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

June 22, 2011 updated by: Children's Mercy Hospital Kansas City

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 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

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: patient decision aid
Other: patient decision aid for endoscopy
patient decision aid will be administered at the point of decision making

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
immeadiately after completing patient decision aid

Collaborators and Investigators

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

Sponsor

Children's Mercy Hospital Kansas City

Investigators

  • Principal Investigator: Nancy A Neilan, MT, Children's Mercy Hospital Kansas City

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

December 1, 2008

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

December 19, 2008

First Submitted That Met QC Criteria

December 19, 2008

First Posted (Estimate)

December 22, 2008

Study Record Updates

Last Update Posted (Estimate)

June 27, 2011

Last Update Submitted That Met QC Criteria

June 22, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CMH080104.2

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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