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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00813033
Recruitment Status : Completed
First Posted : December 22, 2008
Last Update Posted : June 27, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Endoscopy Other: patient decision aid for endoscopy Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2008
Actual Primary Completion Date : February 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00813033

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

Responsible Party: Nancy A. Neilan/ MT (ASCP), CCRC Advanced Clinical Coordinator, Children's Mercy Hospitals and Clinics Identifier: NCT00813033     History of Changes
Other Study ID Numbers: CMH080104.2
First Posted: December 22, 2008    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: June 2011

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