Clinical trial NCT04053075: CLUSTER Trial for Outbreak Detection and Response
Official title: Cluster Linkage Using Statistics to Trigger and Evaluate Response (CLUSTER) Trial for Outbreak Detection and Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cluster Detection
Keywords: Hospital Outbreak Detection
Hospital Outbreak Response
Cluster
Multidrug Resistant Organism
Genetic Relatedness
Whole Genome Sequencing
Lead sponsor: Harvard Pilgrim Health Care
Sponsor class: OTHER
Collaborators: name: Hospital Corporation of America
name: Brigham and Women's Hospital
name: University of California, Irvine
name: Harvard School of Public Health (HSPH)
name: Rush University
name: Duke University
name: University of Massachusetts, Amherst
name: University of California, San Francisco
name: Cook County Health & Hospitals System
name: Centers for Disease Control and Prevention
First posted: 2019-08-12
Enrollment: 2905455
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized controlled trial
Primary purpose: PREVENTION

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


Eligibility 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.

Primary outcomes:
measure: Cluster Size
timeFrame: 30 months
Secondary outcomes:
measure: Cluster Duration
timeFrame: 30 months
Other outcomes:
measure: Genetic Relatedness of Clusters of Microbial Isolates
timeFrame: 30 months
measure: Pathogen Subgroup Analysis
timeFrame: 30 months
Locations:
city: Riverside
country: United States
facility: Riverside Community Hospital
state: California
city: San Jose
country: United States
facility: Regional Medical Center of San Jose
state: California
city: Thousand Oaks
country: United States
facility: Los Robles Regional Medical Center
state: California
city: Denver
country: United States
facility: Swedish Medical Center
state: Colorado
city: Denver
country: United States
facility: Sky Ridge Medical Center
state: Colorado
city: Denver
country: United States
facility: Presbyterian St. Luke's Medical Center
state: Colorado
city: Denver
country: United States
facility: Rose Medical Center
state: Colorado
city: Thornton
country: United States
facility: North Suburban Medical Center - JV
state: Colorado
city: Atlantis
country: United States
facility: JFK Medical Center
state: Florida
city: Brandon
country: United States
facility: Brandon Regional
state: Florida
city: Fort Pierce
country: United States
facility: Lawnwood Regional Medical Center
state: Florida
city: Jacksonville
country: United States
facility: Memorial Hospital Jacksonville
state: Florida
city: Lake City
country: United States
facility: Lake City Medical Center
state: Florida
city: Largo
country: United States
facility: Largo Medical Center
state: Florida
city: Ocala
country: United States
facility: Ocala Regional Medical Center
state: Florida
city: Ocala
country: United States
facility: West Marion Community Hospital
state: Florida
city: Okeechobee
country: United States
facility: Raulerson Hospital
state: Florida
city: Orange Park
country: United States
facility: Orange Park Medical Center
state: Florida
city: Panama City
country: United States
facility: Gulf Coast Medical Center
state: Florida
city: Pensacola
country: United States
facility: West Florida Hospital
state: Florida
city: Port Charlotte
country: United States
facility: Fawcett Memorial Hospital
state: Florida
city: Port Saint Lucie
country: United States
facility: St. Lucie Medical Center
state: Florida
city: Saint Petersburg
country: United States
facility: Northside Hospital
state: Florida
city: Sanford
country: United States
facility: Central Florida Regional Hospital
state: Florida
city: Sarasota
country: United States
facility: Doctor's Hospital Sarasota
state: Florida
city: Sun City Center
country: United States
facility: South Bay Hospital
state: Florida
city: Trinity
country: United States
facility: Medical Center of Trinity
state: Florida
city: West Palm Beach
country: United States
facility: JFK Medical Center - North Campus
state: Florida
city: Dublin
country: United States
facility: Fairview Park
state: Georgia
city: Rome
country: United States
facility: Redmond Regional Medical Center
state: Georgia
city: Snellville
country: United States
facility: Eastside Medical Center
state: Georgia
city: Caldwell
country: United States
facility: West Valley Medical Center
state: Idaho
city: Idaho Falls
country: United States
facility: Eastern Idaho Regional
state: Idaho
city: Overland Park
country: United States
facility: Menorah Medical Center
state: Kansas
city: Overland Park
country: United States
facility: Overland Park Regional Medical Center
state: Kansas
