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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03226366
• Other study ID #: LDS SWARM
• Status: Completed
• Start date: May 16, 2015
• Est. completion date: April 11, 2020

Study information

• Verified date: June 2020
• Source: Intermountain Health Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3230
• Est. completion date: April 11, 2020
• Est. primary completion date: January 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Sepsis
• Septic Shock
• Toxemia

Intervention

Other:
• Immediate evaluation by multidisciplinary team
Simultaneous initial evaluation by the ED physician, nurse, and patient care associate

Locations

Country	Name	City	State
United States	Intermountain Medical Center	Murray	Utah
United States	Riverton Hospital	Riverton	Utah
United States	LDS Hospital	Salt Lake City	Utah
United States	Alta View Hospital	Sandy	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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/j — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time From ED Arrival to Administration of First Dose of Antibiotics		24 hours
Secondary	Hospital Mortality		Up to 1 year
Secondary	ED Length of Stay	Time (minutes) from ED arrival to ED departure	Up to 1 week
Secondary	Door-to-physician Evaluation Time	Time (minutes) from subject's arrival in the ED until initial evaluation by a physician.	Up to 24 hours