Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hospital Corporation of America | INDUSTRY |
| Brigham and Women's Hospital | OTHER |
| University of California, Irvine | OTHER |
| Harvard School of Public Health (HSPH) |
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine cluster detection | Active Comparator | Hospitals will use routine practices for cluster detection with a structured cluster response protocol when a cluster is detected. |
|
| Enhanced cluster detection | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Routine cluster detection | Other | Hospitals will use routine practices for cluster detection with a structured cluster response protocol when a cluster is detected. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Pathogen Subgroup Analysis |
Facility Inclusion Criteria:
Facility Exclusion Criteria:
-
Note: unit of randomization is the hospital.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Richard Platt, MD, MSc | Harvard Pilgrim Health Care Institute | Principal Investigator |
| Susan Huang, MD, MPH | University of California, Irvine | Principal Investigator |
| Meghan Baker, MD, ScD | Brigham and Women's Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Riverside Community Hospital | Riverside | California | 92501 | United States | ||
| Regional Medical Center of San Jose |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38815164 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
2,905,455 patients were involved in the intervention period from the 82 participating hospitals.
82 out of 182 HCA Healthcare hospitals were recruited for this trial. There was a 30 month intervention period from July 2019 through January 2022.
| ID | Title | Description |
|---|---|---|
| FG000 | Routine Cluster Detection | Hospitals will use routine practices for cluster detection with a structured cluster response protocol when a cluster is detected. Routine cluster detection: Hospitals will use routine practices for cluster detection with a structured cluster response protocol when a cluster is detected. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 5, 2019 | May 20, 2024 |
Not provided
| OTHER |
| Rush University | OTHER |
| Duke University | OTHER |
| University of Massachusetts, Amherst | OTHER |
| University of California, San Francisco | OTHER |
| Cook County Health & Hospitals System | OTHER |
| Centers for Disease Control and Prevention | FED |
Cluster randomized controlled trial
Not provided
Not provided
Not provided
Not provided
| Enhanced cluster detection | 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. |
|
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 |
| San Jose |
| California |
| 95116 |
| United States |
| Los Robles Regional Medical Center | Thousand Oaks | California | 91360 | United States |
| Swedish Medical Center | Denver | Colorado | 80113 | United States |
| Sky Ridge Medical Center | Denver | Colorado | 80124 | United States |
| Presbyterian St. Luke's Medical Center | Denver | Colorado | 80218 | United States |
| Rose Medical Center | Denver | Colorado | 80220 | United States |
| North Suburban Medical Center - JV | Thornton | Colorado | 80229 | United States |
| JFK Medical Center | Atlantis | Florida | 33462 | United States |
| Brandon Regional | Brandon | Florida | 33511 | United States |
| Lawnwood Regional Medical Center | Ft. Pierce | Florida | 34950 | United States |
| Memorial Hospital Jacksonville | Jacksonville | Florida | 32216 | United States |
| Lake City Medical Center | Lake City | Florida | 32055 | United States |
| Largo Medical Center | Largo | Florida | 33770 | United States |
| Ocala Regional Medical Center | Ocala | Florida | 34471 | United States |
| West Marion Community Hospital | Ocala | Florida | 34474 | United States |
| Raulerson Hospital | Okeechobee | Florida | 34972 | United States |
| Orange Park Medical Center | Orange Park | Florida | 32073 | United States |
| Gulf Coast Medical Center | Panama City | Florida | 32405 | United States |
| West Florida Hospital | Pensacola | Florida | 32514 | United States |
| Fawcett Memorial Hospital | Port Charlotte | Florida | 33952 | United States |
| St. Lucie Medical Center | Port Saint Lucie | Florida | 34952 | United States |
| Central Florida Regional Hospital | Sanford | Florida | 32771 | United States |
| Doctor's Hospital Sarasota | Sarasota | Florida | 34233 | United States |
| Northside Hospital | St. Petersburg | Florida | 33709 | United States |
| South Bay Hospital | Sun City Center | Florida | 33573 | United States |
| Medical Center of Trinity | Trinity | Florida | 34655 | United States |
| JFK Medical Center - North Campus | West Palm Beach | Florida | 33407 | United States |
| Fairview Park | Dublin | Georgia | 31021 | United States |
| Redmond Regional Medical Center | Rome | Georgia | 30165 | United States |
| Eastside Medical Center | Snellville | Georgia | 30078 | United States |
| West Valley Medical Center | Caldwell | Idaho | 83605 | United States |
| Eastern Idaho Regional | Idaho Falls | Idaho | 83404 | United States |
| Menorah Medical Center | Overland Park | Kansas | 66209 | United States |
| Overland Park Regional Medical Center | Overland Park | Kansas | 66215 | United States |
| Wesley Medical Center | Wichita | Kansas | 67214 | United States |
| Wesley Woodlawn Hospital | Wichita | Kansas | 67220 | United States |
| Greenview Regional Hospital | Bowling Green | Kentucky | 42104 | United States |
| Garden Park Medical Center | Gulfport | Mississippi | 39503 | United States |
| Research Medical Center | Kansas City | Missouri | 64132 | United States |
| Lee's Summit Medical Center | Lee's Summit | Missouri | 64063 | United States |
| Mountainview Hospital - Vegas | Las Vegas | Nevada | 89128 | United States |
| Parkland Medical Center | Derry | New Hampshire | 03038 | United States |
| Portsmouth Regional Hospital | Portsmouth | New Hampshire | 03801 | United States |
| Spotsylvania Regional Medical Center | Fredericksburg | Pennsylvania | 22408 | United States |
| Trident Regional Medical Center | Charleston | South Carolina | 29406 | United States |
| Grand Strand Regional Medical Center | Myrtle Beach | South Carolina | 29572 | United States |
| Summerville Medical Center | Summerville | South Carolina | 29485 | United States |
| Colleton Medical Center | Walterboro | South Carolina | 29488 | United States |
| TriStar Horizon Medical Center | Dickson | Tennessee | 37055 | United States |
| Summit Medical Center | Hermitage | Tennessee | 37076 | United States |
| Centennial Medical Center | Nashville | Tennessee | 37203 | United States |
| Southern Hills Medical Center | Nashville | Tennessee | 37211 | United States |
| Medical City Arlington | Arlington | Texas | 76015 | United States |
| St. David's Medical Center | Austin | Texas | 78705 | United States |
| Heart Hospital of Austin | Austin | Texas | 78756 | United States |
| Valley Regional Medical Center | Brownsville | Texas | 78526 | United States |
| Conroe Regional Medical Center | Conroe | Texas | 77304 | United States |
| Medical City Dallas Hospital | Dallas | Texas | 75230 | United States |
| Medical City Denton | Denton | Texas | 76210 | United States |
| Las Palmas Medical Center | El Paso | Texas | 79902 | United States |
| Medical City Fort Worth | Fort Worth | Texas | 76104 | United States |
| Medical City Alliance | Fort Worth | Texas | 76177 | United States |
| St. David's Georgetown Hospital | Georgetown | Texas | 78626 | United States |
| Kingwood Medical Center | Kingwood | Texas | 77339 | United States |
| Medical Center of Lewisville | Lewisville | Texas | 75057 | United States |
| Rio Grande Regional Hospital | McAllen | Texas | 78503 | United States |
| Medical City McKinney | McKinney | Texas | 75069 | United States |
| Medical City North Hills | North Richland Hills | Texas | 76180 | United States |
| Methodist Hospital | San Antonio | Texas | 78229 | United States |
| Methodist Stone Oak Hospital | San Antonio | Texas | 78229 | United States |
| Northeast Methodist Hospital | San Antonio | Texas | 78229 | United States |
| Mainland Medical Center | Texas City | Texas | 77591 | United States |
| Clearlake Regional Medical Center | Webster | Texas | 77598 | United States |
| Ogden Regional Medical Center | Ogden | Utah | 84405 | United States |
| LewisGale Hospital - Montgomery | Blacksburg | Virginia | 24060 | United States |
| Reston Hospital | Reston | Virginia | 20190 | United States |
| Retreat Doctors' Hospital | Richmond | Virginia | 23220 | United States |
| CJW Medical Center (Chippenham Campus) | Richmond | Virginia | 23225 | United States |
| CJW Medical Center (Johnston Willis Campus) | Richmond | Virginia | 23225 | United States |
| Henrico Doctors' Hospital - Forest Campus | Richmond | Virginia | 23229 | United States |
| Henrico Doctors' Hospital - Parham Campus | Richmond | Virginia | 23294 | United States |
| 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. 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
Number of participant totals reflect total Intervention participants. 82 hospitals were randomized to a study group, 41 began the assigned intervention. 1 hospital withdrew from the intervention arm and 2 hospitals withdrew from the control arm.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1: Routine Cluster Detection | Hospitals will use routine practices for cluster detection with a structured cluster response protocol when a cluster is detected. Routine cluster detection: Hospitals will use routine practices for cluster detection with a structured cluster response protocol when a cluster is detected. |
| BG001 | Arm 2: 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. 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Small differences in the number of patients with various characteristics reflect missing data in the electronic health record. | Count of Participants | Participants |
| |||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The total number of participants analyzed reported here is from the intervention period. | Posted | Number | 95% Confidence Interval | outbreak cases after first signal | 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. | The total number of participants analyzed reported here is from the intervention period. | Posted | Number | 95% Confidence Interval | days | 30 months |
|
| |||||||||||||||||||||||||||||
| Other Pre-specified | 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. | Not Posted | 30 months | Participants | ||||||||||||||||||||||||||||||||||
| Other Pre-specified | 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. | Not Posted | 30 months | Participants |
30 Months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1: Routine Cluster Detection | Hospitals will use routine practices for cluster detection with a structured cluster response protocol when a cluster is detected. Routine cluster detection: Hospitals will use routine practices for cluster detection with a structured cluster response protocol when a cluster is detected. | 0 | 1,446,854 | 0 | 1,446,854 | 0 | 1,446,854 |
| EG001 | Arm 2: 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. 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. | 0 | 1,458,601 | 0 | 1,458,601 | 0 | 1,458,601 |
Not provided
Not provided
[Not Specified]
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Meghan Baker, MD, ScD | Department of Population Medicine, Harvard Medical School/Harvard Pilgrim Healthcare Institute | 617-867-4946 | MBAKER1@BWH.HARVARD.EDU |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 15, 2019 | May 17, 2024 | SAP_001.pdf |
|
|
| Participants |
|
|