Early Warning System for Clinical Deterioration on General Hospital Wards

Study Description

Brief Summary

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 Date	January 19, 2011
Last Update Posted Date	February 07, 2018
Start Date	January 01, 2011
Actual Completion Date	May 01, 2012
Primary Completion Date	May 01, 2012
Results First Submitted Date	May 27, 2014
Received Results Disposit Date	N/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 Title	Early Warning System for Clinical Deterioration on General Hospital Wards
Official Title	Early 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 Type	Interventional
Study Phase	N/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 Method	N/A
Study Population	N/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 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.

Recruitment Information

Recruitment Status:	Completed
Enrollment	20031
Completion Date	May 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.
Gender	All
Age	18 Years to N/A
Accepts Healthy Volunteers	No
Contacts	Not Available
Listed Location Countries	United States

Administrative Information

NCT Number:	NCT01280942
Other Study ID Numbers	10-0514 7322-01
Has Data Monitoring Committee	No
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 Party	Tom 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