CLUSTER Trial for Outbreak Detection and Response

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

Conditions

• Cluster Detection

Interventions

OTHER

Routine cluster detection

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

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.

Sponsors & Collaborators

• Hospital Corporation of America

  collaborator INDUSTRY

• Brigham and Women's Hospital

  collaborator OTHER

• University of California, Irvine

  collaborator OTHER

• Harvard School of Public Health (HSPH)

  collaborator OTHER

• Rush University

  collaborator OTHER

• Duke University

  collaborator OTHER

• University of Massachusetts, Amherst

  collaborator OTHER

• University of California, San Francisco

  collaborator OTHER

• Cook County Health & Hospitals System

  collaborator OTHER

• Centers for Disease Control and Prevention

  collaborator FED

• Harvard Pilgrim Health Care

  lead OTHER

Principal Investigators

• Richard Platt, MD, MSc · Harvard Pilgrim Health Care Institute

• Susan Huang, MD, MPH · University of California, Irvine

• Meghan Baker, MD, ScD · Brigham and Women's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-07-23

Primary Completion

2024-05-20

Completion

2024-05-20

Countries

• United States

Study Locations