Early Warning System for Clinical Deterioration on General Hospital Wards
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.
Escalation of Care
Behavioral: EWS Nursing Alerts
Device: Wireless Remote Sensor
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Early Warning System for Clinical Deterioration on General Hospital Wards.|
- Transfer to ICU or unexpected death within 24 hrs of identification by the EWS algorithm [ Time Frame: Within 24 hrs of an EWS alert ] [ Designated as safety issue: No ]The proportion of patients transferred to ICU, and the time from EWS detection to ICU transfer in patients, for intervention and control wards.
- Clinical outcomes and process measures [ Time Frame: Hospital discharge (avg = 3 days) ] [ Designated as safety issue: No ]Processes of care (fluid rescuscitation, escalation of antibiotics), length of stay, acquired organ dysfunction, and causes of CPR or ICU transfer
|Study Start Date:||January 2011|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01280942
|United States, Missouri|
|Barnes Jewish Hospital|
|St Louis, Missouri, United States, 63108|
|Principal Investigator:||Thomas C Bailey, MD||Washington University School of Medicine|