Expanded Prenatal Testing Options and Informed Choice (EPIC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00505596|
Recruitment Status : Completed
First Posted : July 23, 2007
Last Update Posted : October 21, 2014
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy Related||Behavioral: Informed free choice||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||744 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Expanded Prenatal Testing Options and Informed Choice|
|Study Start Date :||December 2007|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
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.
- Prenatal test use [ Time Frame: 9 months ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00505596
|United States, California|
|San Francisco, California, United States, 94143-0856|
|Principal Investigator:||Miriam Kuppermann, PhD, MPH||University of California, San Francisco|