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Clinical Trials/NCT00813033
NCT00813033
Completed
Not Applicable

Creation and Pilot Evaluation of a Patient Decision Aid as an Adjunct to the Consenting Process for Gastrointestinal Endoscopy in a Pediatric Setting

Children's Mercy Hospital Kansas City1 site in 1 country80 target enrollmentDecember 2008
ConditionsEndoscopy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endoscopy
Sponsor
Children's Mercy Hospital Kansas City
Enrollment
80
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2008
End Date
March 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Children's Mercy Hospital Kansas City

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Time Frame: immeadiately after completing patient decision aid

Study Sites (1)

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