Sepsis, Septic Shock
Conditions
Keywords
door-to-antibiotic time, emergency department care, antimicrobial, care reorganization, severe sepsis, swarming
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.
Detailed 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.
Interventions
OTHERImmediate evaluation by multidisciplinary team
Simultaneous initial evaluation by the ED physician, nurse, and patient care associate
Sponsors
Intermountain Health Care, Inc.
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time From ED Arrival to Administration of First Dose of Antibiotics | 24 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Mortality | Up to 1 year | — |
| ED Length of Stay | Up to 1 week | Time (minutes) from ED arrival to ED departure |
| Door-to-physician Evaluation Time | Up to 24 hours | Time (minutes) from subject's arrival in the ED until initial evaluation by a physician. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 911 |
| 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 | 495 |
| 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 | 1,183 |
| 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 | 641 |
| Total | 3,230 |
Baseline characteristics
| Characteristic | Post-implementation (Control Site) | Total | Pre-implementation (Intervention Site) | Post-implementation (Intervention Site) | Pre-implementation (Control Site) |
|---|---|---|---|---|---|
| Age, Continuous | 58.7 years STANDARD_DEVIATION 20.4 | 57.6 years STANDARD_DEVIATION 19.9 | 55.0 years STANDARD_DEVIATION 19.7 | 55.6 years STANDARD_DEVIATION 19.6 | 59.9 years STANDARD_DEVIATION 19.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 45 Participants | 305 Participants | 117 Participants | 74 Participants | 69 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 596 Participants | 2925 Participants | 794 Participants | 421 Participants | 1114 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 31 Participants | 15 Participants | 9 Participants | 5 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 45 Participants | 14 Participants | 8 Participants | 18 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 50 Participants | 25 Participants | 15 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 13 Participants | 67 Participants | 30 Participants | 12 Participants | 12 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 617 Participants | 3037 Participants | 827 Participants | 451 Participants | 1142 Participants |
| Sex: Female, Male Female | 377 Participants | 1789 Participants | 474 Participants | 251 Participants | 687 Participants |
| Sex: Female, Male Male | 264 Participants | 1441 Participants | 437 Participants | 244 Participants | 496 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 19 / 911 | 7 / 495 | 23 / 1,183 | 11 / 641 |
| other Total, other adverse events | 0 / 911 | 0 / 495 | 0 / 1,183 | 0 / 641 |
| serious Total, serious adverse events | 0 / 911 | 0 / 495 | 0 / 1,183 | 0 / 641 |
Outcome results
Primary
Time From ED Arrival to Administration of First Dose of Antibiotics
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pre-implementation (Intervention Site) | Time From ED Arrival to Administration of First Dose of Antibiotics | 173 minutes | Standard Deviation 98 |
| Post-implementation (Intervention Site) | Time From ED Arrival to Administration of First Dose of Antibiotics | 165 minutes | Standard Deviation 95 |
| Pre-implementation (Control Site) | Time From ED Arrival to Administration of First Dose of Antibiotics | 169 minutes | Standard Deviation 90 |
| Post-implementation (Control Site) | Time From ED Arrival to Administration of First Dose of Antibiotics | 163 minutes | Standard Deviation 85 |
Comparison: Differences-in-differences analysis using multivariable regression to estimate the change in emergency department (ED) door-to-antibiotic time after versus before intervention implementation at the intervention site adjusted for the change observed over the same time period at the control sites and for subject's age, sex, Elixhauser Comorbidity Score, initial systolic blood pressure, initial Glasgow Coma Scale score \<14. initial temperature, ED triage acuity score, and ED arrival via ambulance.p-value: 0.2995% CI: [-20.4, 6.1]Regression, Linear
Secondary
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
Population: Time of physician initial patient evaluation was missing for a small number of participants in each group
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pre-implementation (Intervention Site) | Door-to-physician Evaluation Time | 25 minutes | Standard Deviation 18 |
| Post-implementation (Intervention Site) | Door-to-physician Evaluation Time | 23 minutes | Standard Deviation 15 |
| Pre-implementation (Control Site) | Door-to-physician Evaluation Time | 22 minutes | Standard Deviation 24 |
| Post-implementation (Control Site) | Door-to-physician Evaluation Time | 20 minutes | Standard Deviation 16 |
Comparison: Differences-in-differences analysis using multivariable regression to estimate the change in emergency department (ED) door-to-physician evaluation time after versus before implementation at the intervention site adjusted for the change observed over the same time period at the control sites and for subject's age, sex, Elixhauser Comorbidity Score, initial systolic blood pressure, initial Glasgow Coma Scale score \<14. initial temperature, ED triage acuity score, and ED arrival via ambulance.p-value: 0.5595% CI: [-3.3, 1.8]Regression, Linear
Secondary
ED Length of Stay
Time (minutes) from ED arrival to ED departure
Time frame: Up to 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Pre-implementation (Intervention Site) | ED Length of Stay | 280 minutes | Standard Deviation 1143 |
| Post-implementation (Intervention Site) | ED Length of Stay | 265 minutes | Standard Deviation 110 |
| Pre-implementation (Control Site) | ED Length of Stay | 269 minutes | Standard Deviation 108 |
| Post-implementation (Control Site) | ED Length of Stay | 261 minutes | Standard Deviation 98 |
Comparison: Differences-in-differences analysis using multivariable regression to estimate the change in emergency department length of stay after versus before implementation at the intervention site with adjustment for the change observed over the same time period at the control sites as well as for subject's age, sex, Elixhauser Comorbidity Score, initial systolic blood pressure, an initial Glasgow Coma Scale score \<14. initial temperature, ED triage acuity score, and arrival to the ED via ambulance.p-value: 0.2695% CI: [-25.9, 7]Regression, Linear
Secondary
Hospital Mortality
Time frame: Up to 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Pre-implementation (Intervention Site) | Hospital Mortality | 19 Participants |
| Post-implementation (Intervention Site) | Hospital Mortality | 7 Participants |
| Pre-implementation (Control Site) | Hospital Mortality | 23 Participants |
| Post-implementation (Control Site) | Hospital Mortality | 11 Participants |
Comparison: Differences-in-differences analysis using multivariable regression to estimate the change in odds of hospital mortality after versus before implementation at the intervention site with adjustment for observed change in outcome over the same time period at the control sites as well as for subject's age, sex, Elixhauser Comorbidity Score, initial systolic blood pressure, an initial Glasgow Coma Scale score \<14. initial temperature, ED triage acuity score, and arrival to the ED via ambulance.p-value: 0.7295% CI: [0.25, 2.61]Regression, Logistic