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Specialized Primary and Networked Care in Heart Failure - SPAN CHF
Description:
The goal of the trial was to evaluate a disease management intervention compared with usual care for prevention of hospitalization among patients with heart failure.
Study Design
Study Design:
Patients Enrolled: 200
Mean Follow Up: One year
Mean Patient Age: Mean age 72 years
Female: 42
Mean Ejection Fraction: Mean baseline ejection fraction 31%
Patient Populations:
Primary diagnosis of heart failure resulting from ischemic heart disease, dilated cardiomyopathy, valvular heart disease, or hypertensive heart disease, regardless of ejection fraction or New York Heart Association class
Exclusions:
Noncardiac debilitating illness such as active malignancy, severe liver disease, severe renal insufficiency, dementia, or obstructive lung disease requiring hospitalization; angina at rest or as the principal cause of activity limitation; myocardial infarction or revascularization procedure during the index hospitalization or within the preceding 30 days; planned revascularization or valvular surgery; or restrictive myopathy, pericardial constriction, or hypertrophic cardiomyopathy
Primary Endpoints:
Hospitalization for heart failure during the first 90 days after enrollment
Secondary Endpoints:
Cardiac hospitalizations and all-cause hospitalizations, number of days hospitalized per patient-year of follow-up for heart failure, cardiac and all-cause hospitalizations, and hospitalizations and hospital days over up to one year of follow-up
Drug/Procedures Used:
Patients were randomized to either usual care (n=103) or disease management intervention (n=97) for 90 days. The disease management intervention included a handbook and a home visit from a nurse manager that focused on medical and diet compliance, weight monitoring, and early reporting of changes in weight or clinical status. The nurse manager contacted the patients weekly or biweekly by phone to monitor changes and provide education reinforcement. Intervention patients could also contact the nurse managers 24 hours per day, seven days per week.
Concomitant Medications:
Either angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers were used by 92% of patients at baseline. Beta-blockers were used by 57% of patients at baseline.
Principal Findings:
The primary endpoint of hospitalizations for heart failure during 90-day follow-up was lower in the intervention group compared with the control group (0.55 vs. 1.14 per patient-year alive; relative risk [RR] 0.48, p=0.027), as were hospitalizations for cardiovascular reasons (0.81 vs. 1.43 per patient-year alive; RR 0.57, p=0.043). Additionally, the intervention group had fewer days hospitalized for heart failure (4.3 vs. 7.8 days hospitalized per patient-year; RR 0.54, p<0.001) or for cardiovascular cause (6.6 vs. 10.4 days hospitalized per patient-year; RR 0.64, p<0.001). Mortality by 90 days occurred in 4.1% of the intervention group and 4.9% of the control group.
By one-year follow-up, there was no difference in hospitalization for heart failure (0.74 vs. 0.73 per patient-year alive; RR 1.02, p=0.93) or for cardiovascular reasons (0.94 vs. 1.19 per patient-year alive; RR 0.79, p=0.13), but length of stay in the hospital for heart failure trended lower in the intervention group (4.3 vs. 4.9 days hospitalized per patient-year; RR 0.87, p=0.07) and length of stay for cardiovascular reasons was significantly lower (5.6 vs. 6.4 days hospitalized per patient-year; RR 0.88, p=0.048). Mortality at one year was 11.3% in the intervention group and 13.6% in the control group.
Interpretation:
Among patients with heart failure, a nurse-based disease management intervention was associated with a reduction in the primary endpoint of prevention of heart failure hospitalization through 90 days compared with usual care. However, the reduction in hospitalization was not maintained after the intervention ended. Prior studies have shown a similar benefit with a disease management intervention, but were either single-center studies or enrolled a very restrictive population. The authors speculate that the high rate of baseline medication therapy may explain in part the lack of long-term benefit after cessation of the intervention, given that patients in both arms were optimally treated at study entry.
References:
Kimmelstiel C, Levine D, Perry K, et al. Randomized, controlled evaluation of short- and long-term benefits of heart failure disease management within a diverse provider network: the SPAN-CHF trial. Circulation 2004;110:1450-5.
Keywords: Nurse Administrators, Risk, Myocardial Ischemia, Follow-Up Studies, House Calls, Heart Failure, Heart Valve Diseases, Disease Management, Diet, Cardiomyopathy, Dilated, Length of Stay
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