Clinical Question: Does a disease management program improve outcomes in patients with heart failure?

Setting: Outpatient (any)

Study Design: Randomized controlled trial (nonblinded)

Allocation: Uncertain

Synopsis: In this study, investigators enlisted persons in the community to identify those with possible symptoms of heart failure. Persons with a positive screening result had echocardiography, and those with systolic heart failure (defined as an ejection fraction of less than 49 percent) or diastolic heart failure (defined as left ventricular hypertrophy, E-A reversal, or abnormal transmitral flow) were invited to enroll in the study. Enrollees were randomized in a 2:1 ratio to disease management or usual care.

Disease management was provided by a private firm and consisted of handing out scales, providing a detailed treatment plan, emphasizing that patients received all indicated medications, and placing weekly and then monthly phone calls. One half of the patients also received in-home pulse oximetry and blood pressure monitoring.

Patients underwent a detailed evaluation every six months, and were followed up for 18 months. Groups were balanced at the start of the study and analysis was by intention to treat, but neither the patients nor the investigators were blinded. The average age of participants was 71 years, 29 percent were women, 71 percent were white, 62 percent had coronary artery disease, 72 percent had hypertension, and 28 percent had diabetes. Most patients had systolic heart failure (70 percent) with an average ejection fraction of 35 percent in this group.

After 18 months, all-cause mortality was significantly reduced in patients with systolic heart failure but not in those with diastolic heart failure. Patients with systolic heart failure who were enrolled in the disease management program had a longer mean survival (526 versus 445 days; P = .012) than those receiving usual care. The benefit was greatest for patients with more severe disease (hazard ratio = 1.32 for New York Heart Association [NYHA] class I, 0.76 for NYHA class II, and 0.54 for NYHA class III or IV; only the last hazard ratio was statistically significant). There were no differences between the groups regarding cost, hospitalization, or any other measures of health care use.

Bottom Line: A disease management program reduces mortality in patients with moderate to severe systolic heart failure. Patients with milder symptoms and those with diastolic heart failure did not benefit. The program did not reduce overall health care use or costs. (Level of Evidence: 1b–)