Expanded Prenatal Testing Options and Informed Choice - Full Text View

Sponsors and Collaborators:	University of California, San Francisco Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00505596

Purpose

The proposed study will determine the impact of providing complete information about all prenatal tests for chromosomal disorders to racially/ethnically and sociodemographically diverse women of all ages and allowing them to make informed choices regarding which tests - if any - to undergo. Specifically, we propose to update a validated prenatal testing decision-assisting tool ("PT Tool") to incorporate new screening options and make it more accessible to lower literacy and culturally diverse populations. We then will conduct a randomized controlled trial comparing the effect of an "informed free choice" approach consisting of providing complete information regarding and access to all prenatal testing options to that of usual care among a diverse population of pregnant women.

Condition	Intervention
Pregnancy	Behavioral: Informed free choice

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Expanded Prenatal Testing Options and Informed Choice

Resource links provided by NLM:

MedlinePlus related topics: Prenatal Care

U.S. FDA Resources

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:

Prenatal test use [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Knowledge, satisfaction, decisional conflict [ Time Frame: 9 months ] [ Designated as safety issue: No ]
risk comprehension/perception, health-related quality of life and costs [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	1200
Study Start Date:	December 2007
Estimated Study Completion Date:	February 2011
Estimated Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 600 women will be randomized to the "informed free choice" arm, in which they will be instructed to view the updated PT Tool and will be told that they can have whatever tests they would like (including no tests) and that tests that are not covered by their insurance will be paid for by the study. They will participate in two follow-up telephone interviews.	Behavioral: Informed free choice Women will be instructed to view an updated prenatal testing decision aid and will be told that they can have whatever tests they would like (including no tests) and that tests that are not covered by their insurance will be paid for by the study Behavioral: Informed free choice Computerized decision support guide and access to first and second trimester screening and diagnostic tests
2: Active Comparator 600 women will be randomized to usual care, the control group, in which they will receive no intervention beyond a baseline pre-randomization interview and two follow-up telephone interviews.	Behavioral: Informed free choice Computerized decision support guide and access to first and second trimester screening and diagnostic tests

Arms

Assigned Interventions

1: Experimental

600 women will be randomized to the "informed free choice" arm, in which they will be instructed to view the updated PT Tool and will be told that they can have whatever tests they would like (including no tests) and that tests that are not covered by their insurance will be paid for by the study. They will participate in two follow-up telephone interviews.

Behavioral: Informed free choice

Women will be instructed to view an updated prenatal testing decision aid and will be told that they can have whatever tests they would like (including no tests) and that tests that are not covered by their insurance will be paid for by the study

Behavioral: Informed free choice

Computerized decision support guide and access to first and second trimester screening and diagnostic tests

2: Active Comparator

600 women will be randomized to usual care, the control group, in which they will receive no intervention beyond a baseline pre-randomization interview and two follow-up telephone interviews.

Behavioral: Informed free choice

Computerized decision support guide and access to first and second trimester screening and diagnostic tests

Detailed Description:

Our primary goal is to generate evidence needed to determine whether clinicians should consider an alternative to the current practice of using risk-based thresholds for invasive testing that would allow all women to make informed choices reflective of their values and preferences. A second goal is to expand PT Tool to include new screening tests and modify it for clinical use by lower literacy populations, so that pregnant women of diverse backgrounds will have accurate and unbiased information about the complex array of testing options, thereby minimizing barriers to and disparities in informed choice. Specific Aim 1) Determine which testing strategies are selected by a racially/ethnically, socioeconomically, and age-diverse group of pregnant women who receive complete information on all testing options and have all options available to them compared to women receiving usual care. Specific Aim 2) Update the English-language version of PT Tool to include the most up-to-date information on new and forthcoming prenatal screening options and modify it for use in clinics by women of varying literacy levels.

Specific Aim 3) Assess the impact of receiving complete information on all testing options and having all options available on knowledge, risk comprehension, and decisional conflict compared to usual care.

Specific Aim 4) Evaluate the cost effectiveness of an "informed free choice" approach to providing prenatal testing services compared to usual care.

We will perform an open, parallel-comparison randomized clinical trial of an "informed free choice" approach to prenatal testing to usual care in 1200 women presenting for prenatal care by 23 gestational weeks.

600 women will be randomized to usual care, the control group, in which they will receive no intervention beyond a baseline pre-randomization interview and two follow-up telephone interviews. The other 600 women will be randomized to "informed free choice," in which they will be instructed to view the updated PT Tool and will be told that they can have whatever tests they would like (including no tests) and that tests that are not covered by their insurance will be paid for by the study. They also will participate in two follow-up telephone interviews.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

No more than 24 weeks pregnant.

Exclusion Criteria:

Inability to speak English or Spanish.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00505596

Contacts

Contact: Miriam Kuppermann, PhD, MPH	415 502-4089	kuppermannm@obgyn.ucsf.edu
Contact: Shirley Wong	415 502-4082	wongs@obgyn.ucsf.edu

Locations

United States, California
UCSF	Recruiting
San Francisco, California, United States, 94143-0856
Contact: Miriam Kuppermann, PhD 415-502-4089 kuppermannm@obgyn.ucsf.edu
Contact: Shirley Wong, BA 415 502-4082 wongs@obgyn.ucsf.edu
Sub-Investigator: Aaron Caughey, MD, PhD
Sub-Investigator: Judith Bishop, CNM
Sub-Investigator: Mary Norton, MD
Sub-Investigator: Juan Vargus, MD
Sub-Investigator: Elena Gates, MD

Sponsors and Collaborators

University of California, San Francisco

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

Principal Investigator:

Miriam Kuppermann, PhD, MPH

University of California, San Francisco

More Information

No publications provided

Responsible Party:	UCSF ( Miriam Kuppermann, PhD, MPH )
Study ID Numbers:	R01HD049686
Study First Received:	July 20, 2007
Last Updated:	March 2, 2009
ClinicalTrials.gov Identifier:	NCT00505596 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by University of California, San Francisco:

Prenatal testing
Decisionmaking
Decision aid
Informed choice

ClinicalTrials.gov processed this record on September 11, 2009