Clinical trial NCT03226366: Effect of Emergency Department Care Reorganization on Door-to-antibiotic Times for Sepsis (LDS SWARM)
Official title: Effect of Emergency Department Care Reorganization on Door-to-antibiotic Times for Sepsis (LDS SWARM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Septic Shock
Sepsis
Keywords: door-to-antibiotic time
emergency department care
antimicrobial
care reorganization
severe sepsis
swarming
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 3230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients presenting to the ED with sepsis or septic shock

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time From ED Arrival to Administration of First Dose of Antibiotics
timeFrame: 24 hours
Secondary outcomes:
measure: Hospital Mortality
timeFrame: Up to 1 year
measure: ED Length of Stay
timeFrame: Up to 1 week
measure: Door-to-physician Evaluation Time
timeFrame: Up to 24 hours
Other outcomes:
Locations:
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Riverton
country: United States
facility: Riverton Hospital
state: Utah
city: Salt Lake City
country: United States
facility: LDS Hospital
state: Utah
city: Sandy
country: United States
facility: Alta View Hospital
state: Utah
Study officials:
affiliation: Intermountain Health Care, Inc.
name: Ithan Peltan, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.