Trial Outcomes & Findings for Effects of Code Sepsis Implementation on Emergency Department (ED) Sepsis Care (NCT NCT04148989)
NCT ID: NCT04148989
Last Updated: 2024-03-05
Results Overview
Time from sepsis patients' emergency department arrival to intravenous (or equivalent) antibiotic initiation
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
180402 participants
Primary outcome timeframe
Up to 24 hours from ED arrival (an average of 3 hours)
Results posted on
2024-03-05
Participant Flow
Unit of analysis: Hospitals
Participant milestones
| Measure |
Pre-implementation Usual Care (Intervention Site)
Adult patients age ≥18 years who received usual care after presenting with sepsis to the intervention hospital emergency department before implementation of sepsis care reorganization (Code Sepsis implementation).
|
Code Sepsis Post-implementation (Intervention Site)
Adult patients age ≥18 years exposed to the intervention after presenting to the intervention hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation).
Code Sepsis protocol (full implementation): Implementation of a coordinated, structured, multidisciplinary team-based protocol for initial evaluation and treatment of ED patients with suspected sepsis.
|
Pre-implementation Usual Care (Control Sites)
Adult patients age ≥18 years who received usual care after presenting to the control hospital emergency department with sepsis before implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital.
|
Post-implementation Usual Care (Control Sites)
Adult patients age ≥18 years who receive usual care after presenting to the control hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital.
|
|---|---|---|---|---|
|
Pre-implmentation Period
STARTED
|
50437 1
|
0 0
|
56192 2
|
0 0
|
|
Pre-implmentation Period
COMPLETED
|
50437 1
|
0 0
|
56192 2
|
0 0
|
|
Pre-implmentation Period
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
|
Post-implmementation Period
STARTED
|
0 0
|
33415 1
|
0 0
|
40358 2
|
|
Post-implmementation Period
COMPLETED
|
0 0
|
33415 1
|
0 0
|
40358 2
|
|
Post-implmementation Period
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Code Sepsis Implementation on Emergency Department (ED) Sepsis Care
Baseline characteristics by cohort
| Measure |
Pre-implementation Usual Care (Intervention Site)
n=50437 Participants
Adult patients age ≥18 years who received usual care after presenting with sepsis to the intervention hospital emergency department before implementation of sepsis care reorganization (Code Sepsis implementation).
|
Code Sepsis Post-implementation (Intervention Site)
n=33415 Participants
Adult patients age ≥18 years presenting to the intervention hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation).
Code Sepsis protocol (full implementation): Implementation of a coordinated, structured, multidisciplinary team-based protocol for initial evaluation and treatment of ED patients with suspected sepsis.
|
Pre-implementation Usual Care (Control Sites)
n=56192 Participants
Adult patients age ≥18 years who received usual care after presenting to the control hospital emergency department with sepsis before implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital.
|
Post-implementation Usual Care (Control Sites)
n=40358 Participants
Adult patients age ≥18 years who receive usual care after presenting to the control hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital.
|
Total
n=180402 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
43 years
n=5 Participants
|
45 years
n=7 Participants
|
49 years
n=5 Participants
|
47 years
n=4 Participants
|
47 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
27762 Participants
n=5 Participants
|
17177 Participants
n=7 Participants
|
30458 Participants
n=5 Participants
|
20624 Participants
n=4 Participants
|
96021 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
22675 Participants
n=5 Participants
|
16238 Participants
n=7 Participants
|
25734 Participants
n=5 Participants
|
19734 Participants
n=4 Participants
|
84381 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8710 Participants
n=5 Participants
|
6354 Participants
n=7 Participants
|
6189 Participants
n=5 Participants
|
5176 Participants
n=4 Participants
|
26429 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40120 Participants
n=5 Participants
|
25458 Participants
n=7 Participants
|
48753 Participants
n=5 Participants
|
33541 Participants
n=4 Participants
|
147872 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1607 Participants
n=5 Participants
|
1603 Participants
n=7 Participants
|
1250 Participants
n=5 Participants
|
1641 Participants
n=4 Participants
|
6101 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
660 Participants
n=5 Participants
|
418 Participants
n=7 Participants
|
771 Participants
n=5 Participants
|
567 Participants
n=4 Participants
|
2416 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1012 Participants
n=5 Participants
|
802 Participants
n=7 Participants
|
475 Participants
n=5 Participants
|
362 Participants
n=4 Participants
|
2651 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1802 Participants
n=5 Participants
|
1099 Participants
n=7 Participants
|
895 Participants
n=5 Participants
|
703 Participants
n=4 Participants
|
4499 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1456 Participants
n=5 Participants
|
951 Participants
n=7 Participants
|
704 Participants
n=5 Participants
|
471 Participants
n=4 Participants
|
3582 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
41684 Participants
n=5 Participants
|
26964 Participants
n=7 Participants
|
51444 Participants
n=5 Participants
|
36003 Participants
n=4 Participants
|
156095 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
110 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
111 Participants
n=4 Participants
|
448 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3713 Participants
n=5 Participants
|
3069 Participants
n=7 Participants
|
1788 Participants
n=5 Participants
|
2141 Participants
n=4 Participants
|
10711 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
50437 Participants
n=5 Participants
|
33415 Participants
n=7 Participants
|
56192 Participants
n=5 Participants
|
40358 Participants
n=4 Participants
|
180402 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 24 hours from ED arrival (an average of 3 hours)Population: Restricted to participants who met sepsis criteria (acute organ failure plus suspected or confirmed infection) before ED departure.
Time from sepsis patients' emergency department arrival to intravenous (or equivalent) antibiotic initiation
Outcome measures
| Measure |
Pre-implementation Usual Care (Intervention Site) - Sepsis Patients
n=2384 Participants
Adult patients age ≥18 years who received usual care after presenting with sepsis to the intervention hospital emergency department before implementation of sepsis care reorganization (Code Sepsis implementation).
|
Code Sepsis Post-implementation (Intervention Site) - Sepsis Patients
n=2075 Participants
Adult patients age ≥18 years presenting with sepsis to the intervention hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation).
Code Sepsis protocol (full implementation): Implementation of a coordinated, structured, multidisciplinary team-based protocol for initial evaluation and treatment of ED patients with suspected sepsis.
|
Pre-implementation Usual Care (Control Sites) - Sepsis Patients
n=2976 Participants
Adult patients age ≥18 years who received usual care after presenting with sepsis to the control hospital emergency department with sepsis before implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital.
|
Post-implementation Usual Care (Control Sites) - Sepsis Patients
n=2716 Participants
Adult patients age ≥18 years who receive usual care after presenting with sepsis to the control hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital.
|
|---|---|---|---|---|
|
Door-to-antibiotic Time
|
160 minutes
Interval 114.0 to 219.0
|
146 minutes
Interval 102.0 to 205.0
|
139 minutes
Interval 102.0 to 176.0
|
140 minutes
Interval 105.0 to 177.0
|
SECONDARY outcome
Timeframe: 30 days after ED arrivalPopulation: Restricted to participants who met sepsis criteria (acute organ failure plus suspected or confirmed infection) before ED departure.
Sepsis patient death on or before the 30th day after ED arrival
Outcome measures
| Measure |
Pre-implementation Usual Care (Intervention Site) - Sepsis Patients
n=2384 Participants
Adult patients age ≥18 years who received usual care after presenting with sepsis to the intervention hospital emergency department before implementation of sepsis care reorganization (Code Sepsis implementation).
|
Code Sepsis Post-implementation (Intervention Site) - Sepsis Patients
n=2075 Participants
Adult patients age ≥18 years presenting with sepsis to the intervention hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation).
