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
- 3
- 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.
研究组 & 干预措施
Implementation Core
During baseline Exploration, staff organizational surveys are collected. During Preparation, staff focus groups conduct needs assessment with system mapping of linkage points for screening, assessment, and referral, and the agencies/staff involved in these activities. During Implementation, sites use facilitated local change teams (LCT) provided with a core set implementation strategies to facilitate linkages between probation agencies and local community treatment providers. The LCTs identify barriers to change, approaches to overcome barriers, do goal selection using SMART (specific, measurable, achievable, relevant, timely) goals and evidence for medications, address stigma, and clarify needs/expectations/roles of probation officers and treatment providers, then choose and implement goals and strategies. Sustainability Phase: Facilitators work with LCTs for 12 months using a written action plan based on goal selection.
干预措施: Core Intervention (Behavioral)
Randomized Trial of Peer Support Specialist Model
After Core implementation is complete, half of adult participants in probation who consent will be randomly assigned to a Peer Support Specialist (PSS) condition. PSS are assigned to adults diagnosed with OUD within 6 months of entry into probation, in addition to treatment as usual. PSS establish linkages to community providers (medical, mental health, substance use treatment); educate about recovery support services, transportation assistance, MOUD; provide experiential, non-clinical support to individuals with SUD; share skills, offer support for setting goals and navigating the recovery process); and provide referrals and support for treatment, housing, employment, drug court, and probation.
干预措施: Peer Support Specialists (PSS) (Behavioral)
Randomized to Treatment as Usual
After Core Implementation is complete, half of adult participants in probation who consent will be randomly assigned to continue with usual care.
干预措施: Treatment as Usual (TAU) (Behavioral)
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)