Using Implementation Interventions and Peer Recovery Support to Improve Opioid Treatment Outcomes in Community Supervision: Protocol
Rosemarie Martin
LAR Stein
Damaris Rohsenow
Steven Belenko
Linda Hurley
SimpleOriginal

Summary

This study tests whether local change teams and peer support improve MOUD access for people on probation. It tracks outcomes like treatment engagement, opioid use, and revocation to guide system reforms and assess cost-effectiveness.

2021

Using Implementation Interventions and Peer Recovery Support to Improve Opioid Treatment Outcomes in Community Supervision: Protocol

Keywords justice; opioid use disorder; medications; probation

Abstract

Objective: 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 use of peer support specialists (PSS). Methods: This Type 1 hybrid implementation-effectiveness study involves a pre-post design (implementation study) followed by a randomized trial of PSS (effectiveness study). Participants are at least 114 justice and service staff from 7 sites in three states: probation officers, community treatment providers, a supervisor from each agency, and key stakeholders. The study will recruit up to 680 individuals on probation from seven adult community probation offices; eligible individuals will be recently committed, English speakers, with opioid use disorder (OUD). Core Implementation Study: The study will use the exploration, preparation, implementation, sustainability (EPIS) framework to guide system-change through facilitated LCTs of probation and community treatment staff given a core set of implementation strategies to set goals. The study will collect program-level and staff survey data at the end of each EPIS stage. Implementation outcomes: Organizational engagement in MOUD (primary), plus changes in staff knowledge/attitudes and organizational outcomes (secondary). Effectiveness Study of PSS: After completing implementation, the study will randomize adults on probation to receive PSS vs. treatment as usual, with assessments at baseline, 3, 6 and 12 months. Effectiveness outcomes include participant engagement in MOUD (primary), probation revocation, illicit opioid use, and overdoses. Other aims include identifying barriers and facilitators, and cost-benefit analysis of PSS. Adaptations in response to COVID-19 included moving many procedures to remote methods.

Using Implementation Interventions and Peer Recovery Support to Improve Opioid Treatment Outcomes in Community Supervision: Protocol

1. Rationale and overview

Individuals released from incarceration have increased risk of overdose death in the first two weeks postrelease (Binswanger et al., 2010; Ranapurwala et al., 2018). Although rates of substance use disorder (SUD) are nearly 50%, there is limited access to SUD treatment while on community supervision. However, providing medication for opioid use disorder (MOUD) significantly decreases relapse and recidivism, and increases retention in SUD treatment (Gordon et al., 2015; Clark et al, 2014). While a department of corrections (DOC) system-wide program offering MOUDs in all prison/jail settings resulted in a significant decrease in state-wide overdose deaths (Green et al., 2018), only 33% of individuals newly on MOUD continued with treatment postrelease (Martin et al., 2018).

Community supervision provides a unique opportunity to engage individuals in treatment. Probation agencies are not structured for service delivery (Taxman 2012; Taxman & Belenko, 2012). Probation officers (POs) often lack the training and motivation to refer individuals to OUD treatment, indicating a need for informed partnerships to supplement current practices for those with OUD. Improved contact, communication, and role expectations between community corrections and community service providers stands to improve the continuum of care (i.e., screening, referral and linkage) for MOUD (Monico et al., 2016; Taxman & Belenko, 2012; Welsh et al., 2016). Additionally, peer support specialists (PSSs) may assist in linking individuals on probation to MOUD and other services; research has shown that PSSs are increasingly used, with limited but strong empirical evidence among criminal justice (CJ) populations (Bauldry et al., 2009; Cos et al., 2019; Marlow et al., 2015; Reingle Gonzalez et al., 2019).

Study Overview:

We evaluate a systems-change approach for increasing MOUD engagement in seven probation sites across Rhode Island, North Carolina, and Pennsylvania, using a hybrid Type 1 implementation-effectiveness design (Figure 1). Stage 1 — Core implementation study: The exploration, preparation, implementation, sustainability (EPIS) framework guides system-change through facilitated local change teams (LCTs) of CJ and community treatment providers using a core set of implementation strategies at the agency level, with assessments after each stage. The study’s objective is to improve linkage to the continuum of evidence-based care for probation-involved adults with OUD. Stage 2 — PSS effectiveness study: After implementation, the study will randomize 680 individuals on probation to receive PSS vs. treatment as usual (TAU), with 3-, 6- and 12-month follow-up assessments. This trial tests whether having a trained peer improves clinical outcomes beyond effects of core implementation.

