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Evaluation of a Decision Assisting Tool for Prenatal Testing

This study has been completed.
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by:
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00686062
First received: May 27, 2008
Last updated: May 28, 2008
Last verified: May 2008
History of Changes
  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 Blind (Investigator)
Official Title: Adaptation and Implementation of a Prenatal Genetic Testing Decision-Assisting Tool for Clinical Use

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   16 Years to 50 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by University of California, San Francisco

Additional 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
Study First Received: May 27, 2008
Last Updated: May 28, 2008
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013