Evaluation of a Decision Assisting Tool for Prenatal Testing

University of California San Francisco (UCSF)

Status: Completed

Conditions: Pregnancy

Treatments: Other: PT Tool - interactive, computerized, prenatal testing decision tool; Other: Control - computerized age-appropriate prenatal testing educational brochure

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT00686062

H8937-16337

AHRQ Grant # R18-HS10214

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Ages: 16 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant at less than 24 gestational weeks

Exclusion criteria

• Not able to speak English or Spanish

Trial design

494 participants in 2 patient groups

1

Experimental group

Description:

Women in this arm view the interactive, computerized, prenatal testing decision tool (PT Tool) we created.

Treatment:

Other: PT Tool - interactive, computerized, prenatal testing decision tool

2

Active Comparator group

Description:

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

Treatment:

Other: Control - computerized age-appropriate prenatal testing educational brochure