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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180402 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-13

Study Completion Date

2023-12-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Emergency Department Care Reorganization on Door-to-antibiotic Times for Sepsis (LDS SWARM)

NCT03226366

Septic Shock Sepsis

COMPLETED

Impact of COVID-19 on the Incidence, Characteristics, Management and Outcome of Sepsis

NCT04698382

Sepsis Septic Shock

WITHDRAWN

Infected Elders in the Emergency Department: Outcomes and Processes of Care

NCT00591955

Sepsis

COMPLETED

TELEmedicine as an Intervention for Sepsis in Emergency Departments

NCT04441944

Sepsis

COMPLETED

Impact of a Prehospital Sepsis Protocol on Timely Antibiotic Administration and Subsequent Adverse Events

NCT05502107

Sepsis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sepsis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Code Sepsis protocol (full implementation)

Intervention Type OTHER

Implementation of a coordinated, structured, multidisciplinary team-based protocol for initial evaluation and treatment of ED patients with suspected sepsis.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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.