Evaluation of a Decision Assisting Tool for Prenatal Testing

May 28, 2008 updated by: University of California, San Francisco

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

494

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • UCSF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant at less than 24 gestational weeks

Exclusion Criteria:

  • Not able to speak English or Spanish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

Agency for Healthcare Research and Quality (AHRQ)

Investigators

  • Principal Investigator: Miriam Kuppermann, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Primary Completion (Actual)

April 1, 2003

Study Completion (Actual)

April 1, 2004

Study Registration Dates

First Submitted

May 27, 2008

First Submitted That Met QC Criteria

May 28, 2008

First Posted (Estimate)

May 29, 2008

Study Record Updates

Last Update Posted (Estimate)

May 29, 2008

Last Update Submitted That Met QC Criteria

May 28, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H8937-16337
  • AHRQ Grant # R18-HS10214

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe