CLUSTER Trial for Outbreak Detection and Response

Study Overview
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Brief Summary
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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

Official Title
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Cluster Linkage Using Statistics to Trigger and Evaluate Response (CLUSTER) Trial for Outbreak Detection and Response

Conditions
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Cluster Detection

Intervention / Treatment
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* Other: Routine cluster detection
* Other: Enhanced cluster detection


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Routine cluster detection<br>Hospitals will use routine practices for cluster detection with a structured cluster response protocol when a cluster is detected. | Other: Routine cluster detection<br>* Hospitals will use routine practices for cluster detection with a structured cluster response protocol when a cluster is detected.<br>|
| Active Comparator: Enhanced cluster detection<br>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. | Other: Enhanced cluster detection<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hospital Outbreak Detection, Hospital Outbreak Response, Cluster, Multidrug Resistant Organism, Genetic Relatedness, Whole Genome Sequencing