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

Sepsis Clinical Trial

— Code Sepsis  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04148989
• Other study ID #: 1051053
• Secondary ID: K23GM129661
• Status: Completed
• Phase: N/A
• Start date: November 13, 2018
• Est. completion date: December 28, 2023

Study information

• Verified date: February 2024
• Source: Intermountain Health Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180402
• Est. completion date: December 28, 2023
• Est. primary completion date: January 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Sepsis
• Toxemia

Intervention

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.

Locations

Country	Name	City	State
United States	Intermountain Medical Center	Murray	Utah
United States	Utah Valley Hospital	Provo	Utah
United States	Dixie Regional Medical Center	Saint George	Utah

Sponsors (2)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Other	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
Other	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.
Other	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)
Other	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)
Other	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)
Primary	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	All-cause 30-day Mortality	Sepsis patient death on or before the 30th day after ED arrival	30 days after ED arrival
Secondary	All-cause 1-year Mortality	Sepsis patient death on or before the 365th day after ED arrival	1 year after ED arrival
Secondary	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)
Secondary	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)
Secondary	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)