NCT00813033

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 22, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

June 27, 2011

Status Verified

June 1, 2011

Enrollment Period

2.2 years

First QC Date

December 19, 2008

Last Update Submit

June 22, 2011

Conditions

Endoscopy

Keywords

create a patient decision aid for endoscopyevaluate efficacy of a patient decision aid for endoscopy

Outcome Measures

Primary Outcomes (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.

    immeadiately after completing patient decision aid

Study Arms (1)

patient decision aid

OTHER
Other: patient decision aid for endoscopy

Interventions

patient decision aid for endoscopyOTHER

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

patient decision aid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • parents or LARs who are considering a gastro-endoscopy for their child

You may not qualify if:

  • child has previously undergone an endoscopy
  • parent of child has undergone an endoscopy
  • non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Interventions

Endoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Nancy A Neilan, MT

    Children's Mercy Hospital Kansas City

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 19, 2008

First Posted

December 22, 2008

Study Start

December 1, 2008

Primary Completion

February 1, 2011

Study Completion

March 1, 2011

Last Updated

June 27, 2011

Record last verified: 2011-06

Locations

US(1)