Expanded Prenatal Testing Options and Informed Choice

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.