Opioid Treatment and Peer Recovery Support
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Core Intervention, Peer Support Specialists (PSS), Treatment as Usual (TAU).
- Who it may be relevant to
- Registry conditions: Opioid-use Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Using Implementation Interventions and Peer Recovery Support to Improve Opioid Treatment Outcomes in Community Supervision
Overview
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.
Detailed description
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:
The primary aim is to test the effectiveness of PSS compared to TAU (agency approach after implementation) on outcomes of individuals on probation: Engagement in MOUD (primary effectiveness outcome), probation revocation (secondary), illicit opioid use (secondary), and overdose (tertiary).
The second aim is to test the effectiveness of EPIS-based Core Implementation Intervention relative to baseline on engagement in MOUD (primary implementation outcome).
The third aim is to test the effects of the EPIS implementation strategies relative to baseline on program-level (organizational and staff-level) outcomes.
The fourth aim is to conduct a cost-benefit analysis of implementing PSS compared to TAU.
The fifth aim is to identify organizational and staff barriers and facilitators to intervention implementation by conducting qualitative interviews with key probation and community treatment stakeholders who are managing and delivering the MOUD program.
Interventions
- Behavioral Core Intervention
Staff are provided with a core set of implementation strategies to facilitate interorganizational linkages between probation agencies and local community treatment providers. - Behavioral Peer Support Specialists (PSS)
Participants randomized to PSS will meet with a PSS for 6 months. Contact scheduled is flexible and based on the participant's needs and wants, plus written guidance for PSS-participant interactions. - Behavioral Treatment as Usual (TAU)
Participants randomized to TAU will receive the services that will be offered at the time the Core Implementation intervention is completed.
Primary outcome measures
- Individual-Level Experimental (Period 2) Outcome: Engagement in MOUD [Time frame: 26 weeks]
- Program-Level Implementation Outcome: Engagement in MOUD [Time frame: 26 weeks]
Secondary outcome measures (8)
- Detainment during Assessment Period (Individual-Level Experimental (Period 2) Outcome) [Time frame: 26 weeks]
- Opioid Use (Individual-Level Experimental (Period 2) Outcome) [Time frame: 26 weeks]
- Non-Fatal Overdose Events (Individual-Level Experimental (Period 2) Outcome) [Time frame: 26 weeks]
- Staff MOUD Knowledge and Attitudes (Program-Level Implementation Outcome) [Time frame: 26 weeks]
- Organizational Readiness for Change (Program-Level Implementation Outcome) [Time frame: 26 weeks]
- Input Costs: PSS time (Program-Level Implementation Outcome) [Time frame: 26 weeks]
- Input Costs: Medical Usage (Program-Level Implementation Outcome) [Time frame: 26 weeks]
- Outcome Costs (Program-Level Implementation Outcome) [Time frame: 26 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Individuals on Probation: Currently incarcerated or in a court-mandated inpatient treatment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 3 centers
- Duke University — Durham
- Temple University — Philadelphia
- Brown University — Providence
Identifiers
NCT: NCT04978168 · 2002002636 · U01DA050442-01