Improving the Informed Consent Process for Youth Undergoing Pediatric Endoscopy and Their Parents
Not Applicable
Completed
- Conditions
- Children
- Interventions
- Behavioral: video
- Registration Number
- NCT02671734
- Lead Sponsor
- Huang, Jeannie, M.D.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 77
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
- None.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description intervention video Subjects in this arm viewed a video detailing key elements of informed consent. Subjects in this arm also received the standard consent form to read and underwent standard discussions with the procedurist prior to the procedure.
- Primary Outcome Measures
Name Time Method Evaluation of Comprehension of Informed Consent Process via a scored scale Day 1 Structured Interview
- Secondary Outcome Measures
Name Time Method