Code Sepsis protocol (full implementation): Implementation of a coordinated, structured, multidisciplinary team-based protocol for initial evaluation and treatment of ED patients with suspected sepsis.
|
Pre-implementation Usual Care (Control Sites) - Sepsis Patients
n=2976 Participants
Adult patients age ≥18 years who received usual care after presenting with sepsis to the control hospital emergency department with sepsis before implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital.
|
Post-implementation Usual Care (Control Sites) - Sepsis Patients
n=2716 Participants
Adult patients age ≥18 years who receive usual care after presenting with sepsis to the control hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital.
|
|---|---|---|---|---|
|
All-cause 30-day Mortality
|
201 Participants
|
262 Participants
|
280 Participants
|
332 Participants
|
SECONDARY outcome
Timeframe: 1 year after ED arrivalPopulation: Restricted to participants who met sepsis criteria (acute organ failure plus suspected or confirmed infection) before ED departure.
Sepsis patient death on or before the 365th day after ED arrival
Outcome measures
| Measure |
Pre-implementation Usual Care (Intervention Site) - Sepsis Patients
n=2384 Participants
Adult patients age ≥18 years who received usual care after presenting with sepsis to the intervention hospital emergency department before implementation of sepsis care reorganization (Code Sepsis implementation).
|
Code Sepsis Post-implementation (Intervention Site) - Sepsis Patients
n=2075 Participants
Adult patients age ≥18 years presenting with sepsis to the intervention hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation).
Code Sepsis protocol (full implementation): Implementation of a coordinated, structured, multidisciplinary team-based protocol for initial evaluation and treatment of ED patients with suspected sepsis.
|
Pre-implementation Usual Care (Control Sites) - Sepsis Patients
n=2976 Participants
Adult patients age ≥18 years who received usual care after presenting with sepsis to the control hospital emergency department with sepsis before implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital.
|
Post-implementation Usual Care (Control Sites) - Sepsis Patients
n=2716 Participants
Adult patients age ≥18 years who receive usual care after presenting with sepsis to the control hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital.
|
|---|---|---|---|---|
|
All-cause 1-year Mortality
|
467 Participants
|
483 Participants
|
603 Participants
|
628 Participants
|
SECONDARY outcome
Timeframe: From the time of admission to hospital discharge (up to 1 year, average 14 days)Population: Restricted to participants who met sepsis criteria (acute organ failure plus suspected or confirmed infection) before ED departure.
Sepsis patient death prior to hospital discharge
Outcome measures
| Measure |
Pre-implementation Usual Care (Intervention Site) - Sepsis Patients
n=2384 Participants
Adult patients age ≥18 years who received usual care after presenting with sepsis to the intervention hospital emergency department before implementation of sepsis care reorganization (Code Sepsis implementation).
|
Code Sepsis Post-implementation (Intervention Site) - Sepsis Patients
n=2075 Participants
Adult patients age ≥18 years presenting with sepsis to the intervention hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation).
Code Sepsis protocol (full implementation): Implementation of a coordinated, structured, multidisciplinary team-based protocol for initial evaluation and treatment of ED patients with suspected sepsis.
|
Pre-implementation Usual Care (Control Sites) - Sepsis Patients
n=2976 Participants
Adult patients age ≥18 years who received usual care after presenting with sepsis to the control hospital emergency department with sepsis before implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital.
|
Post-implementation Usual Care (Control Sites) - Sepsis Patients
n=2716 Participants
Adult patients age ≥18 years who receive usual care after presenting with sepsis to the control hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital.
|
|---|---|---|---|---|
|
All-cause In-hospital Mortality
|
113 Participants
|
148 Participants
|
149 Participants
|
190 Participants
|
SECONDARY outcome
Timeframe: From the time of admission to hospital discharge (up to 1 year, average 14 days)Population: Restricted to participants who met sepsis criteria (acute organ failure plus suspected or confirmed infection) before ED departure. Subjects who met sepsis criteria but were missing outcome data (N=80 overall) were also excluded from this analysis.
