Evaluation of a decision aid for early pregnancy loss: A pilot randomized controlled trial in Philadelphia, Pennsylvania

Abstract

ObjectivesTo evaluate the effect of a decision aid on decisional conflict scale in patients choosing management for early pregnancy loss. Study designWe conducted a pilot randomized control trial to assess the effect of the Healthwise patient decision aid on decisional conflict scale in patients with early pregnancy loss as compared with a control website. Patients 18years and older were eligible if they had an early pregnancy loss between 5 and 12 completed weeks of gestation. Participants completed surveys at baseline, poststudy intervention, after consultation, and 1week postconsultation. Surveys assessed participant scores on the decisional conflict scale (scale 0–100), knowledge, assessment of shared decision-making, satisfaction, and decision regret. Our primary outcome was the poststudy-intervention decisional conflict scale score. ResultsFrom July 2020 through March 2021 we randomized 60 participants. After the intervention, the median decisional conflict scale score for the control group was 10 [0–30] and 0 [0–20] for the intervention group (p = 0.17). When assessing the decisional conflict scale subscales postintervention, the informed subscale for the control group was 16.7 [0–33.3] as opposed to 0 [0] for the patient decision aid group (p = 0.003). Knowledge remained significantly higher in the experimental arm from the postintervention to the 1-week follow-up. We found no differences between groups when assessing our other metrics. ConclusionsUse of a validated decision aid did not result in statistically significant differences in the total decisional conflict scale scores as compared with the control. Participants allocated to the intervention were more informed postintervention and had consistently higher knowledge scores. ImplicationsUse of a validated decision aid prior to early pregnancy loss management consultation did not affect overall decisional conflict but resulted in improved knowledge.