Draft

Background

Patients with severe heart failure are frequently or systematically hospitalized, often the risk of adverse events is unknown and the options for rapid follow-up are insufficient. Whether the use of a strategy to support clinicians in making decisions about discharging or admitting patients, coupled with rapid follow-up in an outpatient clinic, is uncertain.

Methods

In a stepwise, cluster-randomized trial conducted in Ontario, Canada, we randomly assigned 10 hospitals to cross over from the control phase (usual care) to the intervention phase. -A care algorithm to stratify patients with acute heart failure based on risk of death. In the intervention phase, low-risk patients received early (within ≤3 days) and standardized outpatient care, while high-risk patients were hospitalized. The primary outcomes were hospitalization for cardiovascular causes at 30 days and the composite outcome was death or hospitalization from any cause at 20 months.

Results

A total of 5452 patients were enrolled in the trial (2972 in the control period and 2480 in the intervention period). Death from any cause or hospitalization for cardiovascular causes within 30 days was recorded in 301 patients (12.1%) during the intervention and in 430 patients (14.5%) during the intervention (adjusted hazard ratio, 0.88; 95% confidence interval [CI]0.78 to 0.99; P = 0.04). At 20 months, the cumulative incidence of primary-outcome events was 54.4% (95% CI, 48.6 to 59.9) among patients enrolled during the intervention and 56.2% (95% CI, 54.2 to 58.1) among enrolled patients. in the control phase (adjusted hazard ratio, 0.95; 95% CI, 0.92 to 0.99). Fewer than six deaths or hospitalizations from any cause occurred in low- or moderate-risk patients before the first outpatient visit within 30 days of discharge.

Conclusions

Among patients with acute heart failure who seek emergency care, using a hospital-based strategy to support clinical decisions and rapid follow-up reduces the risk of dying from any cause or in-hospital cardiovascular causes within 30 years. Days of normal care. (Sponsored by Ontario SPOR Support Unit et al.; COACH ClinicalTrials.gov no.; NCT02674438.)

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