Amount charged to sepsis patient for their medical care during index ED visit and associated hospitalization
Outcome measures
| Measure |
Pre-implementation Usual Care (Intervention Site) - Sepsis Patients
n=2366 Participants
Adult patients age ≥18 years who received usual care after presenting with sepsis to the intervention hospital emergency department before implementation of sepsis care reorganization (Code Sepsis implementation).
|
Code Sepsis Post-implementation (Intervention Site) - Sepsis Patients
n=2061 Participants
Adult patients age ≥18 years presenting with sepsis to the intervention hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation).
Code Sepsis protocol (full implementation): Implementation of a coordinated, structured, multidisciplinary team-based protocol for initial evaluation and treatment of ED patients with suspected sepsis.
|
Pre-implementation Usual Care (Control Sites) - Sepsis Patients
n=2952 Participants
Adult patients age ≥18 years who received usual care after presenting with sepsis to the control hospital emergency department with sepsis before implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital.
|
Post-implementation Usual Care (Control Sites) - Sepsis Patients
n=2692 Participants
Adult patients age ≥18 years who receive usual care after presenting with sepsis to the control hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital.
|
|---|---|---|---|---|
|
Hospital Charges
|
7.3 US dollars * 1000
Interval 3.6 to 14.3
|
15.0 US dollars * 1000
Interval 7.0 to 32.7
|
7.6 US dollars * 1000
Interval 3.8 to 14.7
|
15.2 US dollars * 1000
Interval 7.6 to 30.1
|
SECONDARY outcome
Timeframe: From the time of admission to hospital discharge (up to 1 year, average 14 days)Population: Restricted to participants who met sepsis criteria (acute organ failure plus suspected or confirmed infection) before ED departure.
Length of time from sepsis patients' ED arrival until hospital discharge
Outcome measures
| Measure |
Pre-implementation Usual Care (Intervention Site) - Sepsis Patients
n=2384 Participants
Adult patients age ≥18 years who received usual care after presenting with sepsis to the intervention hospital emergency department before implementation of sepsis care reorganization (Code Sepsis implementation).
|
Code Sepsis Post-implementation (Intervention Site) - Sepsis Patients
n=2075 Participants
Adult patients age ≥18 years presenting with sepsis to the intervention hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation).
Code Sepsis protocol (full implementation): Implementation of a coordinated, structured, multidisciplinary team-based protocol for initial evaluation and treatment of ED patients with suspected sepsis.
|
Pre-implementation Usual Care (Control Sites) - Sepsis Patients
n=2976 Participants
Adult patients age ≥18 years who received usual care after presenting with sepsis to the control hospital emergency department with sepsis before implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital.
|
Post-implementation Usual Care (Control Sites) - Sepsis Patients
n=2716 Participants
Adult patients age ≥18 years who receive usual care after presenting with sepsis to the control hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital.
|
|---|---|---|---|---|
|
Hospital Length of Stay
|
2.7 days
Interval 1.0 to 5.0
|
3.0 days
Interval 1.1 to 6.1
|
2.7 days
Interval 1.1 to 4.8
|
2.9 days
Interval 1.2 to 5.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 24 hours from ED arrival (an average of 6 hours)Fraction of all ED patients receiving antibiotics within 24 hours of ED arrival
Outcome measures
| Measure |
Pre-implementation Usual Care (Intervention Site) - Sepsis Patients
n=50437 Participants
Adult patients age ≥18 years who received usual care after presenting with sepsis to the intervention hospital emergency department before implementation of sepsis care reorganization (Code Sepsis implementation).
|
Code Sepsis Post-implementation (Intervention Site) - Sepsis Patients
n=33415 Participants
Adult patients age ≥18 years presenting with sepsis to the intervention hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation).
