Electronic Early Notification of Sepsis in Hospitalized Ward Patients

Study Overview
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Brief Summary
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Screening for sepsis has been recommended by the Surviving Sepsis Campaign Clinical Practice Guidelines to facilitate early identification and early management of sepsis. However, the optimal tool remains unknown.The objective of this trial is to examine the effect of an electronic sepsis alert tool on reducing hospital mortailty in patients admitted to medical-surgical-oncology wards.

Detailed Description
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The study aims to examine the effect of screening for sepsis using an electronic sepsis alert versus no alert in hospitalized patients admitted to wards using an active sepsis alert system compared with wards with no active (masked) sepsis alert system on hospital mortality by day 90. The wards will be randomized in a stepped-wedge cluster fashion.

Official Title
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Stepped-wedge Cluster Randomized Controlled Trial of Electronic Early Notification of Sepsis in Hospitalized Ward Patients (SCREEN)

Conditions
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Sepsis

Intervention / Treatment
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* Other: sepsis e-alert


Participation Criteria
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Eligibility Criteria
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Ward level inclusion and exclusion criteria Inclusion Criteria: 1. Inpatient wards, defined as wards used to manage inpatients, in the five Ministry of National Guard Health Affairs (MNGHA) hospitals, Kingdom of Saudi Arabia Exclusion Criteria: Cardiology, transplant, pediatric, obstetric wards Intensive Care Units and Emergency Department Operating rooms Outpatients Day care wards, endoscopy, outpatient procedure areas, hemodialysis units. Patient level inclusion and exclusion criteria Inclusion Criteria: Aged 14 years or older Checked in as inpatient status to one of the study ward Exclusion Criteria: 1. No commitment for full life support on the time of arrival to the study ward

Ages Eligible for Study
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Minimum Age: 14 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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Stepped-wedge Cluster Randomized Controlled Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental wards<br>Active sepsis e-alert | Other: sepsis e-alert<br>* At 2-each month interval, the e-alert will be activated in five new randomly selected wards, until all wards eventually will have active alert<br>|
| No Intervention: Contol wards<br>Masked sepsis e-alert. The wards will have masked sepsis e-alert. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause hospital mortality by day 90 | Percentage of all-cause hospital mortality | 90 Day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay | Censored at 90 days | 90 Day | 
| Transfer to ICU | ICU admission within 90 days | 90 Day | 
| ICU-free days | In the first 90 days | 90 Day | 
| Critical care response team activation | Critical care response team activation within 90 days | 90 Day | 
| Cardiac arrest | Cardiac arrest within 90 days | 90 Day | 
| The need for mechanical ventilation, vasopressor therapy, and incident renal replacement therapy | Within 90 days | 90 Day | 
| Antibiotic-free days | Antibiotic-free days within 90 days | 90 Day | 
| The acquisition of MDROs | The percentage of patients with MDROs within 90 days | 90 Day | 
| Clostridium difficile infection | The percentage of patients with clostridium difficile infection within 90 days | 90 Day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sepsis, ward patients, Screening, qSOFA