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

This study has been completed.
Sponsor:
Information provided by:
Children's Mercy Hospital Kansas City
ClinicalTrials.gov Identifier:
NCT00813033
First received: December 19, 2008
Last updated: June 22, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention
Endoscopy
Other: patient decision aid for endoscopy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Creation and Pilot Evaluation of a Patient Decision Aid as an Adjunct to the Consenting Process for Gastrointestinal Endoscopy in a Pediatric Setting

Resource links provided by NLM:


Further study details as provided by Children's Mercy Hospital Kansas City:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: December 2008
Study Completion Date: March 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
patient decision aid Other: patient decision aid for endoscopy
patient decision aid will be administered at the point of decision making

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00813033

Locations
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Sponsors and Collaborators
Children's Mercy Hospital Kansas City
Investigators
Principal Investigator: Nancy A Neilan, MT Children's Mercy Hospital Kansas City
  More Information

No publications provided

Responsible Party: Nancy A. Neilan/ MT (ASCP), CCRC Advanced Clinical Coordinator, Children's Mercy Hospitals and Clinics
ClinicalTrials.gov Identifier: NCT00813033     History of Changes
Other Study ID Numbers: CMH080104.2
Study First Received: December 19, 2008
Last Updated: June 22, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Mercy Hospital Kansas City:
create a patient decision aid for endoscopy
evaluate efficacy of a patient decision aid for endoscopy

ClinicalTrials.gov processed this record on April 17, 2014