Project STAMINA (Syringe Service Telemedicine Access for Medication-assisted Intervention Through NAvigation): Development and Testing of a Health Navigation Approach for Linking Syringe Service Program Clients to Medication Assisted Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 275
- 试验地点
- 2
- 主要终点
- Linkage to Medication for Opioid Use Disorder (MOUD)
研究概览
简要总结
Project STAMINA is a clinical trial that seeks to establish effectiveness of a telemedicine approach for linking syringe exchange clients to medications for opioid use disorder. This pilot study aims to recruit n=275 people and utilizes two study arms: (1) a treatment arm consisting of immediate telemedicine linkage and (2) a control arm consisting of standard referral to treatment. Half of the study participants will be randomly enrolled in each arm. The study will utilize qualitative and quantitative data, including questionnaire data, drug test results, and administrative treatment data, at multiple time points to determine what effect telemedicine linkage has on clients in relation to the comparison group.
详细描述
INTERVENTION DESCRIPTION:
Project STAMINA utilizes two study arms: (1) a treatment arm consisting of immediate telemedicine linkage (2) a control arm consisting of standard referral to treatment. Half of the study participants will be randomly enrolled in each arm. All enrollment and telemedicine care will occur at one of two Chicago-based and university-affiliated syringe service program (SSP) sites, where the primary purpose is providing free access to syringes for people who inject drugs.
Intervention Arm (1): Participants enrolled into the telemedicine linkage intervention will be immediately linked to telemedicine care provided by a university-affiliated federally qualified health center (FQHC) that can prescribe buprenorphine and naltrexone and has a relationship with a methadone treatment provider they can refer patients to as appropriate. Study participants prescribed buprenorphine or naltrexone will be able to receive MOUD treatment at any of the 6 FQHC locations across the city, three of which are in relatively close proximity to the SSP sites, and a no-cost induction buprenorphine prescription can be dispensed from their main office. The FQHC can also refer to a methadone provider with various locations throughout the city. At the SSP, the participant will have their vitals checked by a research team member and be connected with the FQHC provider via an iPad. The research assistant will share the participant's vitals with the provider, and the provider will complete a virtual treatment appointment. The research assistant will offer the participant transportation assistance to pick up the first buprenorphine or naltrexone prescriptions or to attend the first methadone referral appointment. Transportation to pick up the prescription will be provided via a HIPAA compliant ride-share company, and a bus pass will be provided to the participant for the return trip. Further, to support the intervention, the research assistant will also provide a visual guide at enrollment (i.e. picture directions) that describes how to navigate the FQHC pharmacy, as well as a scheduling card that allows them to record any MOUD appointment dates. All follow-up OUD care and prescribing will be conducted based on the provider's standards and may include in-person or telemedicine appointments.
Standard Care Arm (2): Participants enrolled in the control arm will receive a standard referral to an in-person appointment, also with a provider from the same FQHC sites or a methadone provider of their choice. This appointment will involve an in-person meeting with the provider, which will occur within 24-72 hours of the enrollment time. After study enrollment, the research assistant will schedule this in-person appointment. The research assistant will also provide the participant with an appointment reminder card for this appointment and bus passes to cover the transportation to and from the appointment, which aligns with standard care at the SSP. All follow-up OUD care and prescribing will be conducted based on the provider's standards and may include in-person or telemedicine appointments.
RESEARCH DESIGN:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •communicate in English
- •be at least 18 years of age
- •reside in Cook County, Illinois
- •score at least "2" on the Opioid Use Disorder Screening tool (DSM), indicating mild opioid use disorder
- •express interest in receiving medication for an opioid use disorder (MOUD)
排除标准
- •have plans to move outside of Cook County, Illinois within the next 6 months
- •have plans to serve a sentence that requires reporting to jail or prison within the next 6 months
- •score "36" or higher on the Clinical Opioid Withdrawal Scale (COWS), indicating severe opioid withdrawal symptoms
- •currently taking any form of medication that has been prescribed by a healthcare provider to treat opioid use disorder
- •demonstrate inadequate ability to provide informed consent, as indicated by poor understanding of research based on 3 competency questions asked related to study.
结局指标
主要结局
Linkage to Medication for Opioid Use Disorder (MOUD)
时间窗: Within 14 days of enrollment
Whether the participant attends 1 in-person MOUD treatment appointment
次要结局
- Medication for Opioid Use Disorder (MOUD) Treatment Retention(3 month study period)
- Medication for Opioid Use Disorder (MOUD) Treatment Engagement(Within 34 days of enrollment)
- Detected Non-prescribed Opioids(3 month study period)
- Self-report Non-medication for Opioid Use Disorder (MOUD) Opioid Use(3 month study period)
