Trial Outcomes & Findings for CLUSTER Trial for Outbreak Detection and Response (NCT NCT04053075)
NCT ID: NCT04053075
Last Updated: 2025-01-16
Results Overview
Cluster size defined as number of cases identified after the initial cluster signal through the last cluster case. NOTE: this outcome is intended for the primary manuscript.
COMPLETED
NA
2905455 participants
30 months
2025-01-16
Participant Flow
82 out of 182 HCA Healthcare hospitals were recruited for this trial. There was a 30 month intervention period from July 2019 through January 2022.
2,905,455 patients were involved in the intervention period from the 82 participating hospitals.
Unit of analysis: Hospitals
Participant milestones
| Measure |
Routine Cluster Detection
Hospitals will use routine practices for cluster detection with a structured cluster response protocol when a cluster is detected.
Routine cluster detection: Hospitals will use routine practices for cluster detection with a structured cluster response protocol when a cluster is detected.
|
Enhanced Cluster Detection
Hospitals will use an automated statistical cluster detection tool in addition to routine practices for cluster detection with a structured cluster response protocol when a cluster is detected.
Enhanced cluster detection: Hospitals will use an automated statistical cluster detection tool in addition to routine practices for cluster detection with a structured cluster response protocol when a cluster is detected.
|
|---|---|---|
|
Overall Study
STARTED
|
1446854 41
|
1458601 41
|
|
Overall Study
COMPLETED
|
1446854 39
|
1458601 40
|
|
Overall Study
NOT COMPLETED
|
0 2
|
0 1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
Baseline characteristics by cohort
| Measure |
Arm 1: Routine Cluster Detection
n=1446854 Participants
Hospitals will use routine practices for cluster detection with a structured cluster response protocol when a cluster is detected.
Routine cluster detection: Hospitals will use routine practices for cluster detection with a structured cluster response protocol when a cluster is detected.
|
Arm 2: Enhanced Cluster Detection
n=1458601 Participants
Hospitals will use an automated statistical cluster detection tool in addition to routine practices for cluster detection with a structured cluster response protocol when a cluster is detected.
Enhanced cluster detection: Hospitals will use an automated statistical cluster detection tool in addition to routine practices for cluster detection with a structured cluster response protocol when a cluster is detected.
|
Total
n=2905455 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.0 years
n=1446854 Participants
|
56.0 years
n=1458601 Participants
|
57.0 years
n=2905455 Participants
|
|
Sex: Female, Male
Female
|
800932 Participants
n=1443661 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
|
805509 Participants
n=1454501 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
|
1606441 Participants
n=2898162 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
|
|
Sex: Female, Male
Male
|
642729 Participants
n=1443661 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
|
648992 Participants
n=1454501 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
|
1291721 Participants
n=2898162 Participants • Small differences in the number of patients with various characteristics reflect missing data in the electronic health record.
|
|
Race/Ethnicity, Customized
Race · White
|
1017301 Participants
n=1446854 Participants
|
996468 Participants
n=1458601 Participants
|
2013769 Participants
n=2905455 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
196654 Participants
n=1446854 Participants
|
229501 Participants
n=1458601 Participants
|
426155 Participants
n=2905455 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
84017 Participants
n=1446854 Participants
|
65406 Participants
n=1458601 Participants
|
149423 Participants
n=2905455 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
148882 Participants
n=1446854 Participants
|
167226 Participants
n=1458601 Participants
|
316108 Participants
n=2905455 Participants
|
PRIMARY outcome
Timeframe: 30 monthsPopulation: The total number of participants analyzed reported here is from the intervention period.
Cluster size defined as number of cases identified after the initial cluster signal through the last cluster case. NOTE: this outcome is intended for the primary manuscript.
Outcome measures
| Measure |
Arm 1: Routine Cluster Detection
n=1446854 Participants
Hospitals will use routine practices for cluster detection with a structured cluster response protocol when a cluster is detected.
Routine cluster detection: Hospitals will use routine practices for cluster detection with a structured cluster response protocol when a cluster is detected.
|
Arm 2: Enhanced Cluster Detection
n=1458601 Participants
Hospitals will use an automated statistical cluster detection tool in addition to routine practices for cluster detection with a structured cluster response protocol when a cluster is detected.
Enhanced cluster detection: Hospitals will use an automated statistical cluster detection tool in addition to routine practices for cluster detection with a structured cluster response protocol when a cluster is detected.
|
|---|---|---|
|
Cluster Size
|
1.81 outbreak cases after first signal
Interval 1.11 to 2.96
|
1.41 outbreak cases after first signal
Interval 0.88 to 2.24
|
SECONDARY outcome
Timeframe: 30 monthsPopulation: The total number of participants analyzed reported here is from the intervention period.
Cluster duration defined as number of days from the initial cluster signal through the last cluster case. NOTE: this outcome is intended for the primary manuscript.
Outcome measures
| Measure |
Arm 1: Routine Cluster Detection
n=1446854 Participants
Hospitals will use routine practices for cluster detection with a structured cluster response protocol when a cluster is detected.
Routine cluster detection: Hospitals will use routine practices for cluster detection with a structured cluster response protocol when a cluster is detected.
|
Arm 2: Enhanced Cluster Detection
n=1458601 Participants
Hospitals will use an automated statistical cluster detection tool in addition to routine practices for cluster detection with a structured cluster response protocol when a cluster is detected.
Enhanced cluster detection: Hospitals will use an automated statistical cluster detection tool in addition to routine practices for cluster detection with a structured cluster response protocol when a cluster is detected.
|
|---|---|---|
|
Cluster Duration
|
1.12 days
Interval 0.81 to 1.56
|
0.88 days
Interval 0.64 to 1.21
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 monthsCompare the genetic relatedness of isolates within a cluster, defined by the automated cluster detection tool or routine cluster detection methods. NOTE: this exploratory analysis is intended for a secondary manuscript.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 30 monthsSubset analyses of trial outcomes (e.g., Gram-positive clusters, Gram-negative clusters, fungal clusters, Clostridium difficile \& multidrug-resistant organism clusters). NOTE: this exploratory analysis is intended for a secondary manuscript.
Outcome measures
Outcome data not reported
Adverse Events
Arm 1: Routine Cluster Detection
Arm 2: Enhanced Cluster Detection
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Meghan Baker, MD, ScD
Department of Population Medicine, Harvard Medical School/Harvard Pilgrim Healthcare Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place