Short Stay Unit vs Hospitalization in Acute Heart Failure

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.

Inclusion:

1. ED physician clinical diagnosis of AHF;

2. Planned admission for AHF

3. Systolic blood pressure > 110mmHg, heart rate < 115bpm*, Oxygen saturation > 93% on
room air;

4. 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 written informed consent.

Exclusion:

1. Transplanted organ of any kind or ventricular assist device patient;

2. End stage renal disease, on dialysis, or eGFR < 30 mL/min;

3. Acute coronary syndrome (e.g. EKG changes consistent with ischemia or troponin
elevation secondary to ACS);

4. Other acute co-morbid conditions (e.g. sepsis, altered mental status) that are
unlikely to be treated within a SSU stay;

5. High risk lab values, specifically hemoglobin < 9, sodium greater than or equal to 131

6. 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.

7. Pregnant patients or any patient who has been pregnant in the last 3 months

8. < 18 years of age

9. 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

10. Planned discharge from the emergency department

11. Patients hospitalized within the last 30 days ONLY if the institution mandates these
patients are observed. Otherwise these patients are eligible.

12. De Novo (new Onset) AHF