Short Stay Unit vs Hospitalization in Acute Heart Failure

NCT ID: NCT03302910

Last Updated: 2024-11-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-06
• Study Completion Date: 2021-07-22

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.

Conditions

Acute Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Short Stay Unit

Intervention Type: OTHER

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 are assigned to inpatient hospitalization. During hospitalization, patients will receive usual care for AHF, which includes loop diuretics and nitroglycerin, as needed.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

Subjects who come to the ER with acute heart failure who are randomized to inpatient stay.

Interventions

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.

Intervention Type: OTHER

Standard of Care

Subjects who come to the ER with acute heart failure who are randomized to inpatient stay.

Intervention Type: OTHER

Other Intervention Names

SSU; SOC

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

PETER S PANG

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter S Pang, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

University of Alabama - Birmingham

Birmingham, Alabama, United States

Indiana University

Indianapolis, Indiana, United States

Henry Ford Health System

Detroit, Michigan, United States

Beaumont Health System

Royal Oak, Michigan, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Washington University

St Louis, Missouri, United States

Wake Forest School of Medicine

Winston-Salem, North Carolina, United States

Ohio State University

Columbus, Ohio, United States

Allegheny Health Network

Pittsburgh, Pennsylvania, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

References

Pang PS, Berger DA, Mahler SA, Li X, Pressler SJ, Lane KA, Bischof JJ, Char D, Diercks D, Jones AE, Hess EP, Levy P, Miller JB, Venkat A, Harrison NE, Collins SP. Short-Stay Units vs Routine Admission From the Emergency Department in Patients With Acute Heart Failure: The SSU-AHF Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2350511. doi: 10.1001/jamanetworkopen.2023.50511.

Reference Type: DERIVED

PMID: 38198141 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R01HS025411

Identifier Type: AHRQ

Identifier Source: org_study_id

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