Early Warning System

Cancer Clinical Trial

Official title:

Comparing an Early Warning Alert With a Standardized Triage Intervention to Standard Care for the Management of Hospitalized Patients on General Hospital Wards.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01741480
• Other study ID #: 201210003
• Status: Completed
• Phase: N/A
• Start date: February 2013
• Est. completion date: May 2013

Study information

• Verified date: April 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 571
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients with a do-not-resuscitate order,

• Patients not expected to survive their hospitalization.

Related Conditions & MeSH terms

• Cancer
• Chronic Obstructive Pulmonary Disease
• Congestive Heart Failure
• Diabetes Mellitus
• Heart Failure
• Lung Diseases, Obstructive
• Obstructive Sleep Apnea
• Pulmonary Disease, Chronic Obstructive
• Sleep Apnea, Obstructive

Intervention

Other:
• Early warning system monitoring.
General hospital ward patients will be monitored 24/7 for clinical deterioration using the early warning system monitoring developed at Washington University.
• routine care

Locations

Country	Name	City	State
United States	Barnes-Jewish Hospital	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	American College of Chest Physicians, The Foundation for Barnes-Jewish Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICU Transfer	Patients transferred to the ICU from a general hospital ward will be assessed as having met the outcome.	Patients will be assessed for the primary outcome measure during their hospital with an average of 14 days.
Secondary	Mortality	Death during hospitalization will be used to determine the presence of this outcome.	Patients will be asessed for the secondary outcome measure during an average of 28 days..