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(Circulation. 2004;110:3518-3526.)
© 2004 American Heart Association, Inc.
Late-Breaking Clinical Trials |
From the Division of Cardiology, University of Texas Health Science Center, San Antonio (A.D.G., G.L.F.); University of Texas Disease Management Center, San Antonio (A.D.G., B.S., G.L.F.); Division of Cardiology, Wilford Hall Medical Center, San Antonio, Tex (R.A.K.); Altarum Institute, San Antonio, Tex (B.S.); Division of Cardiology, Brooke Army Medical Center, San Antonio, Tex (K.C.S., M.D.K.); and Tricare Southwest, San Antonio, Tex (R.E.).
Correspondence to Gregory L. Freeman, MD, Medicine/Cardiology, 7703 Floyd Curl Dr, San Antonio, TX 78229. E-mail freeman{at}uthscsa.edu
Received September 1, 2004; revision received October 12, 2004; accepted October 13, 2004.
Abstract
Background Because of the prevalence and expense of congestive heart failure (CHF), significant efforts have been made to develop disease management (DM) programs that will improve clinical and financial outcomes. The effectiveness of such programs in a large, heterogeneous population of CHF patients remains unknown.
Methods and Results We randomized 1069 patients (aged 70.9±10.3 years) with systolic (ejection fraction 35±9%) or echocardiographically confirmed diastolic heart failure (HF) to assess telephonic DM over an 18-month period. Data were collected at baseline and at 6-month intervals. Survival analysis was performed by Kaplan-Meier and Cox regression methods. Healthcare utilization was defined after extensive record review, with an attempt to account for all inpatient and outpatient visits, medications, and diagnostic tests. We obtained data on 92% of the patients, from nearly 53 000 health-related encounters. Total cost per patient was defined by adding estimated costs for the observed encounters, excluding the cost of the DM. Kaplan-Meier analysis showed that DM patients had a reduced mortality rate (P=0.037), with DM patients surviving an average of 76 days longer than controls. Subgroup analysis showed that DM had beneficial outcomes in patients with systolic HF (hazard ratio 0.62; P=0.040), which was more pronounced in NYHA classes III and IV. Although improvements in NYHA class were more likely with DM (P<0.001), 6-minute walk data from 217 patients in whom data were available at each visit showed no significant benefit from DM (P=0.08). Total and CHF-related healthcare utilization, including medications, office or emergency department visits, procedures, or hospitalizations, was not decreased by DM. Repeated-measures ANOVA for cost by group showed no significant differences, even in the higher NYHA class groups.
Conclusions Participation in DM resulted in a significant survival benefit, most notably in symptomatic systolic HF patients. Although DM was associated with improved NYHA class, 6-minute walk test results did not improve. Healthcare utilization was not reduced by DM, and it conferred no cost savings. DM in HF results in improved life expectancy but does not improve objective measures of functional capacity and does not reduce cost.
Key Words: heart failure cost-benefit analysis disease management
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