Cluster Detection
Conditions
Keywords
Hospital Outbreak Detection, Hospital Outbreak Response, Cluster, Multidrug Resistant Organism, Genetic Relatedness, Whole Genome Sequencing
Brief summary
Despite the critical importance of identifying hospital-associated outbreaks as early as possible in order to limit their spread, there are currently no standardized methods for cluster detection. The CLUSTER Trial (Cluster Linkage Using Statistics to Trigger and Evaluate Response) will assess whether a statistically-based automated cluster detection method coupled with a robust response protocol will enable rapid containment of hospital clusters as measured by a reduction in cluster size and duration as compared to routine hospital cluster detection methods coupled with the same response protocol. Note: that enrolled subjects represents 82 individual HCA Healthcare hospitals that have been randomized
Interventions
OTHERRoutine cluster detection
Hospitals will use routine practices for cluster detection with a structured cluster response protocol when a cluster is detected.
OTHEREnhanced 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.
Sponsors
Hospital Corporation of America
Brigham and Women's Hospital
University of California, Irvine
Harvard School of Public Health (HSPH)
Rush University
Duke University
University of Massachusetts, Amherst
University of California, San Francisco
Cook County Health & Hospitals System
Centers for Disease Control and Prevention
Harvard Pilgrim Health Care
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Cluster randomized controlled trial
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Facility Inclusion Criteria: * All U.S. HCA Healthcare hospitals that provide inpatient care. * Facilities that are reporting to the centralized data warehouse during the study period. Facility
Exclusion criteria
\- Note: unit of randomization is the hospital.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cluster Size | 30 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cluster Duration | 30 months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Genetic Relatedness of Clusters of Microbial Isolates | 30 months | Compare 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. |
| Pathogen Subgroup Analysis | 30 months | Subset 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
2,905,455 patients were involved in the intervention period from the 82 participating hospitals.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: 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. | 1,446,854 |
| Arm 2: 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. | 1,458,601 |
| Total | 2,905,455 |
Baseline characteristics
| Characteristic | Arm 1: Routine Cluster Detection | Arm 2: Enhanced Cluster Detection | Total |
|---|---|---|---|
| Age, Continuous | 58.0 years | 56.0 years | 57.0 years |
| Race/Ethnicity, Customized Race Black | 196654 Participants | 229501 Participants | 426155 Participants |
| Race/Ethnicity, Customized Race Other | 84017 Participants | 65406 Participants | 149423 Participants |
| Race/Ethnicity, Customized Race Unknown | 148882 Participants | 167226 Participants | 316108 Participants |
| Race/Ethnicity, Customized Race White | 1017301 Participants | 996468 Participants | 2013769 Participants |
| Sex: Female, Male Female | 800932 Participants | 805509 Participants | 1606441 Participants |
| Sex: Female, Male Male | 642729 Participants | 648992 Participants | 1291721 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,446,854 | 0 / 1,458,601 |
| other Total, other adverse events | 0 / 1,446,854 | 0 / 1,458,601 |
| serious Total, serious adverse events | 0 / 1,446,854 | 0 / 1,458,601 |
Outcome results
Primary
Cluster Size
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.
Time frame: 30 months
Population: The total number of participants analyzed reported here is from the intervention period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: Routine Cluster Detection | Cluster Size | 1.81 outbreak cases after first signal |
| Arm 2: Enhanced Cluster Detection | Cluster Size | 1.41 outbreak cases after first signal |
Secondary
Cluster Duration
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.
Time frame: 30 months
Population: The total number of participants analyzed reported here is from the intervention period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1: Routine Cluster Detection | Cluster Duration | 1.12 days |
| Arm 2: Enhanced Cluster Detection | Cluster Duration | 0.88 days |
Other Pre-specified
Genetic Relatedness of Clusters of Microbial Isolates
Compare 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.
Time frame: 30 months
Other Pre-specified
Pathogen Subgroup Analysis
Subset 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.
Time frame: 30 months