NCT01741480

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
571

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 27, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 5, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
5.2 years until next milestone

Results Posted

Study results publicly available

July 26, 2018

Completed
Last Updated

May 11, 2022

Status Verified

April 1, 2022

Enrollment Period

3 months

First QC Date

November 27, 2012

Results QC Date

January 26, 2015

Last Update Submit

April 11, 2022

Conditions

Keywords

OutcomesEarly warning systemsICU transfer

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 COMPARATOR

General hospital ward patients will receive routine care.

Other: routine care

Intervention arm

EXPERIMENTAL

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

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

Intervention arm
Routine care

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Heart FailurePulmonary Disease, Chronic ObstructiveNeoplasmsDiabetes MellitusSleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesSleep Apnea SyndromesApneaRespiration DisordersSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Results Point of Contact

Title
Dr. Marin Kollef
Organization
WashingtonU

Study Officials

  • Marin Kollef, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

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

Locations