Enhanced Cluster Detection Methods for Outbreak Control

(CLUSTER Trial)

Recruiting at 81 trial locations

Overseen By Micaela Coady, MS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Harvard Pilgrim Health Care

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

2905455 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Richard Platt, MD, MSc

Principal Investigator

Harvard Pilgrim Health Care Institute

Susan Huang, MD, MPH

Principal Investigator

University of California, Irvine

Meghan Baker, MD, ScD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

The CLUSTER Trial is for U.S. HCA Healthcare hospitals providing inpatient care and reporting to a centralized data warehouse during the study period. It's not specified which facilities can't participate, suggesting all eligible ones can join.

Inclusion Criteria

The clinical trial may only be conducted at certain medical facilities.

The study includes all HCA Healthcare hospitals in the United States that admit patients for hospital care.

The healthcare facility where you receive treatment must be able to share data with a central database during the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cluster Detection and Response

Hospitals implement either enhanced or routine cluster detection methods with a structured response protocol

30 months

Follow-up

Participants are monitored for outcomes such as cluster size and duration

4 weeks

Treatment Details

Interventions

• Enhanced cluster detection
• Routine cluster detection

Trial Overview This trial tests an automated statistical method for detecting hospital-associated outbreaks against routine methods. The goal is to see if this new approach helps contain outbreaks faster by reducing their size and duration.

Participant Groups

Group I: Enhanced cluster detection Active Control 1 Intervention

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 II: Routine cluster detection Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Harvard Pilgrim Health Care

Lead Sponsor

Trials

61

Recruited

27,990,000+

Hospital Corporation of America

Industry Sponsor

Trials

8

Recruited

3,433,000+

Centers for Disease Control and Prevention

Collaborator

Trials

902

Recruited

25,020,000+

Harvard School of Public Health (HSPH)

Collaborator

Trials

283

Recruited

17,030,000+

Hospital Corporation of America (HCA) Healthcare

Collaborator

Trials

1

Recruited

2,905,000+

University of Massachusetts, Amherst

Collaborator

Trials

83

Recruited

3,474,000+

Cook County Health & Hospitals System

Collaborator

Trials

7

Recruited

2,910,000+

Duke University

Collaborator

Trials

2,495

Recruited

5,912,000+

Rush University

Collaborator

Trials

46

Recruited

3,294,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+