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

Overview

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.

Full Title of Study: “Creation and Pilot Evaluation of a Patient Decision Aid as an Adjunct to the Consenting Process for Gastrointestinal Endoscopy in a Pediatric Setting”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2011

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.

Interventions

  • Other: patient decision aid for endoscopy
    • patient decision aid will be administered at the point of decision making

Arms, Groups and Cohorts

  • Other: patient decision aid

Clinical Trial Outcome Measures

Primary 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Children’s Mercy Hospital Kansas City
  • Provider of Information About this Clinical Study
    • Nancy A. Neilan/ MT (ASCP), CCRC Advanced Clinical Coordinator, Children’s Mercy Hospitals and Clinics
  • Overall Official(s)
    • Nancy A Neilan, MT, Principal Investigator, Children’s Mercy Hospital Kansas City

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