CLUSTER Trial for Outbreak Detection and Response (CLUSTER)

September 22, 2023 updated by: Richard Platt, Harvard Pilgrim Health Care

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

82

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Riverside, California, United States, 92501
        • Riverside Community Hospital
      • San Jose, California, United States, 95116
        • Regional Medical Center of San Jose
      • Thousand Oaks, California, United States, 91360
        • Los Robles Regional Medical Center
    • Colorado
      • Denver, Colorado, United States, 80220
        • Rose Medical Center
      • Denver, Colorado, United States, 80113
        • Swedish Medical Center
      • Denver, Colorado, United States, 80124
        • Sky Ridge Medical Center
      • Denver, Colorado, United States, 80218
        • Presbyterian St. Luke's Medical Center
      • Thornton, Colorado, United States, 80229
        • North Suburban Medical Center - JV
    • Florida
      • Atlantis, Florida, United States, 33462
        • JFK Medical Center
      • Brandon, Florida, United States, 33511
        • Brandon Regional
      • Fort Pierce, Florida, United States, 34950
        • Lawnwood Regional Medical Center
      • Jacksonville, Florida, United States, 32216
        • Memorial Hospital Jacksonville
      • Lake City, Florida, United States, 32055
        • Lake City Medical Center
      • Largo, Florida, United States, 33770
        • Largo Medical Center
      • Ocala, Florida, United States, 34471
        • Ocala Regional Medical Center
      • Ocala, Florida, United States, 34474
        • West Marion Community Hospital
      • Okeechobee, Florida, United States, 34972
        • Raulerson Hospital
      • Orange Park, Florida, United States, 32073
        • Orange Park Medical Center
      • Panama City, Florida, United States, 32405
        • Gulf Coast Medical Center
      • Pensacola, Florida, United States, 32514
        • West Florida Hospital
      • Port Charlotte, Florida, United States, 33952
        • Fawcett Memorial Hospital
      • Port Saint Lucie, Florida, United States, 34952
        • St. Lucie Medical Center
      • Saint Petersburg, Florida, United States, 33709
        • Northside Hospital
      • Sanford, Florida, United States, 32771
        • Central Florida Regional Hospital
      • Sarasota, Florida, United States, 34233
        • Doctor's Hospital Sarasota
      • Sun City Center, Florida, United States, 33573
        • South Bay Hospital
      • Trinity, Florida, United States, 34655
        • Medical Center of Trinity
      • West Palm Beach, Florida, United States, 33407
        • JFK Medical Center - North Campus
    • Georgia
      • Dublin, Georgia, United States, 31021
        • Fairview Park
      • Rome, Georgia, United States, 30165
        • Redmond Regional Medical Center
      • Snellville, Georgia, United States, 30078
        • Eastside Medical Center
    • Idaho
      • Caldwell, Idaho, United States, 83605
        • West Valley Medical Center
      • Idaho Falls, Idaho, United States, 83404
        • Eastern Idaho Regional
    • Kansas
      • Overland Park, Kansas, United States, 66209
        • Menorah Medical Center
      • Overland Park, Kansas, United States, 66215
        • Overland Park Regional Medical Center
      • Wichita, Kansas, United States, 67214
        • Wesley Medical Center
      • Wichita, Kansas, United States, 67220
        • Wesley Woodlawn Hospital
    • Kentucky
      • Bowling Green, Kentucky, United States, 42104
        • Greenview Regional Hospital
    • Mississippi
      • Gulfport, Mississippi, United States, 39503
        • Garden Park Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Research Medical Center
      • Lee's Summit, Missouri, United States, 64063
        • Lee's Summit Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Mountainview Hospital - Vegas
    • New Hampshire
      • Derry, New Hampshire, United States, 03038
        • Parkland Medical Center
      • Portsmouth, New Hampshire, United States, 03801
        • Portsmouth Regional Hospital
    • Pennsylvania
      • Fredericksburg, Pennsylvania, United States, 22408
        • Spotsylvania Regional Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Trident Regional Medical Center
      • Myrtle Beach, South Carolina, United States, 29572
        • Grand Strand Regional Medical Center
