Using Media to Improve the Informed Consent Process for Youth Undergoing Pediatric Endoscopy and Their Parents
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Children
- Sponsor
- Huang, Jeannie, M.D.
- Enrollment
- 77
- Primary Endpoint
- Evaluation of Comprehension of Informed Consent Process via a scored scale
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
The investigators employed a randomized control study design to evaluate the efficacy of a video intervention augmenting informed consent discussions in improving parental and youth informed consent comprehension.
Detailed Description
IC = informed consent The investigators employed a randomized control study design to evaluate the efficacy of a video intervention augmenting IC discussions in improving parental and youth IC comprehension. Sample size was selected to detect a 30% improvement in comprehension scores in the intervention v. control group. The local Institutional Review Board approved the study. Informed consent and assent were obtained prior to all study procedures.
Investigators
Jeannie Huang, MD, MPH
Associate Professor
Huang, Jeannie, M.D.
Eligibility Criteria
Inclusion Criteria
- •For children admitted, age limits listed. Youth-parent pairs were admitted into the study.
- •Had to be undergoing pediatric endoscopy.
- •English speaking
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Evaluation of Comprehension of Informed Consent Process via a scored scale
Time Frame: Day 1
Structured Interview