Early Warning System

Not Applicable

Completed

• Conditions: Cancer; Diabetes Mellitus; Obstructive Sleep Apnea; Chronic Obstructive Pulmonary Disease; Congestive Heart Failure
• Interventions: Other: Early warning system monitoring.; Other: routine care

• Registration Number: NCT01741480
• Lead Sponsor: Washington University School of Medicine

Brief Summary

The study will begin in 2013 whereby patients having an early warning system (EWS) alert will be randomized to be seen by the rapid response team (RRT) for triage versus usual care. A RRT is usually made up of a nurse and/or a physician who respond to a requested activation of the RRT (called an "ACT"). The intervention will occur as follows:

Detailed Description

The study will begin in 2013 whereby patients having an early warning system (EWS) alert will be randomized to be seen by the rapid response team (RRT) for triage versus usual care. A RRT is usually made up of a nurse and/or a physician who respond to a requested activation of the RRT (called an "ACT"). The intervention will occur as follows:

1. Real-time monitoring of the eight general hospital wards (GHWs)((10100, 10200, 11100,11200, 12100, 12200, 14400, 14500)will occur 24 hours daily. Through multiple past collaborative efforts and studies involving interventions at BJH, informatics personnel have already demonstrated that they can accomplish this task using their computing and algorithmic resources. The prediction tool (PT) employed is a validated PT aimed at identifying any form of clinical deterioration occurring on a GHW requiring ICU transfer or leading to patient death.

2. Patients meeting the prediction criteria for an increased risk of clinical deterioration will be identified on the GHWs. An automated text message will be generated that provides the patient's name, their room number, the date and time of the message, and text indicating that they meet the criteria for risk of deterioration. Messages will only be generated for patients assigned to the intervention group.

3. The EWS text message will be sent to the on-call RRT nurse's phone. These are phones that are transferred from one RRT nurse to the other as changes of shift occur. It is their primary means of communicating with the hospital.

4. The RRT nurse for the intervention patients will go into the flagged patient's room within 10 to 15 minutes of receiving the message and perform a clinical assessment. Based on the RRT nurse's assessment either no additional action need occur or he/she will call either the physician on duty or activate an ACT as well as apply the "four D's", which was internally established at Barnes-Jewish Hospital (BJH) for treatment of patients on GHWs identified to have impending clinical deterioration. The four "D's" refer to the following: Discuss level of care, Drugs for treatment (e.g., antibiotics), Diagnostics (lab tests, cultures), and Damage control (e.g., use of intravenous fluids, oxygen).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2012-11-27
• Study First Submitted QC: 2012-12-04
• Study First Posted: 2012-12-05
• Study Start: 2013-02
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Results First Submitted: 2015-01-26
• Results First Submitted QC: 2018-07-24
• Results First Posted: 2018-07-26
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-11
• Last Update Posted: 2022-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 571

Inclusion Criteria

• Patients hospitalized on the General Hospitals Wards of Barnes-Jewish Hospital.

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Exclusion Criteria

• Patients with a do-not-resuscitate order,
• Patients not expected to survive their hospitalization.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm	Early warning system monitoring.	The intervention with early warning system monitoring is to have the rapid response team assess the patients real-time.
Routine care	routine care	General hospital ward patients will receive routine care.

Primary Outcome Measures

Name	Time	Method
ICU Transfer	Patients will be assessed for the primary outcome measure during their hospital with an average of 14 days.	Patients transferred to the ICU from a general hospital ward will be assessed as having met the outcome.

Secondary Outcome Measures

Name	Time	Method
Mortality	Patients will be asessed for the secondary outcome measure during an average of 28 days..	Death during hospitalization will be used to determine the presence of this outcome.

Trial Locations

Locations (1)

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