Miriam Kuppermann1, Mary E Norton, Elena Gates, Steven E Gregorich, Lee A Learman, Sanae Nakagawa, Vickie A Feldstein, James Lewis, A Eugene Washington, Robert F Nease. 1. From the Departments of Obstetrics, Gynecology & Reproductive Sciences, Epidemiology & Biostatistics, Medicine, and Radiology and the Medical Effectiveness Research Center for Diverse Populations, University of California, San Francisco, California; the Department of Obstetrics and Gynecology, Kaiser Permanente, San Francisco, California; and Washington University in St. Louis and Express Scripts, Inc., St. Louis, Missouri.
Abstract
OBJECTIVE: Guidelines for fetal aneuploidy testing recommend that screening and diagnostic testing be made available to pregnant women of all ages and that providers explain the differences between these tests to help their patients make informed testing decisions. We sought to estimate the effect of a computerized, interactive prenatal testing decision tool on prenatal testing decision making. METHODS: Four hundred ninety-six English- or Spanish-speaking women at 20 or fewer weeks of gestation were randomly assigned to view the interactive prenatal testing decision tool or the California Department of Health Services' educational booklet. Primary outcomes were knowledge, risk awareness, intervention satisfaction, decisional conflict, and among women aged at least 35 years, use of invasive diagnostic testing. RESULTS: Women assigned to the interactive prenatal testing decision tool had higher knowledge scores (79.5% compared with 64.9%, P<.001), were more likely to correctly estimate their risk of procedure-related miscarriage (64.9% compared with 48.1%, P=.002) and carrying a Down syndrome-affected fetus (63.5% compared with 15.1%, P<.001), were more satisfied with the intervention (P<.001), and had less decision uncertainty (P<.001) than controls after viewing the intervention. Most of these differences persisted over time. Among women aged at least 35 years, the interactive prenatal testing decision tool viewers who were originally less inclined to undergo invasive testing were ultimately more likely than similarly inclined controls to have amniocentesis or chorionic villus sampling (44.8% compared with 29.2%), whereas those who were originally more inclined to undergo an invasive procedure ultimately were less likely than similarly inclined controls to have a diagnostic procedure (84.6% compared with 94.9%; P=.015 for interaction). CONCLUSION: Using an interactive prenatal testing decision tool results in more informed prenatal genetic testing decisions than viewing standard educational booklets. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, www.clinicaltrials.gov, NCT00686062 LEVEL OF EVIDENCE: I.
RCT Entities:
OBJECTIVE: Guidelines for fetal aneuploidy testing recommend that screening and diagnostic testing be made available to pregnant women of all ages and that providers explain the differences between these tests to help their patients make informed testing decisions. We sought to estimate the effect of a computerized, interactive prenatal testing decision tool on prenatal testing decision making. METHODS: Four hundred ninety-six English- or Spanish-speaking women at 20 or fewer weeks of gestation were randomly assigned to view the interactive prenatal testing decision tool or the California Department of Health Services' educational booklet. Primary outcomes were knowledge, risk awareness, intervention satisfaction, decisional conflict, and among women aged at least 35 years, use of invasive diagnostic testing. RESULTS:Women assigned to the interactive prenatal testing decision tool had higher knowledge scores (79.5% compared with 64.9%, P<.001), were more likely to correctly estimate their risk of procedure-related miscarriage (64.9% compared with 48.1%, P=.002) and carrying a Down syndrome-affected fetus (63.5% compared with 15.1%, P<.001), were more satisfied with the intervention (P<.001), and had less decision uncertainty (P<.001) than controls after viewing the intervention. Most of these differences persisted over time. Among women aged at least 35 years, the interactive prenatal testing decision tool viewers who were originally less inclined to undergo invasive testing were ultimately more likely than similarly inclined controls to have amniocentesis or chorionic villus sampling (44.8% compared with 29.2%), whereas those who were originally more inclined to undergo an invasive procedure ultimately were less likely than similarly inclined controls to have a diagnostic procedure (84.6% compared with 94.9%; P=.015 for interaction). CONCLUSION: Using an interactive prenatal testing decision tool results in more informed prenatal genetic testing decisions than viewing standard educational booklets. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, www.clinicaltrials.gov, NCT00686062 LEVEL OF EVIDENCE: I.
Authors: S Trent Rosenbloom; Titus L Daniels; Thomas R Talbot; Taylor McClain; Robert Hennes; Shane Stenner; Sue Muse; Jim Jirjis; Gretchen Purcell Jackson Journal: J Am Med Inform Assoc Date: 2011-12-01 Impact factor: 4.497
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