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Clinical Trials/NCT01280942
NCT01280942CompletedNot Applicable

Early Warning System for Clinical Deterioration on General Hospital Wards.

Washington University School of Medicine2 sites in 1 country20,031 target enrollmentStarted: January 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20,031
Locations
2
Primary Endpoint
Transfer to ICU or Unexpected Death Within 24 Hrs of Identification by the EWS Algorithm

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • All patients age 18 and above, hospitalized in GHWs at Barnes Jewish Hospital.

Exclusion Criteria

  • Minors, patients younger than 18 years old.

Arms & Interventions

Control

No Intervention

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

Experimental

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.

Intervention: EWS Nursing Alerts (Behavioral)

Nurse notification of EWS alert

Experimental

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.

Intervention: Wireless Remote Sensor (Device)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Clinical Outcomes and Process Measures(Hospital discharge)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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