The IRIS Program: A Novel Pathway to Optimize Treatment of Injection-related Infections for People Who Inject Drugs in Hamilton, Ontario
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Number of emergency department visits and hospital readmission
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 105 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Intervention group
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.
干预措施: Holistic injection-related injection treatment (Other)
结局指标
主要结局
Number of emergency department visits and hospital readmission
时间窗: Within 30 days of initial hospital admission or program enrolment
次要结局
- Number of hospital readmissions specifically for the infection that was the primary reason for program enrolment(Within 90-days of hospital discharge or program enrolment)
- Number of emergency department visits(Within 90-days of hospital discharge or program enrolment)
- Rates of program drop-out and reasons for discontinuation(Within 6-months of hospital discharge or program enrolment)
- Completion of intended course of treatment for the injection-related infection(Within 6 months of initial hospital admission or program enrolment)
- Number of new initiations or record of continuation of substance use treatment(Within 90-days of hospital discharge or program enrolment)
- Mortality rates(Within 6-months of hospital discharge or program enrolment)