Clinical trial NCT03302910: Short Stay Unit vs Hospitalization in Acute Heart Failure
Official title: Using Short Stay Units Instead of Routine Admission to Improve Patient Centered Health Outcomes for AHF Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Heart Failure
Keywords: Acute Heart Failure, Chronic Heart Failure, Heart Failure, Heart conditions, nitroglycerin
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2017-10-05
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: Inclusion:

1. ED physician clinical diagnosis of AHF;
2. Planned admission for AHF
3. Systolic blood pressure \> 100mmHg, heart rate \< 115bpm\*
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 verbal informed consent.

Exclusion:

1. Transplanted organ of any kind or ventricular assist device patient;
2. End stage renal disease, on dialysis, or eGFR \< 20 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. 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.
6. Pregnant patients or any patient who has been pregnant in the last 3 months
7. \< 18 years of age
8. 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
9. Planned discharge from the emergency department
10. Patients hospitalized within the last 30 days ONLY if the institution mandates these patients are observed. Otherwise these patients are eligible.
11. De Novo (new Onset) AHF

Primary outcomes:
measure: Days Alive and Out of Hospital
timeFrame: 30 day outcome
Secondary outcomes:
measure: Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: 30 day outcome
Other outcomes:
measure: All Cause Mortality and Re-hospitalization
timeFrame: 30 and 90 days from randomization
Locations:
city: Birmingham
country: United States
facility: University of Alabama - Birmingham
state: Alabama
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Royal Oak
country: United States
facility: Beaumont Health System
state: Michigan
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Pittsburgh
country: United States
facility: Allegheny Health Network
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: Indiana University
name: Peter S Pang, MD
role: PRINCIPAL_INVESTIGATOR
References: