Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
450 participants
INTERVENTIONAL
2021-03-02
2026-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
The initial Core Implementation study involved four phases: Exploration (baseline), Preparation, Implementation, Sustainability (6- and 12-month follow-ups). The subsequent Effectiveness study starts after the Implementation phase is completed, with its own baseline data and follow-ups up to 6 months.
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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.
Core Intervention
Staff are provided with a core set of implementation strategies to facilitate interorganizational linkages between probation agencies and local community treatment providers.
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.
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.
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.
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.
Interventions
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Core Intervention
Staff are provided with a core set of implementation strategies to facilitate interorganizational linkages between probation agencies and local community treatment providers.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of North Carolina, Chapel Hill
OTHER
Temple University
OTHER
University of Rhode Island
OTHER
The Miriam Hospital
OTHER
National Institute on Drug Abuse (NIDA)
NIH
CODAC Behavioral Healthcare
UNKNOWN
Duke University
OTHER
Brown University
OTHER
Responsible Party
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Principal Investigators
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Rosemarie A Martin, PhD
Role: PRINCIPAL_INVESTIGATOR
Brown University
Damaris J Rohsenow, PhD
Role: PRINCIPAL_INVESTIGATOR
Brown University
Lauren Brinkley-Rubinstein, PhD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Steven Belenko, PhD
Role: PRINCIPAL_INVESTIGATOR
Temple University
Lynda Stein, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Rhode Island
Josiah Rich, MD
Role: PRINCIPAL_INVESTIGATOR
The Miriam Hospital
Locations
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Duke University
Durham, North Carolina, United States
Temple University
Philadelphia, Pennsylvania, United States
Brown University
Providence, Rhode Island, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2002002636
Identifier Type: -
Identifier Source: org_study_id
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