1. In this randomized, stepped-wedge control trial of patients with heart failure under consideration for mechanical circulatory support (MCS), a shared decision-making educational intervention was linked with improved patient comprehension of left ventricular assist devices (LVAD) and concordance of treatment choice with patient values.
2. The shared decision making intervention did not significantly alter the concordance between patient values and the final therapy pursued.
Evidence Rating Level: 2 (Good)
Study Rundown: Patients with high-mortality medical conditions are often presented with different choices for therapy. Decision making reflects patient values, understanding of the underlying condition, and perceived risks and benefits of the available interventions. In patients with severe heart failure who are not transplant candidates, destination therapy with LVAD may prolong life, but also involves alterations in caregiver needs, lifestyle, and intervention-related complications. Patient education on LVAD destination therapy is limited by poor communication by the clinician, and biased industry provided literature on available devices. The current study sought to evaluate the impact of an education and literature-based decision aid program on patient comprehension and concordance with pre-existing values. The study found that the intervention improved patient knowledge, and concordance between values and patient choice of therapy. However, concordance of patient values and final therapy received at 6 months did not significantly change following the therapy.
The main strengths of this study included the evaluation of all patients initially considered for LVAD destination therapy, rather than only those who received the devices. The main limitations of the study included low rate of follow-up in those who declined LVAD therapy, a predominantly white and male population, and the difficulty in generalizing the results to those outside very specialized centers.
In-Depth [randomized controlled trial]: This study, the Multicenter Trial of a Shared Decision Support Intervention for Patients and their Caregivers Offered Destination Therapy for End-Stage Heart Failure (DECIDE-LVAD), was a hospital-level randomized, stepped-wedge (phased roll-out) trial involved 6 MCS programs in the United States. During the 20-month enrollment period, clinician-patient dyads were included if they were 18-years or older with severe heart failure not a candidate for transplant and being considered for destination LVAD therapy. The intervention consisted of a 2.5-hour clinician training session on shared decision support, and the use of video and pamphlet decision aids for patients. The primary outcome of decision quality was assessed by evaluation of patient knowledge through a 10-item test, and concordance between patient value score and treatment choice.
The study found that for the 248 patients enrolled in the study, patient knowledge scores increased by 5.5% (p = 0.03). Patients in the control group favored LVAD more often (47 [59.5%] vs 95 [91.3%], p < 0.001), and concordance between patient values and treatment choice improved (difference in Kendall’s τ, 0.28; 95%CI, 0.05-0.45). There was no change in concordance for patient values and actual treatment received.
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