Cluster Detection Clinical Trial
— CLUSTEROfficial title:
Cluster Linkage Using Statistics to Trigger and Evaluate Response (CLUSTER) Trial for Outbreak Detection and Response
| Verified date | September 2023 |
| Source | Harvard Pilgrim Health Care |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Active, not recruiting |
| Enrollment | 82 |
| Est. completion date | December 23, 2025 |
| Est. primary completion date | December 23, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Medical City Arlington | Arlington | Texas |
| United States | JFK Medical Center | Atlantis | Florida |
| United States | Heart Hospital of Austin | Austin | Texas |
| United States | St. David's Medical Center | Austin | Texas |
| United States | LewisGale Hospital - Montgomery | Blacksburg | Virginia |
| United States | Greenview Regional Hospital | Bowling Green | Kentucky |
| United States | Brandon Regional | Brandon | Florida |
| United States | Valley Regional Medical Center | Brownsville | Texas |
| United States | West Valley Medical Center | Caldwell | Idaho |
| United States | Trident Regional Medical Center | Charleston | South Carolina |
| United States | Conroe Regional Medical Center | Conroe | Texas |
| United States | Medical City Dallas Hospital | Dallas | Texas |
| United States | Medical City Denton | Denton | Texas |
| United States | Presbyterian St. Luke's Medical Center | Denver | Colorado |
| United States | Rose Medical Center | Denver | Colorado |
| United States | Sky Ridge Medical Center | Denver | Colorado |
| United States | Swedish Medical Center | Denver | Colorado |
| United States | Parkland Medical Center | Derry | New Hampshire |
| United States | TriStar Horizon Medical Center | Dickson | Tennessee |
| United States | Fairview Park | Dublin | Georgia |
| United States | Las Palmas Medical Center | El Paso | Texas |
| United States | Lawnwood Regional Medical Center | Fort Pierce | Florida |
| United States | Medical City Alliance | Fort Worth | Texas |
| United States | Medical City Fort Worth | Fort Worth | Texas |
| United States | Spotsylvania Regional Medical Center | Fredericksburg | Pennsylvania |
| United States | St. David's Georgetown Hospital | Georgetown | Texas |
| United States | Garden Park Medical Center | Gulfport | Mississippi |
| United States | Summit Medical Center | Hermitage | Tennessee |
| United States | Eastern Idaho Regional | Idaho Falls | Idaho |
| United States | Memorial Hospital Jacksonville | Jacksonville | Florida |
| United States | Research Medical Center | Kansas City | Missouri |
| United States | Kingwood Medical Center | Kingwood | Texas |
| United States | Lake City Medical Center | Lake City | Florida |
| United States | Largo Medical Center | Largo | Florida |
| United States | Mountainview Hospital - Vegas | Las Vegas | Nevada |
| United States | Lee's Summit Medical Center | Lee's Summit | Missouri |
| United States | Medical Center of Lewisville | Lewisville | Texas |
| United States | Rio Grande Regional Hospital | McAllen | Texas |
| United States | Medical City McKinney | McKinney | Texas |
| United States | Grand Strand Regional Medical Center | Myrtle Beach | South Carolina |
| United States | Centennial Medical Center | Nashville | Tennessee |
| United States | Southern Hills Medical Center | Nashville | Tennessee |
| United States | Medical City North Hills | North Richland Hills | Texas |
| United States | Ocala Regional Medical Center | Ocala | Florida |
| United States | West Marion Community Hospital | Ocala | Florida |
| United States | Ogden Regional Medical Center | Ogden | Utah |
| United States | Raulerson Hospital | Okeechobee | Florida |
| United States | Orange Park Medical Center | Orange Park | Florida |
| United States | Menorah Medical Center | Overland Park | Kansas |
| United States | Overland Park Regional Medical Center | Overland Park | Kansas |
| United States | Gulf Coast Medical Center | Panama City | Florida |
| United States | West Florida Hospital | Pensacola | Florida |
| United States | Fawcett Memorial Hospital | Port Charlotte | Florida |
| United States | St. Lucie Medical Center | Port Saint Lucie | Florida |
| United States | Portsmouth Regional Hospital | Portsmouth | New Hampshire |
| United States | Reston Hospital | Reston | Virginia |
| United States | CJW Medical Center (Chippenham Campus) | Richmond | Virginia |
| United States | CJW Medical Center (Johnston Willis Campus) | Richmond | Virginia |
| United States | Henrico Doctors' Hospital - Forest Campus | Richmond | Virginia |
| United States | Henrico Doctors' Hospital - Parham Campus | Richmond | Virginia |
| United States | Retreat Doctors' Hospital | Richmond | Virginia |
| United States | Riverside Community Hospital | Riverside | California |
| United States | Redmond Regional Medical Center | Rome | Georgia |
| United States | Northside Hospital | Saint Petersburg | Florida |
| United States | Methodist Hospital | San Antonio | Texas |
| United States | Methodist Stone Oak Hospital | San Antonio | Texas |
| United States | Northeast Methodist Hospital | San Antonio | Texas |
| United States | Regional Medical Center of San Jose | San Jose | California |
| United States | Central Florida Regional Hospital | Sanford | Florida |
| United States | Doctor's Hospital Sarasota | Sarasota | Florida |
| United States | Eastside Medical Center | Snellville | Georgia |
| United States | Summerville Medical Center | Summerville | South Carolina |
| United States | South Bay Hospital | Sun City Center | Florida |
| United States | Mainland Medical Center | Texas City | Texas |
| United States | North Suburban Medical Center - JV | Thornton | Colorado |
| United States | Los Robles Regional Medical Center | Thousand Oaks | California |
| United States | Medical Center of Trinity | Trinity | Florida |
| United States | Colleton Medical Center | Walterboro | South Carolina |
| United States | Clearlake Regional Medical Center | Webster | Texas |
| United States | JFK Medical Center - North Campus | West Palm Beach | Florida |
| United States | Wesley Medical Center | Wichita | Kansas |
| United States | Wesley Woodlawn Hospital | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| Harvard Pilgrim Health Care | Brigham and Women's Hospital, Centers for Disease Control and Prevention, Cook County Health & Hospitals System, Duke University, Harvard School of Public Health (HSPH), Hospital Corporation of America (HCA) Healthcare, Rush University, University of California, Irvine, University of California, San Francisco, University of Massachusetts, Amherst |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Genetic relatedness of clusters of microbial isolates | 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 | |
| Other | Pathogen subgroup analysis | 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 | |
| Primary | Cluster size | 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 | Cluster duration | 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 |