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

Primary Purpose

Sepsis

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Code Sepsis protocol (full implementation)
Sponsored by
Intermountain Health Care, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Sepsis focused on measuring Sepsis, Clinical Protocols, Emergency Medicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Intermountain Medical Center
  • Utah Valley Hospital
  • Dixie Regional Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

No Intervention

No Intervention

Arm Label

Pre-implementation usual care (intervention site)

Code Sepsis post-implementation (intervention site)

Pre-implementation usual care (control sites)

Post-implementation usual care (control sites)

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Door-to-antibiotic time
Time from sepsis patients' emergency department arrival to intravenous (or equivalent) antibiotic initiation

Secondary Outcome Measures

All-cause 30-day mortality
Sepsis patient death on or before the 30th day after ED arrival
All-cause 1-year mortality
Sepsis patient death on or before the 365th day after ED arrival
All-cause in-hospital mortality
Sepsis patient death prior to hospital discharge
Hospital charges
Amount charged to sepsis patient for their medical care during index ED visit and associated hospitalization
Hospital length of stay
Length of time from sepsis patients' ED arrival until hospital discharge

Full Information

First Posted
October 31, 2019
Last Updated
January 24, 2023
Sponsor
Intermountain Health Care, Inc.
Collaborators
National Institute of General Medical Sciences (NIGMS)
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1. Study Identification

Unique Protocol Identification Number
NCT04148989
Brief Title
Effects of Code Sepsis Implementation on Emergency Department (ED) Sepsis Care
Acronym
Code Sepsis
Official Title
Effects of Code Sepsis Implementation on Emergency Department (ED) Sepsis Care
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 13, 2018 (Actual)
Primary Completion Date
January 23, 2023 (Actual)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Intermountain Health Care, Inc.
Collaborators
National Institute of General Medical Sciences (NIGMS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
Keywords
Sepsis, Clinical Protocols, Emergency Medicine

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
11854 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-implementation usual care (intervention site)
Arm Type
No Intervention
Arm Description
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.
Arm Title
Code Sepsis post-implementation (intervention site)
Arm Type
Experimental
Arm Description
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.
Arm Title
Pre-implementation usual care (control sites)
Arm Type
No Intervention
Arm Description
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.
Arm Title
Post-implementation usual care (control sites)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Code Sepsis protocol (full implementation)
Intervention Description
Implementation of a coordinated, structured, multidisciplinary team-based protocol for initial evaluation and treatment of ED patients with suspected sepsis.
Primary Outcome Measure Information:
Title
Door-to-antibiotic time
Description
Time from sepsis patients' emergency department arrival to intravenous (or equivalent) antibiotic initiation
Time Frame
Up to 24 hours from ED arrival (an average of 3 hours)
Secondary Outcome Measure Information:
Title
All-cause 30-day mortality
Description
Sepsis patient death on or before the 30th day after ED arrival
Time Frame
30 days after ED arrival
Title
All-cause 1-year mortality
Description
Sepsis patient death on or before the 365th day after ED arrival
Time Frame
1 year after ED arrival
Title
All-cause in-hospital mortality
Description
Sepsis patient death prior to hospital discharge
Time Frame
From the time of admission to hospital discharge (up to 1 year, average 14 days)
Title
Hospital charges
Description
Amount charged to sepsis patient for their medical care during index ED visit and associated hospitalization
Time Frame
From the time of admission to hospital discharge (up to 1 year, average 14 days)
Title
Hospital length of stay
Description
Length of time from sepsis patients' ED arrival until hospital discharge
Time Frame
From the time of admission to hospital discharge (up to 1 year, average 14 days)
Other Pre-specified Outcome Measures:
Title
Antibiotic utilization'
Description
Fraction of all ED patients receiving antibiotics within 24 hours of ED arrival
Time Frame
Up to 24 hours from ED arrival (an average of 6 hours)
Title
Adverse effects of antibiotics
Description
Measured as the fraction of patients with a discharge diagnosis code consistent with anaphylaxis or with an adverse reaction to antibiotics
Time Frame
From the time of ED arrival to hospital discharge (up to 1 year, average 14 days)
Title
New onset Clostridium difficile colitis incidence
Description
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.
Time Frame
Beginning 72 hours after ED arrival to 90 days after ED arrival
Title
Antibiotic overtreatment rate
Description
Fraction of ED patients with a primary hospital discharge diagnosis of congestive heart failure or venous thromboembolism who received antibiotics in the ED
Time Frame
Up to 24 hours from ED arrival (an average of 6 hours)
Title
Antibiotic spectrum
Description
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.
Time Frame
Up to 24 hours from ED arrival (an average of 6 hours)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ithan Peltan, MD
Organizational Affiliation
Intermountain Health Care, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Utah Valley Hospital
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
Facility Name
Dixie Regional Medical Center
City
Saint George
State/Province
Utah
ZIP/Postal Code
84790
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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