Clinical trial NCT06660433: Respiratory Outbreak Mitigation in Long-Term Care Using Point-of-Care Testing
Official title: ImProving Respiratory Outbreak Mitigation Through Point-of-care Testing in Long Term Care (PROMPT-LTC): a Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Outbreaks
Keywords: respiratory virus outbreaks
outbreak mitigation
long-term care home
Lead sponsor: Michael Garron Hospital
Sponsor class: OTHER
Collaborators: name: Sunnybrook Health Sciences Centre
name: Humber River Health
First posted: 2024-10-28
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster Randomized Trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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, COVID-19 and Respiratory Syncytial Virus) can impact the number and size of respiratory virus outbreaks in long-term care homes.


Eligibility criteria: 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

Primary outcomes:
measure: Number of long-term care residents infected with COVID-19, Influenza, or RSV
timeFrame: 7 months
Secondary outcomes:
measure: The number of outbreaks of Influenza, COVID-19 or RSV
timeFrame: 7 months
measure: The number of long-term care residents infected during an outbreak of Influenza, COVID-19 or RSV
timeFrame: 28 days
measure: Frequency of hospital transfers for long-term care residents infected with Influenza, COVID-19 or RSV
timeFrame: 14 days
measure: Number of deaths in long-term care residents infected with Influenza, COVID-19 or RSV
timeFrame: 28 days
measure: Duration of outbreaks in of Influenza, COVID-19 or RSV in long-term care facilities
timeFrame: 60 days
measure: Secondary attack rate of high-risk exposures to each long-term care resident with Influenza, COVID-19 or RSV infection
timeFrame: 28 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Michael Garron Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
References:
citation: 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.