CLUSTER Trial for Outbreak Detection and Response

NCT ID: NCT04053075

Last Updated: 2025-01-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2905455 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-23

Study Completion Date

2024-05-20

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

Detailed Description

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Conditions

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Cluster Detection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster randomized controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Routine cluster detection

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

Group Type ACTIVE_COMPARATOR

Routine cluster detection

Intervention Type OTHER

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

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.

Group Type ACTIVE_COMPARATOR

Enhanced cluster detection

Intervention Type OTHER

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.

Interventions

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Routine cluster detection

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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.

Exclusion Criteria

\-

Note: unit of randomization is the hospital.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Corporation of America

INDUSTRY

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role collaborator

Rush University

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role collaborator

University of Massachusetts, Amherst

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role collaborator

Cook County Health & Hospitals System

OTHER

Sponsor Role collaborator

Centers for Disease Control and Prevention

FED

Sponsor Role collaborator

Harvard Pilgrim Health Care

OTHER

Sponsor Role lead

Responsible Party

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Richard Platt

Professor and Department Chair

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Richard Platt, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Harvard Pilgrim Health Care Institute

Susan Huang, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Meghan Baker, MD, ScD

Role: STUDY_DIRECTOR

Brigham and Women's Hospital

Locations

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Riverside Community Hospital

Riverside, California, United States

Site Status

Regional Medical Center of San Jose

San Jose, California, United States

Site Status

Los Robles Regional Medical Center

Thousand Oaks, California, United States

Site Status

Swedish Medical Center

Denver, Colorado, United States

Site Status

Sky Ridge Medical Center

Denver, Colorado, United States

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Presbyterian St. Luke's Medical Center

Denver, Colorado, United States

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Rose Medical Center

Denver, Colorado, United States

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North Suburban Medical Center - JV

Thornton, Colorado, United States

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JFK Medical Center

Atlantis, Florida, United States

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Brandon Regional

Brandon, Florida, United States

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Lawnwood Regional Medical Center

Ft. Pierce, Florida, United States

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Memorial Hospital Jacksonville

Jacksonville, Florida, United States

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Lake City Medical Center

Lake City, Florida, United States

Site Status

Largo Medical Center

Largo, Florida, United States

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Ocala Regional Medical Center

Ocala, Florida, United States

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West Marion Community Hospital

Ocala, Florida, United States

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Raulerson Hospital

Okeechobee, Florida, United States

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Orange Park Medical Center

Orange Park, Florida, United States

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Gulf Coast Medical Center

Panama City, Florida, United States

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West Florida Hospital

Pensacola, Florida, United States

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Fawcett Memorial Hospital

Port Charlotte, Florida, United States

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St. Lucie Medical Center

Port Saint Lucie, Florida, United States

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Central Florida Regional Hospital

Sanford, Florida, United States

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Doctor's Hospital Sarasota

Sarasota, Florida, United States

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Northside Hospital

St. Petersburg, Florida, United States

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South Bay Hospital

Sun City Center, Florida, United States

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Medical Center of Trinity

Trinity, Florida, United States

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JFK Medical Center - North Campus

West Palm Beach, Florida, United States

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Fairview Park

Dublin, Georgia, United States

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Redmond Regional Medical Center

Rome, Georgia, United States

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Eastside Medical Center

Snellville, Georgia, United States

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West Valley Medical Center

Caldwell, Idaho, United States

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Eastern Idaho Regional

Idaho Falls, Idaho, United States

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Menorah Medical Center

Overland Park, Kansas, United States

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Overland Park Regional Medical Center

Overland Park, Kansas, United States

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Wesley Medical Center

Wichita, Kansas, United States

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Wesley Woodlawn Hospital

Wichita, Kansas, United States

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Greenview Regional Hospital

Bowling Green, Kentucky, United States

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Garden Park Medical Center

Gulfport, Mississippi, United States

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Research Medical Center

Kansas City, Missouri, United States

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Lee's Summit Medical Center

Lee's Summit, Missouri, United States

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Mountainview Hospital - Vegas

Las Vegas, Nevada, United States

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Parkland Medical Center

Derry, New Hampshire, United States

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Portsmouth Regional Hospital

Portsmouth, New Hampshire, United States

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Spotsylvania Regional Medical Center

Fredericksburg, Pennsylvania, United States

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Trident Regional Medical Center

Charleston, South Carolina, United States

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Grand Strand Regional Medical Center

Myrtle Beach, South Carolina, United States

Site Status

Summerville Medical Center

Summerville, South Carolina, United States

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Colleton Medical Center

Walterboro, South Carolina, United States

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TriStar Horizon Medical Center

Dickson, Tennessee, United States

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Summit Medical Center

Hermitage, Tennessee, United States

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Centennial Medical Center

Nashville, Tennessee, United States

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Southern Hills Medical Center

Nashville, Tennessee, United States

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Medical City Arlington

Arlington, Texas, United States

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St. David's Medical Center

Austin, Texas, United States

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Heart Hospital of Austin

Austin, Texas, United States

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Valley Regional Medical Center

Brownsville, Texas, United States

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Conroe Regional Medical Center

Conroe, Texas, United States

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Medical City Dallas Hospital

Dallas, Texas, United States

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Medical City Denton

Denton, Texas, United States

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Las Palmas Medical Center

El Paso, Texas, United States

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Medical City Fort Worth

Fort Worth, Texas, United States

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Medical City Alliance

Fort Worth, Texas, United States

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St. David's Georgetown Hospital

Georgetown, Texas, United States

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Kingwood Medical Center

Kingwood, Texas, United States

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Medical Center of Lewisville

Lewisville, Texas, United States

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Rio Grande Regional Hospital

McAllen, Texas, United States

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Medical City McKinney

McKinney, Texas, United States

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Medical City North Hills

North Richland Hills, Texas, United States

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Methodist Hospital

San Antonio, Texas, United States

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Methodist Stone Oak Hospital

San Antonio, Texas, United States

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Northeast Methodist Hospital

San Antonio, Texas, United States

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Mainland Medical Center

Texas City, Texas, United States

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Clearlake Regional Medical Center

Webster, Texas, United States

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Ogden Regional Medical Center

Ogden, Utah, United States

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LewisGale Hospital - Montgomery

Blacksburg, Virginia, United States

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Reston Hospital

Reston, Virginia, United States

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Retreat Doctors' Hospital

Richmond, Virginia, United States

Site Status

CJW Medical Center (Chippenham Campus)

Richmond, Virginia, United States

Site Status

CJW Medical Center (Johnston Willis Campus)

Richmond, Virginia, United States

Site Status

Henrico Doctors' Hospital - Forest Campus

Richmond, Virginia, United States

Site Status

Henrico Doctors' Hospital - Parham Campus

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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Baker MA, Septimus E, Kleinman K, Moody J, Sands KE, Varma N, Isaacs A, McLean LE, Coady MH, Blanchard EJ, Poland RE, Yokoe DS, Stelling J, Haffenreffer K, Clark A, Avery TR, Sljivo S, Weinstein RA, Smith KN, Carver B, Meador B, Lin MY, Lewis SS, Washington C, Bhattarai M, Shimelman L, Kulldorff M, Reddy SC, Jernigan JA, Perlin JB, Platt R, Huang SS. A Trial of Automated Outbreak Detection to Reduce Hospital Pathogen Spread. NEJM Evid. 2024 May;3(5):EVIDoa2300342. doi: 10.1056/EVIDoa2300342. Epub 2024 Apr 23.

Reference Type RESULT
PMID: 38815164 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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PH000599B

Identifier Type: -

Identifier Source: org_study_id

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