Early Warning System for Clinical Deterioration on General Hospital Wards

ID: NCT01280942
Status: Completed
Phase: N/A
Start Date: January 01, 2011
First Submitted: January 19, 2011
Last Updated: February 07, 2018
Results: Available
Success Rate: 100%
Sponsors & Collaborators: Washington University School of Medicine
Location: United States
Conditions: Escalation of Care, Cardiopulmonary Arrest, Respiratory Arrest, Severe Sepsis, Septic Shock
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Study Description

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.

Detailed Description

Condition or disease Intervention/treatment Phase

Cardiopulmonary Arrest

Escalation of Care

Respiratory Arrest

Septic Shock

Severe Sepsis

Behavioral: EWS Nursing Alerts
Other Names
Device: Wireless Remote Sensor
Other Names
N/A

Tracking Information

First Submitted DateJanuary 19, 2011
Last Update Posted DateFebruary 07, 2018
Start DateJanuary 01, 2011
Actual Completion DateMay 01, 2012
Primary Completion DateMay 01, 2012
Results First Submitted DateMay 27, 2014
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Transfer to ICU or Unexpected Death Within 24 Hrs of Identification by the EWS Algorithm [Time Frame: Within 24 hrs of an EWS alert]

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

Original Primary Outcome Measures

  • 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.

Current Secondary Outcome Measures

  • Clinical Outcomes and Process Measures [Time Frame: Hospital discharge]

    length of stay

Original Secondary Outcome Measures

  • Clinical Outcomes and Process Measures

    length of stay

Study Design

Brief TitleEarly Warning System for Clinical Deterioration on General Hospital Wards
Official TitleEarly Warning System for Clinical Deterioration on General Hospital Wards.
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.

Detailed Description

Study TypeInterventional
Study PhaseN/A
Estimated Enrollment
20031
Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
None (Open Label)
Primary Purpose
Prevention
Conditions
Cardiopulmonary Arrest
Escalation of Care
Respiratory Arrest
Septic Shock
Severe Sepsis
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
Behavioral: EWS Nursing Alerts

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.

Other Names
Device: Wireless Remote Sensor

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.

Other Names
Study Groups/Cohorts
Control
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
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.

Study Arms
Experimental Nurse notification of EWS alert
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 Alerts
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.

Experimental Nurse notification of EWS alert
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.
Device : Wireless Remote Sensor
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.

Arm Intervention/Treatment
Experimental Nurse notification of EWS alert
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 Alerts
Experimental Nurse notification of EWS alert
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.
Device : Wireless Remote Sensor

Recruitment Information

Recruitment Status:Completed
Enrollment20031
Completion DateMay 01, 2012
Eligibility Criteria: Inclusion Criteria:
- All patients age 18 and above, hospitalized in GHWs at Barnes Jewish Hospital.

Exclusion Criteria:
- Minors, patients younger than 18 years old.
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Not Available
Listed Location Countries
United States

Administrative Information

NCT Number:NCT01280942
Other Study ID Numbers
10-0514
7322-01
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible PartyTom Bailey, MD, Washington University
Study Sponsor
Washington University School of Medicine
Collaborators
Not Available
Investigators
Principal Investigator
Thomas C Bailey, MD
Washington University School of Medicine

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Not Available

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Not Available

Reporting Groups

TitleDescription
Control
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
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. EWS Nursing Alerts: 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. Wireless Remote Sensor: 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.

Participant Flow: Overall

ControlNurse Notification of EWS Alert
Started101209911
Completed101209911
Not Completed00

Baseline Characteristics

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Not Available

Reporting Groups

TitleDescription
Control
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
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. EWS Nursing Alerts: 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. Wireless Remote Sensor: 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.
Total
Total of all reporting groups

Baseline Measures

ControlNurse Notification of EWS AlertTotal
Overall Participants Analyzed
Units: Participants
Participants Analyzed
10120991120031
10120991120031
Age
Units: years - Median (Inter-Quartile Range)
Participants Analyzed
10120991120031
575757
Sex: Female, Male
Units: Participants - Count of Participants
Participants Analyzed
10120991120031
Female5355530810663
Male476546039368
Race (NIH/OMB)
Units: Participants - Count of Participants
Participants Analyzed
10120991120031
American Indian or Alaska Native000
Asian000
Black or African American486447909654
More than one race000
Native Hawaiian or Other Pacific Islander000
Unknown or Not Reported194187381
White506249349996
Region of Enrollment
Units: participants - Number
Participants Analyzed
10120991120031
United States10120991120031

Outcome Measures

1. Primary: Transfer to ICU or Unexpected Death Within 24 Hrs of Identification by the EWS Algorithm

Measure Type
Primary
Measure Title
Transfer to ICU or Unexpected Death Within 24 Hrs of Identification by the EWS Algorithm
Measure Description
The proportion of patients transferred to ICU or death within 24 hrs of identification by the EWS algorithm for intervention and control wards.
Time Frame
Within 24 hrs of an EWS alert

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Not Available

Reporting Groups

TitleDescription
Control
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
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. EWS Nursing Alerts: 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. Wireless Remote Sensor: 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.

Outcome Measures

ControlNurse Notification of EWS Alert
Participants Analyzed
Units: Participants
101209911
Transfer to ICU or Unexpected Death Within 24 Hrs of Identification by the EWS Algorithm
Units: participants - Number
426444

2. Secondary: Clinical Outcomes and Process Measures

Measure Type
Secondary
Measure Title
Clinical Outcomes and Process Measures
Measure Description
length of stay
Time Frame
Hospital discharge

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Not Available

Reporting Groups

TitleDescription
Control
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
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. EWS Nursing Alerts: 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. Wireless Remote Sensor: 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.

Outcome Measures

ControlNurse Notification of EWS Alert
Participants Analyzed
Units: Participants
101209911
Clinical Outcomes and Process Measures
Units: days - Median (Inter-Quartile Range)
6.927.07

Serious Adverse Events

Time Frame
Not Available
Additional Description
Not Available
Frequency Threshold0% (Threshold above which other adverse events are reported)

Reporting Groups

TitleDescription
Control
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
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. EWS Nursing Alerts: 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. Wireless Remote Sensor: 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.

Serious Adverse Events

ControlNurse Notification of EWS Alert
Total, serious adverse events
No. of participants affected / at risk0/10120 (0.00%)0/9911 (0.00%)

Other Adverse Events

Time Frame
Not Available
Additional Description
Not Available
Frequency Threshold0% (Threshold above which other adverse events are reported)

Reporting Groups

TitleDescription
Control
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
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. EWS Nursing Alerts: 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. Wireless Remote Sensor: 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.

Other Adverse Events

ControlNurse Notification of EWS Alert
Total, other adverse events
No. of participants affected / at risk0/10120 (0.00%)0/9911 (0.00%)

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/TitleOrganizationPhoneEmail
Thomas C. Bailey, MD
Washington Univ Sch of Medicine
314-454-8293