Acute Heart Failure
Conditions
Keywords
Acute Heart Failure, Chronic Heart Failure, Heart Failure, Heart conditions, nitroglycerin
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.
Interventions
OTHERShort 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.
OTHERStandard of Care
Subjects who come to the ER with acute heart failure who are randomized to inpatient stay.
Sponsors
Agency for Healthcare Research and Quality (AHRQ)
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Days Alive and Out of Hospital | 30 day outcome | To demonstrate the effectiveness of a SSU AHF management strategy vs standard of care |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| All Cause Mortality and Re-hospitalization | 30 and 90 days from randomization | Assessment of time to event for this composite outcome |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 93 |
| 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). | 100 |
| Total | 193 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Short Stay Unit | Hospitalization | Total |
|---|---|---|---|
| Age, Continuous | 63.4 years STANDARD_DEVIATION 14.3 | 66.1 years STANDARD_DEVIATION 15.3 | 64.8 years STANDARD_DEVIATION 14.8 |
| Left Ventricular Ejection Fraction, mean (sd) | 36.8 Percentage STANDARD_DEVIATION 16.5 | 41.4 Percentage STANDARD_DEVIATION 15.3 | 39.3 Percentage STANDARD_DEVIATION 16 |
| Race/Ethnicity, Customized Race and Ethnicity : Black | 51 Participants | 57 Participants | 108 Participants |
| Race/Ethnicity, Customized Race and Ethnicity : Hispanic or Latino ethnicity | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Race and Ethnicity : White | 38 Participants | 42 Participants | 80 Participants |
| Region of Enrollment United States | 93 participants | 100 participants | 193 participants |
| Sex: Female, Male Female | 32 Participants | 47 Participants | 79 Participants |
| Sex: Female, Male Male | 61 Participants | 53 Participants | 114 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 93 | 4 / 100 |
| other Total, other adverse events | 15 / 93 | 16 / 100 |
| serious Total, serious adverse events | 6 / 93 | 6 / 100 |
Outcome results
Primary
Days Alive and Out of Hospital
To demonstrate the effectiveness of a SSU AHF management strategy vs standard of care
Time frame: 30 day outcome
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Short Stay Unit | Days Alive and Out of Hospital | 26.9 Days Alive and Out of Hospital |
| Hospitalization | Days Alive and Out of Hospital | 25.4 Days Alive and Out of Hospital |
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.
Time frame: 30 day outcome
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Short Stay Unit | Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) | 51.3 score on a scale | Standard Deviation 25.7 |
| Hospitalization | Quality of Life as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ) | 45.8 score on a scale | Standard Deviation 23.8 |
Other Pre-specified
All Cause Mortality and Re-hospitalization
Assessment of time to event for this composite outcome
Time frame: 30 and 90 days from randomization
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Short Stay Unit | All Cause Mortality and Re-hospitalization | 30 day all cause death or rehospitalization | 16 participants |
| Short Stay Unit | All Cause Mortality and Re-hospitalization | 90 day all cause death or rehospitalization | 36 participants |
| Hospitalization | All Cause Mortality and Re-hospitalization | 30 day all cause death or rehospitalization | 18 participants |
| Hospitalization | All Cause Mortality and Re-hospitalization | 90 day all cause death or rehospitalization | 35 participants |