Evaluation of a Decision Assisting Tool for Prenatal Testing

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.

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Key information

Conditions

Pregnancy Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Down Syndrome Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations

Age range

16 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UCSF

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Pregnant at less than 24 gestational weeks

Exclusion criteria

Not able to speak English or Spanish

Treatment and study plan

Control - computerized age-appropriate prenatal testing educational brochure

Other

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

PT Tool - interactive, computerized, prenatal testing decision tool

Other

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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

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

Important dates

Study start: 2001
Primary completion: 2003
Study completion: 2004
First posted: May 29, 2008
Registry last updated: May 29, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed