Health Literacy in Patients Considering a Left Ventricular Assist Device: Findings From the DECIDE-LVAD Trial

Objective: To assess the interaction of health literacy and a shared intervention concerning decision quality in patients considering the destination therapy of left ventricular assist device (DT LVAD) implantation. Background: Evidence is limited for the use of decision aids by patients with low health literacy and with life-threatening illnesses. Methods: We performed a secondary analysis of the DECIDE-LVAD Trial, a randomized, stepped-wedge trial conducted from 2015–2017 in the United States. The intervention was the integration of a formal shared decision-making intervention. The main outcome was decision quality as measured by LVAD knowledge and values-treatment concordance. Two components of health literacy were measured by the Rapid Estimate of Adult Literacy in Medicine and Subjective Numeracy Scale instruments. Results: Of the 228 patients studied, 44% (n = 101) received the formal shared decision-making intervention, and half had low health literacy. Knowledge of LVAD improved for patients with low literacy in the intervention group compared to the control group: the difference in increased knowledge score was 10.6%; P = 0.04. Values-treatment concordance improved significantly for patients with low literacy in the intervention group compared to the control group: the median improvement in values-treatment correlation coefficient was 0.43; P = 0.03. These benefits were not significant in those with adequate literacy (n = 171). Patients with low numeracy (n = 94) did not show significant improvements in either measure of decision quality, and patients with adequate numeracy (n = 134) showed improvement in LVAD knowledge but not in values-treatment concordance. Conclusions: Patients considering DT LVAD implantation with low literacy showed improvement in decision quality after the integration of a shared decision-making intervention.