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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immediate evaluation by multidisciplinary team | Other | Simultaneous initial evaluation by the ED physician, nurse, and patient care associate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time From ED Arrival to Administration of First Dose of Antibiotics | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital Mortality | Up to 1 year | |
| ED Length of Stay | Time (minutes) from ED arrival to ED departure | Up to 1 week |
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Primary inclusion criteria:
Inclusion criteria for supplemental sensitivity analyses:
Overall exclusion criteria:
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Adult patients presenting to the ED with sepsis or septic shock
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| Name | Affiliation | Role |
|---|---|---|
| Ithan Peltan, MD, MSc | Intermountain Health Care, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intermountain Medical Center | Murray | Utah | 84157 | United States | ||
| Riverton Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32369531 | Result | 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. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 November 15, 2016 Immediate evaluation by multidisciplinary team: Simultaneous initial evaluation by the ED physician, nurse, and patient care associate |
| FG002 | 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 |
| FG003 | 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 November 15, 2016 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Post-implementation (Intervention Site) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time From ED Arrival to Administration of First Dose of Antibiotics | Posted | Mean | Standard Deviation | minutes | 24 hours |
|
1 year
Intervention effects on hospital mortality and emergency department length of stay were evaluated as study outcomes. Other adverse events were not systematically collected given this was a retrospective study employing review of the electronic clinical record to evaluate a previously-implemented quality improvement initiative reordering of routine emergency department care for patients with sepsis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Office of Research | Intermountain Healthcare | (801) 408-1991 | officeofresearch@imail.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 11, 2020 | Feb 11, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C116143 | RsbA protein, Proteus mirabilis |
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|
| Door-to-physician Evaluation Time |
Time (minutes) from subject's arrival in the ED until initial evaluation by a physician. |
| Up to 24 hours |
| Riverton |
| Utah |
| 84065 |
| United States |
| LDS Hospital | Salt Lake City | Utah | 84143 | United States |
| Alta View Hospital | Sandy City | Utah | 84094 | United States |
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 November 15, 2016 Immediate evaluation by multidisciplinary team: Simultaneous initial evaluation by the ED physician, nurse, and patient care associate |
| BG002 | 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 |
| BG003 | 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 November 15, 2016 |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG002 | 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 |
| OG003 | 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 November 15, 2016 |
|
|
|
| Secondary | Hospital Mortality | Posted | Count of Participants | Participants | Up to 1 year |
|
|
|
|
| Secondary | ED Length of Stay | Time (minutes) from ED arrival to ED departure | Posted | Mean | Standard Deviation | minutes | 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. | Time of physician initial patient evaluation was missing for a small number of participants in each group | Posted | Mean | Standard Deviation | minutes | Up to 24 hours |
|
|
|
|
| 19 |
| 911 |
| 0 |
| 911 |
| 0 |
| 911 |
| EG001 | 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 November 15, 2016 Immediate evaluation by multidisciplinary team: Simultaneous initial evaluation by the ED physician, nurse, and patient care associate | 7 | 495 | 0 | 495 | 0 | 495 |
| EG002 | 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 | 23 | 1,183 | 0 | 1,183 | 0 | 1,183 |
| EG003 | 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 November 15, 2016 | 11 | 641 | 0 | 641 | 0 | 641 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| Superiority |
| Superiority |
| Superiority |