Effect of Emergency Department Care Reorganization on Door-to-antibiotic Times for Sepsis (LDS SWARM)

Sepsis is a common syndrome resulting from a dysregulated response to infection. The timing of antibiotic initiation is an important determinant of outcomes for patients presenting to the emergency department with sepsis. The potential effect of care reorganization on very early care for sepsis is unknown. This study will investigate whether multidisciplinary coordination of the initial patient evaluation in the emergency department influences door-to-antibiotic time for septic patients.

Study Overview

• Status: Completed
• Conditions: Sepsis; Septic Shock
• Intervention / Treatment: Other: Immediate evaluation by multidisciplinary team

Detailed Description

This is a retrospective cohort study of emergency department sepsis care before versus after implementation of a "swarming" model for simultaneous patient evaluation by multidisciplinary care providers. The analysis will use data from similar hospitals that did not change sepsis care organization during the study period to control for changes in sepsis care not resulting from the "swarming" intervention.

• Study Type: Observational
• Enrollment (Actual): 3230

Contacts and Locations

Study Locations

• United States
  • Utah
    • Murray, Utah, United States, 84157
      • Intermountain Medical Center
    • Riverton, Utah, United States, 84065
      • Riverton Hospital
    • Salt Lake City, Utah, United States, 84143
      • LDS Hospital
    • Sandy, Utah, United States, 84094
      • Alta View Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients presenting to the ED with sepsis or septic shock

Description

Primary inclusion criteria:

• Adult patients age ≥18 years
• Presented to the ED of study hospital from May 16, 2015 to April 15, 2016 (pre-implementation cohort) or May 16 to November 15, 2016 (post-implementation cohort)
• Sepsis present in ED (Sequential Organ Failure Assessment [SOFA] score ≥2 points above baseline while in ED plus antibiotic initiation while in the ED)
• Triage acuity score 2-5

Inclusion criteria for supplemental sensitivity analyses:

• Presented to the ED of study hospital between May 16, 2015 and April 15, 2016 (pre-implementation cohort) or May 16, 2016 and February 15, 2017 (post-implementation cohort).
• Sepsis on presentation to ED, defined as initial Sequential Organ Failure Assessment (SOFA) score ≥2 points above baseline plus antibiotics initiation within 24 hours of ED arrival.

Overall exclusion criteria:

• Age <18 years
• No antibiotics within 24 hours of ED arrival

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pre-implementation (intervention site); Adult patients age ≥18 years who received usual care after presenting to the ED of the intervention hospital with sepsis or septic shock between May 16, 2015 and April 15, 2016
Post-implementation (intervention site); Adult patients age ≥18 years eligible to receive immediate evaluation by multidisciplinary team ("swarming") after presenting to the ED of the intervention hospital with sepsis or septic shock between May 16, 2016 and February 15, 2017	Other: Immediate evaluation by multidisciplinary team; Simultaneous initial evaluation by the ED physician, nurse, and patient care associate; Other Names: Swarming
Pre-implementation (control site); Adult patients age ≥18 years who received usual care after presenting to the ED of a non-intervention study hospital with sepsis or septic shock between May 16, 2015 and April 15, 2016
Post-implementation (control site); Adult patients age ≥18 years who received usual care after presenting to the ED of a non-intervention study hospital with sepsis or septic shock between May 16, 2016 and February 15, 2017

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time From ED Arrival to Administration of First Dose of Antibiotics	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Mortality		Up to 1 year
ED Length of Stay	Time (minutes) from ED arrival to ED departure	Up to 1 week
Door-to-physician Evaluation Time	Time (minutes) from subject's arrival in the ED until initial evaluation by a physician.	Up to 24 hours

Collaborators and Investigators

• Sponsor: Intermountain Health Care, Inc.
• Investigators: Principal Investigator: Ithan Peltan, MD, MSc, Intermountain Health Care, Inc.

Publications and helpful links

General Publications

• Peltan ID, Bledsoe JR, Brems D, McLean S, Murnin E, Brown SM. Institution of an emergency department "swarming" care model and sepsis door-to-antibiotic time: A quasi-experimental retrospective analysis. PLoS One. 2020 May 5;15(5):e0232794. doi: 10.1371/journal.pone.0232794. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2015
• Primary Completion (Actual): January 31, 2017
• Study Completion (Actual): April 11, 2020

Study Registration Dates

• First Submitted: July 19, 2017
• First Submitted That Met QC Criteria: July 20, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): June 18, 2020
• Last Update Submitted That Met QC Criteria: June 1, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: antimicrobial; severe sepsis; door-to-antibiotic time; emergency department care; care reorganization; swarming
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Sepsis; Toxemia; Emergencies
• Other Study ID Numbers: LDS SWARM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No