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Evaluation of a Decision Assisting Tool for Prenatal Testing

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00686062
Enrollment
494
Registered
2008-05-29
Start date
2001-04-30
Completion date
2004-04-30
Last updated
2008-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

Keywords

Prenatal testing, Amniocentesis, Decision making, Down syndrome

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.

Interventions

OTHERControl - computerized age-appropriate prenatal testing educational brochure

Computerized version of the age-appropriate prenatal testing educational brochure distributed by the State of California.

OTHERPT Tool - interactive, computerized, prenatal testing decision tool

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

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
FEMALE
Age
16 Years to 50 Years
Healthy volunteers
Yes

Inclusion criteria

* Pregnant at less than 24 gestational weeks

Exclusion criteria

* Not able to speak English or Spanish

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026