Effect of Enhanced Information, Values Clarification, and Removal of Financial Barriers on Use of Prenatal Genetic Testing

Abstract

Importance Prenatal genetic testing guidelines recommend providing patients with detailed information to allow informed, preference-based screening and diagnostic testing decisions. The effect of implementing these guidelines is not well understood. Objective Toanalyze the effect of a decision support guide and elimination of financial barriers to testing on use of prenatal genetic testing and decision-making among women of varying literacy and numeracy levels. Design Randomized trial conducted from 2010-2013. Setting Prenatal clinics at three county hospitals, a community clinic, an academic center, and three medical centers of an integrated health care delivery system in the San Francisco Bay area. Participants English- or Spanish-speaking women who had not yet undergone screening and/or diagnostic testing and remained pregnant at 11 weeks gestation (n=710). Interventions A computerized, interactive decision support guide and access to prenatal testing with no out-of-pocket expense (n=357) or usual care as per current guidelines (n=353). Main Outcome Measures The primary outcome was invasive diagnostic test use, obtained via medical record review. Secondary outcomes included testing strategy undergone, and knowledge, risk comprehension, decisional conflict and decision regret at 24-36 weeks' gestation. Results Women randomized to the intervention group, compared to those randomized to the control group, were less likely to have invasive testing [5.9% vs. 12.3%, odds ratio (OR) 0.45, 95% CI 0.25-0.80] and more likely to forego testing altogether [25.6% vs. 20.4%, OR 3.30 (reference group screening followed by invasive testing), CI 1.43-7.64]. They also had higher knowledge scores (9.4 vs. 8.6 on a 15-point scale, mean group difference 0.82, CI 0.34-1.31), and were more likely to correctly estimate the amniocentesis-related miscarriage risk (73.8% vs. 59.0%, OR 1.95, CI 1.39-2.75) and their age-adjusted chance of carrying a fetus with trisomy 21 (58.7% vs. 46.1%, OR 1.66, CI 1.22-2.28). Significant differences did not emerge in decisional conflict or decision regret. Conclusions and Relevance Full implementation of prenatal testing guidelines using a computerized, interactive decision support guide in the absence of financial barriers to testing resulted in lesser test use and more informed choices. If validated in additional populations, this approach may result in more informed and preference-based prenatal testing decision making, and fewer women undergoing testing.

Variation in Women's Understanding of Prenatal Testing

“…The parent study for the current analysis found that women who were randomized to use an interactive decision-support guide made more informed testing choices than women randomized to usual care 12 . That a disparity by site of care in recall of diagnostic testing discussions was only seen in the usual care group in the current study may suggest that this kind of decision support could prove a useful adjunct to the current paradigm of counseling women and assure provision of consistent information to all women.…”

“…We conducted a secondary analysis of a randomized controlled trial that explored the effect of providing a prenatal testing decision-support guide that included enhanced information about prenatal testing and its voluntary nature, along with a series of values clarification exercises, and removing financial barriers on use of prenatal screening and diagnostic tests 12 . A diverse group of 710 English and Spanish speaking women of varying literacy levels and sociodemographic backgrounds was recruited for study participation at less than 20 weeks gestation.…”

Trial by Dutch laboratories for evaluation of non‐invasive prenatal testing. Part II—women's perspectives

“…To safeguard informed decision‐making, emphasis has to be placed on further development of information tools and maintaining good counseling. The use of decision aids29, 30 or visuals aids such as an informational film31 may have a positive effect on informed decision‐making by improving knowledge and assisting women in making decisions that are consistent with their values. Special attention should be given to women with a lower educational level and/or inadequate health literacy.…”

#36: Prenatal aneuploidy screening using cell-free DNA

“…In addition, some women may prefer diagnostic testing or no testing, regardless of age. 31 It is appropriate therefore to offer diagnostic testing, screening, or the option of no testing to women of all ages. 32,33 The offer of prenatal screening requires discussion of the pros and cons of all test options, including the detection rates, screen positive rates, and recommended follow up if an abnormal result is obtained (Table 2).…”