An interventional study of Holistic injection-related injection treatment in Peer Support, Injection-related Infections and Infections, sponsored by McMaster University. Not yet recruiting at 2 sites in Canada. Open to participants aged 16 Years to 105 Years. Per ClinicalTrials.gov, last updated 2023-12-13.
Sponsored by McMaster University · Not applicable, Interventional, and Treatment
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 80 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →McMaster University is the lead sponsor of 720 studies on the registry; 124 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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Participants in the IRIS program will be offered a one-stop, low-barrier combined care model to address their injection-related infections. Specific program components include: (1) Diagnosis and treatment of injection-related infections; (2) Substance use treatment (3) Peer support; and (4) Care coordination/systems navigation.
Other: Holistic injection-related injection treatment
Participants in the intervention group will be provided additional supports to address their social and medical needs, including infectious disease management, addictions medicine, peer support, and systems navigation. Each participant will receive individualized care depending on their unique needs.
Number of emergency department visits and hospital readmission
Time frame: Within 30 days of initial hospital admission or program enrolment
Completion of intended course of treatment for the injection-related infection
Investigators will record whether or not participants have completed the intended course of treatment for their injection-related infection (e.g. completed course of antibiotics - YES or NO).
Time frame: Within 6 months of initial hospital admission or program enrolment
Number of hospital readmissions specifically for the infection that was the primary reason for program enrolment
Time frame: Within 90-days of hospital discharge or program enrolment
Number of emergency department visits
Time frame: Within 90-days of hospital discharge or program enrolment
Number of new initiations or record of continuation of substance use treatment
Time frame: Within 90-days of hospital discharge or program enrolment
Mortality rates
Time frame: Within 6-months of hospital discharge or program enrolment
Rates of program drop-out and reasons for discontinuation
Time frame: Within 6-months of hospital discharge or program enrolment
Plan to share: No
This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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