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Long-Term Impact of Disease Management in a Large, Diverse Heart Failure Population - Long-Term Impact of Disease Management in a Large, Diverse Heart Failure Population
Description:
The goal of the trial was to evaluate a disease management intervention compared with usual care for improvements in clinical outcomes among patients with heart failure.
Study Design
Study Design:
Patients Enrolled: 1,096
NYHA Class: Class I 19%, Class II 57%, Class III 21%, Class IV 3%
Mean Follow Up: 18 months
Mean Patient Age: Mean age 71 years
Female: 29
Patient Populations:
Age ≥18 years, symptoms of congestive heart failure, and documented systolic or diastolic dysfunction
Primary Endpoints:
All-cause mortality
Secondary Endpoints:
Performance on a six-minute walk test, improvement in functional therapeutic class, and total health care costs
Drug/Procedures Used:
Patients were randomized to disease management (n=710) or usual care (n=359). Potential participants were identified by lists generated at participating hospitals and the Centers for Medicare and Medicaid Services of patients with a heart failure diagnosis.
Disease management, which lasted 18 months, was led by a registered nurse with specialized cardiac training. Disease management consisted of medication modification as needed, as well as education of patients on issues of diet, exercise, and weight monitoring.
Concomitant Medications:
Diuretic (75%), angiotensin-converting enzyme inhibitor (60%), beta-blocker (47%), and angiotensin-receptor blocker (13%)
Principal Findings:
The primary endpoint of all-cause mortality was significantly lower in the disease management group (p=0.037). Survival during the study was 450.5 days for the disease management group compared with 526.9 days for the control group. Survival free from death or cardiac event trended lower in the disease management group (p=0.074). In the subgroup of patients with systolic dysfunction (70% of the population), both mortality and cardiac-event free survival (p=0.012) were improved in the disease management group. Survival in the disease management group was 526 days compared with 445 days for the control arm. The largest mortality benefit was seen in the subgroup of patients in New York Heart Association (NYHA) classes III and IV (p=0.048).
There was no difference in exercise capacity as assessed by six-minute walk test at follow-up (856.7 m for disease management vs. 964.1 m for usual care, p=0.075). Improvement in NYHA class was more frequent in the disease management group (24.8% vs. 12.6%, p<0.001). There was no difference by treatment group in total costs during the study (p=0.856) or any of the measures of health care utilization, including emergency department visits, office visits, or hospitalizations.
Interpretation:
Among patients with heart failure, a nurse-based disease management intervention was associated with a reduction in the primary endpoint of all-cause mortality compared with usual care.
There have been several prior studies of a disease management strategy for heart failure, but many were non-randomized and not as large as the current study. While the present study showed an improvement in mortality, there was no cost reduction associated with the intervention. Further analysis of the data will be undertaken to evaluate the cost-effectiveness of the intervention program, which will provide insight into how the cost associated with the improvement in mortality compares with other heart failure therapies.
References:
Galbreath AD, Krasuski RA, Smith B, et al. Long-Term Healthcare and Cost Outcomes of Disease Management in a Large, Randomized, Community-Based Population With Heart Failure. Circulation 2004 Nov 7; [Epub ahead of print].
Presented by Autumn D. Galbreath at the American Heart Association Scientific Sessions, November 2004, New Orleans, LA.
Keywords: Follow-Up Studies, Patient Readmission, Heart Failure, Disease Management, Disease-Free Survival, Centers for Medicare and Medicaid Services, U.S., Diet, Emergency Service, Hospital, Office Visits
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