      • Summerville, South Carolina, United States, 29485
        • Summerville Medical Center
      • Walterboro, South Carolina, United States, 29488
        • Colleton Medical Center
    • Tennessee
      • Dickson, Tennessee, United States, 37055
        • TriStar Horizon Medical Center
      • Hermitage, Tennessee, United States, 37076
        • Summit Medical Center
      • Nashville, Tennessee, United States, 37203
        • Centennial Medical Center
      • Nashville, Tennessee, United States, 37211
        • Southern Hills Medical Center
    • Texas
      • Arlington, Texas, United States, 76015
        • Medical City Arlington
      • Austin, Texas, United States, 78756
        • Heart Hospital of Austin
      • Austin, Texas, United States, 78705
        • St. David's Medical Center
      • Brownsville, Texas, United States, 78526
        • Valley Regional Medical Center
      • Conroe, Texas, United States, 77304
        • Conroe Regional Medical Center
      • Dallas, Texas, United States, 75230
        • Medical City Dallas Hospital
      • Denton, Texas, United States, 76210
        • Medical City Denton
      • El Paso, Texas, United States, 79902
        • Las Palmas Medical Center
      • Fort Worth, Texas, United States, 76104
        • Medical City Fort Worth
      • Fort Worth, Texas, United States, 76177
        • Medical City Alliance
      • Georgetown, Texas, United States, 78626
        • St. David's Georgetown Hospital
      • Kingwood, Texas, United States, 77339
        • Kingwood Medical Center
      • Lewisville, Texas, United States, 75057
        • Medical Center of Lewisville
      • McAllen, Texas, United States, 78503
        • Rio Grande Regional Hospital
      • McKinney, Texas, United States, 75069
        • Medical City McKinney
      • North Richland Hills, Texas, United States, 76180
        • Medical City North Hills
      • San Antonio, Texas, United States, 78229
        • Methodist Hospital
      • San Antonio, Texas, United States, 78229
        • Methodist Stone Oak Hospital
      • San Antonio, Texas, United States, 78229
        • Northeast Methodist Hospital
      • Texas City, Texas, United States, 77591
        • Mainland Medical Center
      • Webster, Texas, United States, 77598
        • Clearlake Regional Medical Center
    • Utah
      • Ogden, Utah, United States, 84405
        • Ogden Regional Medical Center
    • Virginia
      • Blacksburg, Virginia, United States, 24060
        • LewisGale Hospital - Montgomery
      • Reston, Virginia, United States, 20190
        • Reston Hospital
      • Richmond, Virginia, United States, 23220
        • Retreat Doctors' Hospital
      • Richmond, Virginia, United States, 23225
        • CJW Medical Center (Chippenham Campus)
      • Richmond, Virginia, United States, 23225
        • CJW Medical Center (Johnston Willis Campus)
      • Richmond, Virginia, United States, 23229
        • Henrico Doctors' Hospital - Forest Campus
      • Richmond, Virginia, United States, 23294
        • Henrico Doctors' Hospital - Parham Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 months

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harvard Pilgrim Health Care

Collaborators

Duke University
Brigham and Women's Hospital
University of California, San Francisco
Centers for Disease Control and Prevention
University of California, Irvine
Harvard School of Public Health (HSPH)
University of Massachusetts, Amherst
Rush University
Cook County Health & Hospitals System
Hospital Corporation of America (HCA) Healthcare

Investigators

  • Study Director: Meghan Baker, MD, ScD, Brigham and Women's Hospital
  • Principal Investigator: Susan Huang, MD, MPH, University of California, Irvine
  • Principal Investigator: Richard Platt, MD, MS, Harvard Pilgrim Health Care Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2019

Primary Completion (Estimated)

December 23, 2024

Study Completion (Estimated)

December 23, 2025

Study Registration Dates

First Submitted

August 8, 2019

First Submitted That Met QC Criteria

August 8, 2019

First Posted (Actual)

August 12, 2019

Study Record Updates

Last Update Posted (Actual)

September 25, 2023

Last Update Submitted That Met QC Criteria

September 22, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PH000599B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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