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 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.

The effect of a decision aid on informed decision-making in the era of non-invasive prenatal testing: a randomised controlled trial

“…Previous studies have reported on the application of booklets with worksheets, 22,23 information films, 24,25 and interactive computer programmes. [26][27][28] Although results from these studies cannot easily be compared because of heterogeneity in settings, interventions and outcome measures, most have general findings that correspond with the results of the present study. Nearly all found the application of a decision aid to increase pregnant women's decision-relevant knowledge [22][23][24][25][26][27] and informed decision-making.…”

“…[26][27][28] Although results from these studies cannot easily be compared because of heterogeneity in settings, interventions and outcome measures, most have general findings that correspond with the results of the present study. Nearly all found the application of a decision aid to increase pregnant women's decision-relevant knowledge [22][23][24][25][26][27] and informed decision-making. 23,25 In this trial, high baseline levels of informed decision-making in the control group notwithstanding the application of the web-based multimedia decision aid resulted in an increase in informed decision-making that was slightly higher than the effect found in previous evaluations.…”

Comparing genetic counselor's and patient's perceptions of needs in prenatal chromosomal microarray testing

“…Because of the small amount of time in early prenatal visits devoted to discussion of genetic tests and the increasing number and complexity of testing options available, there are concerns that women are making decisions after receiving only minimal information and with poor understanding . In response, various modalities to evaluate risk, provide education, and support decision‐making for prenatal testing have been developed and evaluated, and Minkoff and Berkowitz have suggested all women meet with a genetic counselor early in pregnancy to review personal genetic risks and testing options.…”

The Quiet Progress of the New Eugenics. Ending the Lives of Persons With Intellectual and Developmental Disabilities for Reasons of Presumed Poor Quality of Life

“…Looking at practices of genetic counselors, one finds that they usually focus on information derived from a risk analysis, leaving the task of weighing various possible outcomes to the “patient.” In a major study in California, women were encouraged to consider all their options—including the option of foregoing testing altogether—in the light of their own values. The findings of their study show that they were less likely to opt for invasive testing (Kuppermann et al, ). The wider approach to relevant information for informed decision‐making not only improved patient knowledge of the risks involved, but also showed that weighing these risks in view of their own values created a moral space to decide not to participate that earlier studies suggested women did not experience.…”