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| Name | Class |
|---|---|
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Short Stay Unit | Experimental | 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 | Active Comparator | Subjects are assigned to inpatient hospitalization. During hospitalization, patients will receive usual care for AHF, which includes loop diuretics and nitroglycerin, as needed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Short Stay Unit | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Days Alive and Out of Hospital | To demonstrate the effectiveness of a SSU AHF management strategy vs standard of care | 30 day outcome |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) | 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. | 30 day outcome |
| Measure | Description | Time Frame |
|---|---|---|
| All Cause Mortality and Re-hospitalization | Assessment of time to event for this composite outcome | 30 and 90 days from randomization |
Inclusion:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Peter S Pang, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama - Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Indiana University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38198141 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| FG001 | Hospitalization | Subjects are assigned to inpatient hospitalization. During hospitalization, patients will receive usual care for AHF, which includes loop diuretics and nitroglycerin, as needed. Subjects who come to the ER with acute heart failure who are randomized to inpatient stay (i.e. usual care or hospitalization). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Days Alive and Out of Hospital | To demonstrate the effectiveness of a SSU AHF management strategy vs standard of care | Posted | Median | Inter-Quartile Range | Days Alive and Out of Hospital | 30 day outcome |
|
The study period during which AEs must be reported begins after informed consent is obtained and initiation of study treatment and for 5 days after randomization. Patients will be followed out to 90 days for death, ED utilization, and re-hospitalization as part of the study outcomes, which will also count as safety measures. Subject's hospital discharge summaries will be examined at hospital discharge and all non-exempt AEs will be investigated by examining necessary medical records.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Investigations | Non-systematic Assessment | No deaths were considered related to the study or a SAE. Re-hospitalization is considered an outcome and not an adverse event. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CTCAE Category | Blood and lymphatic system disorders | Non-systematic Assessment |
The COVID 19 pandemic significantly impacted our enrollment. As a result, we changed our primary endpoint to KCCQ-12 and our main secondary to 30-day DAOOH.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter S. Pang | Indiana University School of Medicine | 317-880-3900 | ppang@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2019 | Mar 17, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Standard of Care | Other | Subjects who come to the ER with acute heart failure who are randomized to inpatient stay. |
|
|
| Indianapolis |
| Indiana |
| 46201 |
| United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Beaumont Health System | Royal Oak | Michigan | 48073 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Washington University | St Louis | Missouri | 63130 | United States |
| Wake Forest School of Medicine | Winston-Salem | North Carolina | 27157 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Allegheny Health Network | Pittsburgh | Pennsylvania | 15212 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| BG001 | Hospitalization | Subjects are assigned to inpatient hospitalization. During hospitalization, patients will receive usual care for AHF, which includes loop diuretics and nitroglycerin, as needed. Subjects who come to the ER with acute heart failure who are randomized to inpatient stay (i.e. usual care or hospitalization). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race/Ethnicity, Customized | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| Left Ventricular Ejection Fraction, mean (sd) | Mean | Standard Deviation | Percentage |
|
Subjects are assigned to inpatient hospitalization. During hospitalization, patients will receive usual care for AHF, which includes loop diuretics and nitroglycerin, as needed.
Hospitalization: Subjects who come to the ER with acute heart failure who are randomized to inpatient stay.
|
|
| Secondary | Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) | 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. | Posted | Mean | Standard Deviation | score on a scale | 30 day outcome |
|
|
|
| Other Pre-specified | All Cause Mortality and Re-hospitalization | Assessment of time to event for this composite outcome | Posted | Number | participants | No | 30 and 90 days from randomization |
|
|
|
| 3 |
| 93 |
| 6 |
| 93 |
| 15 |
| 93 |
| EG001 | Hospitalization | Subjects are assigned to inpatient hospitalization. During hospitalization, patients will receive usual care for AHF, which includes loop diuretics and nitroglycerin, as needed. Hospitalization: Subjects who come to the ER with acute heart failure who are randomized to inpatient stay. | 4 | 100 | 6 | 100 | 16 | 100 |
|
| CTCAE | Cardiac disorders | Non-systematic Assessment |
|
| CTCAE | Gastrointestinal disorders | Non-systematic Assessment |
|
| CTCAE | Hepatobiliary disorders | Non-systematic Assessment |
|
| CTCAE | Renal and urinary disorders | Non-systematic Assessment |
|
| CTCAE | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| CTCAE | Cardiac disorders | Non-systematic Assessment |
|
| CTCAE | Gastrointestinal disorders | Non-systematic Assessment |
|
| CTCAE | Hepatobiliary disorders | Non-systematic Assessment |
|
| CTCAE | Infections and infestations | Non-systematic Assessment |
|
| CTCAE | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| CTCAE | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| CTCAE | Renal and urinary disorders | Non-systematic Assessment |
|
| CTCAE | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| CTCAE | Surgical and medical procedures | Non-systematic Assessment |
|
| CTCAE | Vascular disorders | Non-systematic Assessment |
|
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