Evaluation of a Decision Assisting Tool for Prenatal Testing

Pregnancy Clinical Trial

Official title:

Adaptation and Implementation of a Prenatal Genetic Testing Decision-Assisting Tool for Clinical Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00686062
• Other study ID #: H8937-16337
• Secondary ID: AHRQ Grant # R18
• Status: Completed
• Phase: N/A
• First received: May 27, 2008
• Last updated: May 28, 2008
• Start date: April 2001
• Est. completion date: April 2004

Study information

• Verified date: May 2008
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 494
• Est. completion date: April 2004
• Est. primary completion date: April 2003
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 50 Years

Eligibility

Inclusion Criteria:

• Pregnant at less than 24 gestational weeks

Exclusion Criteria:

• Not able to speak English or Spanish

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator)

Related Conditions & MeSH terms

• Pregnancy

Intervention

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.
• PT Tool - interactive, computerized, prenatal testing decision tool
An interactive, computerized prenatal testing decision-assisting tool (PT Tool).

Locations

Country	Name	City	State
United States	UCSF	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States,