Code Sepsis protocol (full implementation): Implementation of a coordinated, structured, multidisciplinary team-based protocol for initial evaluation and treatment of ED patients with suspected sepsis.
|
Pre-implementation Usual Care (Control Sites) - Sepsis Patients
n=56192 Participants
Adult patients age ≥18 years who received usual care after presenting with sepsis to the control hospital emergency department with sepsis before implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital.
|
Post-implementation Usual Care (Control Sites) - Sepsis Patients
n=40358 Participants
Adult patients age ≥18 years who receive usual care after presenting with sepsis to the control hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital.
|
|---|---|---|---|---|
|
Antibiotic Utilization'
|
5404 Participants
|
3834 Participants
|
6039 Participants
|
4458 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From the time of ED arrival to hospital discharge (up to 1 year, average 14 days)Population: Restricted to participants who met sepsis criteria (acute organ failure plus suspected or confirmed infection) before ED departure.
Measured as the fraction of sepsis patients with a discharge diagnosis code consistent with anaphylaxis or with an adverse reaction to antibiotics
Outcome measures
| Measure |
Pre-implementation Usual Care (Intervention Site) - Sepsis Patients
n=2384 Participants
Adult patients age ≥18 years who received usual care after presenting with sepsis to the intervention hospital emergency department before implementation of sepsis care reorganization (Code Sepsis implementation).
|
Code Sepsis Post-implementation (Intervention Site) - Sepsis Patients
n=2075 Participants
Adult patients age ≥18 years presenting with sepsis to the intervention hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation).
Code Sepsis protocol (full implementation): Implementation of a coordinated, structured, multidisciplinary team-based protocol for initial evaluation and treatment of ED patients with suspected sepsis.
|
Pre-implementation Usual Care (Control Sites) - Sepsis Patients
n=2976 Participants
Adult patients age ≥18 years who received usual care after presenting with sepsis to the control hospital emergency department with sepsis before implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital.
|
Post-implementation Usual Care (Control Sites) - Sepsis Patients
n=2716 Participants
Adult patients age ≥18 years who receive usual care after presenting with sepsis to the control hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital.
|
|---|---|---|---|---|
|
Adverse Effects of Antibiotics (Sepsis Patients)
|
79 Participants
|
66 Participants
|
79 Participants
|
63 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From the time of ED arrival to hospital discharge (up to 1 year, average 14 days)Measured as the fraction of all ED patients with a discharge diagnosis code consistent with anaphylaxis or with an adverse reaction to antibiotics
Outcome measures
| Measure |
Pre-implementation Usual Care (Intervention Site) - Sepsis Patients
n=50437 Participants
Adult patients age ≥18 years who received usual care after presenting with sepsis to the intervention hospital emergency department before implementation of sepsis care reorganization (Code Sepsis implementation).
|
Code Sepsis Post-implementation (Intervention Site) - Sepsis Patients
n=33415 Participants
Adult patients age ≥18 years presenting with sepsis to the intervention hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation).
Code Sepsis protocol (full implementation): Implementation of a coordinated, structured, multidisciplinary team-based protocol for initial evaluation and treatment of ED patients with suspected sepsis.
|
Pre-implementation Usual Care (Control Sites) - Sepsis Patients
n=56192 Participants
Adult patients age ≥18 years who received usual care after presenting with sepsis to the control hospital emergency department with sepsis before implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital.
|
Post-implementation Usual Care (Control Sites) - Sepsis Patients
n=40358 Participants
Adult patients age ≥18 years who receive usual care after presenting with sepsis to the control hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital.
|
|---|---|---|---|---|
|
Adverse Effect of Antibiotics (All ED Patients)
|
259 Participants
|
172 Participants
|
287 Participants
|
202 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Beginning 72 hours after ED arrival to 90 days after ED arrivalPopulation: Restricted to participants who met sepsis criteria (acute organ failure plus suspected or confirmed infection) before ED departure. Patients with a positive stool test for Clostridium difficile colitis at baseline (from 14 days prior to ED arrival to 72 hours after ED arrival) were excluded from analysis.
Incidence of positive stool test for Clostridium difficile colitis between 72 hours and 90 days after ED arrival among ED sepsis patients and (2) all ED patients.
