Expanded Prenatal Testing Options and Informed Choice (EPIC)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||Expanded Prenatal Testing Options and Informed Choice|
- 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.
- 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.
|Study Start Date:||December 2007|
|Study Completion Date:||January 2013|
|Primary Completion Date:||January 2013 (Final data collection date for primary outcome measure)|
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00505596
|United States, California|
|San Francisco, California, United States, 94143-0856|
|Principal Investigator:||Miriam Kuppermann, PhD, MPH||University of California, San Francisco|