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 ]
- 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
|Study Start Date:||December 2007|
|Estimated Study Completion Date:||July 2015|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
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.
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|United States, California|
|San Francisco, California, United States, 94143-0856|
|Principal Investigator:||Miriam Kuppermann, PhD, MPH||University of California, San Francisco|