Figure 1: Flow chart of study.

2. Study protocol

2.1. Aims and hypotheses

The study aims are: 1) To compare PSS 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). 2) To test the effectiveness of the EPIS core implementation intervention relative to baseline on engagement in MOUD (primary implementation outcome). 3) To test the effectiveness of the EPIS-based core implementation intervention relative to baseline on organizational and staff-level outcomes: staff MOUD knowledge and attitudes, commitment and efficacy, readiness for change; organizational readiness for change, commitment and efficacy; penetration, adoption, sustainability. 4) To conduct a cost-benefit analysis of the societal cost implications of implementing a PSS model compared to TAU. 5) 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. We hypothesize that the core implementation intervention will improve MOUD engagement compared to baseline (implementation outcome), that PSS will improve MOUD engagement relative to TAU after implementation (participant-level outcome), and that staff attitudes and perceptions regarding MOUD will improve over time (implementation outcomes).

2.2. Design

A Type 1 hybrid implementation-effectiveness study.11 The core implementation study involves a pre-post design. The effectiveness study uses randomized parallel assignment with two arms.

2.3. Participants and sites

Program-level core implementation study (Stage 1):At least 114 POs and service staff from seven adult probation offices in three states: 8–10 POs and 1 supervisor from each office, 2–3 treatment providers and 1 supervisor from each community treatment agency, and up to 30 key stakeholders.

Probation participant-level effectiveness study (Stage 2): Up to 680 individuals on probation recruited from the same probation offices.

Inclusion criteria. Participants will be at least 18 years old, English speakers able to provide written and/or verbal informed consent.

A. Treatment provider staff. Treatment provider at a participating agency who provides support to MOUD clients, has an active caseload including some individuals on probation, and has been employed at least 3 months. One supervisor of such staff per agency.

B. Probation staff. PO at a participating office who has an active caseload and has been employed at least 6 months. One supervisor from each probation office. A local champion will be recruited to lead the LCT.

C. Key stakeholders. Key stakeholders include POs, medical staff, administrative staff, community MOUD staff, case managers, and leadership currently employed by the probation offices or community treatment agency; or involved in the implementation, oversight, or provision of MOUD at each site.

D. Probation participants. Adults committed to probation within 90 days prior to study enrollment; diagnosed with OUD; able to provide locator information (see section 2.7.2.1).

2.4. Recruitment

Staff surveys and stakeholder interviews. The study will hold an orientation meeting at each site. Research staff will verify the few inclusionary criteria then discuss the consent form. Participants will give consent on-line at the start of the survey. The study will obtain informed consent for key stakeholders in person or via videoconferencing.

Probation participants. Research staff will inform potential participants that study participation is completely voluntary and will not affect their terms of probation or status, and will review the informed consent form before obtaining consent. Research staff screen for inclusionary criteria in a private space, and confirm OUD diagnosis and capability to consent with agency staff. POs will not be involved in recruitment or informed as to the participation of any individual.

2.5. Incentives

In sites that allow incentives, POs and treatment staff will receive a $10 gift card for each completed assessment ($40 total), with a $100 gift card drawing (per site) every 3 months for staff who complete that cycle’s assessment. Stakeholders will receive a $5 gift card for each completed interview ($20 total). Probation participants receive $30 for the baseline survey and $35 for each completed follow-up ($135 total).

2.6. Stage 1: Core implementation study

2.6.1. Baseline observation period

Rates of OUD referrals and MOUD treatment engagement are collected at each site for the 6-month period before the core intervention. The study also assesses PO and supervisor MOUD knowledge and attitudes toward innovation.

2.6.2. Core intervention

An orientation with PO and community treatment stakeholders discusses project goals and procedures, and agency leadership demonstrate study endorsement.

Needs assessment and systems mapping. This exercise identifies processes that POs use to screen and assess OUD, and link individuals to treatment. A focus group with probation and treatment staff will construct a systems map showing linkage points for screening, assessment, and referral, and the agencies/staff involved in these activities.

Local change teams (LCT). Each state forms a LCT that an implementation facilitator leads. Core interventions include the needs assessment/systems mapping, and development of community-specific best practices for POs and community treatment providers, and trainings. The LCT will be led through a goal selection exercise to identify part(s) of the OUD screening/referral process in need of improvement. Trainings, pending goal selection, include SMART (specific, measurable, achievable, relevant, timely) goals; Plan-Do-Study-Act; evidence for MOUD; stigma (effects, causes, how to address), and clarification of needs/expectations/roles of POs and community treatment providers. Such clarification involves a walk-through of justice and service agencies, and working knowledge of recovery supports and MOUD. The facilitator assists the LCT in developing commitment to MOUD, identifying facilitators/barriers to MOUD, and problem-solving to reduce barriers and increase PO and treatment provider efficacy for linkage to MOUD. The facilitator will explicitly address the need for communication between justice- and community treatment partners to enhance MOUD linkage. Strategies used for systems change emphasize knowledge about OUD and MOUD, commitment to change (implementation benefits outweigh challenges), and efficacy for change (e.g., probation has means of facilitating MOUD). LCTs will be asked to choose goals and strategies for long-term sustainment. Facilitators will work with LCTs for 12 months following a written action plan based on goal selection. Each LCT (N = 8–10 per LCT) will comprise a PO leader to assist the facilitator, POs, community treatment providers, and at least one PO supervisor.

Implementation facilitators (study staff, one per state) will guide each LCT through the process of organizational improvement. The facilitator will train a local champion (LCT leader) who will become a local facilitator to move toward sustainability using a transition protocol. LCT and facilitator will be guided by detailed manuals with extensive guidance on strategies, activities, and practical resources to foster rapid-cycle changes through the use of Plan-Do-Study-Act. Facilitators will be centrally trained. The study will monitor fidelity of implementation in terms of adherence, dose, delivery quality and participant responsiveness (Dane & Schneider, 1998).

2.6.3 Measures for core intervention

2.6.3.1. Timing of assessments

Assessments are timed with EPIS phases. Baseline assessment occurs before the core intervention (exploration phase); preparation ends with choosing goals from needs assessment; implementation ends with LCT accomplishment of goal(s); sustainability will be assessed over 12 months.

2.6.3.2. Primary implementation outcomes

The study defines MOUD engagement as enrollment in MOUD treatment program, or filling a prescription for buprenorphine from a provider (if not on MOUD at time of recruitment), or remaining in MOUD treatment (if on MOUD when recruited or at previous follow-up), coded dichotomously. The study will track rate of MOUD engagement via medical and probation records.

2.6.3.3. Staff surveys: Experiences, attitudes, and perceptions

Staff will complete a web-based survey (mailed paper versions optional) across two weeks (reminder after one week) at each time point. The survey includes: The Inter-Organizational Relationships (IOR) survey (Welsh et al., 2016), which focuses on organizational linkages for collaboration and coordination between correctional and treatment agency dyads. Measures of organizational climate, functioning, innovation support, leadership, and staff attributes were adapted from the Evidence-Based Practices Attitudes Scale (Aarons, 2004), Survey of Organizational Functioning (IBR, 2005), and Organizational Readiness for Change (IBR, 2009). The Medications Opinion Survey(Friedmann et al, 2012) assesses PO and supervisor knowledge/attitudes toward MOUD.

2.6.3.3. Qualitative interviews with key stakeholders: Barriers and facilitators

Study staff will conduct semistructured qualitative interviews (60–90 min) with key stakeholders three times: pre-implementation, early implementation, and late implementation, to assess sustainability and learning. Interviews will identify organizational and staff inner context factors: 1) organizational characteristics (i.e., readiness for change); 2) individual adopter characteristics; 3) fidelity (e.g., integrity and quality of the program); and 4) penetration of the program (i.e., has the program become standard). Outer context issues include the sociopolitical environment (e.g. funding, legislative landscape, policy, community access to MOUD). The study will transcribe audio-recorded interviews for analysis.

2.7. Stage 2: Randomized trial of PSS

2.7.1. PSS and control conditions

At the conclusion of the core implementation intervention, the study will recruit and randomize individuals on probation with OUD to PSS vs. TAU.

Participants in the experimental arm will meet with a PSS for 12 months. The schedule and content of meetings will be based on the participant’s needs and wants, plus written guidance for PSS-participant interactions. PSSs have lived experience with addiction, recovery, and CJ involvement. PSSs establish linkages to community treatment providers; educate about recovery support services, transportation assistance, and MOUD; provide experiential, nonclinical support to individuals with SUD; share skills, offer support for setting goals and navigating the recovery process (Bassuk et al., 2016; Reif et al., 2014; Kelly & Hoeppner, 2015); and provide referrals and support for treatment, housing, employment, drug court, and probation (SAMHSA, 2009).

PSS training will cover both state requirements for certification (46–75 hr specialist training) and the skills and knowledge needed for peer work with this population. PSSs will be certified according to each state’s specifications and be supervised by a peer supervisor. The study will assess delivery via PSS logs of participant contacts (date, type, duration). The study will track fidelity via participant and PSS ratings of 12 core competencies, each including 4–7 indicators (Bassett et al., 2016; SAMHSA, 2015).

Participants randomized to TAU will receive the usual services offered at the sites.

2.7.2. Measures for effectiveness trial

2.7.2.1. Assessment procedures and timing

The study will conduct assessments (about 60 min each) at baseline, 3, 6, and 12 months. Locator information (consent to contact a family member, close friend, employer; numerous methods of contact) will facilitate tracking participants. Blinded research staff will conduct interviews. The study will conduct urine drug screens at each time point. Research staff will access medical records data on opioid use and overdoses from participating treatment agencies and public health records, and records from participating CJ agencies.

2.7.2.2. Participant-level baseline

Obtained from survey: Age, sex, gender identity/sexual orientation, race, ethnicity, marital status, education, employment, criminal justice history, substance use history, social supports, other health conditions, health services utilization, HIV risk behaviors, perceived discrimination/stigma, and history of MOUD. Obtained from agency record: OUD diagnosis.

2.7.2.3. Participant-level outcomes

Primary outcome: Engagement in MOUD across 12 months is assessed with The Treatment Services Review (TSR-6) and medical record review from participating treatment agencies (dichotomous at each time point).

Secondary outcomes: (1) Probation revocation obtained from DOC data. (2) Opioid use per self-report and urine toxicology screen. (3) Overdoses (incidence and death), per medical records and surveys.

Adverse events: Research staff will report unexpected adverse events or unexpected ill health to the PI for evaluation, with serious adverse events or loss of confidentiality reported per NIDA’s reporting requirements.

2.7.2.5. Cost-benefit data for PSS

Input costs: The study will record the time PSSs spend with participants in logs at the person-level and valued using the human capital approach based on appropriate wage rates from the Bureau of Labor Statistics.2 The study will track for each participant visits to medical providers from participant assessments (outpatient, emergency, hospitalizations) and use of MOUD. These will be valued at Medicare fee-for-service payment rates.3

Outcome costs: The study will track criminal offenses and re-incarceration time and value it for costs associated with criminal activity and jail time.

2.8. Power analysis

Power for Aim 1: For a 35% increase in MOUD engagement (Hazard ratio=1.30) in PSS versus TAU (modest effect size), N=680 will give ≥80% power at 3 months after adjustments for clustering effects and up to 25% attrition, with greater power at later follow-ups due to greater disengagement with MOUD over time in the TAU arm.

Power for Aims 2–3: The EPIS core intervention should have a small to medium effect size on staff and organizational outcomes (Knight et al., 2015). Assuming d=.3 and N=114, power is ≥80% after adjustments for clustering effects.

2.9. Statistical data analysis methods

Aim 1: Effectiveness study. First we will investigate differences in relevant characteristics between arms to enter as covariates (e.g., years of OUD, past MOUD). Log binomial regression will model condition differences in MOUD engagement at each follow-up. Generalized estimating equations (GEE) will analyze group differences over time while accounting for state-level clustering. Using intent-to-treat analysis, the study will code participants lost to follow-up as not engaging in MOUD; incarceration or death will be censored at the time of event. To examine efficacy (the true impact had everyone adhered to the intervention), we will address loss to follow-up as missingness (attrition) and use inverse probability of attrition weighting to examine what would happen if everyone had adhered to their assigned intervention. The study will analyze secondary outcomes the same way.

Aim 2 and 3: Implementation study. The study will analyze engagement in MOUD, knowledge, attitudes, organizational readiness for change, commitment and efficacy among agency staff pre-to post-EPIS implementation with Poisson regression with GEE to control for facility-level clustering.

Aim 4: Cost analysis. For each condition we will evaluate costs using the Second Panel on Cost-Effectiveness in Health and Medicine cost-benefit analysis framework.4 We estimate the differences in input and outcome costs by condition, allowing for clustering within states or PSS, adjusting for person-level characteristics, using two-part models with boot-strapped standard errors, if there are large numbers of zero costs for services. Finally, the study will compare adjusted input and outcome costs for each intervention using net savings, benefit-to-cost ratios, and return on investment calculations.

Aim 5: Qualitative data. The study will analyze qualitative data iteratively and rapidly to optimize intervention implementation. Interviewers will complete debriefing forms and discuss them at weekly meetings, with additional probes as needed to follow up on unanticipated themes. The study will develop meaningful analytical units by using a coding scheme based on the dominant themes in the data, with each theme and subtheme assigned a code compiled in a codebook. We will use open and axial coding, with analysis guided by a thematic approach due to its emphasis in pin-pointing, examining, and recording patterns in the data. After initial coding, researchers will summarize and organize the resulting data in Nvivo 11 (QSR International, Burlington, Massachusetts, USA). Two coders will work in tandem to code data after attaining inter-rater reliability of 90%.

3. Potential adaptations in response to COVID-19

The study may conduct orientation meetings via videoconferencing, with eligibility screening and informed consent discussion done individually by telephone or videoconferencing. Informed consent forms for staff are embedded in electronic surveys. The study may conduct informed consent for key stakeholder interviews by telephone or videoconferencing, with electronic copies of the informed consent form shared, and verbal consent obtained. Informed consent for participants may change to these methods. All surveys are electronic. The study may conduct qualitative interviews via videoconferencing. LCTs (agency employees) will use whatever interaction methods their sites have approved. PSSs will meet with participants either in person or via telehealth methods, based on participant and agency preferences.

4. Conclusions

This study is uniquely poised to evaluate the implementation and impact of MOUD among CJ-involved individuals, and changes in staff attitudes and behaviors related to MOUD; answer questions of urgent public health significance; improve service delivery methods via implementation science; and assess the efficacy of adding a PSS to MOUD treatment among individuals on probation.

Abstract

Objective: 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 use of peer support specialists (PSS). Methods: This Type 1 hybrid implementation-effectiveness study involves a pre-post design (implementation study) followed by a randomized trial of PSS (effectiveness study). Participants are at least 114 justice and service staff from 7 sites in three states: probation officers, community treatment providers, a supervisor from each agency, and key stakeholders. The study will recruit up to 680 individuals on probation from seven adult community probation offices; eligible individuals will be recently committed, English speakers, with opioid use disorder (OUD). Core Implementation Study: The study will use the exploration, preparation, implementation, sustainability (EPIS) framework to guide system-change through facilitated LCTs of probation and community treatment staff given a core set of implementation strategies to set goals. The study will collect program-level and staff survey data at the end of each EPIS stage. Implementation outcomes: Organizational engagement in MOUD (primary), plus changes in staff knowledge/attitudes and organizational outcomes (secondary). Effectiveness Study of PSS: After completing implementation, the study will randomize adults on probation to receive PSS vs. treatment as usual, with assessments at baseline, 3, 6 and 12 months. Effectiveness outcomes include participant engagement in MOUD (primary), probation revocation, illicit opioid use, and overdoses. Other aims include identifying barriers and facilitators, and cost-benefit analysis of PSS. Adaptations in response to COVID-19 included moving many procedures to remote methods.

Rationale and Overview

High overdose mortality risk characterizes the initial two weeks following release from incarceration. Despite a substantial prevalence of substance use disorder (SUD) among this population, access to SUD treatment during community supervision remains limited. Medication for opioid use disorder (MOUD) demonstrably reduces relapse, recidivism, and enhances retention in SUD treatment. While system-wide MOUD programs within correctional facilities have yielded significant decreases in overdose fatalities, continuation of MOUD post-release remains a challenge. Community supervision presents a crucial opportunity for treatment engagement, however, probation agencies lack the structure for optimal service delivery. Probation officers (POs) frequently lack adequate training and motivation to refer individuals to OUD treatment. Collaborative partnerships are thus needed to augment current practices. Strengthened communication and clarified roles between community corrections and service providers are vital for improving the continuum of MOUD care. Furthermore, peer support specialists (PSSs) show promise in facilitating access to MOUD and other services within criminal justice populations.

Study Overview

This study employs a systems-change approach to enhance MOUD engagement across multiple probation sites. Utilizing a hybrid Type 1 implementation-effectiveness design, the study comprises two stages. Stage 1, a core implementation study, utilizes the exploration, preparation, implementation, and sustainability (EPIS) framework to guide system-wide change through facilitated local change teams (LCTs). This phase assesses the improvement in linkage to evidence-based care for probation-involved adults with OUD. Stage 2, a PSS effectiveness study, involves the randomization of probationers to receive PSS or treatment as usual (TAU), with follow-up assessments to evaluate the impact of trained peer support on clinical outcomes.

Aims and Hypotheses

The study aims to compare PSS versus TAU on probationer outcomes, assess the effectiveness of the EPIS core implementation intervention, evaluate the impact on organizational and staff-level outcomes, conduct a cost-benefit analysis, and identify implementation barriers and facilitators. The study hypothesizes that the core implementation intervention will improve MOUD engagement, that PSS will enhance MOUD engagement relative to TAU, and that staff attitudes towards MOUD will improve.

Design, Participants, and Sites

The study design is a Type 1 hybrid implementation-effectiveness study, incorporating a pre-post design for the core implementation study and a randomized parallel assignment for the effectiveness study. Participants include probation officers, treatment staff, key stakeholders, and probationers meeting specific inclusion criteria. Recruitment strategies vary across participant groups, utilizing both online and in-person methods.

Recruitment and Incentives

Recruitment involves orientation meetings, online surveys, and in-person or videoconferencing interviews. Financial incentives are offered to participants to encourage engagement. Probation officer involvement in recruitment is strictly limited to avoid bias.

Core Implementation Study

The core implementation study involves a baseline observation period to collect data on OUD referrals and MOUD engagement. The core intervention includes an orientation, needs assessment, systems mapping, and the formation of LCTs. Implementation facilitators guide LCTs through organizational improvement using the EPIS framework. Assessments are conducted at multiple time points using a range of surveys and interviews.

Randomized Trial of PSS

The randomized trial of PSS compares the effectiveness of PSS versus TAU on probationer outcomes. PSSs receive specialized training and provide support services to participants. Assessment procedures involve surveys, urine drug screens, and medical record reviews at multiple time points. Cost-benefit data will be collected to compare the two conditions.

Power Analysis and Statistical Methods

Power analyses demonstrate adequate power for the study aims. Statistical analyses will employ various methods to account for clustering effects and attrition, including log binomial regression, generalized estimating equations (GEE), and intent-to-treat analysis. Qualitative data will be analyzed using thematic analysis.

Adaptations in Response to COVID-19

The study has developed strategies to adapt its procedures for the conduct of research during the COVID-19 pandemic.

Conclusions

This study aims to provide valuable insights into the implementation and impact of MOUD and the addition of PSSs within the criminal justice system, contributing to improvements in service delivery and public health outcomes.

Abstract

Objective: 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 use of peer support specialists (PSS). Methods: This Type 1 hybrid implementation-effectiveness study involves a pre-post design (implementation study) followed by a randomized trial of PSS (effectiveness study). Participants are at least 114 justice and service staff from 7 sites in three states: probation officers, community treatment providers, a supervisor from each agency, and key stakeholders. The study will recruit up to 680 individuals on probation from seven adult community probation offices; eligible individuals will be recently committed, English speakers, with opioid use disorder (OUD). Core Implementation Study: The study will use the exploration, preparation, implementation, sustainability (EPIS) framework to guide system-change through facilitated LCTs of probation and community treatment staff given a core set of implementation strategies to set goals. The study will collect program-level and staff survey data at the end of each EPIS stage. Implementation outcomes: Organizational engagement in MOUD (primary), plus changes in staff knowledge/attitudes and organizational outcomes (secondary). Effectiveness Study of PSS: After completing implementation, the study will randomize adults on probation to receive PSS vs. treatment as usual, with assessments at baseline, 3, 6 and 12 months. Effectiveness outcomes include participant engagement in MOUD (primary), probation revocation, illicit opioid use, and overdoses. Other aims include identifying barriers and facilitators, and cost-benefit analysis of PSS. Adaptations in response to COVID-19 included moving many procedures to remote methods.

Summary

This study investigates a systems-change approach to improve medication for opioid use disorder (MOUD) engagement among individuals under community supervision. High overdose risk following release from incarceration necessitates improved access to and continuation of MOUD treatment. The study uses a hybrid implementation-effectiveness design across multiple probation sites, combining a core implementation intervention with a randomized trial of peer support specialists (PSSs).

Study Overview

The study employs a two-stage approach. Stage 1, the core implementation study, uses the exploration, preparation, implementation, and sustainability (EPIS) framework to guide systems change through local change teams (LCTs) composed of criminal justice (CJ) and community treatment providers. This stage aims to improve linkage to evidence-based care for probation-involved adults with opioid use disorder (OUD). Stage 2, the PSS effectiveness study, randomizes participants to receive PSS support or treatment as usual (TAU), evaluating the impact of PSS on clinical outcomes.

Aims and Hypotheses

The study aims to compare PSS to TAU on various outcomes, including MOUD engagement, probation revocation, illicit opioid use, and overdose. It also aims to assess the effectiveness of the EPIS intervention on MOUD engagement and organizational/staff outcomes, conduct a cost-benefit analysis, and identify implementation barriers and facilitators through qualitative interviews. The study hypothesizes that the core intervention will improve MOUD engagement, that PSS will improve engagement compared to TAU, and that staff attitudes toward MOUD will improve.

Design and Participants

The study utilizes a hybrid Type 1 implementation-effectiveness design, incorporating a pre-post design for the core implementation study and a randomized parallel assignment for the effectiveness study. Participants include probation officers, treatment staff, key stakeholders, and individuals on probation with OUD. Inclusion criteria focus on age, language proficiency, and consent capacity. Recruitment strategies involve orientation meetings, online surveys, and in-person/virtual consent processes.

Implementation and Effectiveness Measures

The core implementation study assesses MOUD engagement rates, staff knowledge and attitudes, and utilizes various surveys to measure organizational factors. Qualitative interviews explore barriers and facilitators. The effectiveness trial assesses MOUD engagement as the primary outcome, along with probation revocation, opioid use, and overdoses as secondary outcomes. Cost-benefit data collection will include PSS time, healthcare utilization, and criminal justice costs. Statistical analysis will employ log binomial regression, generalized estimating equations (GEE), and appropriate cost-analysis techniques.

Adapting to COVID-19

The study plan includes adaptations for conducting meetings and assessments remotely using videoconferencing and electronic platforms to accommodate potential COVID-19 related limitations.

Conclusion

This study will provide valuable insights into implementing and impacting MOUD among individuals involved in the criminal justice system, enhancing service delivery, and assessing the efficacy of integrating PSS into MOUD treatment.

Abstract

Objective: 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 use of peer support specialists (PSS). Methods: This Type 1 hybrid implementation-effectiveness study involves a pre-post design (implementation study) followed by a randomized trial of PSS (effectiveness study). Participants are at least 114 justice and service staff from 7 sites in three states: probation officers, community treatment providers, a supervisor from each agency, and key stakeholders. The study will recruit up to 680 individuals on probation from seven adult community probation offices; eligible individuals will be recently committed, English speakers, with opioid use disorder (OUD). Core Implementation Study: The study will use the exploration, preparation, implementation, sustainability (EPIS) framework to guide system-change through facilitated LCTs of probation and community treatment staff given a core set of implementation strategies to set goals. The study will collect program-level and staff survey data at the end of each EPIS stage. Implementation outcomes: Organizational engagement in MOUD (primary), plus changes in staff knowledge/attitudes and organizational outcomes (secondary). Effectiveness Study of PSS: After completing implementation, the study will randomize adults on probation to receive PSS vs. treatment as usual, with assessments at baseline, 3, 6 and 12 months. Effectiveness outcomes include participant engagement in MOUD (primary), probation revocation, illicit opioid use, and overdoses. Other aims include identifying barriers and facilitators, and cost-benefit analysis of PSS. Adaptations in response to COVID-19 included moving many procedures to remote methods.

Summary

Studies show a high risk of overdose for individuals who are recently incarcerated, particularly within the first two weeks of release. While medication for opioid use disorder (MOUD) significantly reduces return to use and recidivism, continuation of treatment after release is low. This study investigates a system-wide approach to improve MOUD engagement among individuals on probation, using a combination of implementation strategies and peer recovery support specialists (PSSs).

Study Overview

This research uses a two-stage approach. Stage 1 focuses on improving systems for connecting probationers with MOUD treatment through a core implementation study. Local change teams (LCTs) made up of correctional and treatment providers will work to improve the process using specific implementation strategies. Stage 2, an effectiveness study, will randomly assign probationers to receive support from a PSS or standard treatment to determine if adding PSSs improves outcomes.

Aims and Hypotheses

The study aims to compare the effectiveness of PSS support versus standard treatment on outcomes like MOUD engagement, probation revocation, and opioid use. It will also assess the effectiveness of the implementation intervention itself and conduct a cost-benefit analysis. The researchers hypothesize that the implementation intervention will improve MOUD engagement, that PSS support will further enhance engagement, and that staff attitudes towards MOUD will improve.

Design and Participants

The study uses a hybrid implementation-effectiveness design. Stage 1 uses a pre-post design, while Stage 2 uses a randomized controlled trial. Participants in Stage 1 include probation officers, treatment providers, and key stakeholders. Participants in Stage 2 include individuals on probation with opioid use disorder (OUD).

Recruitment and Incentives

Recruitment involves orientation meetings and individual consent processes. Participants will receive financial incentives for their involvement.

Stage 1: Core Implementation Study

This stage includes a baseline observation period, followed by the core intervention. The intervention focuses on needs assessment, systems mapping, and LCT development of best practices. Training will cover SMART goals, evidence-based practices, and effective communication between justice and treatment systems. Assessments will take place at multiple points to gauge progress.

Stage 2: Randomized Trial of PSS

This stage randomly assigns participants to receive support from a PSS or standard treatment. PSSs will provide support, education, and referrals. Assessments will include surveys, urine drug screens, and medical record review. A cost-benefit analysis comparing PSS support to standard treatment will be conducted.

Statistical Analysis

Statistical analysis will use various methods including regression analysis, generalized estimating equations, and cost-benefit analysis to examine the effectiveness of both the implementation intervention and the PSS support. Qualitative data from interviews will be analyzed thematically.

Adaptations for COVID-19

The study may adapt methods to accommodate the COVID-19 pandemic by using videoconferencing and telehealth options as needed.

Conclusions

This study seeks to evaluate the combined impact of improved systems and peer support on MOUD engagement among probationers, offering valuable insights into improving treatment outcomes and reducing the risk of overdose.

Abstract

Objective: 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 use of peer support specialists (PSS). Methods: This Type 1 hybrid implementation-effectiveness study involves a pre-post design (implementation study) followed by a randomized trial of PSS (effectiveness study). Participants are at least 114 justice and service staff from 7 sites in three states: probation officers, community treatment providers, a supervisor from each agency, and key stakeholders. The study will recruit up to 680 individuals on probation from seven adult community probation offices; eligible individuals will be recently committed, English speakers, with opioid use disorder (OUD). Core Implementation Study: The study will use the exploration, preparation, implementation, sustainability (EPIS) framework to guide system-change through facilitated LCTs of probation and community treatment staff given a core set of implementation strategies to set goals. The study will collect program-level and staff survey data at the end of each EPIS stage. Implementation outcomes: Organizational engagement in MOUD (primary), plus changes in staff knowledge/attitudes and organizational outcomes (secondary). Effectiveness Study of PSS: After completing implementation, the study will randomize adults on probation to receive PSS vs. treatment as usual, with assessments at baseline, 3, 6 and 12 months. Effectiveness outcomes include participant engagement in MOUD (primary), probation revocation, illicit opioid use, and overdoses. Other aims include identifying barriers and facilitators, and cost-benefit analysis of PSS. Adaptations in response to COVID-19 included moving many procedures to remote methods.

Summary

This study will help people who have been in jail and have problems with opioid addiction. Many people die from overdoses soon after leaving jail, so this study aims to help them get treatment. It will test two things: first, a special program to help jails and treatment centers work better together to get people the medicine they need to stop using opioids; second, whether adding a person with experience in recovery (a peer support specialist) to help people can improve things even more.

Study Overview

The study will take place in several places and has two parts. The first part will help jails and treatment centers work together better by creating teams that will find ways to improve how they get people opioid treatment. The second part will compare people who get extra help from a recovery specialist to those who don’t. Researchers will check how many people get and stay on the medication to help them recover.

Aims and Hypotheses

The study wants to see if extra help from a recovery specialist improves things like getting the opioid treatment, staying out of trouble, and avoiding overdoses. It also wants to see if the program to help jails and treatment centers work better helps people get treatment. Researchers believe the program will help jails and treatment centers work better and the extra help from the recovery specialist will improve results.

Design

The study uses a special design that combines testing a new program with comparing two different approaches.

Participants and Sites

The study involves many people: probation officers, treatment staff, and people on probation who have opioid problems. It will take place at several different probation offices across different states.

Recruitment

People were asked to join the study, and they'll be given information about what it involves before they decide.

Incentives

People were rewarded for completing surveys and interviews.

Stage 1: Core Implementation Study

This part focuses on improving how jails and treatment centers work together.

Stage 2: Randomized Trial of PSS

This part compares people getting extra help from a recovery specialist to those who don't. Researchers will track how well people are doing.

Potential Adaptations in Response to COVID-19

The study can change how things are done (like using video calls) if needed due to the COVID-19 pandemic.

Conclusions

This study is important because it will help find better ways to get people with opioid problems the help they need.

Footnotes and Citation

Cite

Martin, R. A., Stein, L. A. R., Rohsenow, D. J., Belenko, S., Hurley, L. E., Clarke, J. G., & Brinkley-Rubinstein, L. (2021). Using implementation interventions and peer recovery support to improve opioid treatment outcomes in community supervision: Protocol. Journal of substance abuse treatment, 128, 108364. https://doi.org/10.1016/j.jsat.2021.108364

    Highlights