Using Implementation Interventions and Peer Recovery Support to Improve Opioid Treatment Outcomes in Community Supervision
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 6
- 主要终点
- Individual-Level Experimental (Period 2) Outcome: Engagement in MOUD
研究概览
简要总结
Determine whether a facilitated local change team intervention improves a probation organization's client-level medication for opioid use disorder (MOUD) outcomes and implementation outcomes relative to baseline across multiple sites. Determine whether client-level outcomes are further enhanced by the introduction of Peer Support Services.
详细描述
Background: The purpose is to determine whether a facilitated local change team (LCT) intervention improves linkage to medication for opioid use disorder (MOUD) and implementation outcomes, and whether participant-level outcomes are further enhanced by the use of Peer Support Specialists (PSS).
Methods/Design: This Type 1 hybrid implementation-effectiveness study involves a pre-post design (implementation study) followed by a randomized trail of PSS (effectiveness study). The study is conducted at 7 performance sites in 3 states.
Phase 1 (Core Implementation Study): The Exploration, Preparation, Implementation, Sustainability (EPIS) framework is used to guide system-change through facilitated LCTs consisting of probation and community treatment staff who are given a core set of implementation strategies which are used to conduct a needs assessment and set goals. The overall objective is to improve linkage to the continuum of evidence-based care for justice-involved individuals with opioid use disorder (OUD). Organizational (program-level) and staff survey are collected at the end of each EPIS stage (baseline Exploration, end of Preparation, end of Implementation, and 12 months [Sustainability]). Implementation outcomes: Organizational engagement in MOUD (primary), plus changes in staff knowledge/attitudes and organizational outcomes (secondary).
Phase 2 (Effectiveness Study of PSS): After completing implementation, 450 adults on probation are randomized to receive PSS vs. treatment as usual (TAU), with assessments at baseline, 3, and 6 months. This trial tests whether having a trained peer improves clinical outcomes beyond effects of Core Implementation. Implementation program-level outcomes include organizational engagement in MOUD use (primary outcome); changes in staff knowledge and attitudes about MOUD, commitment and efficacy, readiness for change; organizational attitudes for change, commitment and efficacy (secondary outcomes). Client-level effectiveness outcomes include participant engagement in MOUD (primary outcome), probation revocation, illicit opioid use, and overdoses (secondary outcomes). Other aims include identifying barriers and facilitators, and cost-benefit analysis of PSS.
Primary Research Questions:
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
- 否
入选标准
- •Community Provider Staff: Any front-line treatment provider at an agency participating in this study who: (a) provides support to MOUD clients, (b) has an active caseload including some individuals on probation, and (c) willing to commit to 12 months to the project.
- •Probation/Parole Staff: Any probation officer (PO) at an agency participating in this study who (a) has an active caseload, and (b) is willing to commit to 12 months to the project.
- •Individuals on Probation: (a) 18 years or older, (b) committed to probation within 90 days prior to study enrollment, (c) English speaking, (d) diagnosed with OUD, (e) have stable method of contact in community
排除标准
- •Individuals on Probation: Currently incarcerated or in a court-mandated inpatient treatment.
结局指标
主要结局
Individual-Level Experimental (Period 2) Outcome: Engagement in MOUD
时间窗: 26 weeks
Calculated from self-report survey of being enrolled in MOUD (yes or no) at each assessment.
Program-Level Implementation Outcome: Engagement in MOUD
时间窗: 26 weeks
MOUD engagement (primary implementation outcome) is defined as enrollment in MOUD treatment program, or filling a prescription for buprenorphine from a provider (in not on MOUD at time of recruitment), or remaining in MOUD treatment (if already on MOUD when recruited or at previous follow-up), coded dichotomously. Number of clients in probation enrolled in MOUD is tracked via medical and probation records.
次要结局
- Non-Fatal Overdose Events (Individual-Level Experimental (Period 2) Outcome)(26 weeks)
- Staff MOUD Knowledge and Attitudes (Program-Level Implementation Outcome)(26 weeks)
- Outcome Costs (Program-Level Implementation Outcome)(26 weeks)
- Opioid Use (Individual-Level Experimental (Period 2) Outcome)(26 weeks)
- Input Costs: PSS time (Program-Level Implementation Outcome)(26 weeks)
- Input Costs: Medical Usage (Program-Level Implementation Outcome)(26 weeks)
- Detainment during Assessment Period (Individual-Level Experimental (Period 2) Outcome)(26 weeks)
- Organizational Readiness for Change (Program-Level Implementation Outcome)(26 weeks)