Short Stay Unit vs Hospitalization in Acute Heart Failure

Study Overview
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Brief Summary
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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
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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.

Official Title
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Using Short Stay Units Instead of Routine Admission to Improve Patient Centered Health Outcomes for AHF Patients

Conditions
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Acute Heart Failure

Intervention / Treatment
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* Other: Short Stay Unit
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion: ED physician clinical diagnosis of AHF; Planned admission for AHF Systolic blood pressure > 100mmHg, heart rate < 115bpm* Previous history of HF *Patients with atrial fibrillation but controlled HR are eligible For Caregiver Burden assessments. The eligibility criteria for a caregiver: 1) person either self-identifies, or when asked identifies themselves, as the primary caregiver for the patient. If there are multiple caregivers, the person who self-identifies as providing the most care will be asked to provide verbal informed consent. Exclusion: Transplanted organ of any kind or ventricular assist device patient; End stage renal disease, on dialysis, or eGFR < 20 mL/min; Acute coronary syndrome (e.g. EKG changes consistent with ischemia or troponin elevation secondary to ACS); Other acute co-morbid conditions (e.g. sepsis, altered mental status) that are unlikely to be treated within a SSU stay; Patients who require ventilatory support of any kind or intravenous vasodilators/vasopressor/inotropic support. Patients who receive a one-time dose of an intravenious vasodiolator, but are no longer on this medication, are eligible. Pregnant patients or any patient who has been pregnant in the last 3 months < 18 years of age Any patient who in the opinion of the clinician or investigator requires hospitalization or ICU level care or will require rehabilitation or skilled nursing after discharge from the ED or hospital Planned discharge from the emergency department Patients hospitalized within the last 30 days ONLY if the institution mandates these patients are observed. Otherwise these patients are eligible. De Novo (new Onset) AHF

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Short Stay Unit<br>Subjects are assigned to the short stay unit (SSU) for approximately 23 hours treatment and observation period. In the SSU, patients will receive usual care for AHF, which includes loop diuretics and nitroglycerin, as needed. | Other: Short Stay Unit<br>* 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.<br>* Other names: SSU;|
| Active Comparator: Standard of Care<br>Subjects are assigned to inpatient hospitalization. During hospitalization, patients will receive usual care for AHF, which includes loop diuretics and nitroglycerin, as needed. | Other: Standard of Care<br>* Subjects who come to the ER with acute heart failure who are randomized to inpatient stay.<br>* Other names: SOC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days alive and out of hospital | To demonstrate the effectiveness of a SSU AHF management strategy vs standard of care | 30 day outcome | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life as measured by Kansas City Cardiomyopathy Questionnaire | To determine quality of life using a heart failure questionnaire | 30 day outcome | 
| Cost Effectiveness Analysis | Determine differences in costs between the two strategy of care arms | 30 day outcome | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Heart Failure, Chronic Heart Failure, Heart Failure, Heart conditions, nitroglycerin