Respiratory Outbreak Mitigation in Long-Term Care Using Point-of-Care Testing (PROMPT-LTC)

imProving Respiratory Outbreak Mitigation Through Point-of-care Testing in Long Term Care (PROMPT-LTC): A Cluster Randomized Trial

Outbreaks of seasonal respiratory viruses can spread rapidly in long-term care homes. Timely results for diagnostic tests remains a challenge for respiratory viruses due to the logistics of using a reference laboratory with delays leading to missed opportunities to implement virus-specific control measures to interrupt transmission resulting in larger outbreaks. Use of a point-of-care testing platform is a potential solution that provides faster results, but it is uncertain whether this translates into benefits for long-term care residents. This trial aims to assess whether rapid test results for respiratory pathogens (Influenza, Coronavirus disease of 2019 (COVID-19) and Respiratory Syncytial Virus) can impact the number and size of respiratory virus outbreaks in long-term care homes.

Study Overview

• Status: Recruiting
• Conditions: Outbreaks
• Intervention / Treatment: Device: Point-of-care respiratory test platform; Other: Existing respiratory virus testing platform

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christopher Kandel, MD, PhD; Phone Number: 416-469-6252; Email: christopher.kandel@tehn.ca
• Study Contact Backup: Name: Jerome Leis, MD, MSc; Phone Number: 416-480-4243; Email: jerome.leis@sunnybrook.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Recruiting
      • Sunnybrook Health Sciences Centre
      • Contact: Jerome Leis, MD, MSc; Phone Number: 416-480-4243; Email: jerome.leis@sunnybrook.ca
    • Toronto, Ontario, Canada, M4C 3E7
      • Recruiting
      • Michael Garron Hospital
      • Contact: Christopher Kandel, MD, PhD; Phone Number: 416-469-6252; Email: christopher.kandel@tehn.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- Long-term care facility engaged with an Ontario Health Team overseen by Sunnybrook Health Science Centre, Michael Garron Hospital or Humber River Health

Exclusion Criteria:

• No signed statement of agreement for study participation
• Pre-existing use of a point-of-care testing platform

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Point-of-Care Polymerase Chain Reaction Testing Platform	Device: Point-of-care respiratory test platform; A point-of-care respiratory multiplex testing platform situated within a long-term care facility to provide rapid test results
Active Comparator: Existing Testing Platform for Respiratory Viruses	Other: Existing respiratory virus testing platform; Currently used respiratory virus testing platforms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of long-term care residents infected with COVID-19, Influenza, or respiratory syncytial virus (RSV)	The number of long-term care residents who contract Influenza, COVID-19 or RSV separated into the number of residents infected after an introduction is identified and the size of an outbreak of each virus.	7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of outbreaks of Influenza, COVID-19 or RSV	The number of Influenza, COVID-19 or RSV outbreaks as declared by the local Public Health Unit	7 months
The number of long-term care residents infected during an outbreak of Influenza, COVID-19 or RSV	The number of long-term care residents with a confirmed or suspected Influenza, COVID-19 or RSV infection during each outbreak as tracked by the local Public Health Unit	28 days
Frequency of hospital transfers for long-term care residents infected with Influenza, COVID-19 or RSV	The number of hospital transfers for long-term care residents with Influenza, COVID-19 or RSV	14 days
Number of deaths in long-term care residents infected with Influenza, COVID-19 or RSV	The number of long-term care residents who die following an infection with Influenza, COVID-19 or RSV	28 days
Duration of outbreaks in of Influenza, COVID-19 or RSV in long-term care facilities	The total duration of an outbreak of Influenza, COVID-19 or RSV as declared by the local Public Health Unit	60 days
Secondary attack rate of high-risk exposures to each long-term care resident with Influenza, COVID-19 or RSV infection	The proportion of identified high risk contacts of an infected long-term care resident with Influenza, COVID-19 or RSV infection	28 days

Collaborators and Investigators

• Sponsor: Michael Garron Hospital
• Collaborators: Sunnybrook Health Sciences Centre; Humber River Health

Publications and helpful links

General Publications

• Tan C, Chan CK, Ofner M, O'Brien J, Thomas NR, Callahan J, Pascual B, Palmer SJ, Serapion V, Fabro H, Kozak RA, Candon H, Chan AK, Powis JE, Leis JA. Implementation of point-of-care molecular testing for respiratory viruses in congregate living settings. Infect Control Hosp Epidemiol. 2024 Apr 25;45(9):1-5. doi: 10.1017/ice.2024.72. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2024
• Primary Completion (Actual): May 30, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: October 24, 2024
• First Submitted That Met QC Criteria: October 24, 2024
• First Posted (Actual): October 28, 2024

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: respiratory virus outbreaks; outbreak mitigation; long-term care home
• Other Study ID Numbers: CK-19-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes