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CLUSTER Trial for Outbreak Detection and Response (CLUSTER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04053075
Recruitment Status : Active, not recruiting
First Posted : August 12, 2019
Last Update Posted : January 26, 2022
Sponsor:
Collaborators:
Hospital Corporation of America (HCA) Healthcare
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
Information provided by (Responsible Party):
Richard Platt, Harvard Pilgrim Health Care

Tracking Information
First Submitted Date  ICMJE August 8, 2019
First Posted Date  ICMJE August 12, 2019
Last Update Posted Date January 26, 2022
Actual Study Start Date  ICMJE July 23, 2019
Estimated Primary Completion Date December 23, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 8, 2019)
Cluster size [ Time Frame: 30 months ]
Cluster size defined as number of cluster cases identified after the initial cluster signal. NOTE: this outcome is intended for the primary manuscript.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2019)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2019)
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.
Current Other Pre-specified Outcome Measures
 (submitted: November 7, 2019)
  • Genetic relatedness of clusters of microbial isolates [ Time Frame: 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 [ Time Frame: 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.
Original Other Pre-specified Outcome Measures
 (submitted: August 8, 2019)
  • Genetic relatedness of clusters of microbial isolates [ Time Frame: 30 months ]
    Compare the genetic relatedness of isolates within a cluster, defined by both routine methods and the automated cluster detection tool. NOTE: this outcome is intended for a secondary manuscript.
  • Pathogen subgroup analysis [ Time Frame: 30 months ]
    Subset analyses of trial outcomes (e.g., Gram-positive clusters, Gram-negative clusters, fungal clusters, C. difficile & multidrug resistant organism clusters). NOTE: this outcome is intended for a secondary manuscript.
 
Descriptive Information
Brief Title  ICMJE CLUSTER Trial for Outbreak Detection and Response
Official Title  ICMJE Cluster Linkage Using Statistics to Trigger and Evaluate Response (CLUSTER) Trial for Outbreak Detection and Response
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Cluster randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Cluster Detection
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: Routine cluster detection
    Hospitals will use routine practices for cluster detection with a structured cluster response protocol when a cluster is detected.
    Intervention: Other: Routine cluster detection
  • 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.
    Intervention: Other: Enhanced cluster detection
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 8, 2019)
82
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 23, 2025
Estimated Primary Completion Date December 23, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04053075
Other Study ID Numbers  ICMJE PH000599B
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Richard Platt, Harvard Pilgrim Health Care
Study Sponsor  ICMJE Harvard Pilgrim Health Care
Collaborators  ICMJE
  • Hospital Corporation of America (HCA) Healthcare
  • 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
Investigators  ICMJE
Principal Investigator: Richard Platt, MD, MS Harvard Pilgrim Health Care Institute
Principal Investigator: Susan Huang, MD, MPH University of California, Irvine
Study Director: Meghan Baker, MD, ScD Brigham and Women's Hospital
PRS Account Harvard Pilgrim Health Care
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP