Effects of Code Sepsis Implementation on Emergency Department (ED) Sepsis Care

Study Overview
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Brief Summary
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Sepsis is a life-threatening complication of infection that can be difficult to recognize and treat promptly. Timely administration of antibiotics for emergency department (ED) patients with sepsis is challenging. The goal of this study is to determine the potential effectiveness and unintended consequences of reorganizing ED care for patients with suspected sepsis.

Official Title
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Effects of Code Sepsis Implementation on Emergency Department (ED) Sepsis Care

Conditions
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Sepsis

Intervention / Treatment
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* Other: Code Sepsis protocol (full implementation)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria (overall): Adult (age ≥18 years) ED patient at Intermountain Medical Center, Utah Valley Hospital, Dixie Regional Medical Center Arrival to study emergency department (ED) during study period of 11/13/2018 to 2/12/2021. Exclusion criteria (overall): (1) Trauma patient

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: Health Services Research
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Patients presenting to the intervention emergency department after implementation of the care reorganization intervention - Code Sepsis protocol - will be compared to patients presenting prior to the intervention. Patients presenting to control emergency departments will receive usual care both before and after Code Sepsis implementation and are included in this study to control for changes in intervention-site outcomes over time unrelated to the tested intervention.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Pre-implementation usual care (intervention site)<br>Adult patients age ≥18 years who receive usual care after presenting to the ED of the intervention hospital emergency department before implementation of sepsis care reorganization (Code Sepsis implementation). The primary analysis will focus on the subset of patients with sepsis. | |
| Experimental: Code Sepsis post-implementation (intervention site)<br>Adult patients age ≥18 years presenting to the ED of the intervention hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation). The primary analysis will focus on the subset of patients with sepsis. | Other: Code Sepsis protocol (full implementation)<br>* Implementation of a coordinated, structured, multidisciplinary team-based protocol for initial evaluation and treatment of ED patients with suspected sepsis.<br>|
| No Intervention: Pre-implementation usual care (control sites)<br>Adult patients age ≥18 years who receive usual care after presenting to the ED of the control hospital emergency department before implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital. The primary analysis will focus on the subset of patients with sepsis. | |
| No Intervention: Post-implementation usual care (control sites)<br>Adult patients age ≥18 years who receive usual care after presenting to the ED of the control hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital. The primary analysis will focus on the subset of patients with sepsis. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Door-to-antibiotic time | Time from sepsis patients' emergency department arrival to intravenous (or equivalent) antibiotic initiation | Up to 24 hours from ED arrival (an average of 3 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause 30-day mortality | Sepsis patient death on or before the 30th day after ED arrival | 30 days after ED arrival | 
| All-cause 1-year mortality | Sepsis patient death on or before the 365th day after ED arrival | 1 year after ED arrival | 
| All-cause in-hospital mortality | Sepsis patient death prior to hospital discharge | From the time of admission to hospital discharge (up to 1 year, average 14 days) | 
| Hospital charges | Amount charged to sepsis patient for their medical care during index ED visit and associated hospitalization | From the time of admission to hospital discharge (up to 1 year, average 14 days) | 
| Hospital length of stay | Length of time from sepsis patients' ED arrival until hospital discharge | From the time of admission to hospital discharge (up to 1 year, average 14 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sepsis, Clinical Protocols, Emergency Medicine