Early Warning System for Clinical Deterioration on General Hospital Wards

Not Applicable

Completed

• Conditions: Escalation of Care; Cardiopulmonary Arrest; Severe Sepsis; Septic Shock; Respiratory Arrest
• Interventions: Behavioral: EWS Nursing Alerts; Device: Wireless Remote Sensor

• Registration Number: NCT01280942
• Lead Sponsor: Washington University School of Medicine

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-19
• Study First Submitted QC: 2011-01-20
• Study First Posted: 2011-01-21
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Results First Submitted: 2014-05-27
• Status Verified: 2018-02
• Results First Submitted QC: 2018-02-07
• Last Update Submitted: 2018-02-07
• Results First Posted: 2018-02-14
• Last Update Posted: 2018-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20031

Inclusion Criteria

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

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Exclusion Criteria

• Minors, patients younger than 18 years old.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nurse notification of EWS alert	EWS Nursing Alerts	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.
Nurse notification of EWS alert	Wireless Remote Sensor	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.

Primary Outcome Measures

Name	Time	Method
Transfer to ICU or Unexpected Death Within 24 Hrs of Identification by the EWS Algorithm	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 Outcome Measures

Name	Time	Method
Clinical Outcomes and Process Measures	Hospital discharge	length of stay

Trial Locations

Locations (1)

Barnes Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States