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| ID | Type | Description | Link |
|---|---|---|---|
| 7322-01 | Other Grant/Funding Number | BJH Foundation/ICTS |
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The goal is to develop a two-tiered monitoring system to improve the care of patients at risk for clinical deterioration on general hospital wards (GHWs) at Barnes-Jewish Hospital (BJH). The investigators hypothesize that the use of an automated early warning system (EWS) that identifies patients at risk of clinical deterioration, with notification of nurses on the GHWs when patients are identified, will reduce the risk of ICU transfer or death within 24 hrs of an alert. As a substudy, the investigators will pilot the use of a wireless pulse oximeter to establish feasibility and to develop algorithms for a real-time event detection system (RDS) in these high-risk patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Patients admitted to 4 GHWs designated as controls. Nurses will not be notified when patients on these GHWs satisfy the EWS algorithm. They will also not wear the wireless sensor devices. | |
| Nurse notification of EWS alert | Experimental | Patients admitted to 4 GHWs designated as intervention wards at BJH. Nurses will be notified when patients on these wards satisfy the EWS algorithm. Some patients will be asked to wear the wireless remote sensors. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EWS Nursing Alerts | Behavioral | An automated algorithm (EWS) will identify patients at potential risk of clinical deterioration. When a patient satisfies the algorithm, a nurse on the patient's ward will be notified. S/he will assess the patient and institute any interventions that are clinically required. |
| Measure | Description | Time Frame |
|---|---|---|
| Transfer to ICU or Unexpected Death Within 24 Hrs of Identification by the EWS Algorithm | The proportion of patients transferred to ICU or death within 24 hrs of identification by the EWS algorithm for intervention and control wards. | Within 24 hrs of an EWS alert |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Outcomes and Process Measures | length of stay | Hospital discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas C Bailey, MD | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barnes Jewish Hospital | St Louis | Missouri | 63108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23440923 | Result | Bailey TC, Chen Y, Mao Y, Lu C, Hackmann G, Micek ST, Heard KM, Faulkner KM, Kollef MH. A trial of a real-time alert for clinical deterioration in patients hospitalized on general medical wards. J Hosp Med. 2013 May;8(5):236-42. doi: 10.1002/jhm.2009. Epub 2013 Feb 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Patients admitted to 4 GHWs designated as controls. Nurses will not be notified when patients on these GHWs satisfy the EWS algorithm. They will also not wear the wireless sensor devices. |
| FG001 | Nurse Notification of EWS Alert | Patients admitted to 4 GHWs designated as intervention wards at BJH. Nurses will be notified when patients on these wards satisfy the EWS algorithm. Some patients will be asked to wear the wireless remote sensors. EWS Nursing Alerts: An automated algorithm (EWS) will identify patients at potential risk of clinical deterioration. When a patient satisfies the algorithm, a nurse on the patient's ward will be notified. S/he will assess the patient and institute any interventions that are clinically required. Wireless Remote Sensor: A subset of patients will be consented to wear a wireless sensor device which will monitor heart rate and level of oxygen in the blood. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Patients admitted to 4 GHWs designated as controls. Nurses will not be notified when patients on these GHWs satisfy the EWS algorithm. They will also not wear the wireless sensor devices. |
| BG001 | Nurse Notification of EWS Alert |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Transfer to ICU or Unexpected Death Within 24 Hrs of Identification by the EWS Algorithm | The proportion of patients transferred to ICU or death within 24 hrs of identification by the EWS algorithm for intervention and control wards. | Posted | Number | participants | Within 24 hrs of an EWS alert |
|
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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 | Control | Patients admitted to 4 GHWs designated as controls. Nurses will not be notified when patients on these GHWs satisfy the EWS algorithm. They will also not wear the wireless sensor devices. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas C. Bailey, MD | Washington Univ Sch of Medicine | 314-454-8293 | tbailey@dom.wustl.edu |
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D001049 | Apnea |
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| D000075902 | Clinical Deterioration |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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Random allocation of study wards to intervention and control, with washout period and crossover of assignment.
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|
| Wireless Remote Sensor | Device | A subset of patients will be consented to wear a wireless sensor device which will monitor heart rate and level of oxygen in the blood. |
|
Patients admitted to 4 GHWs designated as intervention wards at BJH. Nurses will be notified when patients on these wards satisfy the EWS algorithm. Some patients will be asked to wear the wireless remote sensors. EWS Nursing Alerts: An automated algorithm (EWS) will identify patients at potential risk of clinical deterioration. When a patient satisfies the algorithm, a nurse on the patient's ward will be notified. S/he will assess the patient and institute any interventions that are clinically required. Wireless Remote Sensor: A subset of patients will be consented to wear a wireless sensor device which will monitor heart rate and level of oxygen in the blood. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Clinical Outcomes and Process Measures | length of stay | Posted | Median | Inter-Quartile Range | days | Hospital discharge |
|
|
|
| 0 |
| 10,120 |
| 0 |
| 10,120 |
| EG001 | Nurse Notification of EWS Alert | Patients admitted to 4 GHWs designated as intervention wards at BJH. Nurses will be notified when patients on these wards satisfy the EWS algorithm. Some patients will be asked to wear the wireless remote sensors. EWS Nursing Alerts: An automated algorithm (EWS) will identify patients at potential risk of clinical deterioration. When a patient satisfies the algorithm, a nurse on the patient's ward will be notified. S/he will assess the patient and institute any interventions that are clinically required. Wireless Remote Sensor: A subset of patients will be consented to wear a wireless sensor device which will monitor heart rate and level of oxygen in the blood. | 0 | 9,911 | 0 | 9,911 |
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| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D012769 | Shock |
| D018450 | Disease Progression |
| D020969 | Disease Attributes |