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

NCT ID: NCT00813033

Last Updated: 2011-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2011-03-31

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.

Conditions

Endoscopy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

patient decision aid

Group Type: OTHER

patient decision aid for endoscopy

Intervention Type: OTHER

patient decision aid will be administered at the point of decision making

Interventions

patient decision aid for endoscopy

patient decision aid will be administered at the point of decision making

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Mercy Hospital Kansas City

OTHER

Sponsor Role: lead

Responsible Party

Children's Mercy Hospitals and Clinics

Principal Investigators

Nancy A Neilan, MT

Role: PRINCIPAL_INVESTIGATOR

Children's Mercy Hospital Kansas City

Locations

Children's Mercy Hospital

Kansas City, Missouri, United States

Countries

United States

Other Identifiers

CMH080104.2

Identifier Type: -

Identifier Source: org_study_id