Use of a Patient Decision Aid for Gastrologic 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.

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Key information

Conditions

Endoscopy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

patient decision aid for endoscopy

Other

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

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Children's Mercy Hospital Kansas City

Other

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: Dec 22, 2008
Registry last updated: Jun 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed