Expanded Prenatal Testing Options and Informed Choice (EPIC)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
March of Dimes
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00505596
First received: July 20, 2007
Last updated: October 7, 2013
Last verified: October 2013
  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 Related
Behavioral: Informed free choice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Expanded Prenatal Testing Options and Informed Choice

Resource links provided by NLM:


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:
  • Patient reported outcome questionnaire [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    198 item questionaire covering the following: Knowledge, risk comprehension, decisional conflict/decision regret. pregnancy worry/anxiety, and resource utilization, indirect costs


Enrollment: 745
Study Start Date: December 2007
Estimated Study Completion Date: July 2015
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Computerized decision aid
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 one follow-up telephone interview.
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
No Intervention: Usual care
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 one follow-up telephone interview.

  Show Detailed Description

  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 20 weeks pregnant.

Exclusion Criteria:

  • Inability to speak English or Spanish.
  • Those carrying triplets or higher order gestation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00505596

Locations
United States, California
UCSF
San Francisco, California, United States, 94143-0856
Sponsors and Collaborators
University of California, San Francisco
March of Dimes
Investigators
Principal Investigator: Miriam Kuppermann, PhD, MPH University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00505596     History of Changes
Other Study ID Numbers: R01HD049686
Study First Received: July 20, 2007
Last Updated: October 7, 2013
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 April 14, 2014