Evaluation of a Decision Assisting Tool for Prenatal Testing

Study Overview
=================
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.

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

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Other: Control - computerized age-appropriate prenatal testing educational brochure
* Other: PT Tool - interactive, computerized, prenatal testing decision tool


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant at less than 24 gestational weeks Exclusion Criteria: Not able to speak English or Spanish

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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<br>* An interactive, computerized prenatal testing decision-assisting tool (PT Tool).<br>|
| Active Comparator: 2<br>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<br>* Computerized version of the age-appropriate prenatal testing educational brochure distributed by the State of California.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prenatal testing, Amniocentesis, Decision making, Down syndrome