Early Warning System for Clinical Deterioration on General Hospital Wards

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Tom Bailey, MD, Washington University

ClinicalTrials.gov Identifier:

NCT01280942

First received: January 19, 2011

Last updated: July 25, 2012

Last verified: July 2012

History of Changes

Purpose

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.

Condition	Intervention
Escalation of Care Cardiopulmonary Arrest Respiratory Arrest Severe Sepsis Septic Shock	Behavioral: EWS Nursing Alerts Device: Wireless Remote Sensor

Study Type:	Interventional
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.

Resource links provided by NLM:

MedlinePlus related topics: Cardiac Arrest Sepsis Shock

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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

Enrollment:	20031
Study Start Date:	January 2011
Study Completion Date:	May 2012
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01280942

Locations

United States, Missouri
Barnes Jewish Hospital
St Louis, Missouri, United States, 63108

Sponsors and Collaborators

Tom Bailey, MD

Investigators

Principal Investigator:

Thomas C Bailey, MD

Washington University School of Medicine

More Information

No publications provided

Responsible Party:	Tom Bailey, MD, Professor of Medicine, Washington University
ClinicalTrials.gov Identifier:	NCT01280942 History of Changes
Other Study ID Numbers:	10-0514, 7322-01
Study First Received:	January 19, 2011
Last Updated:	July 25, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:

clinical deterioration
detection algorithms
automated warning systems

Additional relevant MeSH terms:

Apnea
Heart Arrest
Sepsis
Shock
Shock, Septic
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory

Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013

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