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Improving Informed Consent in Pediatric Endoscopy

NCT00899392 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 148

Last updated 2013-07-30

Study results available
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Summary

Informed consent/assent in pediatric medicine is an accepted and important practice that has been rarely studied, tested for quality, or optimized for patient satisfaction. In the pursuit of enhancing and studying pediatric care, the investigators propose, as pediatric gastroenterologists, assessing the current state of parental and adolescent consent/assent in upper gastrointestinal endoscopy and offering a computer based education program to improve it. The investigators will look at outcomes that include anxiety, satisfaction, attainment of informed consent, and patient flow efficiency in a GI endoscopy suite.

Conditions

  • Informed Consent
  • Procedural State Anxiety
  • Subject's Satisfaction

Interventions

OTHER

Emmi Pediatric Upper Endoscopy Patient Education Module

Emmi Pediatric Upper Endoscopy Patient Education Module as designed by EMMI SOLUTIONS, LLC

Sponsors & Collaborators

Principal Investigators

  • Petar Mamula, M.D. · Children's Hospital of Philadelphia

  • Joel Friedlander, D.O., M.Be. · Children's Hospital of Phildelphia

  • Greg Loeben, Ph.D. · Midwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00899392 on ClinicalTrials.gov