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Short Stay Unit vs Hospitalization in Acute Heart Failure (SSU-AHF)

Primary Purpose

Acute Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Short Stay Unit
Standard of Care
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acute Heart Failure focused on measuring Acute Heart Failure, Chronic Heart Failure, Heart Failure, Heart conditions, nitroglycerin

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama - Birmingham
  • Indiana University
  • Henry Ford Health System
  • Beaumont Health System
  • University of Mississippi Medical Center
  • Washington University
  • Wake Forest School of Medicine
  • Ohio State University
  • Allegheny Health Network
  • Vanderbilt University Medical Center
  • UT Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Short Stay Unit

Standard of Care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Days alive and out of hospital
To demonstrate the effectiveness of a SSU AHF management strategy vs standard of care

Secondary Outcome Measures

Quality of life as measured by Kansas City Cardiomyopathy Questionnaire
To determine quality of life using a heart failure questionnaire
Cost Effectiveness Analysis
Determine differences in costs between the two strategy of care arms

Full Information

First Posted
October 2, 2017
Last Updated
August 13, 2023
Sponsor
Indiana University
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
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1. Study Identification

Unique Protocol Identification Number
NCT03302910
Brief Title
Short Stay Unit vs Hospitalization in Acute Heart Failure
Acronym
SSU-AHF
Official Title
Using Short Stay Units Instead of Routine Admission to Improve Patient Centered Health Outcomes for AHF Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 6, 2017 (Actual)
Primary Completion Date
July 22, 2021 (Actual)
Study Completion Date
July 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Agency for Healthcare Research and Quality (AHRQ)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Heart Failure
Keywords
Acute Heart Failure, Chronic Heart Failure, Heart Failure, Heart conditions, nitroglycerin

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
194 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Short Stay Unit
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Subjects are assigned to inpatient hospitalization. During hospitalization, patients will receive usual care for AHF, which includes loop diuretics and nitroglycerin, as needed.
Intervention Type
Other
Intervention Name(s)
Short Stay Unit
Other Intervention Name(s)
SSU
Intervention Description
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
Intervention Name(s)
Standard of Care
Other Intervention Name(s)
SOC
Intervention Description
Subjects who come to the ER with acute heart failure who are randomized to inpatient stay.
Primary Outcome Measure Information:
Title
Days alive and out of hospital
Description
To demonstrate the effectiveness of a SSU AHF management strategy vs standard of care
Time Frame
30 day outcome
Secondary Outcome Measure Information:
Title
Quality of life as measured by Kansas City Cardiomyopathy Questionnaire
Description
To determine quality of life using a heart failure questionnaire
Time Frame
30 day outcome
Title
Cost Effectiveness Analysis
Description
Determine differences in costs between the two strategy of care arms
Time Frame
30 day outcome
Other Pre-specified Outcome Measures:
Title
Caregiver Burden
Description
Measure caregiver burden
Time Frame
30 and 90 days
Title
Cost Effectiveness Analysis
Description
Determine differences in costs between the two strategy of care arms
Time Frame
90 days
Title
Modified Resource Utilization Questionnaire for Heart Failure
Description
Measures resource utilization
Time Frame
30 days
Title
All cause mortality and re-hospitalization
Description
Assessment of time to event for this composite outcome
Time Frame
30 and 90 days from randomization
Title
Days alive and out of hospital
Description
To demonstrate the effectiveness of a SSU AHF management strategy vs standard of care
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion: ED physician clinical diagnosis of AHF; Planned admission for AHF Systolic blood pressure > 100mmHg, heart rate < 115bpm* 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: Transplanted organ of any kind or ventricular assist device patient; End stage renal disease, on dialysis, or eGFR < 20 mL/min; Acute coronary syndrome (e.g. EKG changes consistent with ischemia or troponin elevation secondary to ACS); Other acute co-morbid conditions (e.g. sepsis, altered mental status) that are unlikely to be treated within a SSU stay; 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. Pregnant patients or any patient who has been pregnant in the last 3 months < 18 years of age 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 Planned discharge from the emergency department Patients hospitalized within the last 30 days ONLY if the institution mandates these patients are observed. Otherwise these patients are eligible. De Novo (new Onset) AHF
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter S Pang, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama - Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46201
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Beaumont Health System
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63130
Country
United States
Facility Name
Wake Forest School of Medicine
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Allegheny Health Network
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Short Stay Unit vs Hospitalization in Acute Heart Failure

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