Data-Driven Approaches for Opioid Use Disorder Treatment, Recovery, and Overdose Prevention in Rural Communities Via Mobile Health Clinics and Peer Support Services
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Medications for Opioid Use Disorder (MOUD) Initiation
研究概览
简要总结
This study will provide longitudinal data for 6-months on a target sample of patients with Opioid Use Disorder (OUD) recruited from Prisma Health Mobile Health Clinics in South Carolina. The goal of our study is to increase OUD treatment initiation and retention and maximize prevention of overdose deaths in underserved communities through development, testing, and delivery of a novel intervention targeting areas of optimal allocation of MHC with a Peer Support Specialist (PSS) intervention.
详细描述
This study will provide longitudinal data for 6-months on a target sample of patients with Opioid Use Disorder (OUD) recruited from Prisma Health Mobile Health Clinics in South Carolina. The goal of our study is to increase OUD treatment initiation and retention and maximize prevention of overdose deaths in underserved communities through development, testing, and delivery of a novel intervention targeting areas of optimal allocation of MHC with a Peer Support Specialist (PSS) intervention. In this project phase, the study will conduct an RCT to examine the effectiveness of the PSS on medications for OUD (MOUD) initiation and retention among these at-risk populations; and extend and optimize the modeling framework to improve effectiveness and utility of the MHC-directed PSS intervention, including cost-effectiveness. The primary outcomes are MOUD initiation and retention.
The study aims to enroll 750 participants with moderate to severe OUD. Through a 1:1 ratio using a computer randomization algorithm, 375 participants will be enrolled in the MHC + PSS intervention condition, while 375 will receive the standard MHC protocol. The MHC + PSS intervention condition entails linkage, via potential participants' visiting of a MHC, of participants to PSS services. PSSs are individuals who have had a direct experience with and successful recovery from OUD. PSSs are trained to provide recovery support services according to the Assertive Community Engagement (ACE) model of recovery support. To consistently deliver the ACE model of recovery support, the PSSs use the PSS checklist, developed and validated by our team in the R61 phase. In the R33 phase (Aim 1), the MHC + PSS protocol will be delivered to communities identified by the modeling framework as optimal locations for MHC delivery. The control condition involves the standard MHC protocol. Through the opioid use surveillance metrics and modeling framework from R61 Aim 2, the MHC will be allocated to the communities that are determined to be at highest risk for OUD, opioid-related hospitalizations, and overdose. Participants in the standard of care condition will receive MHC services for OUD screening, treatment, and overdose prevention, including enrollment in MOUD treatment and provided with fentanyl test strips and take-home naloxone for overdose reversal, without the added PSS support. The R33 phase (Aim 2) will also develop a model to evaluate the population impact and cost-effectiveness of the PSS on preventing fatal overdose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Have diagnosis of OUD
- •New mobile health MOUD patient
排除标准
- •Unable to read and comprehend the consent materials and other study materials
- •Currently working with a Certified Peer Support Specialist
- •Having severe medical or psychiatric disability that would hinder participation in the study, as determined by the clinical provider
研究组 & 干预措施
Standard of Care
The control condition involves the standard mobile recovery program (MRP) protocol. The MRP MOUD-specific capabilities are providing screening and assessments; induction monitoring; maintenance buprenorphine treatment; and follow-up care. The MRP is a facilitator of MOUD induction through partnerships with 340B pharmacies. Participants in both the standard of care condition and CPSS condition will receive MRP services for OUD screening, treatment, and overdose prevention, including enrollment in MOUD treatment and provision of take-home naloxone, fentanyl and/or xylazine test strips as needed.
Certified Peer Intervention Specialist
The intervention includes standard of care described above and also involves a participant meeting with a certified peer support specialist (CPSS) throughout MOUD initiation and early maintenance phases (up to 24 weeks post-initiation). CPSS encounters may be in-person or virtual. CPSS will track their services provided throughout the study period utilizing the newly developed checklist, incorporated into REDCap.
干预措施: Certified Peer Support Specialist Intervention (Behavioral)
结局指标
主要结局
Medications for Opioid Use Disorder (MOUD) Initiation
时间窗: 3 months
MOUD initiation defined as receipt of first MOUD prescription within 3 months since baseline assessment.
Medications for Opioid Use Disorder (MOUD) Retention
时间窗: 6 months
MOUD retention at 6 months defined as receipt of 80% of MOUD prescriptions in first 6 months since baseline assessment.
次要结局
- Adherence to Buprenorphine(Weekly; 24 weeks)
- Barriers to Healthcare(90 days)
- Frequency of Opioid Use(Monthly)
- Overdose(Weekly; 24 weeks)
- Hospitalizations/Emergency Department Visits(Weekly; 24 weeks)
- Engagement in other Recovery Support Services(Weekly; 24 weeks)
- Naloxone/Narcan Administration(Weekly; 24 weeks)
- Fentanyl Test Strip Use(Weekly; 24 weeks)
- Recovery Capital(90 days)
- Social Support(90 days)
- Depression symptoms(90 days)
- Anxiety symptoms(90 days)
- Post-Traumatic Stress Disorder (PTSD) symptoms(90 days)
- Frequency of Opioid Use(Monthly; 24 weeks)