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| Name | Class |
|---|---|
| The Foundation for Barnes-Jewish Hospital | OTHER |
| American College of Chest Physicians | OTHER |
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The study will begin in 2013 whereby patients having an early warning system (EWS) alert will be randomized to be seen by the rapid response team (RRT) for triage versus usual care. A RRT is usually made up of a nurse and/or a physician who respond to a requested activation of the RRT (called an "ACT"). The intervention will occur as follows:
The study will begin in 2013 whereby patients having an early warning system (EWS) alert will be randomized to be seen by the rapid response team (RRT) for triage versus usual care. A RRT is usually made up of a nurse and/or a physician who respond to a requested activation of the RRT (called an "ACT"). The intervention will occur as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine care | Placebo Comparator | General hospital ward patients will receive routine care. |
|
| Intervention arm | Experimental | The intervention with early warning system monitoring is to have the rapid response team assess the patients real-time. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early warning system monitoring. | Other | General hospital ward patients will be monitored 24/7 for clinical deterioration using the early warning system monitoring developed at Washington University. |
| Measure | Description | Time Frame |
|---|---|---|
| ICU Transfer | Patients transferred to the ICU from a general hospital ward will be assessed as having met the outcome. | Patients will be assessed for the primary outcome measure during their hospital with an average of 14 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | Death during hospitalization will be used to determine the presence of this outcome. | Patients will be asessed for the secondary outcome measure during an average of 28 days.. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marin Kollef, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Routine Care | General hospital ward patients will receive routine care. routine care =286 |
| FG001 | Intervention Arm | Patients will have active surveillance by the early warning system performed on a real-time basis to identify clinical deterioration. Early warning system monitoring.: General hospital ward patients will be monitored 24/7 for clinical deterioration using the early warning system developed at Washington University. = 285 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Routine Care | General hospital ward patients will receive routine care. routine care |
| BG001 | Intervention Arm | Patients will have active surveillance by the early warning system performed on a real-time basis to identify clinical deterioration. Early warning system monitoring.: General hospital ward patients will be monitored 24/7 for clinical deterioration using the early warning system developed at Washington University. |
| 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 | ICU Transfer | Patients transferred to the ICU from a general hospital ward will be assessed as having met the outcome. | Posted | Number | participants | Patients will be assessed for the primary outcome measure during their hospital with an average of 14 days. |
|
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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 | Routine Care | General hospital ward patients will receive routine care. routine care =286 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marin Kollef | WashingtonU | 314-454-8764 | mkollef@dom.wustl.edu |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D009369 | Neoplasms |
| D003920 | Diabetes Mellitus |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| routine care | Other |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Saint louis Region | Number | participants |
|
|
|
| Secondary | Mortality | Death during hospitalization will be used to determine the presence of this outcome. | Not Posted | Patients will be asessed for the secondary outcome measure during an average of 28 days.. | Participants |
| 0 |
| 285 |
| 0 |
| 285 |
| EG001 | Intervention Arm | Patients will have active surveillance by the early warning system performed on a real-time basis to identify clinical deterioration. Early warning system monitoring.: General hospital ward patients will be monitored 24/7 for clinical deterioration using the early warning system developed at Washington University. = 285 | 0 | 286 | 0 | 286 |
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| D012140 |
| Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |