Clinical trial NCT06169553: The Injection-Related InfectionS (IRIS) Program
Official title: The IRIS Program: A Novel Pathway to Optimize Treatment of Injection-related Infections for People Who Inject Drugs in Hamilton, Ontario
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Peer Support
Injection-related Infections
Infections
People Who Infect Drugs (PWID)
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: HAMSMaRT
name: Keeping Six
name: YWCA Hamilton
First posted: 2023-12-13
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Maximum age (years): 105
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: People who inject drugs are at risk of injection-related infections, like abscesses or infective endocarditis. The Injection-Related InfectionS (IRIS) program hopes to improve treatment for participants by providing a low-barrier, one-stop shop model for people who inject drugs who experience injection-related infections to access more holistic and compassionate care. IRIS is a non-randomized clinical trial, meaning that it offers a specific program to eligible patients. This program offers care for substance use and infectious disease with additional peer support and systems navigation, if interested. The investigators anticipate enrolling 80 participants in the intervention and will follow participants throughout the infection treatment period (estimated 6-12 weeks). The investigators will collect information at the time of enrolment, at the 6-month mark, and monthly via electronic medical chart review. The investigators will use an interrupted time series analysis to evaluate the impact of the intervention on rates of treatment completion, emergency department visits, hospitalizations, and death, before versus after the intervention.


Eligibility criteria: Inclusion Criteria:

* Age 16 or older
* Able to provide informed consent
* Presenting with a confirmed or suspected injection-related infection (including skin and soft tissue infections, osteomyelitis, infective endocarditis, Hepatitis C, HIV, etc)
* History of injection drug use within 3 months of recruitment
* Lives in Hamilton, Ontario

Exclusion Criteria:

-

Primary outcomes:
measure: Number of emergency department visits and hospital readmission
timeFrame: Within 30 days of initial hospital admission or program enrolment
Secondary outcomes:
measure: Completion of intended course of treatment for the injection-related infection
timeFrame: Within 6 months of initial hospital admission or program enrolment
measure: Number of hospital readmissions specifically for the infection that was the primary reason for program enrolment
timeFrame: Within 90-days of hospital discharge or program enrolment
measure: Number of emergency department visits
timeFrame: Within 90-days of hospital discharge or program enrolment
measure: Number of new initiations or record of continuation of substance use treatment
timeFrame: Within 90-days of hospital discharge or program enrolment
measure: Mortality rates
timeFrame: Within 6-months of hospital discharge or program enrolment
measure: Rates of program drop-out and reasons for discontinuation
timeFrame: Within 6-months of hospital discharge or program enrolment
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: HAMSMaRT Clinic
state: Ontario
city: Hamilton
country: Canada
facility: David Braley Health Science Centre
state: Ontario
Study officials:
References: