Evaluation of a Decision Assisting Tool for Prenatal Testing

Not Applicable

Completed

• Conditions: Pregnancy
• Interventions: Other: PT Tool - interactive, computerized, prenatal testing decision tool; Other: Control - computerized age-appropriate prenatal testing educational brochure

• Registration Number: NCT00686062
• Lead Sponsor: University of California, San Francisco

Brief 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.

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.

Study Timeline

• Study Start: 2001-04
• Primary Completion: 2003-04
• Study Completion: 2004-04
• Status Verified: 2008-05
• Study First Submitted: 2008-05-27
• Study First Submitted QC: 2008-05-28
• Last Update Submitted: 2008-05-28
• Study First Posted: 2008-05-29
• Last Update Posted: 2008-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 494

Inclusion Criteria

• Pregnant at less than 24 gestational weeks

Exclusion Criteria

• Not able to speak English or Spanish

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	PT Tool - interactive, computerized, prenatal testing decision tool	Women in this arm view the interactive, computerized, prenatal testing decision tool (PT Tool) we created.
2	Control - computerized age-appropriate prenatal testing educational brochure	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

Trial Locations

Locations (1)

UCSF; 🇺🇸 San Francisco, California, United States