A Phase 3 interventional study of Recovery Management Checkups (RMC) delivered by community-based agencies (RMC adopters) and Recovery Management Checkups (RMC) delivered by staff under the research team (RMC by research staff) in Substance Use Disorder (SUD), Opioid Use Disorders and Stimulant Overdose, sponsored by Chestnut Health Systems. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Chestnut Health Systems · Phase 3, Interventional, and Treatment
Individuals who are involved in the criminal-legal system (CLS) are at high risk of drug-related overdose; they also face significant barriers to engaging in substance use disorder (SUD) treatment and recovery support services. To address this public health challenge, this study will test the implementation and outcomes of an evidence-based intervention, Recovery Management Check-ups (RMC), delivered within community-based programs in four Chicago communities that have high rates of drug-related overdose and arrests. The study has the potential to increase uptake of RMC in community-based programs, thereby reducing overdose-related deaths and crime-related costs and improving individual health and community public health.
This project is a hybrid type 2 design for three key reasons based on the hybrid design literature. First, while RMC has proven efficacy, its delivery by community-based recovery staff represents a new context where prior assumptions may not hold. Our study design will enable us to compare the feasibility and scalability of delivering RMC with staff in a research setting to staff in a range of community settings. Second, our prior research and studies on recovery-oriented service settings offer insights into determinants affecting implementation outcomes. Third, guided by this knowledge and the literature we have identified the implementation phases at which these barriers are likely most salient and selected a package of discrete implementation strategies to address them. We will use a multiple case study design, which is well suited for understanding how specific strategies used to support RMC Adopters impact implementation outcomes. The study is guided by the Exploration, Preparation, Implementation, and Sustainment (EPIS) model, which groups implementation determinants into intervention, inner and outer context, and bridging factors (elements connecting inner and outer contexts). The project provides an Implementation Research Logic Model mapping implementation determinants, selected strategies, theorized mechanisms of action, and proposed outcomes.
AIMS 1. EVALUATE THE EQUIVALENCE OF RMC PROVIDED BY COMMUNITY ORGANIZATIONS AND RESEARCH TEAMS IN TERMS OF:
1a) days of any SUD treatment (primary outcome); and
b) structural equation modeling (SEM) invariance of effects on SUD intervention dose (medication, other SUD treatment, mutual-help group, overdose prevention), public health outcomes (substance use, SUD symptoms, overdose, risk behaviors), and public safety outcomes (types of drug-related, property and interpersonal/violent crime and days of illegal activity).
AIM1: OVERVIEW OF EQUIVALENCE COMPONENT DESIGN. Using data obtained from Cook County Coroner's Office and the Chicago Police Department, we identified 4 discrete community areas of Chicago with the highest risk of substance-related fatalities and arrest and recruited one or more RMC Adopters from each area to implement and sustain RMC. We will recruit approximately 150 people from each area who have been arrested and report weekly use of alcohol, stimulants, or opioids in the prior 90 days. The Cook County Sheriff's Department has approved our use of their first appearance court (aka pre-bond) processing area as the primary recruitment location. Jail staff will refer individuals whose home zip code/community is in one of the four target areas to on-site research staff for initial screening and consent to contact; individuals who consent will be contacted for study enrollment by research staff following their release after court (Illinois is a cashless bail state some most are released). Eligible clients who complete study consent and enrollment with research staff (at the research office) will be randomly assigned at to receive RMC for 9 months either from Linkage Mangers (LM) who are located and supervised at the community-based RMC Adopter agency or by research staff at Chestnut's research office. Through the implementation strategy described below, LMs and their supervisors at the RMC Adopter agencies will be provided with strategies aimed at supporting equivalent knowledge, skills, and performance with that of research-supervised RMC staff. Both groups will have access to the same AI-based tools for continued role playing and skill practice. Research interviewers will assess clients at enrollment and quarterly for 12 months. Data will include standardized surveys using the JCOIN core and additional local measures; AI-based linkage meeting ratings; and treatment, arrest and death records. The primary hypothesis for Aim 1 is that there will be no statistical (p\<.05) or clinical (Cohen's \|d\|\<.3) differences between groups receiving RMC from either the RMC Adopters sites or Chestnut research site in terms of the cumulative days of SUD treatment over 12 months. The study will also examine mean and path invariance in an established structural equation model (SEM) of the relationship between RMC (by setting), Justice System Involvement (n of arrests, days in jail, on probation/parole, and meeting with probation officer), SUD intervention[s] received (days of medication, SUD treatment modality, days of mutual-help group participation, overdose prevention), public health outcomes (substance use, symptoms, overdose, risk behaviors, recovery environment) and public safety outcomes (types of drug-, property- and interpersonal/violence-related crimes, days of illegal activity).
