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

Ofra Kalter-Leibovici 1,2 Dov Freimark 2,3 Laurence Freedman 4 Arnona Ziv 5 Havi Murad 4 Michal Benderly 1,2 Nurit Friedman 6 Galit Kaufman 7 Haim Silber 8
1Unit of Cardiovascular Epidemiology, Gertner Institute, Tel-Hashomer, Israel
2Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel
3Heart Center, Sheba Medical Center, Tel-Hashomer, Israel
4Unit of Biostatistics, Gertner Institute, Tel-Hashomer, Israel
5Information and Computer Unit, Gertner Institute, Tel-Hashomer, Israel
6Research and Evaluation Department, Maccabi Health Services, Tel-Aviv, Israel
7Nursing, Health Division, Tel-Aviv, Israel
8Cardiology, Maccabi Health Services, Raanana, Israel

Introduction: Disease management (DM) programs in heart failure (HF) have been employed with varying effect on patient outcome and healthcare costs.

Objective: To investigate the efficacy of a nationwide community DM program, delivered by teams of cardiologists and nurses, in reducing HF hospital readmissions and mortality in patients with chronic HF.

Methods: HF Patients (n=1,360; NYHA classification: II-IV) were randomized either to DM arm or usual care (UC) arm. 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.

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 for HF in 628 patients. The primary endpoint occurred in 387 (57.1%) patients assigned to UC and 388 (56.9%) assigned to DM [adjusted HR (95% CI): 0.908 (0.788-1.047); p=0.185]. Patients assigned to DM had lower risk for first HF hospital admission [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: DM was not superior to UC with respect to the primary composite endpoint. DM caused a modest delay in the time till first hospital admission for HF, and modest savings of total in-hospital days and hospital admissions for HF during follow-up. The intervention significantly improved HRQoL and reduced depression.









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