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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Control   Nurse Notification of EWS Alert
STARTED   10120   9911 
COMPLETED   10120   9911 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
   Control   Nurse Notification of EWS Alert   Total 
Overall Participants Analyzed 
[Units: Participants]
 10120   9911   20031 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 57 
 (44 to 69) 
 57 
 (44 to 70) 
 57 
 (44 to 70) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      5355  52.9%      5308  53.6%      10663  53.2% 
Male      4765  47.1%      4603  46.4%      9368  46.8% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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 
[Units: Participants]
     
United States   10120   9911   20031 


  Outcome Measures

1.  Primary:   Transfer to ICU or Unexpected Death Within 24 Hrs of Identification by the EWS Algorithm   [ Time Frame: Within 24 hrs of an EWS alert ]

2.  Secondary:   Clinical Outcomes and Process Measures   [ Time Frame: Hospital discharge ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Thomas C. Bailey, MD
Organization: Washington Univ Sch of Medicine
phone: 314-454-8293
e-mail: tbailey@dom.wustl.edu


Publications of Results:

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