Short Stay Unit vs Hospitalization in Acute Heart Failure

Not Applicable

Completed

• Conditions: Acute Heart Failure
• Interventions: Other: Short Stay Unit; Other: Standard of Care

• Registration Number: NCT03302910
• Lead Sponsor: Indiana University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-10-02
• Study First Submitted QC: 2017-10-02
• Study First Posted: 2017-10-05
• Study Start: 2017-12-06
• Primary Completion: 2021-07-22
• Study Completion: 2021-07-22
• Results First Submitted: 2024-03-18
• Status Verified: 2024-09
• Results First Submitted QC: 2024-09-18
• Last Update Submitted: 2024-09-18
• Results First Posted: 2024-11-20
• Last Update Posted: 2024-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 194

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Short Stay Unit	Short Stay Unit	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.
Standard of Care	Standard of Care	Subjects are assigned to inpatient hospitalization. During hospitalization, patients will receive usual care for AHF, which includes loop diuretics and nitroglycerin, as needed.

Primary Outcome Measures

Name	Time	Method
Days Alive and Out of Hospital	30 day outcome	To demonstrate the effectiveness of a SSU AHF management strategy vs standard of care

Secondary Outcome Measures

Name	Time	Method
Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)	30 day outcome	To determine quality of life using a heart failure questionnaire. We used the Short KCCQ, and the overall summary KCCQ score. The score ranges from 0 to 100, with 100 being the best possible score. Differences of 5 or more points are considered clinically significant.

Trial Locations

Locations (11)

Beaumont Health System; 🇺🇸 Royal Oak, Michigan, United States

University of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

University of Alabama - Birmingham; 🇺🇸 Birmingham, Alabama, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

Allegheny Health Network; 🇺🇸 Pittsburgh, Pennsylvania, United States

Wake Forest School of Medicine; 🇺🇸 Winston-Salem, North Carolina, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States