Clinical trial NCT04148989: Effects of Code Sepsis Implementation on Emergency Department (ED) Sepsis Care
Official title: Effects of Code Sepsis Implementation on Emergency Department (ED) Sepsis Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Keywords: Sepsis
Clinical Protocols
Emergency Medicine
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
Collaborators: name: National Institute of General Medical Sciences (NIGMS)
First posted: 2019-11-04
Enrollment: 180402
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Door-to-antibiotic Time
timeFrame: Up to 24 hours from ED arrival (an average of 3 hours)
Secondary outcomes:
measure: All-cause 30-day Mortality
timeFrame: 30 days after ED arrival
measure: All-cause 1-year Mortality
timeFrame: 1 year after ED arrival
measure: All-cause In-hospital Mortality
timeFrame: From the time of admission to hospital discharge (up to 1 year, average 14 days)
measure: Hospital Charges
timeFrame: From the time of admission to hospital discharge (up to 1 year, average 14 days)
measure: Hospital Length of Stay
timeFrame: From the time of admission to hospital discharge (up to 1 year, average 14 days)
Other outcomes:
measure: Antibiotic Utilization'
timeFrame: Up to 24 hours from ED arrival (an average of 6 hours)
measure: Adverse Effects of Antibiotics (Sepsis Patients)
timeFrame: From the time of ED arrival to hospital discharge (up to 1 year, average 14 days)
measure: Adverse Effect of Antibiotics (All ED Patients)
timeFrame: From the time of ED arrival to hospital discharge (up to 1 year, average 14 days)
measure: New Onset Clostridium Difficile Colitis Incidence (Sepsis Patients)
timeFrame: Beginning 72 hours after ED arrival to 90 days after ED arrival
measure: New Onset Clostridium Difficile Colitis Incidence (All ED Patients)
timeFrame: Beginning 72 hours after ED arrival to 90 days after ED arrival.
measure: Antibiotic Overtreatment Rate
timeFrame: Up to 24 hours from ED arrival (an average of 6 hours)
measure: Antibiotic Spectrum (Sepsis Patients)
timeFrame: Up to 24 hours from ED arrival (an average of 6 hours)
measure: Antibiotic Spectrum (All ED Patients)
timeFrame: Up to 24 hours from ED arrival (an average of 6 hours)
Locations:
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Provo
country: United States
facility: Utah Valley Hospital
state: Utah
city: Saint George
country: United States
facility: Dixie Regional Medical Center
state: Utah
Study officials:
affiliation: Intermountain Health Care, Inc.
name: Ithan Peltan, MD
role: PRINCIPAL_INVESTIGATOR
References: