Expanded Prenatal Testing Options and Informed Choice (EPIC)

This study has been completed.
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 17, 2014
Last verified: October 2014
  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

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 ]
    Information on prenatal test use was obtained from medical charts and used to classify women according to the testing strategy they underwent: no screening or diagnostic testing for chromosomal problems; starting with a screening test prior to deciding about diagnostic testing; and going straight to invasive diagnostic testing.


Secondary Outcome Measures:
  • Patient reported outcome questionnaire [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Knowledge, risk comprehension, decisional conflict/decision regret as assessed during a 20-minute follow-up telephone interview: 5-item measure adapted from the Maternal Serum Screening Knowledge Questionnaire; risk comprehension was assessed by asking participants to estimate, out of 1000 pregnant women who had an amniocentesis, how many would experience a miscarriage caused by the procedure (women who reported the risk to be greater than zero but less than 10 were scored as correct), and out of 1000 pregnant women their age, how many are carrying a fetus affected by Down syndrome (we compared this risk to the participant's age-related Down syndrome risk and scored concordant replies as correct); decisional conflict and regret were assessed using 15-items from the Decisional Conflict Scale and the 5-item Decision Regret Scale.


Enrollment: 744
Study Start Date: December 2007
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Computerized decision aid
Participants instructed to view the updated PT Tool and 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 (Informed free choice). They also participate in a baseline pre-randomization interview and 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
Control group, in which participants 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional Information:
No publications provided by University of California, San Francisco

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00505596     History of Changes
Other Study ID Numbers: R01HD049686, R01HD049686, 12-FY09-213
Study First Received: July 20, 2007
Last Updated: October 17, 2014
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 October 22, 2014