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

NCT04148989 | Completed Results

• 2 other identifiers: 1051053K23GM129661
• Study Type: interventional
• Target: 180,402
• Locations: 1 country
• Sites: 3

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.

Conditions

Sepsis

Keywords

Sepsis; Clinical Protocols; Emergency Medicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• All-cause 30-day Mortality

  30 days after ED arrival

• All-cause 1-year Mortality

  1 year after ED arrival

• All-cause In-hospital Mortality

  From the time of admission to hospital discharge (up to 1 year, average 14 days)

• Hospital Charges

  From the time of admission to hospital discharge (up to 1 year, average 14 days)

• Hospital Length of Stay

  From the time of admission to hospital discharge (up to 1 year, average 14 days)

Other Outcomes (8)

• Antibiotic Utilization'

  Up to 24 hours from ED arrival (an average of 6 hours)

• Adverse Effects of Antibiotics (Sepsis Patients)

  From the time of ED arrival to hospital discharge (up to 1 year, average 14 days)

• Adverse Effect of Antibiotics (All ED Patients)

  From the time of ED arrival to hospital discharge (up to 1 year, average 14 days)

Study Arms (4)

Pre-implementation usual care (intervention site)

NO INTERVENTION

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.

Code Sepsis post-implementation (intervention site)

EXPERIMENTAL

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)

Pre-implementation usual care (control sites)

NO INTERVENTION

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.

Post-implementation usual care (control sites)

NO INTERVENTION

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.

Interventions

Code Sepsis protocol (full implementation) OTHER

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

Code Sepsis post-implementation (intervention site)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• (1) Trauma patient

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (3)

Intermountain Medical Center

Murray, Utah, 84107, United States

Location

Utah Valley Hospital

Provo, Utah, 84604, United States

Location

Dixie Regional Medical Center

St. George, Utah, 84790, United States

Location

Related Publications (1)

• Peltan ID, Bledsoe JR, Jacobs JR, Groat D, Klippel C, Adamson M, Hooper GA, Tinker NJ, Foster RA, Stenehjem EA, Moores Todd TD, Balls A, Avery J, Brunson G, Jones J, Bair J, Dorais A, Samore MH, Hough CL, Brown SM. Effectiveness and Safety of an Emergency Department Code Sepsis Protocol: A Pragmatic Clinical Trial. Ann Am Thorac Soc. 2024 Nov;21(11):1560-1571. doi: 10.1513/AnnalsATS.202403-286OC.

  PMID: 38996086 DERIVED

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director, Office of Research
• Organization: Intermountain Health

officeofresearch@imail.org

(801) 408-1991

Study Officials

• Ithan Peltan, MD

  Intermountain Health Care, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 4, 2019
• Study Start: November 13, 2018
• Primary Completion: January 23, 2023
• Study Completion: December 28, 2023
• Last Updated: March 5, 2024
• Results First Posted: March 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share

Locations

US (3)