CLUSTER Trial for Outbreak Detection and Response

Harvard Pilgrim Health Care

Status: Active, not recruiting

Conditions: Cluster Detection

Treatments: Other: Routine cluster detection; Other: Enhanced cluster detection

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04053075

PH000599B

Details and patient eligibility

About

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

Enrollment: 82 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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82 participants in 2 patient groups

Routine cluster detection

Active Comparator group

Description:

Hospitals will use routine practices for cluster detection with a structured cluster response protocol when a cluster is detected.

Treatment:

Other: Routine cluster detection

Enhanced cluster detection

Active Comparator group

Description:

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.

Treatment:

Other: Enhanced cluster detection