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Early Warning System

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ClinicalTrials.gov Identifier: NCT01741480
Recruitment Status : Completed
First Posted : December 5, 2012
Results First Posted : July 26, 2018
Last Update Posted : October 30, 2018
Sponsor:
Collaborators:
Barnes-Jewish Hospital
American College of Chest Physicians
Information provided by (Responsible Party):
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:

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Chronic Obstructive Pulmonary Disease Cancer Diabetes Mellitus Obstructive Sleep Apnea Other: Early warning system monitoring. Other: routine care Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 571 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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.
Study Start Date : February 2013
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Routine care
General hospital ward patients will receive routine care.
Other: routine care
Experimental: Intervention arm
The intervention with early warning system monitoring is to have the rapid response team assess the patients real-time.
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.




Primary Outcome Measures :
  1. ICU Transfer [ Time Frame: 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 :
  1. Mortality [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01741480


Locations
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United States, Missouri
Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Barnes-Jewish Hospital
American College of Chest Physicians
Investigators
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Principal Investigator: Marin Kollef, MD Washington University School of Medicine
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01741480    
Other Study ID Numbers: 201210003
First Posted: December 5, 2012    Key Record Dates
Results First Posted: July 26, 2018
Last Update Posted: October 30, 2018
Last Verified: October 2018
Keywords provided by Washington University School of Medicine:
Outcomes
Early warning systems
ICU transfer
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Sleep Apnea, Obstructive
Heart Failure
Heart Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases