Clinical trial NCT04978168: Opioid Treatment and Peer Recovery Support
Official title: Using Implementation Interventions and Peer Recovery Support to Improve Opioid Treatment Outcomes in Community Supervision
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid-use Disorder
Keywords: Opioid Use
Medications for Opioid Use
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: Temple University
name: University of Rhode Island
name: The Miriam Hospital
name: National Institute on Drug Abuse (NIDA)
name: CODAC Behavioral Healthcare
name: Duke University
First posted: 2021-07-27
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Type 1 hybrid implementation-effectiveness study conducted in two phases. The first recruits as staff/leaders from probation agencies and community treatment agencies. The second phase (which starts after the implementation in the first period is completed) recruits adults on probation and staff of probation agencies. The Core Implementation study (first phase) involves a pre-post design. The effectiveness study (second phase) uses randomized parallel assignment with two arms.

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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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.

Primary outcomes:
measure: Individual-Level Experimental (Period 2) Outcome: Engagement in MOUD
timeFrame: 26 weeks
measure: Program-Level Implementation Outcome: Engagement in MOUD
timeFrame: 26 weeks
Secondary outcomes:
measure: Detainment during Assessment Period (Individual-Level Experimental (Period 2) Outcome)
timeFrame: 26 weeks
measure: Opioid Use (Individual-Level Experimental (Period 2) Outcome)
timeFrame: 26 weeks
measure: Non-Fatal Overdose Events (Individual-Level Experimental (Period 2) Outcome)
timeFrame: 26 weeks
measure: Staff MOUD Knowledge and Attitudes (Program-Level Implementation Outcome)
timeFrame: 26 weeks
measure: Organizational Readiness for Change (Program-Level Implementation Outcome)
timeFrame: 26 weeks
measure: Input Costs: PSS time (Program-Level Implementation Outcome)
timeFrame: 26 weeks
measure: Input Costs: Medical Usage (Program-Level Implementation Outcome)
timeFrame: 26 weeks
measure: Outcome Costs (Program-Level Implementation Outcome)
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Providence
country: United States
facility: Brown University
state: Rhode Island
Study officials:
affiliation: Brown University
name: Rosemarie A Martin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Brown University
name: Damaris J Rohsenow, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Lauren Brinkley-Rubinstein, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Temple University
name: Steven Belenko, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Rhode Island
name: Lynda Stein, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Miriam Hospital
name: Josiah Rich, MD
role: PRINCIPAL_INVESTIGATOR
References: