RANDOMIZED TRIAL OF AN INFORMED FREE CHOICE APPROACH TO PRENATAL TESTING AMONG WOMEN OF VARYING LITERACY LEVELS

Purpose: In 2007, the American College of Obstetricians and Gynecologists issued guidelines suggesting that all women, regardless of age, should be offered prenatal screening and diagnostic testing for aneuploidy. This change in the 35-year old threshold for offering testing was in part a response to evidence on women’s preferences generated by members of SMDM, and took place despite concerns that offering testing to all women could result in increased use of diagnostic testing with higher costs and greater miscarriage risk. The guidelines emphasized that pretest counseling should entail “discussion of the risk and benefits of invasive testing compared with screening tests,” including their screen positive, true positive, and detection rates, and the “type and prognosis of aneuploidies likely to be missed by serum screening,” leading to questions regarding how to communicate this complex information during a prenatal visit.

Method: We created an engaging, interactive decision support guide for women of varying literacy levels that addresses these issues, and conducted a randomized trial of an “informed free choice” (IFC) approach to prenatal testing among English- or Spanish-speaking pregnant women. Women randomized to IFC viewed the guide and were told they could have any of the tests described, free of charge, while women randomized to usual care received no intervention and were not offered testing free of charge. At 24-36 weeks gestation, participants completed a telephone interview to assess patient-reported outcomes. After delivery, charts were reviewed to ascertain which prenatal tests, if any, the participant underwent.

Result: We recruited a diverse population of 710 women with varying numeracy and literacy levels. Half (47.6%) of the participants were Latina, 25.4% had poor literacy (REALM-R scores < 6), and 44.5% had low numeracy scores (<2 on a 0-to-5 scale). Compared to women randomized to usual care, women randomized to IFC had higher knowledge scores (9.4 versus 8.6, p=.001) and were less likely to undergo invasive testing (5.6% versus 12.4%, p=.004). No differences emerged in decisional conflict, pregnancy worry, or depression.

Conclusion: Providing women of varying literacy levels the opportunity to use an engaging decision support guide and to choose between differing prenatal screening and diagnostic testing strategies (including no testing) without financial barriers enabled them to make more informed choices that led to lesser use of invasive testing options.