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

January 29, 2016 updated by: Jeannie Huang, MD, MPH, Huang, Jeannie, M.D.

Using Media to Improve the Informed Consent Process for Youth Undergoing Pediatric Endoscopy and Their Parents

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
Subjects in this arm received the standard consent form to read and underwent standard discussions with the procedurist prior to the procedure.
Active Comparator: intervention
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.
Behavioral: video
Short (2 minute 43 second), animated videos were designed addressing nature of the procedure, risks, benefits, and alternatives for upper and lower endoscopy respectively using PowToon (www.powtoon.com). Sixth grade language was used throughout the video. Videos were shown to youth and their parents on an iPad.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Comprehension of Informed Consent Process via a scored scale
Time Frame: Day 1
Structured Interview
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huang, Jeannie, M.D.

Investigators

  • Principal Investigator: Jeannie Huang, MD, MPH, University of California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

January 25, 2016

First Submitted That Met QC Criteria

January 29, 2016

First Posted (Estimate)

February 2, 2016

Study Record Updates

Last Update Posted (Estimate)

February 2, 2016

Last Update Submitted That Met QC Criteria

January 29, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 121426

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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