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
|Condition or disease||Intervention/treatment||Phase|
|Escalation of Care Cardiopulmonary Arrest Respiratory Arrest Severe Sepsis Septic Shock||Behavioral: EWS Nursing Alerts Device: Wireless Remote Sensor||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20031 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Random allocation of study wards to intervention and control, with washout period and crossover of assignment.|
|Masking:||None (Open Label)|
|Official Title:||Early Warning System for Clinical Deterioration on General Hospital Wards.|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
No Intervention: 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.
Experimental: 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.
Behavioral: 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.
Device: 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 [ Time Frame: Within 24 hrs of an EWS alert ]The proportion of patients transferred to ICU or death within 24 hrs of identification by the EWS algorithm for intervention and control wards.
- Clinical Outcomes and Process Measures [ Time Frame: Hospital discharge ]length of stay
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01280942
|United States, Missouri|
|Barnes Jewish Hospital|
|Saint Louis, Missouri, United States, 63108|
|Principal Investigator:||Thomas C Bailey, MD||Washington University School of Medicine|