Objectives:
- To estimate the feasibility and effectiveness of a nationwide disease management program for heart failure (HF) patients in the community. The program includes delivery of healthcare through regional heart failure centers, a designated call center, and tele-monitoring (the later component will be implemented in a sub-group of patients with an advanced disease);
- To evaluate the costs of HF care in patients participating in the program and compare it with the costs in HF patients receiving usual care.
Working hypothesis:
Compared to patient receiving usual care, HF patients participating in the program will have: 1. 1/3 reduction in the risk for hospital admissions for HF or all-cause mortality;
2. better functional capacity and quality of life (QoL) scores; 3. reduced healthcare costs;
Methodology:
Design: randomized controlled trial comparing outcomes in patients allocated either to disease management arm, where healthcare will be delivered through specialized HF regional centers and a designated call center, or to a control arm, where HF will be managed mainly by primary practitioners (the usual care arm).
Duration of follow-up: two years.
Population: recently discharged HF patientsand community-referred HF patients with a moderate-to-severe disease.
Sample size:600 patients in each study arm.
Patients' evaluation: on entry and every 6 months, thereafter.
Follow-up parameters: the main outcome in this study is hospital admissions for HF or all-cause mortality. Secondary outcomes include: functional capacity, QoL scores, utilization of health services, overall costs of healthcare, patients' compliance, and the proportion of patients treated according to guidelines.
Study significance:
The prevalence of HF in developed countries is on the increase. The disease is associated with increased mortality and impaired QoL, and increased healthcare costs. The proposed study evaluates a unique disease management program combining healthcare delivered through specialized HF centers and a designated call center.
In patients with an advanced disease, a component of tele-monitoring is added. The program is aimed to improve patients' outcomes and contain costs of care, by increasing the proportion of patients treated according to guidelines, patients' self-care practices and adherence to treatment.
Should the program proved to be effective, it can be further implemented for HF patients in other Sick Funds in Israel. It may also motivate further research on similar disease management approach for other chronic disease in Israel.
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