Not provided
Not provided
Not provided
Not provided
Not provided
Study no longer moving forward
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of the OUTPATIENT-WHF study is to characterize the effectiveness of outpatient intravenous diuretic therapy as a treatment for worsening heart failure.
The purpose of this study is to determine whether treating certain patients with worsening heart failure as an outpatient with intravenous and oral medications can work just as well as treating patients in the hospital.
Participants who enter into the study and meet eligibility criteria will be randomly chosen to either get intravenous diuretic like Lasix in the clinic and get outpatient care, versus directly admitted to the hospital to receive intravenous diuretic and normal hospital care.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Initial outpatient management strategy, including outpatient IV diuretics in clinic | Other |
| |
| Initial hospitalization-based management strategy | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Initial outpatient management strategy, including outpatient IV diuretics in clinic | Other | Management strategy including IV diuretic in the outpatient clinic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Days alive and out of hospital | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Days alive and out of hospital | 90 days | |
| Total hospitalizations | 30 days | |
| Total hospitalizations |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stephen Greene | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Initial hospitalization-based management strategy | Other | Direct admission to the hospital |
|
| 90 days |
| Total emergency department visits | 30 days |
| Total emergency department visits | 90 days |
| Death | 30 days |
| Death | 90 days |
| Health status as measured by EuroQOL-5 dimensions (EQ5D) utility index | The EQ5D utility index consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response categories (no problems, slight problems, moderate problems, severe problems, and extreme problems), from which a single EQ-5D index score can be calculated ranging from 0 (dead) to 1 (perfect health). | 30 days |
| Health status as measured by EuroQOL-5 dimensions (EQ5D) visual analog scale (VAS) | The EQ5D VAS measures one's self-perceived health today on a vertical scale from 0 (worst imaginable health) to 100 (best imaginable health) on which participants have to indicate their current health. | 30 days |
| Health status as measured by EuroQOL-5 dimensions (EQ5D) utility index | The EQ5D utility index consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response categories (no problems, slight problems, moderate problems, severe problems, and extreme problems), from which a single EQ-5D index score can be calculated ranging from 0 (dead) to 1 (perfect health). | 90 days |
| Health status as measured by EuroQOL-5 dimensions (EQ5D) visual analog scale (VAS) | The EQ5D VAS measures one's self-perceived health today on a vertical scale from 0 (worst imaginable health) to 100 (best imaginable health) on which participants have to indicate their current health. | 90 days |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000554 | Ambulatory Care Facilities |
| ID | Term |
|---|---|
| D006268 | Health Facilities |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
Not provided