Early Warning System
Comparing an Early Warning Alert With a Standardized Triage Intervention to Standard Care for the Management of Hospitalized Patients on General Hospital Wards.
1 other identifier
interventional
571
1 country
1
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:
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 27, 2012
CompletedFirst Posted
Study publicly available on registry
December 5, 2012
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedResults Posted
Study results publicly available
July 26, 2018
CompletedMay 11, 2022
April 1, 2022
3 months
November 27, 2012
January 26, 2015
April 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Mortality
Patients will be asessed for the secondary outcome measure during an average of 28 days..
Study Arms (2)
Routine care
PLACEBO COMPARATORGeneral hospital ward patients will receive routine care.
Intervention arm
EXPERIMENTALThe intervention with early warning system monitoring is to have the rapid response team assess the patients real-time.
Interventions
General hospital ward patients will be monitored 24/7 for clinical deterioration using the early warning system monitoring developed at Washington University.
Eligibility Criteria
You may qualify if:
- Patients hospitalized on the General Hospitals Wards of Barnes-Jewish Hospital.
You may not qualify if:
- Patients with a do-not-resuscitate order,
- Patients not expected to survive their hospitalization.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Marin Kollef
- Organization
- WashingtonU
Study Officials
- PRINCIPAL INVESTIGATOR
Marin Kollef, MD
Washington University School of Medicine
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 27, 2012
First Posted
December 5, 2012
Study Start
February 1, 2013
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
May 11, 2022
Results First Posted
July 26, 2018
Record last verified: 2022-04