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OpenTrials
Completed

NCT Number: NCT03226366

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Intermountain Medical Center, Murray, Utah, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immediate evaluation by multidisciplinary team

Other

Simultaneous initial evaluation by the ED physician, nurse, and patient care associate

Other names: Swarming

Primary outcomes

  1. Time From ED Arrival to Administration of First Dose of Antibiotics

    Time frame: 24 hours

Secondary outcomes

  1. Hospital Mortality

    Time frame: Up to 1 year

  2. ED Length of Stay

    Time frame: Up to 1 week

    Time (minutes) from ED arrival to ED departure

  3. Door-to-physician Evaluation Time

    Time frame: Up to 24 hours

    Time (minutes) from subject's arrival in the ED until initial evaluation by a physician.

Sponsors and collaborators

Lead sponsor

Intermountain Health Care, Inc.

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2020
First posted
Jul 21, 2017
Registry last updated
Jun 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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