Effect of Emergency Department Care Reorganization on Door-to-antibiotic Times for Sepsis (LDS SWARM)
1 other identifier
observational
3,230
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2015
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2017
CompletedFirst Submitted
Initial submission to the registry
July 19, 2017
CompletedFirst Posted
Study publicly available on registry
July 21, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 11, 2020
CompletedResults Posted
Study results publicly available
June 18, 2020
CompletedJune 18, 2020
June 1, 2020
1.7 years
July 19, 2017
June 1, 2020
June 1, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time From ED Arrival to Administration of First Dose of Antibiotics
24 hours
Secondary Outcomes (3)
Hospital Mortality
Up to 1 year
ED Length of Stay
Up to 1 week
Door-to-physician Evaluation Time
Up to 24 hours
Study Arms (4)
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
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
Interventions
Simultaneous initial evaluation by the ED physician, nurse, and patient care associate
Eligibility Criteria
Adult patients presenting to the ED with sepsis or septic shock
You may qualify if:
- 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
- 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.
You may not qualify if:
- Age \<18 years
- No antibiotics within 24 hours of ED arrival
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Intermountain Medical Center
Murray, Utah, 84157, United States
Riverton Hospital
Riverton, Utah, 84065, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
Alta View Hospital
Sandy City, Utah, 84094, United States
Related 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/journal.pone.0232794. eCollection 2020.
PMID: 32369531RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Office of Research
- Organization
- Intermountain Healthcare
Study Officials
- PRINCIPAL INVESTIGATOR
Ithan Peltan, MD, MSc
Intermountain Health Care, Inc.
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Physician, Intermountain Medical Center
Study Record Dates
First Submitted
July 19, 2017
First Posted
July 21, 2017
Study Start
May 16, 2015
Primary Completion
January 31, 2017
Study Completion
April 11, 2020
Last Updated
June 18, 2020
Results First Posted
June 18, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR, ANALYTIC CODE
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.