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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00813033
Enrollment
80
Registered
2008-12-22
Start date
2008-12-31
Completion date
2011-03-31
Last updated
2011-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endoscopy

Keywords

create a patient decision aid for endoscopy, evaluate efficacy of a patient decision aid for endoscopy

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.

Interventions

OTHERpatient decision aid for endoscopy

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

Sponsors

Children's Mercy Hospital Kansas City
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
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.immeadiately after completing patient decision aid

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026