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CompletedNCT01741480Updated May 11, 2022Results posted

Early Warning System

An interventional study of Early warning system monitoring. and routine care in Congestive Heart Failure, Chronic Obstructive Pulmonary Disease and Cancer, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-05-11.

Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
571
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
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Study 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:

Read the 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).
02

Conditions studied

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

Keywords

  • Outcomes
  • Early warning systems
  • ICU transfer
03

In context

Lung Diseases, Obstructive

2,592 studies on the registry are indexed under Lung Diseases, Obstructive; 198 are open to participants now.

This study's enrollment of 571 is above the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.

Browse Lung Diseases, Obstructive studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.

Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients with a do-not-resuscitate order,
  • Patients not expected to survive their hospitalization.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
571 participants (actual)

Study arms

  • 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.

Interventions

  • OtherEarly 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.

  • Otherroutine care
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What researchers measure

Primary outcomes

  1. ICU Transfer

    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 outcomes

  1. Mortality

    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..

07

Results

Posted Jul 26, 2018

Participant flow

Participant flow — Overall Study
MilestoneRoutine CareIntervention Arm
Started285286
Completed285286
Not completed00

Outcome measures

PrimaryICU Transfer

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.
Reported as:
Number · participants
ICU Transfer
participantsRoutine CareIntervention Arm
ICU Transfer5251
SecondaryMortality

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..

Results for this outcome have not been posted.

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Routine Care—0/285 (0%)0/285 (0%)
Intervention Arm—0/286 (0%)0/286 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Routine CareIntervention ArmTotal
Mean63.1 ± 15.463.7 ± 1663.3 ± 15.5
Sex: Female, Male
Sex: Female, Male(Participants)Routine CareIntervention ArmTotal
Female140132272
Male145154299
Region of Enrollment
Region of Enrollment(participants)Routine CareIntervention ArmTotal
United States285286571
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Study locations

1 site
  • Barnes-Jewish Hospital
    Saint Louis, Missouri 63110, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01741480
Lead sponsor
Washington University School of Medicine
Collaborators
The Foundation for Barnes-Jewish Hospital, American College of Chest Physicians
Responsible party
Sponsor
First posted
Dec 5, 2012
Start date
Feb 2013
Primary completion
May 2013
Completion
May 2013
Results posted
Jul 26, 2018
Last update
May 11, 2022

Study contacts

Marin Kollef, MD
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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