Community Disease Management Program in Patients With Heart Failure: A Randomized Controlled Trial

Introduction: Disease management (DM) programs in heart failure (HF) have been employed with varying effect on patient outcome and healthcare costs. Hypothesis: A nationwide community DM program in patients with moderate-to-severe HF is associated with better outcome. Methods: HF Patients (NYHA classification: II-IV) were randomized either to DM arm (n=682) or usual care (UC) arm (N=678). DM was delivered by teams of cardiologists and DM nurses, operating in 10 HF centers and a central call-center. The primary composite endpoint was time to first hospital admission for HF or death from all-causes. Functional capacity (6-min. walk-test and NYHA classification), health-related quality of life (HRQoL) and depression were also evaluated at 6-month intervals. All analyses were according to intention-to-treat principle. Results: During a median follow-up of 2.7 years (range: 0-5), there were 450 deaths from all causes; 5,748 hospital admissions for all causes in 1,184 patients, and 1,707 admissions due to HF in 628 patients. The primary endpoint occurred in 387 (57.1%) patients allocated to the UC arm and 388 (56.9%) patients allocated to the DM arm [hazard ratio (HR) adjusted for age, sex, HF center, and functional status at entry = 0.908, 95% confidence interval (CI): 0.788-1.047; p=0.185]. Patients enrolled in the DM arm had lower risk for first hospital admission due to HF [adjusted HR=0.832, 95%CI: 0.708-0.977; p=0.025]. DM was associated with a mean saving of 0.96 HF-hospital day/year (95%CI: 0.08-1.56; p=0.035). The number-needed-to-treat to save one HF hospital admission was 11/year (95%CI: 3-500). Patients in the DM arm were more likely to experience clinically-significant improvement in HRQoL and were less likely to have depression symptoms. Conclusions: The study results did not show a significant effect of DM with respect to the composite primary endpoint. Nevertheless, DM was associated with a modest reduction in risk for first hospital admission for HF, and a modest savings of in-hospital days and hospital admissions for HF during follow-up. The intervention was also associated with a significant improvement in HRQoL and depression.