AIM 2. ASSESS THE IMPACT OF MULTI-COMPONENT FACILITATION-BASED STRATEGIES IN SUPPORTING RMC INTEGRATION ACROSS PRE-IMPLEMENTATION, IMPLEMENTATION, AND SUSTAINMENT PHASES, INCLUDING 3 ANALYTICAL SUB-AIMS TO IDENTIFY:
2b) the impact of pre-implementation- and implementation-phase duration and proportion of activities completed on RMC Adopter's ability and time to reach competency; and 2c) organizational-level determinants of achieving and maintaining RMC sustainment.
AIM 2: IMPLEMENTATION COMPONENT DESIGN. We will use a multiple case study design to evaluate the impact of a multi-component external facilitation strategy supporting RMC integration within community organizations across distinct implementation phases. Guided by EPIS, this study will focus on the last three phases (i.e., preparation, implementation, and sustainment) as operationalized through the Stages of Implementation Completion (SIC) measure (see "Other Implementation Measures" under "Aim 2 Approach" section), having already engaged community organizations interested in implementing RMC. It is important to note that the implementation stages are not typically progressed through linearly and the SIC accounts for the overlapping nature of these phases. We will employ a mixed-methods design, analyzing quantitative and qualitative data with input from community partners and our Community Board. We will use a mixed-methods, multiple-case study analysis processes, with each case representing an RMC Adopter. The analysis will examine relationships between strategies and implementation outcomes, using replication logic to identify similar or distinct outcomes and generalize findings across populations. Pattern matching will compare predicted mechanisms with observed processes, exploring mismatches and analyzing strategy-context interactions. Quantitative and qualitative data will be integrated to explain how strategies drive outcomes.
2,181 studies on the registry are indexed under Substance-Related Disorders; 399 are open to participants now.
This study's planned enrollment of 600 is above the median of 108 across 1,770 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →Chestnut Health Systems is the lead sponsor of 24 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria (CLIENTS):
Exclusion Criteria (CLIENTS):
Inclusion Criteria (RMC ADOPTER AGENCIES):
Exclusion Criteria (RMC ADOPTER AGENCIES):
RMC services are delivered by linkage managers (LM) working under the supervision of a COMMUNITY BASED AGENCY.
Behavioral: Recovery Management Checkups (RMC) delivered by community-based agencies (RMC adopters)
RMC services are delivered by linkage managers (LM) working under the supervision of Chestnut RESEARCH STAFF.
Behavioral: Recovery Management Checkups (RMC) delivered by staff under the research team (RMC by research staff)
RMC services are delivered by linkage managers (LM) working under the supervision of a COMMUNITY BASED AGENCY. Core intervention components include a) comprehensive assessment of treatment need, barriers, and motivations; b) motivational interviewing focused on treatment linkage, behavioral change, and reinforcement of progress; c) follow through on treatment linkage planning, enrollment, and verification; d) commitment to and tracking of behavioral changes related to other forms of support, substance use, and overdose prevention; and e) sustained connections with clients through structured tracking and locating protocols. These core components are supported by RMC-specific tools and protocols described below. All study participants will have access to standard post-arrest services and receive RMC checkups on a fixed schedule: enrollment, 1, 3, 6, \& 9 months post enrollment (month 12 is for assessment of client outcome data only).
RMC services are delivered by linkage managers (LM) working under the supervision of Chestnut RESEARCH STAFF. Core intervention components include a) comprehensive assessment of treatment need, barriers, and motivations; b) motivational interviewing focused on treatment linkage, behavioral change, and reinforcement of progress; c) follow through on treatment linkage planning, enrollment, and verification; d) commitment to and tracking of behavioral changes related to other forms of support, substance use, and overdose prevention; and e) sustained connections with clients through structured tracking and locating protocols. These core components are supported by RMC-specific tools and protocols described below. All study participants will have access to standard post-arrest services and receive RMC checkups on a fixed schedule: enrollment, 1, 3, 6, \& 9 months post enrollment (month 12 is for assessment of client outcome data only).
CLIENT: Days of substance use treatment received
Self-reported measure of the days of substance use disorder treatment (any type) received, ranging from 0-90. This is a JCOIN core measure.
Time frame: Enrollment, 1, 3, 6, 9 and 12 months
IMPLEMENTATION: Recovery Management Checkup (RMC) Site Intervention Fidelity
Our main implementation outcomes, assessed using a checklist developed with input from the RMC creators, this includes 21 components (including quality measured by meeting specific treatment cascade benchmarks) evaluated across adherence, exposure/duration, quality of delivery, and client responsiveness. Each component is scored from 0 ("not present") to 5 ("fully present"), resulting in a total fidelity score ranging from 0 ("no components implemented") to 105 ("all components fully implemented"). Scoring will be informed by qualitative data collected during facilitation meetings, site visits, and interviews. The Facilitation Team and implementation researchers will separately complete parallel versions of the checklist, with the former using it to assess progress and inform facilitation activities and the latter using it to assess fidelity as an outcome. It will be collected at multiple points to demonstrate change over time.
