention on parents’ comprehension compared to the conventional discussion. Secondary outcomes will focus on parental satisfaction with the informed consent process and the rate of consent refusal.
Inclusion
- Children, age 0-7 months old who are recommended for lumbar puncture procedure during an ED visit
- Caregiver fluent in English or Spanish
Exclusion
- Previous enrollment in the study, i.e., the patient has been previously part of the current LP study
- Parent/guardian unwilling to complete surveys
Timeline
This study closed to enrollment as of 4/2025.