Expanded Prenatal Testing Options and Informed Choice
Condition: Pregnancy Related
Study type: Interventional

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.

      Revised clinicaltrials.gov protocol. The original study design was proposed and funded during
      the era when guidelines from the American College of Obstetricians and Gynecologists (ACOG)
      regarding access to prenatal testing differed by maternal age stratum (less than 35 years at
      the age of delivery versus 35 years or older). Our original primary hypothesis posited that
      the effect of IFC would increase invasive test use among women who were less than 35 years
      old while decreasing invasive test use among women 35 years or older. The thought underlying
      this hypothesis was that the younger women, who traditionally were not informed of this
      option, and for whom insurance coverage for these procedures was not consistently available,
      would increase their overall invasive test use if these informational and financial barriers
      to were removed in the context of the study. On the other hand, women 35 years and older, for
      whom the offer of invasive diagnostic testing was considered routine, would become more
      informed about the risks and benefits of both screening and invasive diagnostic testing,
      would be less likely to default to invasive testing. The original sample size estimate was
      N=1200 women.

      After we began enrolling women in the study and the new ACOG guidelines were issued, the
      prenatal testing decision support guide we had created was out-of-date with respect to the
      array of available prenatal screening and diagnostic tests and restrictions on invasive test
      use based upon maternal age. We therefore decided to end the original trial (N=381). We
      completely revised the decision support guide to describe the new screening options and
      better represent the current policy landscape. We also reformulated our primary hypothesis to
      eliminate the age dichotomy, and initiated a new randomized trial using the revised decision
      support guide to be completed within the time and budgetary constraints of the initially
      funded project.

      Our primary hypothesis was that women who were randomized to informed free choice would
      undergo invasive prenatal diagnostic testing at a lower rate than women randomized to the
      usual care group, regardless of maternal age. Given that the restrictions on access to
      testing based upon maternal age had been eliminated, we hypothesized that women of all ages
      who were randomized to informed free choice would have lower invasive test use rates compared
      to women randomized to usual care. In our study of trends in the use of invasive diagnostic
      testing among women who delivered at an integrated health care system in California, we found
      that the number of amniocenteses and CVS procedures performed as a percentage of the total
      number of deliveries in 2006 was 12.1% (Norton ref). Assuming N=1200-381=819 participants for
      the new trial, 80% power, two-tailed alpha equal to 0.05, 90% retention at follow-up, and a
      12.1% invasive test use rate within the usual care group, the design was capable of detecting
      a group difference corresponding to an invasive test use rate of ≤6.2% in the informed free
      choice group (OR=2.10, a 'small-medium' effect size). We also hypothesized that compared to
      usual care, women in informed free choice would have increased testing knowledge and risk
      comprehension as well as reduced decisional conflict, regret, and pregnancy worry; the design
      was capable of a minimum detectable a group difference equal to d=0.21 standard deviations,
      which is considered a 'small' effect size.
    

Intervention name(s): Informed free choice
Intervention type(s): Behavioral
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Prenatal testing; Decisionmaking; Decision aid; Informed choice