city: Wichita
country: United States
facility: Wesley Medical Center
state: Kansas
city: Wichita
country: United States
facility: Wesley Woodlawn Hospital
state: Kansas
city: Bowling Green
country: United States
facility: Greenview Regional Hospital
state: Kentucky
city: Gulfport
country: United States
facility: Garden Park Medical Center
state: Mississippi
city: Kansas City
country: United States
facility: Research Medical Center
state: Missouri
city: Lee's Summit
country: United States
facility: Lee's Summit Medical Center
state: Missouri
city: Las Vegas
country: United States
facility: Mountainview Hospital - Vegas
state: Nevada
city: Derry
country: United States
facility: Parkland Medical Center
state: New Hampshire
city: Portsmouth
country: United States
facility: Portsmouth Regional Hospital
state: New Hampshire
city: Fredericksburg
country: United States
facility: Spotsylvania Regional Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Trident Regional Medical Center
state: South Carolina
city: Myrtle Beach
country: United States
facility: Grand Strand Regional Medical Center
state: South Carolina
city: Summerville
country: United States
facility: Summerville Medical Center
state: South Carolina
city: Walterboro
country: United States
facility: Colleton Medical Center
state: South Carolina
city: Dickson
country: United States
facility: TriStar Horizon Medical Center
state: Tennessee
city: Hermitage
country: United States
facility: Summit Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Centennial Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Southern Hills Medical Center
state: Tennessee
city: Arlington
country: United States
facility: Medical City Arlington
state: Texas
city: Austin
country: United States
facility: St. David's Medical Center
state: Texas
city: Austin
country: United States
facility: Heart Hospital of Austin
state: Texas
city: Brownsville
country: United States
facility: Valley Regional Medical Center
state: Texas
city: Conroe
country: United States
facility: Conroe Regional Medical Center
state: Texas
city: Dallas
country: United States
facility: Medical City Dallas Hospital
state: Texas
city: Denton
country: United States
facility: Medical City Denton
state: Texas
city: El Paso
country: United States
facility: Las Palmas Medical Center
state: Texas
city: Fort Worth
country: United States
facility: Medical City Fort Worth
state: Texas
city: Fort Worth
country: United States
facility: Medical City Alliance
state: Texas
city: Georgetown
country: United States
facility: St. David's Georgetown Hospital
state: Texas
city: Kingwood
country: United States
facility: Kingwood Medical Center
state: Texas
city: Lewisville
country: United States
facility: Medical Center of Lewisville
state: Texas
city: McAllen
country: United States
facility: Rio Grande Regional Hospital
state: Texas
city: McKinney
country: United States
facility: Medical City McKinney
state: Texas
city: North Richland Hills
country: United States
facility: Medical City North Hills
state: Texas
city: San Antonio
country: United States
facility: Methodist Hospital
state: Texas
city: San Antonio
country: United States
facility: Methodist Stone Oak Hospital
state: Texas
city: San Antonio
country: United States
facility: Northeast Methodist Hospital
state: Texas
city: Texas City
country: United States
facility: Mainland Medical Center
state: Texas
city: Webster
country: United States
facility: Clearlake Regional Medical Center
state: Texas
city: Ogden
country: United States
facility: Ogden Regional Medical Center
state: Utah
city: Blacksburg
country: United States
facility: LewisGale Hospital - Montgomery
state: Virginia
city: Reston
country: United States
facility: Reston Hospital
state: Virginia
city: Richmond
country: United States
facility: Retreat Doctors' Hospital
state: Virginia
city: Richmond
country: United States
facility: CJW Medical Center (Chippenham Campus)
state: Virginia
city: Richmond
country: United States
facility: CJW Medical Center (Johnston Willis Campus)
state: Virginia
city: Richmond
country: United States
facility: Henrico Doctors' Hospital - Forest Campus
state: Virginia
city: Richmond
country: United States
facility: Henrico Doctors' Hospital - Parham Campus
state: Virginia
Study officials:
affiliation: Harvard Pilgrim Health Care Institute
name: Richard Platt, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Irvine
name: Susan Huang, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Brigham and Women's Hospital
name: Meghan Baker, MD, ScD
role: STUDY_DIRECTOR
References:
citation: 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.