Time frame: Tracked corresponding to -1, 6, 11, 17, 23, 29, 35, & 41 months of facilitation start
CLIENT: Legal System Involvement
Latent construct from structural equation modeling based on self-reported number of arrests; days on probation/parole/community supervision, house arrest/electronic monitoring; meetings with probation officer, and jail/prison. This is a JCOIN core measure.
Time frame: Enrollment, 1, 3, 6, 9 and 12 months
CLIENT: Substance Use Disorder (SUD) Intervention Dose
Latent construct from structural equation modeling based on self-reported days of SUD medication, specialty SUD treatment, self-help meetings, and overdose prevention. This is a JCOIN core measure.
Time frame: Enrollment, 1, 3, 6, 9 and 12 months
CLIENT: Public Health Problems
Latent construct from structural equation modeling based on self-reported days of substance use, SUD symptoms, overdose, risk behaviors, and negative recovery environment. This is a JCOIN core measure.
Time frame: Enrollment, 1, 3, 6, 9 and 12 months
CLIENT: Public Safety Problems
Latent construct from structural equation modeling based on self-reported types of drug-related, property and interpersonal/violent crime and days of illegal activity. This is a JCOIN core measure.
Time frame: Enrollment, 1, 3, 6, 9 and 12 months
IMPLEMENTATION: Motivational Treatment Integrity (MITI) change talk scores
Calculated by Artificial Intelligence (AI) on scheduled linkage meetings, this is a measure of the degree to which linkage management staff were able to get clients to vocalize experience, desire, plans, or intent to change their substance use behavior. This measure has been shown to predict better distal outcomes like substance use. We are using AI to reduce to the time and cost of getting the rating and so that we can have it on every session. But to recheck the validity of the AI-based rating, we will have our experts re-rate 10% random sample blind to the AI's rating and then compare. We will also do this as needed if requested by a supervisor or staff.
Time frame: RMC sessions at 0, 1, 3, 6 and 9 months post facilitation activities start
IMPLEMENTATION: Acceptability of Intervention
This will be based on the 4-item Acceptability of Intervention Measure (AIM) from the Implementation Outcome Repository. Each question asks staff to rate the likely acceptability of an intervention for their population/setting. It was also a core measure of JCOIN 1.0.
Time frame: Tracked corresponding to 0, 20, 32, 44 months of facilitation activities start
IMPLEMENTATION: Intervention Appropriateness
This will be based on the 4-item Intervention Appropriateness Measure (IAM) from the Implementation Outcome Repository. Each question asks staff to rate the likely appropriateness of an intervention for their population/setting. It was also a core measure of JCOIN 1.0.
Time frame: Tracked corresponding to 0, 20, 32, 44 months of facilitation activities start
IMPLEMENTATION: Sustainability
Total score from the Program Sustainability Assessment Tool (PSAT) from the Center for Implementation. The PSAT total score combines 40 Likert ratings across eight domains (e.g., funding stability, partnerships). It has demonstrated internal consistency and validity. This is collected by research staff during annual site visits.
Time frame: Measured at start of sustainability activities and 21 months post-facilitation
IMPLEMENTATION: Client-centeredness of Recovery Management Checkups (RMC)
This is a 3 item rating by clients receiving RMC. Each item is scored on a 5-point Likert-type scale (0 = no effort was made; 4 = every effort was made). The scores of the individual items summed to give a total score, with higher scores indicating greater shared decision making. It will be measured with the CollaboRATE questionnaire recommended by NIH's Phenx toolbox.
Time frame: 1, 3, 6, 9 and 12 month post enrollment client followup interviews
IMPLEMENTATION: Feasibility of Implementation
This is a 3 item rating by clients receiving RMC. Each item is scored on a 5-point Likert-type scale (0 = no effort was made; 4 = every effort was made). The scores of the individual items summed to give a total score, with higher scores indicating greater shared decision making. It will be measured with the CollaboRATE questionnaire recommended by NIH's Phenx toolbox.
Time frame: Tracked corresponding to 0, 20, 32, 44 months of facilitation activities start
Plan to share: No
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Start is estimated for Nov 2026; primary completion for Apr 2029, 29 months later.
Of 14 phase 3 interventional studies under Substance-Related Disorders, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 54. This study's planned 29 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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