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Early Warning System for Clinical Deterioration on General Hospital Wards

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ClinicalTrials.gov Identifier: NCT01280942
Recruitment Status : Completed
First Posted : January 21, 2011
Results First Posted : February 14, 2018
Last Update Posted : February 14, 2018
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Escalation of Care
Cardiopulmonary Arrest
Respiratory Arrest
Severe Sepsis
Septic Shock
Interventions Behavioral: EWS Nursing Alerts
Device: Wireless Remote Sensor
Enrollment 20031
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Nurse Notification of EWS Alert
Hide Arm/Group Description 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.

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.

Period Title: Overall Study
Started 10120 9911
Completed 10120 9911
Not Completed 0 0
Arm/Group Title Control Nurse Notification of EWS Alert Total
Hide Arm/Group Description 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.

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 of all reporting groups
Overall Number of Baseline Participants 10120 9911 20031
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 10120 participants 9911 participants 20031 participants
57
(44 to 69)
57
(44 to 70)
57
(44 to 70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10120 participants 9911 participants 20031 participants
Female
5355
  52.9%
5308
  53.6%
10663
  53.2%
Male
4765
  47.1%
4603
  46.4%
9368
  46.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10120 participants 9911 participants 20031 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4864
  48.1%
4790
  48.3%
9654
  48.2%
White
5062
  50.0%
4934
  49.8%
9996
  49.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
194
   1.9%
187
   1.9%
381
   1.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10120 participants 9911 participants 20031 participants
10120 9911 20031
1.Primary Outcome
Title Transfer to ICU or Unexpected Death Within 24 Hrs of Identification by the EWS Algorithm
Hide Description The proportion of patients transferred to ICU or death within 24 hrs of identification by the EWS algorithm for intervention and control wards.
Time Frame Within 24 hrs of an EWS alert
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Nurse Notification of EWS Alert
Hide Arm/Group Description:
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.

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 Number of Participants Analyzed 10120 9911
Measure Type: Number
Unit of Measure: participants
426 444
2.Secondary Outcome
Title Clinical Outcomes and Process Measures
Hide Description length of stay
Time Frame Hospital discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Nurse Notification of EWS Alert
Hide Arm/Group Description:
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.

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 Number of Participants Analyzed 10120 9911
Median (Inter-Quartile Range)
Unit of Measure: days
6.92
(3.82 to 12.67)
7.07
(3.99 to 12.15)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Nurse Notification of EWS Alert
Hide Arm/Group Description 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.

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.

All-Cause Mortality
Control Nurse Notification of EWS Alert
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control Nurse Notification of EWS Alert
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10120 (0.00%)   0/9911 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Nurse Notification of EWS Alert
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10120 (0.00%)   0/9911 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Thomas C. Bailey, MD
Organization: Washington Univ Sch of Medicine
Phone: 314-454-8293
EMail: tbailey@dom.wustl.edu
Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01280942     History of Changes
Other Study ID Numbers: 10-0514
7322-01 ( Other Grant/Funding Number: BJH Foundation/ICTS )
First Submitted: January 19, 2011
First Posted: January 21, 2011
Results First Submitted: May 27, 2014
Results First Posted: February 14, 2018
Last Update Posted: February 14, 2018