Outcome measures
| Measure |
Pre-implementation Usual Care (Intervention Site) - Sepsis Patients
n=2354 Participants
Adult patients age ≥18 years who received usual care after presenting with sepsis to the intervention hospital emergency department before implementation of sepsis care reorganization (Code Sepsis implementation).
|
Code Sepsis Post-implementation (Intervention Site) - Sepsis Patients
n=2054 Participants
Adult patients age ≥18 years presenting with sepsis to the intervention hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation).
Code Sepsis protocol (full implementation): Implementation of a coordinated, structured, multidisciplinary team-based protocol for initial evaluation and treatment of ED patients with suspected sepsis.
|
Pre-implementation Usual Care (Control Sites) - Sepsis Patients
n=2944 Participants
Adult patients age ≥18 years who received usual care after presenting with sepsis to the control hospital emergency department with sepsis before implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital.
|
Post-implementation Usual Care (Control Sites) - Sepsis Patients
n=2686 Participants
Adult patients age ≥18 years who receive usual care after presenting with sepsis to the control hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital.
|
|---|---|---|---|---|
|
New Onset Clostridium Difficile Colitis Incidence (Sepsis Patients)
|
28 Participants
|
20 Participants
|
44 Participants
|
30 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Beginning 72 hours after ED arrival to 90 days after ED arrival.Population: Patients with a positive stool test for Clostridium difficile colitis at baseline (from 14 days prior to ED arrival to 72 hours after ED arrival) were excluded from analysis.
Incidence of positive stool test for Clostridium difficile colitis between 72 hours and 90 days after ED arrival among all ED patients.
Outcome measures
| Measure |
Pre-implementation Usual Care (Intervention Site) - Sepsis Patients
n=50363 Participants
Adult patients age ≥18 years who received usual care after presenting with sepsis to the intervention hospital emergency department before implementation of sepsis care reorganization (Code Sepsis implementation).
|
Code Sepsis Post-implementation (Intervention Site) - Sepsis Patients
n=33376 Participants
Adult patients age ≥18 years presenting with sepsis to the intervention hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation).
Code Sepsis protocol (full implementation): Implementation of a coordinated, structured, multidisciplinary team-based protocol for initial evaluation and treatment of ED patients with suspected sepsis.
|
Pre-implementation Usual Care (Control Sites) - Sepsis Patients
n=56088 Participants
Adult patients age ≥18 years who received usual care after presenting with sepsis to the control hospital emergency department with sepsis before implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital.
|
Post-implementation Usual Care (Control Sites) - Sepsis Patients
n=40288 Participants
Adult patients age ≥18 years who receive usual care after presenting with sepsis to the control hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital.
|
|---|---|---|---|---|
|
New Onset Clostridium Difficile Colitis Incidence (All ED Patients)
|
104 Participants
|
61 Participants
|
172 Participants
|
79 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 24 hours from ED arrival (an average of 6 hours)Population: Restricted to patients who had a primary hospital discharge diagnosis of congestive heart failure or venous thromboembolism and no discharge diagnosis consistent with infection
Fraction of ED patients with a primary hospital discharge diagnosis of congestive heart failure or venous thromboembolism and no discharge diagnosis consistent with infection who received antibiotics in the ED
Outcome measures
| Measure |
Pre-implementation Usual Care (Intervention Site) - Sepsis Patients
n=1073 Participants
Adult patients age ≥18 years who received usual care after presenting with sepsis to the intervention hospital emergency department before implementation of sepsis care reorganization (Code Sepsis implementation).
|
Code Sepsis Post-implementation (Intervention Site) - Sepsis Patients
n=878 Participants
Adult patients age ≥18 years presenting with sepsis to the intervention hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation).
Code Sepsis protocol (full implementation): Implementation of a coordinated, structured, multidisciplinary team-based protocol for initial evaluation and treatment of ED patients with suspected sepsis.
|
Pre-implementation Usual Care (Control Sites) - Sepsis Patients
n=1081 Participants
Adult patients age ≥18 years who received usual care after presenting with sepsis to the control hospital emergency department with sepsis before implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital.
|
Post-implementation Usual Care (Control Sites) - Sepsis Patients
n=940 Participants
Adult patients age ≥18 years who receive usual care after presenting with sepsis to the control hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital.
|
|---|---|---|---|---|
|
Antibiotic Overtreatment Rate
|
48 Participants
|
42 Participants
|
45 Participants
|
58 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 24 hours from ED arrival (an average of 6 hours)Population: Restricted to participants who met sepsis criteria (acute organ failure plus suspected or confirmed infection) before ED departure. Patients who did not receive antibiotics (i.e., received no antimicrobials or received only antivirals or other non-antibiotic classes of antimicrobials) were excluded from this analysis.
Total antibiotic spectrum score for all unique antibiotics administered in first 24 hours using antibiotic spectrum scoring system developed by Stenehjem et al. (Clin Infect Dis 2016;63:1273-1280). Individual antibiotics have spectrum scores of 1 to 5, with the total score resulting from summation of the spectrum scores for each unique antibiotic administered during the first 24 hours. Minimum total 24-hour score is therefore 1 (administration of a single, minimum-spectrum antibiotic), with no maximum score. Higher values represent treatment with antibiotics with a broader spectrum.
Outcome measures
| Measure |
Pre-implementation Usual Care (Intervention Site) - Sepsis Patients
n=2337 Participants
Adult patients age ≥18 years who received usual care after presenting with sepsis to the intervention hospital emergency department before implementation of sepsis care reorganization (Code Sepsis implementation).
|
Code Sepsis Post-implementation (Intervention Site) - Sepsis Patients
n=2044 Participants
Adult patients age ≥18 years presenting with sepsis to the intervention hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation).
Code Sepsis protocol (full implementation): Implementation of a coordinated, structured, multidisciplinary team-based protocol for initial evaluation and treatment of ED patients with suspected sepsis.
|
Pre-implementation Usual Care (Control Sites) - Sepsis Patients
n=2942 Participants
Adult patients age ≥18 years who received usual care after presenting with sepsis to the control hospital emergency department with sepsis before implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital.
|
Post-implementation Usual Care (Control Sites) - Sepsis Patients
n=2704 Participants
Adult patients age ≥18 years who receive usual care after presenting with sepsis to the control hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital.
|
|---|---|---|---|---|
|
Antibiotic Spectrum (Sepsis Patients)
|
5 score on a scale
Interval 3.0 to 9.0
|
5 score on a scale
Interval 3.0 to 9.0
|
5 score on a scale
Interval 3.0 to 8.0
|
4 score on a scale
Interval 3.0 to 7.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 24 hours from ED arrival (an average of 6 hours)Population: Patients who did not receive antibiotics (i.e., received no antimicrobials or received only antivirals or other non-antibiotic classes of antimicrobials) were excluded from this analysis.
Total antibiotic spectrum score for all unique antibiotics administered in first 24 hours using antibiotic spectrum scoring system developed by Stenehjem et al. (Clin Infect Dis 2016;63:1273-1280). Individual antibiotics have spectrum scores of 1 to 5, with the total score resulting from summation of the spectrum scores for each unique antibiotic administered during the first 24 hours. Minimum total 24-hour score is therefore 1 (administration of a single, minimum-spectrum antibiotic), with no maximum score. Higher values represent treatment with antibiotics with a broader spectrum.
Outcome measures
| Measure |
Pre-implementation Usual Care (Intervention Site) - Sepsis Patients
n=6379 Participants
Adult patients age ≥18 years who received usual care after presenting with sepsis to the intervention hospital emergency department before implementation of sepsis care reorganization (Code Sepsis implementation).
|
Code Sepsis Post-implementation (Intervention Site) - Sepsis Patients
n=4672 Participants
Adult patients age ≥18 years presenting with sepsis to the intervention hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation).
