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Tuesday, July 10 • 11:34 - 11:46
Session 3 | Prenatal Counseling: 3-2 Use of a novel tablet-based decision aid for prenatal aneuploidy screening and testing: A randomized controlled trial

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Use of a novel tablet-based decision aid for prenatal aneuploidy screening and testing: A randomized controlled trial
Laura Carlson1, Emily Hardisty2, Sarah Harris3, Neeta Vora2

1University of North Carolina at Chapel Hill, Chapel Hill, NC, United States
2University of North Carolina School of Medicine, Chapel Hill, NC, United States
3University of North Carolina School of Medicine, Chapel Hill, North Carolina, United States
Decision aids (DA) are known to improve knowledge and decisional conflict surrounding important screening and treatment decisions. Prior DAs for aneuploidy screening showed effectiveness but did not include cell-free DNA.  Our DA was constructed with input from MFMs and genetic counselors in English and Spanish and explores all aneuploidy screening and testing options via a tablet-based platform. We aimed to evaluate our DA in a randomized controlled trial. We hypothesized that knowledge following DA use alone would not be inferior to knowledge following standard genetic counseling (GC), with a noninferiority margin of 1 point on a knowledge questionnaire.
English and Spanish-speaking women <22 weeks with a singleton pregnancy were eligible. Women with abnormal ultrasound findings or prior aneuploidy screening in the current pregnancy were excluded.
Women were randomized to routine GC (group 1) or DA use before GC (group 2). All patients completed an initial KQ. Those in group 1 repeated the KQ and a decisional conflict questionnaire (DCQ) following GC. Those in group 2 self-administered the decision aid, then repeated the KQ and DCQ following DA and again following GC. T-test, chi-square, Wilcoxon rank-sum, and ANOVA were used as appropriate, and analysis was by intent to treat.
365 women were eligible for enrollment; 197 women participated. 105 were randomized to group 1 and 92 to group 2. Demographics and mean knowledge scores at enrollment were similar between groups; 24 women were Spanish-speaking and distribution did not differ between groups. Mean knowledge score in group 2 following completion of DA was not inferior to mean knowledge score following completion of GC in group 1(figure). Decisional conflict was similar in group 2 following completion of DA to group 1, but was significantly reduced in group 2 following DA+GC (1.74 vs. 0.22, p=0.003).
Knowledge and decisional conflict surrounding aneuploidy screening and testing options in women who used a DA only were not inferior to outcomes in women who underwent GC only. Additionally, decisional conflict was significantly reduced among women who both used the DA and underwent GC compared to those who underwent GC alone. Given the non-inferiority of DA to GC with regard to knowledge, the use of a DA can be considered in areas where GC is not available. Additionally, our findings support the the use of DA in addition to GC to decrease decisional conflict.

avatar for Megan Allyse

Megan Allyse

Assistant Professor of Bioethics, Mayo Clinic
avatar for Bettina Blaumeiser

Bettina Blaumeiser

Clinical Geneticist, Antwerp University

avatar for Neeta Vora

Neeta Vora

MFM-Geneticist, University of North Carolina, Chapel Hill

Tuesday July 10, 2018 11:34 - 11:46 CEST
Okapi Room 2&3