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| Sponsored by: |
Children's Mercy Hospital Kansas City |
|---|---|
| Information provided by: | Children's Mercy Hospital Kansas City |
| ClinicalTrials.gov Identifier: | NCT00813033 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Endoscopy |
Other: patient decision aid for endoscopy |
| Study Type: | Interventional |
| Study Design: | Open Label, Single Group Assignment, Efficacy Study |
| Official Title: | Creation and Pilot Evaluation of a Patient Decision Aid as an Adjunct to the Consenting Process for Gastrointestinal Endoscopy in a Pediatric Setting |
| Estimated Enrollment: | 80 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | January 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| patient decision aid |
Other: patient decision aid for endoscopy
patient decision aid will be administered at the point of decision making
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Missouri | |
| Children's Mercy Hospital | |
| Kansas City, Missouri, United States, 64108 | |
| Principal Investigator: | Nancy A Neilan, MT | Children's Mercy Hospital Kansas City |
More Information
| Responsible Party: | Children's Mercy Hospitals and Clinics ( Nancy A. Neilan/ MT (ASCP), CCRC Advanced Clinical Coordinator ) |
| Study ID Numbers: | CMH080104.2 |
| Study First Received: | December 19, 2008 |
| Last Updated: | December 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00813033 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
create a patient decision aid for endoscopy evaluate efficacy of a patient decision aid for endoscopy |
