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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Other: Code Sepsis protocol (full implementation)

• Study Type: Interventional
• Enrollment (Actual): 180402
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center
    • Provo, Utah, United States, 84604
      • Utah Valley Hospital
    • Saint George, Utah, United States, 84790
      • Dixie Regional Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria (overall):

1. Adult (age ≥18 years)
2. ED patient at Intermountain Medical Center, Utah Valley Hospital, Dixie Regional Medical Center
3. Arrival to study emergency department (ED) during study period of 11/13/2018 to 2/12/2021.

Exclusion criteria (overall):

(1) Trauma patient

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Pre-implementation usual care (intervention site); 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); 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); Implementation of a coordinated, structured, multidisciplinary team-based protocol for initial evaluation and treatment of ED patients with suspected sepsis.
No Intervention: Pre-implementation usual care (control sites); 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); 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?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibiotic Utilization'	Fraction of all ED patients receiving antibiotics within 24 hours of ED arrival	Up to 24 hours from ED arrival (an average of 6 hours)
Adverse Effects of Antibiotics (Sepsis Patients)	Measured as the fraction of sepsis patients with a discharge diagnosis code consistent with anaphylaxis or with an adverse reaction to antibiotics	From the time of ED arrival to hospital discharge (up to 1 year, average 14 days)
Adverse Effect of Antibiotics (All ED Patients)	Measured as the fraction of all ED patients with a discharge diagnosis code consistent with anaphylaxis or with an adverse reaction to antibiotics	From the time of ED arrival to hospital discharge (up to 1 year, average 14 days)
New Onset Clostridium Difficile Colitis Incidence (Sepsis Patients)	Incidence of positive stool test for Clostridium difficile colitis between 72 hours and 90 days after ED arrival among ED sepsis patients and (2) all ED patients.	Beginning 72 hours after ED arrival to 90 days after ED arrival
New Onset Clostridium Difficile Colitis Incidence (All ED Patients)	Incidence of positive stool test for Clostridium difficile colitis between 72 hours and 90 days after ED arrival among all ED patients.	Beginning 72 hours after ED arrival to 90 days after ED arrival.
Antibiotic Overtreatment Rate	Fraction of ED patients with a primary hospital discharge diagnosis of congestive heart failure or venous thromboembolism and no discharge diagnosis consistent with infection who received antibiotics in the ED	Up to 24 hours from ED arrival (an average of 6 hours)
Antibiotic Spectrum (Sepsis Patients)	Total antibiotic spectrum score for all unique antibiotics administered in first 24 hours using antibiotic spectrum scoring system developed by Stenehjem et al. (Clin Infect Dis 2016;63:1273-1280). Individual antibiotics have spectrum scores of 1 to 5, with the total score resulting from summation of the spectrum scores for each unique antibiotic administered during the first 24 hours. Minimum total 24-hour score is therefore 1 (administration of a single, minimum-spectrum antibiotic), with no maximum score. Higher values represent treatment with antibiotics with a broader spectrum.	Up to 24 hours from ED arrival (an average of 6 hours)
Antibiotic Spectrum (All ED Patients)	Total antibiotic spectrum score for all unique antibiotics administered in first 24 hours using antibiotic spectrum scoring system developed by Stenehjem et al. (Clin Infect Dis 2016;63:1273-1280). Individual antibiotics have spectrum scores of 1 to 5, with the total score resulting from summation of the spectrum scores for each unique antibiotic administered during the first 24 hours. Minimum total 24-hour score is therefore 1 (administration of a single, minimum-spectrum antibiotic), with no maximum score. Higher values represent treatment with antibiotics with a broader spectrum.	Up to 24 hours from ED arrival (an average of 6 hours)

Collaborators and Investigators

• Sponsor: Intermountain Health Care, Inc.
• Collaborators: National Institute of General Medical Sciences (NIGMS)
• Investigators: Principal Investigator: Ithan Peltan, MD, Intermountain Health Care, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2018
• Primary Completion (Actual): January 23, 2023
• Study Completion (Actual): December 28, 2023

Study Registration Dates

• First Submitted: October 31, 2019
• First Submitted That Met QC Criteria: October 31, 2019
• First Posted (Actual): November 4, 2019

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Emergency Medicine; Sepsis; Clinical Protocols
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Sepsis; Toxemia; Emergencies
• Other Study ID Numbers: 1051053; K23GM129661 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In order to protect patient privacy and comply with relevant regulations, identified data will be unavailable. Requests for deidentified data from qualified researchers with appropriate ethics board approvals and relevant data use agreements will be processed by the Intermountain Office of Research, officeofresearch@imail.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No