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

Not Applicable

Completed

• Conditions: Sepsis
• Interventions: Other: Code Sepsis protocol (full implementation)

• Registration Number: NCT04148989
• Lead Sponsor: Intermountain Health Care, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-13
• Study First Submitted: 2019-10-31
• Study First Submitted QC: 2019-10-31
• Study First Posted: 2019-11-04
• Primary Completion: 2023-01-23
• Study Completion: 2023-12-28
• Results First Submitted: 2024-01-11
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-07
• Last Update Submitted: 2024-02-07
• Results First Posted: 2024-03-05
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180402

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Code Sepsis post-implementation (intervention site)	Code Sepsis protocol (full implementation)	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.

Primary Outcome Measures

Name	Time	Method
Door-to-antibiotic Time	Up to 24 hours from ED arrival (an average of 3 hours)	Time from sepsis patients' emergency department arrival to intravenous (or equivalent) antibiotic initiation

Secondary Outcome Measures

Name	Time	Method
All-cause 1-year Mortality	1 year after ED arrival	Sepsis patient death on or before the 365th day after ED arrival
All-cause 30-day Mortality	30 days after ED arrival	Sepsis patient death on or before the 30th day after ED arrival
Hospital Length of Stay	From the time of admission to hospital discharge (up to 1 year, average 14 days)	Length of time from sepsis patients' ED arrival until hospital discharge
Hospital Charges	From the time of admission to hospital discharge (up to 1 year, average 14 days)	Amount charged to sepsis patient for their medical care during index ED visit and associated hospitalization
All-cause In-hospital Mortality	From the time of admission to hospital discharge (up to 1 year, average 14 days)	Sepsis patient death prior to hospital discharge

Trial Locations

Locations (3)

Dixie Regional Medical Center; 🇺🇸 Saint George, Utah, United States

Utah Valley Hospital; 🇺🇸 Provo, Utah, United States

Intermountain Medical Center; 🇺🇸 Murray, Utah, United States