Short Stay Unit vs Hospitalization in Acute Heart Failure

Acute Heart Failure Clinical Trial

— SSU-AHF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03302910
• Other study ID #: R01HS025411
• Status: Completed
• Phase: N/A
• Start date: December 6, 2017
• Est. completion date: July 22, 2021

Study information

• Verified date: August 2023
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 194
• Est. completion date: July 22, 2021
• Est. primary completion date: July 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Heart Failure
• Heart Failure

Intervention

Other:
• Short Stay Unit
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.
• Standard of Care
Subjects who come to the ER with acute heart failure who are randomized to inpatient stay.

Locations

Country	Name	City	State
United States	University of Alabama - Birmingham	Birmingham	Alabama
United States	Ohio State University	Columbus	Ohio
United States	UT Southwestern Medical Center	Dallas	Texas
United States	Henry Ford Health System	Detroit	Michigan
United States	Indiana University	Indianapolis	Indiana
United States	University of Mississippi Medical Center	Jackson	Mississippi
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Allegheny Health Network	Pittsburgh	Pennsylvania
United States	Beaumont Health System	Royal Oak	Michigan
United States	Washington University	Saint Louis	Missouri
United States	Wake Forest School of Medicine	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Caregiver Burden	Measure caregiver burden	30 and 90 days
Other	Cost Effectiveness Analysis	Determine differences in costs between the two strategy of care arms	90 days
Other	Modified Resource Utilization Questionnaire for Heart Failure	Measures resource utilization	30 days
Other	All cause mortality and re-hospitalization	Assessment of time to event for this composite outcome	30 and 90 days from randomization
Other	Days alive and out of hospital	To demonstrate the effectiveness of a SSU AHF management strategy vs standard of care	90 days
Primary	Days alive and out of hospital	To demonstrate the effectiveness of a SSU AHF management strategy vs standard of care	30 day outcome
Secondary	Quality of life as measured by Kansas City Cardiomyopathy Questionnaire	To determine quality of life using a heart failure questionnaire	30 day outcome
Secondary	Cost Effectiveness Analysis	Determine differences in costs between the two strategy of care arms	30 day outcome