Expanded Prenatal Testing Options and Informed Choice
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 744
- Locations
- 2
- Primary Endpoint
- Prenatal test use
Study Overview
Brief Summary
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.
Detailed Description
Our primary goal is to generate evidence needed to determine whether clinicians should consider an alternative to the current practice of using risk-based thresholds for invasive testing that would allow all women to make informed choices reflective of their values and preferences. A second goal is to expand PT Tool to include new screening tests and modify it for clinical use by lower literacy populations, so that pregnant women of diverse backgrounds will have accurate and unbiased information about the complex array of testing options, thereby minimizing barriers to and disparities in informed choice.
Specific Aim 1) Determine which testing strategies are selected by a racially/ethnically, socioeconomically, and age-diverse group of pregnant women who receive complete information on all testing options and have all options available to them compared to women receiving usual care.
Specific Aim 2) Update the English-language version of PT Tool and create a Spanish-language version to include the most up-to-date information on new and forthcoming prenatal screening options and modify it for use in clinics by women of varying literacy levels.
Specific Aim 3) Assess the impact of receiving complete information on all testing options and having all options available on knowledge, risk comprehension, and decisional conflict compared to usual care.
We will perform an open, parallel-comparison randomized clinical trial of an "informed free choice" approach to prenatal testing to usual care in 1200 women presenting for prenatal care by 20 gestational weeks. 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 a follow-up telephone interview. The other 600 women will be randomized to "informed free choice," 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 also will participate in a follow-up telephone interview.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •No more than 20 weeks pregnant.
Exclusion Criteria
- •Inability to speak English or Spanish.
- •Those carrying triplets or higher order gestation
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Patient reported outcome questionnaire(9 months)