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.

Specific Aim 4) Evaluate the cost effectiveness of an "informed free choice" approach to
providing prenatal testing services 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 23 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 two follow-up telephone interviews. 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 two follow-up telephone interviews.

Inclusion Criteria:

- No more than 20 weeks pregnant.

Exclusion Criteria:

- Inability to speak English or Spanish.