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Early Warning System

Primary Purpose

Congestive Heart Failure, Chronic Obstructive Pulmonary Disease, Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early warning system monitoring.
routine care
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Congestive Heart Failure focused on measuring Outcomes, Early warning systems, ICU transfer

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Barnes-Jewish Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Routine care

Intervention arm

Arm Description

General hospital ward patients will receive routine care.

The intervention with early warning system monitoring is to have the rapid response team assess the patients real-time.

Outcomes

Primary Outcome Measures

ICU Transfer
Patients transferred to the ICU from a general hospital ward will be assessed as having met the outcome.

Secondary Outcome Measures

Mortality
Death during hospitalization will be used to determine the presence of this outcome.

Full Information

First Posted
November 27, 2012
Last Updated
April 11, 2022
Sponsor
Washington University School of Medicine
Collaborators
The Foundation for Barnes-Jewish Hospital, American College of Chest Physicians
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1. Study Identification

Unique Protocol Identification Number
NCT01741480
Brief Title
Early Warning System
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 Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
The Foundation for Barnes-Jewish Hospital, American College of Chest Physicians

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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. 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. 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure, Chronic Obstructive Pulmonary Disease, Cancer, Diabetes Mellitus, Obstructive Sleep Apnea
Keywords
Outcomes, Early warning systems, ICU transfer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
571 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Routine care
Arm Type
Placebo Comparator
Arm Description
General hospital ward patients will receive routine care.
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
The intervention with early warning system monitoring is to have the rapid response team assess the patients real-time.
Intervention Type
Other
Intervention Name(s)
Early warning system monitoring.
Intervention Description
General hospital ward patients will be monitored 24/7 for clinical deterioration using the early warning system monitoring developed at Washington University.
Intervention Type
Other
Intervention Name(s)
routine care
Primary Outcome Measure Information:
Title
ICU Transfer
Description
Patients transferred to the ICU from a general hospital ward will be assessed as having met the outcome.
Time Frame
Patients will be assessed for the primary outcome measure during their hospital with an average of 14 days.
Secondary Outcome Measure Information:
Title
Mortality
Description
Death during hospitalization will be used to determine the presence of this outcome.
Time Frame
Patients will be asessed for the secondary outcome measure during an average of 28 days..

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marin Kollef, 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
63110
Country
United States

12. IPD Sharing Statement

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Early Warning System

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