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Evaluation of a Decision Assisting Tool for Prenatal Testing

NCT ID: NCT00686062

Last Updated: 2008-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

494 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2004-04-30

Brief Summary

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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

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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.

Conditions

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Pregnancy

Keywords

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Prenatal testing Amniocentesis Decision making Down syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

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

Group Type EXPERIMENTAL

PT Tool - interactive, computerized, prenatal testing decision tool

Intervention Type OTHER

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

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

Group Type ACTIVE_COMPARATOR

Control - computerized age-appropriate prenatal testing educational brochure

Intervention Type OTHER

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

Interventions

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Control - computerized age-appropriate prenatal testing educational brochure

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

Intervention Type OTHER

PT Tool - interactive, computerized, prenatal testing decision tool

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Pregnant at less than 24 gestational weeks

Exclusion Criteria

* Not able to speak English or Spanish
Minimum Eligible Age

16 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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University of California, San Francisco

Principal Investigators

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Miriam Kuppermann, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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UCSF

San Francisco, California, United States

Site Status

Countries

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United States

References

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Kuppermann M, Norton ME, Gates E, Gregorich SE, Learman LA, Nakagawa S, Feldstein VA, Lewis J, Washington AE, Nease RF Jr. Computerized prenatal genetic testing decision-assisting tool: a randomized controlled trial. Obstet Gynecol. 2009 Jan;113(1):53-63. doi: 10.1097/AOG.0b013e31818e7ec4.

Reference Type DERIVED
PMID: 19104360 (View on PubMed)

Other Identifiers

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AHRQ Grant # R18-HS10214

Identifier Type: -

Identifier Source: secondary_id

H8937-16337

Identifier Type: -

Identifier Source: org_study_id