NCT01280942

Brief Summary

The goal is to develop a two-tiered monitoring system to improve the care of patients at risk for clinical deterioration on general hospital wards (GHWs) at Barnes-Jewish Hospital (BJH). The investigators hypothesize that the use of an automated early warning system (EWS) that identifies patients at risk of clinical deterioration, with notification of nurses on the GHWs when patients are identified, will reduce the risk of ICU transfer or death within 24 hrs of an alert. As a substudy, the investigators will pilot the use of a wireless pulse oximeter to establish feasibility and to develop algorithms for a real-time event detection system (RDS) in these high-risk patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20,031

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

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

Study Start

First participant enrolled

January 1, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 21, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
5.8 years until next milestone

Results Posted

Study results publicly available

February 14, 2018

Completed
Last Updated

February 14, 2018

Status Verified

February 1, 2018

Enrollment Period

1.3 years

First QC Date

January 19, 2011

Results QC Date

May 27, 2014

Last Update Submit

February 7, 2018

Conditions

Escalation of CareCardiopulmonary ArrestRespiratory ArrestSevere SepsisSeptic Shock

Keywords

clinical deteriorationdetection algorithmsautomated warning systems

Outcome Measures

Primary Outcomes (1)

  • Transfer to ICU or Unexpected Death Within 24 Hrs of Identification by the EWS Algorithm

    The proportion of patients transferred to ICU or death within 24 hrs of identification by the EWS algorithm for intervention and control wards.

    Within 24 hrs of an EWS alert

Secondary Outcomes (1)

  • Clinical Outcomes and Process Measures

    Hospital discharge

Study Arms (2)

Control

NO INTERVENTION

Patients admitted to 4 GHWs designated as controls. Nurses will not be notified when patients on these GHWs satisfy the EWS algorithm. They will also not wear the wireless sensor devices.

Nurse notification of EWS alert

EXPERIMENTAL

Patients admitted to 4 GHWs designated as intervention wards at BJH. Nurses will be notified when patients on these wards satisfy the EWS algorithm. Some patients will be asked to wear the wireless remote sensors.

Behavioral: EWS Nursing AlertsDevice: Wireless Remote Sensor

Interventions

EWS Nursing AlertsBEHAVIORAL

An automated algorithm (EWS) will identify patients at potential risk of clinical deterioration. When a patient satisfies the algorithm, a nurse on the patient's ward will be notified. S/he will assess the patient and institute any interventions that are clinically required.

Nurse notification of EWS alert
Wireless Remote SensorDEVICE

A subset of patients will be consented to wear a wireless sensor device which will monitor heart rate and level of oxygen in the blood.

Nurse notification of EWS alert

Eligibility Criteria

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

You may qualify if:

  • All patients age 18 and above, hospitalized in GHWs at Barnes Jewish Hospital.

You may not qualify if:

  • Minors, patients younger than 18 years old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barnes Jewish Hospital

St Louis, Missouri, 63108, United States

Location

Related Publications (1)

  • Bailey TC, Chen Y, Mao Y, Lu C, Hackmann G, Micek ST, Heard KM, Faulkner KM, Kollef MH. A trial of a real-time alert for clinical deterioration in patients hospitalized on general medical wards. J Hosp Med. 2013 May;8(5):236-42. doi: 10.1002/jhm.2009. Epub 2013 Feb 25.

    PMID: 23440923RESULT

MeSH Terms

Conditions

Heart ArrestApneaSepsisShock, SepticClinical Deterioration

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsInfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesShockDisease ProgressionDisease Attributes

Results Point of Contact

Title
Thomas C. Bailey, MD
Organization
Washington Univ Sch of Medicine
tbailey@dom.wustl.edu
314-454-8293

Study Officials

  • Thomas C Bailey, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Random allocation of study wards to intervention and control, with washout period and crossover of assignment.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2011

First Posted

January 21, 2011

Study Start

January 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

February 14, 2018

Results First Posted

February 14, 2018

Record last verified: 2018-02

Locations

US(1)