Early Warning System for Clinical Deterioration on General Hospital Wards

Study Overview
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Brief Summary
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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.

Official Title
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Early Warning System for Clinical Deterioration on General Hospital Wards.

Conditions
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Cardiopulmonary Arrest, Escalation of Care, Respiratory Arrest, Severe Sepsis, Septic Shock

Intervention / Treatment
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* Behavioral: EWS Nursing Alerts
* Device: Wireless Remote Sensor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients age 18 and above, hospitalized in GHWs at Barnes Jewish Hospital. Exclusion Criteria: Minors, patients younger than 18 years old.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Random allocation of study wards to intervention and control, with washout period and crossover of assignment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>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. | |
| Experimental: Nurse notification of EWS alert<br>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<br>* 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.<br>Device: Wireless Remote Sensor<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Outcomes and Process Measures | length of stay | Hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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clinical deterioration, detection algorithms, automated warning systems