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Randomized, controlled evaluation of short- and long-term benefits of heart failure disease management within a diverse provider network: the SPAN-CHF trial
Kimmelstiel C, Levine D, Perry K, Patel AR, Sadaniantz A, Gorham N, Cunnie M, Duggan L, Cotter L, Shea-Albright P, Poppas A, la Bresh K, Forman D, Brill D, Rand W, Gregory D, Udelson JE, Lorell B, Konstam V, Furlong K, Konstam MA
Circulation 2004 Sep 14;110(11):1450-1455
clinical trial
5/10 [Eligibility criteria: Yes; Random allocation: Yes; Concealed allocation: No; Baseline comparability: No; Blind subjects: No; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: No; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed*

BACKGROUND: Several trials support the usefulness of disease management (DM) for improving clinical outcomes in heart failure (HF). Most of these studies are limited by small sample size; absence of concurrent, randomized controls; limited follow-up; restriction to urban academic centers; and low baseline use of effective medications. METHODS AND RESULTS: We performed a prospective, randomized assessment of the effectiveness of HF DM delivered for 90 days across a diverse provider network in a heterogeneous population of 200 patients with high baseline use of approved HF pharmacotherapy. During a 90-day follow-up, patients randomized to DM experienced fewer hospitalizations for HF (primary end point, 0.55 +/- 0.15 per patient-year alive versus 1.14 +/- 0.22 per patient-year alive in control subjects; relative risk (RR) 0.48, p = 0.027). Intervention patients experienced reductions in hospital days related to a primary diagnosis of HF (4.3 +/- 0.4 versus 7.8 +/- 0.6 days hospitalized per patient-year; RR 0.54; p < 0.001), cardiovascular hospitalizations (0.81 +/- 0.19 versus 1.43 +/- 0.24 per patient-year alive; RR 0.57; p = 0.043), and days in hospital per patient-year alive for cardiovascular cause (RR 0.64; p < 0.001). Intervention patients showed a trend toward reduced all-cause hospitalizations and total hospital days. On long-term (mean 283 days) follow-up, there was substantial attrition of the 3-month gain in outcomes, with sustained significant reduction only in days in hospital for cardiac cause. CONCLUSIONS: In a population with high background use of standard HF therapy, a DM intervention, uniformly delivered across varied clinical sites, produced significant short-term improvement in HF-related clinical outcomes. Longer-term benefit likely requires more active chronic intervention, even among patients who appear clinically stable.
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