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Early Warning System for Clinical Deterioration on General Hospital Wards

Primary Purpose

Escalation of Care, Cardiopulmonary Arrest, Respiratory Arrest

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EWS Nursing Alerts
Wireless Remote Sensor
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Escalation of Care focused on measuring clinical deterioration, detection algorithms, automated warning systems

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Minors, patients younger than 18 years old.

Sites / Locations

  • Barnes Jewish Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Nurse notification of EWS alert

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Transfer to ICU or Unexpected Death Within 24 Hrs of Identification by the EWS Algorithm
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

Clinical Outcomes and Process Measures
length of stay

Full Information

First Posted
January 19, 2011
Last Updated
February 7, 2018
Sponsor
Washington University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01280942
Brief Title
Early Warning System for Clinical Deterioration on General Hospital Wards
Official Title
Early Warning System for Clinical Deterioration on General Hospital Wards.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Escalation of Care, Cardiopulmonary Arrest, Respiratory Arrest, Severe Sepsis, Septic Shock
Keywords
clinical deterioration, detection algorithms, automated warning systems

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Random allocation of study wards to intervention and control, with washout period and crossover of assignment.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20031 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Arm Title
Nurse notification of EWS alert
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
EWS Nursing Alerts
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Wireless Remote Sensor
Intervention Description
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.
Primary Outcome Measure Information:
Title
Transfer to ICU or Unexpected Death Within 24 Hrs of Identification by the EWS Algorithm
Description
The proportion of patients transferred to ICU or death within 24 hrs of identification by the EWS algorithm for intervention and control wards.
Time Frame
Within 24 hrs of an EWS alert
Secondary Outcome Measure Information:
Title
Clinical Outcomes and Process Measures
Description
length of stay
Time Frame
Hospital discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients age 18 and above, hospitalized in GHWs at Barnes Jewish Hospital. Exclusion Criteria: Minors, patients younger than 18 years old.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas C Bailey, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Barnes Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23440923
Citation
Bailey TC, Chen Y, Mao Y, Lu C, Hackmann G, Micek ST, Heard KM, Faulkner KM, Kollef MH. A trial of a real-time alert for clinical deterioration in patients hospitalized on general medical wards. J Hosp Med. 2013 May;8(5):236-42. doi: 10.1002/jhm.2009. Epub 2013 Feb 25.
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Early Warning System for Clinical Deterioration on General Hospital Wards

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