An observational study in Septic Shock and Sepsis, sponsored by Intermountain Health Care, Inc.. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-06-18.
Sponsored by Intermountain Health Care, Inc. · Observational
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.
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.
1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.
This study's enrollment of 3,230 is above the median of 160 across 931 observational studies indexed under Sepsis.
Browse Sepsis studies →Intermountain Health Care, Inc. is the lead sponsor of 118 studies on the registry; 15 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 3 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult patients presenting to the ED with sepsis or septic shock
Primary inclusion criteria:
Inclusion criteria for supplemental sensitivity analyses:
Overall exclusion criteria:
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
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
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
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
Simultaneous initial evaluation by the ED physician, nurse, and patient care associate
Also known as: Swarming
Time From ED Arrival to Administration of First Dose of Antibiotics
Time frame: 24 hours
Hospital Mortality
Time frame: Up to 1 year
ED Length of Stay
Time (minutes) from ED arrival to ED departure
Time frame: Up to 1 week
Door-to-physician Evaluation Time
Time (minutes) from subject's arrival in the ED until initial evaluation by a physician.
Time frame: Up to 24 hours
| Milestone | Pre-implementation (Intervention Site) | Post-implementation (Intervention Site) | Pre-implementation (Control Site) | Post-implementation (Control Site) |
|---|---|---|---|---|
| Started | 911 | 495 | 1183 | 641 |
| Completed | 911 | 495 | 1183 | 641 |
| Not completed | 0 | 0 | 0 | 0 |
| minutes | Pre-implementation (Intervention Site) | Post-implementation (Intervention Site) | Pre-implementation (Control Site) | Post-implementation (Control Site) |
|---|---|---|---|---|
| Time From ED Arrival to Administration of First Dose of Antibiotics | 173 ± 98 | 165 ± 95 | 169 ± 90 | 163 ± 85 |
| Participants | Pre-implementation (Intervention Site) | Post-implementation (Intervention Site) | Pre-implementation (Control Site) | Post-implementation (Control Site) |
|---|---|---|---|---|
| Hospital Mortality | 19 | 7 | 23 | 11 |
Time (minutes) from ED arrival to ED departure
| minutes | Pre-implementation (Intervention Site) | Post-implementation (Intervention Site) | Pre-implementation (Control Site) | Post-implementation (Control Site) |
|---|---|---|---|---|
| ED Length of Stay | 280 ± 1143 | 265 ± 110 | 269 ± 108 | 261 ± 98 |
Time (minutes) from subject's arrival in the ED until initial evaluation by a physician.
| minutes | Pre-implementation (Intervention Site) | Post-implementation (Intervention Site) | Pre-implementation (Control Site) | Post-implementation (Control Site) |
|---|---|---|---|---|
| Door-to-physician Evaluation Time | 25 ± 18 | 23 ± 15 | 22 ± 24 | 20 ± 16 |
Collected over 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pre-implementation (Intervention Site) | 19/911 (2.1%) | 0/911 (0%) | 0/911 (0%) |
| Post-implementation (Intervention Site) | 7/495 (1.4%) | 0/495 (0%) | 0/495 (0%) |
| Pre-implementation (Control Site) | 23/1,183 (1.9%) | 0/1,183 (0%) | 0/1,183 (0%) |
| Post-implementation (Control Site) | 11/641 (1.7%) | 0/641 (0%) | 0/641 (0%) |
| Age, Continuous(years) | Pre-implementation (Intervention Site) | Post-implementation (Intervention Site) | Pre-implementation (Control Site) | Post-implementation (Control Site) | Total |
|---|---|---|---|---|---|
| Mean | 55.0 ± 19.7 | 55.6 ± 19.6 | 59.9 ± 19.7 | 58.7 ± 20.4 | 57.6 ± 19.9 |
| Sex: Female, Male(Participants) | Pre-implementation (Intervention Site) | Post-implementation (Intervention Site) | Pre-implementation (Control Site) | Post-implementation (Control Site) | Total |
|---|---|---|---|---|---|
| Female | 474 | 251 | 687 | 377 | 1789 |
| Male | 437 | 244 | 496 | 264 | 1441 |
| Ethnicity (NIH/OMB)(Participants) | Pre-implementation (Intervention Site) | Post-implementation (Intervention Site) | Pre-implementation (Control Site) | Post-implementation (Control Site) | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 117 | 74 | 69 | 45 | 305 |
| Not Hispanic or Latino | 794 | 421 | 1114 | 596 | 2925 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Pre-implementation (Intervention Site) | Post-implementation (Intervention Site) | Pre-implementation (Control Site) | Post-implementation (Control Site) | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 15 | 9 | 5 | 2 | 31 |
| Asian | 14 | 8 | 18 | 5 | 45 |
| Native Hawaiian or Other Pacific Islander | 30 | 12 | 12 | 13 | 67 |
| Black or African American | 25 | 15 | 6 | 4 | 50 |
| White | 827 | 451 | 1142 | 617 | 3037 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — 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.
Supporting information: Study protocol, Csr, Analytic code
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Intermountain Health Care, Inc.