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Evaluation of a Decision Assisting Tool for Prenatal Testing

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00686062
First Posted: May 29, 2008
Last Update Posted: May 29, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by:
University of California, San Francisco
  Purpose
This is a randomized study of an interactive, computerized descision-assisting tool for prenatal testing decision making (PT Tool) versus standard educational booklets distributed to all pregnant women by the State of California (control). We hypothesize that, compared to controls, women randomized to view PT Tool will have greater knowledge about prenatal testing and its potential outcomes and better risk comprehension, and that they will be more satisfied with the intervention and have lower decisional conflict.

Condition Intervention
Pregnancy Other: Control - computerized age-appropriate prenatal testing educational brochure Other: PT Tool - interactive, computerized, prenatal testing decision tool

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Official Title: Adaptation and Implementation of a Prenatal Genetic Testing Decision-Assisting Tool for Clinical Use

Further study details as provided by University of California, San Francisco:

Estimated Enrollment: 494
Study Start Date: April 2001
Study Completion Date: April 2004
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Women in this arm view the interactive, computerized, prenatal testing decision tool (PT Tool) we created.
Other: PT Tool - interactive, computerized, prenatal testing decision tool
An interactive, computerized prenatal testing decision-assisting tool (PT Tool).
Active Comparator: 2
Women in this arm view the age-appropriate computerized version of the educational pamphlet on prenatal testing developed and distributed by the State of California
Other: Control - computerized age-appropriate prenatal testing educational brochure
Computerized version of the age-appropriate prenatal testing educational brochure distributed by the State of California.

Detailed Description:
We will evaluate the tool in a randomized controlled trial among 500 patients receiving prenatal care at one of the obstetrics clinics and practices affiliated with the University of California at San Francisco (UCSF), San Francisco General Hospital (SFGH), Kaiser San Francisco, or California Pacific Medical Center (CPMC). After completing a baseline questionnaire, participants will be randomized to view either a control or intervention group. Patients assigned to the control group will view the computerized version of the age-appropriate educational pamphlet concerning prenatal testing developed by the State of California. Patients assigned to the intervention group will use the computerized decision support tool/educational module which provides important background information about chromosomal abnormalities, and patient-tailored information about the advantages and limitations of diagnostic testing.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant at less than 24 gestational weeks

Exclusion Criteria:

  • Not able to speak English or Spanish
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00686062


Locations
United States, California
UCSF
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Agency for Healthcare Research and Quality (AHRQ)
Investigators
Principal Investigator: Miriam Kuppermann, PhD University of California, San Francisco
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Miriam Kuppermann, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00686062     History of Changes
Other Study ID Numbers: H8937-16337
AHRQ Grant # R18-HS10214
First Submitted: May 27, 2008
First Posted: May 29, 2008
Last Update Posted: May 29, 2008
Last Verified: May 2008

Keywords provided by University of California, San Francisco:
Prenatal testing
Amniocentesis
Decision making
Down syndrome