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

Sponsor

Intermountain Health Care, Inc. (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04148989

Collaborator

National Institute of General Medical Sciences (NIGMS) (NIH)

11,854

Enrollment

Locations

Arms

45.6

Anticipated Duration (Months)

3951.3

Patients Per Site

86.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis	Other: Code Sepsis protocol (full implementation)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

11854 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

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.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.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Nov 13, 2018

Actual Primary Completion Date :

Feb 18, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

All-cause 30-day mortality [30 days after ED arrival]
Sepsis patient death on or before the 30th day after ED arrival
All-cause 1-year mortality [1 year after ED arrival]
Sepsis patient death on or before the 365th day after ED arrival
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
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
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

Other Outcome Measures

Antibiotic utilization' [Up to 24 hours from ED arrival (an average of 6 hours)]
Fraction of all ED patients receiving antibiotics within 24 hours of ED arrival
Adverse effects of antibiotics [From the time of ED arrival to hospital discharge (up to 1 year, average 14 days)]
Measured as the fraction of patients with a discharge diagnosis code consistent with anaphylaxis or with an adverse reaction to antibiotics
New onset Clostridium difficile colitis incidence [Beginning 72 hours after ED arrival to 90 days after ED arrival]
Incidence of positive stool test for Clostridium difficile colitis between 72 hours and 90 days after ED arrival among (1) ED sepsis patients and (2) all ED patients.
Antibiotic overtreatment rate [Up to 24 hours from ED arrival (an average of 6 hours)]
Fraction of ED patients with a primary hospital discharge diagnosis of congestive heart failure or venous thromboembolism who received antibiotics in the ED
Antibiotic spectrum [Up to 24 hours from ED arrival (an average of 6 hours)]
Total antibiotic spectrum score for all 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. Values measured for (1) all ED patients and (2) sepsis patients.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion criteria (overall):

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

Exclusion criteria (overall):

(1) Trauma patient

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Intermountain Medical Center	Murray	Utah	United States	84107
2	Utah Valley Hospital	Provo	Utah	United States	84604
3	Dixie Regional Medical Center	Saint George	Utah	United States	84790