Evaluation of a Decision Assisting Tool for Prenatal Testing

NCT00686062 | Completed

• 2 other identifiers: H8937-16337AHRQ Grant # R18-HS10214
• Study Type: interventional
• Target: 494
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

Prenatal testing; Amniocentesis; Decision making; Down syndrome

Study Arms (2)

1

EXPERIMENTAL

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

2

ACTIVE COMPARATOR

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

Interventions

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.

2

PT Tool - interactive, computerized, prenatal testing decision tool OTHER

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

1

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pregnant at less than 24 gestational weeks

You may not qualify if:

• Not able to speak English or Spanish

Sponsors & Collaborators

• University of California, San Francisco: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

UCSF

San Francisco, California, 94143, United States

Location

Related Publications (1)

• 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.

  PMID: 19104360 DERIVED

MeSH Terms

Conditions

Down Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

• Miriam Kuppermann, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 27, 2008
• First Posted: May 29, 2008
• Study Start: April 1, 2001
• Primary Completion: April 1, 2003
• Study Completion: April 1, 2004
• Last Updated: May 29, 2008

Record last verified: 2008-05

Locations

US (1)