Trial Outcomes & Findings for Effect of Emergency Department Care Reorganization on Door-to-antibiotic Times for Sepsis (LDS SWARM) (NCT NCT03226366)
NCT ID: NCT03226366
Last Updated: 2020-06-18
Results Overview
Recruitment status
COMPLETED
Target enrollment
3230 participants
Primary outcome timeframe
24 hours
Results posted on
2020-06-18
Participant Flow
Participant milestones
| Measure |
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 November 15, 2016
Immediate evaluation by multidisciplinary team: Simultaneous initial evaluation by the ED physician, nurse, and patient care associate
|
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 November 15, 2016
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
911
|
495
|
1183
|
641
|
|
Overall Study
COMPLETED
|
911
|
495
|
1183
|
641
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Emergency Department Care Reorganization on Door-to-antibiotic Times for Sepsis (LDS SWARM)
Baseline characteristics by cohort
| Measure |
Pre-implementation (Intervention Site)
n=911 Participants
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)
n=495 Participants
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
|
Pre-implementation (Control Site)
n=1183 Participants
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)
n=641 Participants
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
|
Total
n=3230 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
55.0 years
STANDARD_DEVIATION 19.7 • n=39 Participants
|
55.6 years
STANDARD_DEVIATION 19.6 • n=41 Participants
|
59.9 years
STANDARD_DEVIATION 19.7 • n=35 Participants
|
58.7 years
STANDARD_DEVIATION 20.4 • n=31 Participants
|
57.6 years
STANDARD_DEVIATION 19.9 • n=146 Participants
|
|
Sex: Female, Male
Female
|
474 Participants
n=39 Participants
|
251 Participants
n=41 Participants
|
687 Participants
n=35 Participants
|
377 Participants
n=31 Participants
|
1789 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
437 Participants
n=39 Participants
|
244 Participants
n=41 Participants
|
496 Participants
n=35 Participants
|
264 Participants
n=31 Participants
|
1441 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
117 Participants
n=39 Participants
|
74 Participants
n=41 Participants
|
69 Participants
n=35 Participants
|
45 Participants
n=31 Participants
|
305 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
794 Participants
n=39 Participants
|
421 Participants
n=41 Participants
|
1114 Participants
n=35 Participants
|
596 Participants
n=31 Participants
|
2925 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
15 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
31 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
5 Participants
n=31 Participants
|
45 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
30 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
13 Participants
n=31 Participants
|
67 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=39 Participants
|
15 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
4 Participants
n=31 Participants
|
50 Participants
n=146 Participants
|
|
Race (NIH/OMB)
White
|
827 Participants
n=39 Participants
|
451 Participants
n=41 Participants
|
1142 Participants
n=35 Participants
|
617 Participants
n=31 Participants
|
3037 Participants
n=146 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
PRIMARY outcome
Timeframe: 24 hoursOutcome measures
| Measure |
Pre-implementation (Intervention Site)
n=911 Participants
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)
n=495 Participants
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
|
Pre-implementation (Control Site)
n=1183 Participants
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)
n=641 Participants
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
|
|---|---|---|---|---|
|
Time From ED Arrival to Administration of First Dose of Antibiotics
|
173 minutes
Standard Deviation 98
|
165 minutes
Standard Deviation 95
|
169 minutes
Standard Deviation 90
|
163 minutes
Standard Deviation 85
|
SECONDARY outcome
Timeframe: Up to 1 yearOutcome measures
| Measure |
Pre-implementation (Intervention Site)
n=911 Participants
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)
n=495 Participants
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
|
Pre-implementation (Control Site)
n=1183 Participants
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)
n=641 Participants
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
|
|---|---|---|---|---|
|
Hospital Mortality
|
19 Participants
|
7 Participants
|
23 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Up to 1 weekTime (minutes) from ED arrival to ED departure
Outcome measures
| Measure |
Pre-implementation (Intervention Site)
n=911 Participants
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)
n=495 Participants
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
|
Pre-implementation (Control Site)
n=1183 Participants
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)
n=641 Participants
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
|
|---|---|---|---|---|
|
ED Length of Stay
|
280 minutes
Standard Deviation 1143
|
265 minutes
Standard Deviation 110
|
269 minutes
Standard Deviation 108
|
261 minutes
Standard Deviation 98
|
SECONDARY outcome
Timeframe: Up to 24 hoursPopulation: Time of physician initial patient evaluation was missing for a small number of participants in each group
Time (minutes) from subject's arrival in the ED until initial evaluation by a physician.
Outcome measures
| Measure |
Pre-implementation (Intervention Site)
n=901 Participants
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)
n=489 Participants
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
|
Pre-implementation (Control Site)
n=1164 Participants
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)
n=624 Participants
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
|
|---|---|---|---|---|
|
Door-to-physician Evaluation Time
|
25 minutes
Standard Deviation 18
|
23 minutes
Standard Deviation 15
|
22 minutes
Standard Deviation 24
|
20 minutes
Standard Deviation 16
|
Adverse Events
Pre-implementation (Intervention Site)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 19 deaths
Post-implementation (Intervention Site)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 7 deaths
Pre-implementation (Control Site)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 23 deaths
Post-implementation (Control Site)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 11 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director, Office of Research
Intermountain Healthcare
Phone: (801) 408-1991
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place