N/A
N=2,905,455
CLUSTER Trial for Outbreak Detection and Response
Cluster Detection
Bottom Line
View on ClinicalTrials.gov: NCT04053075 ↗Enrolled (actual)
2,905,455
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Cluster Size — 1.81; 1.41 outbreak cases after first signal
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Routine cluster detection (Other); Enhanced cluster detection (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Harvard Pilgrim Health Care
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cluster Size |
1.81; 1.41 | — |
| SECONDARY Cluster Duration |
1.12; 0.88 | — |
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
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT04053075). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.