CLUSTER Trial for Outbreak Detection and Response

Overview

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

Full Title of Study: “Cluster Linkage Using Statistics to Trigger and Evaluate Response (CLUSTER) Trial for Outbreak Detection and Response”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 23, 2024

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: Routine cluster detection
    • Hospitals will use routine practices for cluster detection with a structured cluster response protocol when a cluster is detected.
  • Active Comparator: 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.

Clinical Trial Outcome Measures

Primary Measures

  • Cluster size
    • Time Frame: 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 Measures

  • Cluster duration
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Harvard Pilgrim Health Care
  • Collaborator
    • Hospital Corporation of America (HCA) Healthcare
  • Provider of Information About this Clinical Study
    • Principal Investigator: Richard Platt, Professor and Department Chair – Harvard Pilgrim Health Care
  • Overall Official(s)
    • Richard Platt, MD, MS, Principal Investigator, Harvard Pilgrim Health Care Institute
    • Susan Huang, MD, MPH, Principal Investigator, University of California, Irvine
    • Meghan Baker, MD, ScD, Study Director, Brigham and Women’s Hospital

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