Improving the Informed Consent Process for Youth Undergoing Pediatric Endoscopy and Their Parents

Huang, Jeannie, M.D.

Status: Completed

Conditions: Children

Treatments: Behavioral: video

Study type: Interventional

Identifiers

NCT02671734

121426

Details and patient eligibility

About

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.

Full 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.

Enrollment: 77 patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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77 participants in 2 patient groups

control

No Intervention group

Description:

Subjects in this arm received the standard consent form to read and underwent standard discussions with the procedurist prior to the procedure.

intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: video