Use of a Patient Decision Aid for Gastrologic Endoscopy in a Pediatric Setting

Not Applicable

Completed

• Conditions: Endoscopy
• Interventions: Other: patient decision aid for endoscopy

• Registration Number: NCT00813033
• Lead Sponsor: Children's Mercy Hospital Kansas City

Brief Summary

Parents need understandable information in order to make appropriate choices for their child's health care. This is especially true when making decisions about invasive medical procedures. Parents need to understand what will happen, the risks involved, how these risks will be managed and what other options they have before they can decide what is best for their child. The present proposal involves the creation of a novel patient decision aid about the gastro endoscopy procedure, called a "scope." The purpose of the aid is to provide parents with information so they are able to discuss the options with their child's health care providers.

Detailed Description

True informed consent depends on effective, bi-directional communication between parents and their child's healthcare providers. Many things affect the quality of the consenting process including the parents' level of health literacy, English proficiency and cultural perspectives. Our long-term goal is to develop a standardized consenting process that ultimately addresses the needs of the patient and the patient's family so that a truly informed decision can occur. The specific hypothesis is that incorporating the use of a multimedia patient decision aid to assist in the education of patients and their families about an invasive medical procedure (i.e. gastro-endoscopy) will improve knowledge and positively impact the ability of the parent to act on this knowledge when making decisions regarding their child's health care.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-19
• Study First Submitted QC: 2008-12-19
• Study First Posted: 2008-12-22
• Primary Completion: 2011-02
• Study Completion: 2011-03
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-22
• Last Update Posted: 2011-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• parents or LARs who are considering a gastro-endoscopy for their child

Exclusion Criteria

• child has previously undergone an endoscopy
• parent of child has undergone an endoscopy
• non-English speaking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patient decision aid	patient decision aid for endoscopy	-

Primary Outcome Measures

Name	Time	Method
Validated survey tools will be used to assess change in the consenting parent's knowledge, expectations of outcomes, clarity of values, decision and decision conflict.	immeadiately after completing patient decision aid

Trial Locations

Locations (1)

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States