Code Sepsis protocol (full implementation): Implementation of a coordinated, structured, multidisciplinary team-based protocol for initial evaluation and treatment of ED patients with suspected sepsis.
|
Pre-implementation Usual Care (Control Sites) - Sepsis Patients
n=7634 Participants
Adult patients age ≥18 years who received usual care after presenting with sepsis to the control hospital emergency department with sepsis before implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital.
|
Post-implementation Usual Care (Control Sites) - Sepsis Patients
n=5826 Participants
Adult patients age ≥18 years who receive usual care after presenting with sepsis to the control hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital.
|
|---|---|---|---|---|
|
Antibiotic Spectrum (All ED Patients)
|
3 score on a scale
Interval 3.0 to 5.0
|
3 score on a scale
Interval 3.0 to 5.0
|
3 score on a scale
Interval 3.0 to 5.0
|
3 score on a scale
Interval 3.0 to 5.0
|
Adverse Events
Pre-implementation Usual Care (Intervention Site)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 2085 deaths
Code Sepsis Post-implementation (Intervention Site)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 1426 deaths
Pre-implementation Usual Care (Control Sites)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 2520 deaths
Post-implementation Usual Care (Control Sites)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 1760 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pre-implementation Usual Care (Intervention Site)
n=50437 participants at risk
Adult patients age ≥18 years who received usual care after presenting with sepsis to the intervention hospital emergency department before implementation of sepsis care reorganization (Code Sepsis implementation).
|
Code Sepsis Post-implementation (Intervention Site)
n=33415 participants at risk
Adult patients age ≥18 years presenting to the intervention hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation).
Code Sepsis protocol (full implementation): Implementation of a coordinated, structured, multidisciplinary team-based protocol for initial evaluation and treatment of ED patients with suspected sepsis.
|
Pre-implementation Usual Care (Control Sites)
n=56192 participants at risk
Adult patients age ≥18 years who received usual care after presenting to the control hospital emergency department with sepsis before implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital.
|
Post-implementation Usual Care (Control Sites)
n=40358 participants at risk
Adult patients age ≥18 years who receive usual care after presenting to the control hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital.
|
|---|---|---|---|---|
|
Immune system disorders
Anaphylaxis
|
0.08%
2/2384 • 1 year
Reportable adverse events of anaphylaxis or anaphylaxis-like adverse events were defined as events occurring within 72 hours of ED arrival in the subset of subjects who met sepsis criterial in the emergency department. Per protocol, reportable serious adverse events and non-serious adverse events were defined as events possibly, probably, or definitely related to study procedures (or of uncertain relationship). Non-reportable serious and non-serious adverse events were not recorded.
|
0.14%
3/2075 • 1 year
Reportable adverse events of anaphylaxis or anaphylaxis-like adverse events were defined as events occurring within 72 hours of ED arrival in the subset of subjects who met sepsis criterial in the emergency department. Per protocol, reportable serious adverse events and non-serious adverse events were defined as events possibly, probably, or definitely related to study procedures (or of uncertain relationship). Non-reportable serious and non-serious adverse events were not recorded.
|
0.03%
1/2976 • 1 year
Reportable adverse events of anaphylaxis or anaphylaxis-like adverse events were defined as events occurring within 72 hours of ED arrival in the subset of subjects who met sepsis criterial in the emergency department. Per protocol, reportable serious adverse events and non-serious adverse events were defined as events possibly, probably, or definitely related to study procedures (or of uncertain relationship). Non-reportable serious and non-serious adverse events were not recorded.
|
0.07%
2/2716 • 1 year
Reportable adverse events of anaphylaxis or anaphylaxis-like adverse events were defined as events occurring within 72 hours of ED arrival in the subset of subjects who met sepsis criterial in the emergency department. Per protocol, reportable serious adverse events and non-serious adverse events were defined as events possibly, probably, or definitely related to study procedures (or of uncertain relationship). Non-reportable serious and non-serious adverse events were not recorded.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place