Short Stay Unit vs Hospitalization in Acute Heart Failure



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 99
Updated:10/31/2018
Start Date:December 6, 2017
End Date:June 30, 2021
Contact:Peter S Pang, MD
Email:ppang@iu.edu
Phone:317-880-3900

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

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.

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
We found this trial at
7
sites
425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Peter S Pang, MD
Phone: 312-515-4025
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Indianapolis, IN
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5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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Detroit, MI
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: Lauren Southerland, MD
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Columbus, OH
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PIttsburgh, Pennsylvania 15212
Principal Investigator: Arvindo Venkat, MD
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Royal Oak, Michigan 48073
Principal Investigator: David Berger, MD
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Royal Oak, MI
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Winston-Salem, North Carolina 27157
Principal Investigator: Simon Mahler, MD, MS
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Winston-Salem, NC
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