Principal investigator

Dr. Ofra Kalter-Leibovici

Subinvestigators

At the Gertner Institute:

          Information and Computerization Unit: Ms Arnona Ziv

          Biostatistics Unit: Prof. Laurence Freedman and Dr. Havi Murad

Maccabi Health Services:

Dr. Haim Silver, Dr. Nurit Friedman Ms. Dorit Goldman

Sheba Medical Center:

Ms Galit Kaufman, Dr. Dov Freimark 

Background

• Heart failure (HF) is becoming increasingly prevalent in western society, both due to the fact that the population is aging and due to increased survival after myocardial infarctions. The disease leads to a significant decline in the patient's life expectancy and quality of life (QoL), is difficult for the patient's family and is a financial burden on the health system, especially because of repeat hospitalizations.

• Disease management plans, particularly those implemented by nurses, have significant potential for improving the prognosis and reducing repeat hospitalizations. 

Objectives

To develop, implement and examine the effectiveness of a nation-wide intervention plan for treating patients suffering from advanced HF in the community. The plan will be based on nurse treatment-managers and cardiologists at regional HF centers and a national telephone call-center using tele-monitoring technology to measure the patient's weight, pulse and blood pressure from home.

The plan is the product of cooperation between the Gertner Institute, Maccabi Health Services and Sheba Medical Center at Tel Hashomer.

Implications

If the plan's effectiveness is proven, it can be implemented by other Health Maintenance Organizations, in order to improve HF patients' life expectancy and QoL, and reduce costs to the health system by preventing the need to hospitalize patients whose situation is unstable. Furthermore, the model can also be used to manage other severe, chronic diseases.

Type of study

Controlled clinical trial with random assignment to one of two research groups:

• Treatment according to the plan
• Treatment by a primary care physician and cardiologist, using the accepted methodology

Methodology

Research population:

Men and women suffering from advanced chronic heart failure (NYHA Stage III-IV) and insured by Maccabi Health Services. Participants were recruited following hospitalization for deterioration of their condition or in the community.

Outcome variables:

Principle: Death for any reason or repeat hospitalization for worsened HF.

Secondary: Improvement in QoL and depression; functional capacity

Evaluation:

Upon acceptance to the program and every six months thereafter, including:

• Functional capacity (six-minute walking test)
• QoL and depression
• Taking medication for heart failure, according to clinical guidelines
• Repeat hospitalization for worsened HF (monthly update)
• Death (monthly update)

The plan is also subject to economic evaluation.

Once a month, a panel of external experts and researchers monitors the safety of the program.

Commencement and planned duration

Commencement date: August 2007 

Planned duration: approximately three years

Status

Five regional HF centers and a national call center have been established.

Approximately 300 participants have been recruited to date. Of these, approximately one-half have been randomly assigned to the research group and connected to tele-monitoring. 

Financing organization

1. Maccabi Institute for Health Services Research

2. Gertner Institute

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