Trial Outcomes & Findings for Early Warning System for Clinical Deterioration on General Hospital Wards (NCT NCT01280942)
NCT ID: NCT01280942
Last Updated: 2018-02-14
Results Overview
The proportion of patients transferred to ICU or death within 24 hrs of identification by the EWS algorithm for intervention and control wards.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20031 participants
Primary outcome timeframe
Within 24 hrs of an EWS alert
Results posted on
2018-02-14
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
10120
|
9911
|
|
Overall Study
COMPLETED
|
10120
|
9911
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Early Warning System for Clinical Deterioration on General Hospital Wards
Baseline characteristics by cohort
| Measure |
Control
n=10120 Participants
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
n=9911 Participants
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.
|
Total
n=20031 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57 years
n=5 Participants
|
57 years
n=7 Participants
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5355 Participants
n=5 Participants
|
5308 Participants
n=7 Participants
|
10663 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4765 Participants
n=5 Participants
|
4603 Participants
n=7 Participants
|
9368 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4864 Participants
n=5 Participants
|
4790 Participants
n=7 Participants
|
9654 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5062 Participants
n=5 Participants
|
4934 Participants
n=7 Participants
|
9996 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
194 Participants
n=5 Participants
|
187 Participants
n=7 Participants
|
381 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10120 participants
n=5 Participants
|
9911 participants
n=7 Participants
|
20031 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Within 24 hrs of an EWS alertThe proportion of patients transferred to ICU or death within 24 hrs of identification by the EWS algorithm for intervention and control wards.
Outcome measures
| Measure |
Control
n=10120 Participants
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
n=9911 Participants
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.
|
|---|---|---|
|
Transfer to ICU or Unexpected Death Within 24 Hrs of Identification by the EWS Algorithm
|
426 participants
|
444 participants
|
SECONDARY outcome
Timeframe: Hospital dischargelength of stay
Outcome measures
| Measure |
Control
n=10120 Participants
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
n=9911 Participants
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.
|
|---|---|---|
|
Clinical Outcomes and Process Measures
|
6.92 days
Interval 3.82 to 12.67
|
7.07 days
Interval 3.99 to 12.15
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nurse Notification of EWS Alert
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place