Short Stay Unit vs Hospitalization in Acute Heart Failure
Condition: Acute Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      The majority of the over one million annual AHF hospitalizations originate from the emergency
      department. Admitting and re-admitting lower risk AHF patients who don't need prolonged
      hospitalization may increase their risk for poor outcomes and decrease their quality of life:
      Safe alternatives to hospitalization from the ED are needed. We propose a strategy-of-care,
      short stay unit management of AHF (i.e. less than 24 hours), will lead to improved outcomes
      for lower risk AHF patients.
    

Detailed description: 
      Nearly 85% of acute heart failure (AHF) patients who present to the emergency department (ED)
      with acute heart failure (AHF) are hospitalized. Once hospitalized, within 30 days
      post-discharge, 27% of patients are re-hospitalized or die. Attempts to improve outcomes with
      novel therapies have all failed. The evidence for existing AHF therapies are poor: No
      currently used AHF treatment is known to improve outcomes. ED treatment is largely the same
      today as 40 years ago. Hospitalizing patients who don't need it may contribute to adverse
      outcomes. Hospitalization is not benign; patients enter a vulnerable phase post-discharge, at
      increased risk for morbidity and mortality. Patients would prefer to be home, not
      hospitalized. Furthermore, hospitalization and re-hospitalization for AHF predominantly
      affects patients of lower socioeconomic status (SES). Avoiding hospitalization in patients
      who don't need it may improve outcomes and quality of life, while reducing costs.

      Short stay unit (SSU: less than 24 hours) management of AHF is effective for lower risk
      patients. However, it's only been studied in small studies or retrospective analyses. In
      addition, some have considered the SSU 'cheating' for hospitals trying to avoid 30 day
      readmission penalties, since SSU or observation didn't count as an admission. However, this
      quality measure is now changing. A robust clinical effectiveness trial would demonstrate the
      effectiveness of this patient-centered strategy.

      Using a multi-center, randomized controlled design, this clinical effectiveness trial will
      test whether Short Stay Unit AHF management for < 24 hours increases
      days-alive-and-out-of-hospital, Quality of Life assessment (QoL), caregiver burden, and costs
      compared to inpatient management.
    

Intervention name(s): Short Stay Unit; Standard of Care
Intervention type(s): Other; Other
Intervention description(s): Subjects will be treated for acute heart failure in the SSU and observed for improvement then, if appropriate, discharged. If not appropriate for discharge they will be admitted to inpatient.; Subjects who come to the ER with acute heart failure who are randomized to inpatient stay.
Other intervention name(s): SSU; SOC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Acute Heart Failure, Chronic Heart Failure, Heart Failure, Heart conditions, nitroglycerin