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Published in final edited form as: J Subst Abuse Treat. 2021 Jan 9;128:108284. doi: 10.1016/j.jsat.2021.108284

Kentucky Women’s Justice Community Opioid Innovation Network (JCOIN): A type 1 effectiveness-implementation hybrid trial to increase utilization of medications for opioid use disorder among justice-involved women

Michele Staton a, J Matthew Webster a, Carl Leukefeld a, Martha Tillson b,c, Katherine Marks d, Carrie Oser c, Heather M Bush e, Laura Fanucchi b,f, Amanda Fallin-Bennett g, Bryan R Garner h, Kathryn McCollister i, Sarah Johnson j, Erin Winston b
PMCID: PMC8267049  NIHMSID: NIHMS1663062  PMID: 33455828

Abstract

The opioid crisis has disproportionately affected women, but research on approaches to increase initiation of medications for opioid use disorder (MOUD) among women is limited. The Kentucky Justice Community Opioid Innovation Network (JCOIN) will implement a type 1 hybrid effectiveness and implementation trial to examine an innovative MOUD pretreatment model using telehealth (alone and in combination with peer navigators) for justice-involved women in transition from jail to the community. The overall goal of the project is to increase initiation and maintenance of MOUD among high-risk justice-involved women during community reentry to reduce opioid relapse and overdose. This project and other studies through the JCOIN network have the potential to significantly impact the OUD treatment field by contributing empirical evidence about the effectiveness and implementation of innovative technologies to increase initiation and maintenance of MOUD during a critical, high-risk time of community reentry among vulnerable, justice-involved individuals in both urban and nonurban communities.

Keywords: JCOIN, Women offenders, Opioid use disorder treatment, Peer navigation, Implementation, Cost-effectiveness

1. Introduction

1.1. Background

The opioid crisis has significantly affected women, due in large part to their increased pain sensitivity, overprescribing practices, and self-medication (Mazure & Fiellin, 2018), and pressures associated with partners who use opioids (e.g., Mayock, Cronly, & Clatts). In addition, they have a faster trajectory from opioid exposure to the development of an opioid use disorder (OUD; Greenfield, Back, Lawson, & Brady, 2010). The opioid overdose death rate among women increased 492% from 1999 to 2017 (VanHouten, Rudd, Ballesteros, & Mack, 2019). Women are more likely to be at risk for health consequences associated with high-risk opioid use (Strickland, Staton, Leukefeld, Oser, & Webster, 2018), as well as criminal justice consequences (Staton et al., 2018). In Kentucky, the number of incarcerated women has increased more than 30% in recent years, largely attributed to opioid-related arrests (Cheves, 2017). Because treatment opportunities are often limited in jails, there is substantial risk for relapse and overdose during community reentry (Mital, Wolff, & Carroll, 2020).

Nationally, less than 20% of individuals with OUD receive treatment (Saloner & Karthikeyan, 2015), and even fewer in nonIsaurban areas due to limited services (Oser & Harp, 2015). Though treatment with methadone or buprenorphine, two of the three FDA-approved medications for opioid use disorder (MOUD), reduce mortality by approximately 50% or more (Pearce et al., 2020; Sordo et al., 2017), these medications are widely underutilized in criminal justice settings (SAMHSA, 2019). For incarcerated persons with OUD, the risk of overdose death within two weeks of release from prison may be 10–40 times higher without MOUD (e.g., Marsden et al., 2017; Pizzicato, Drake, Domer-Shank, Johnson, & Viner, 2018; SAMHSA, 2019). Thus, incarceration is a critical window to reach individuals in need of OUD treatment.

In recent systematic reviews on the effectiveness of corrections-based MOUD, 60% of studies did not include women offenders (Hedrich et al., 2011; Sharma et al., 2016). In addition, the majority of corrections MOUD research has been in prisons (e.g., Hedrich et al., 2011), with limited work in jail settings other than in large urban areas (e.g., Lee et al., 2015a, 2015b, 2016). This is a critical research gap because jails are typically short-term facilities where people are likely to go through detoxification, achieve a short-term period of abstinence, and reenter the community where they are at high risk for relapse and overdose.

The Kentucky Women’s Justice Community Opioid Innovation Network (JCOIN) project seeks to address important gaps in the literature regarding MOUD for justice-involved women as they transition from jails to the community with the overall aim of increasing access to MOUD. This protocol paper provides an overview of the Kentucky JCOIN, which examines the use of a pretreatment intervention, delivered via telehealth, incorporating critical components of the MOUD cascade of care (Socías, Volkow, & Wood, 2016), including screening, assessment, and treatment linkage. Second, peer navigation, an approach which has primarily been used in mental health (Cabassa, Camacho, Velez-Grau, & Stefancic, 2017) and cancer (Wells et al., 2008) research to help reduce treatment barriers, will also be incorporated to support MOUD treatment linkage following jail release. This protocol paper is guided by the SPIRIT framework (Standard Protocl Items: Recommendations for Intervention Trials) (Chan et al., 2013).

1.2. Trial design

The project utilizes a type 1 hybrid effectiveness and implementation design (Curran, Bauer, Mittman, Pyne, & Stetler, 2012) to test the effectiveness of delivering MOUD pretreatment telehealth (alone and with peer navigation) to increase MOUD initiation following jail release while collecting longitudinal data on several constructs hypothesized to influence successful innovation implementation (Aarons, Hurlburt, & Horwitz, 2011). The rationale for the hybrid design is that, by understanding both the effectiveness and implementation issues in delivering telehealth interventions through the jail/community treatment provider partnership, we can decrease the lag between translating research findings into routine MOUD clinical practice (Curran et al., 2012). In addition, there are significant gaps in the literature around cost-effectiveness of telehealth as a platform to link community treatment to justice environments. The effectiveness trial includes an unblinded randomized design with an additional contemporary control group that is not randomized.

1.3. Objectives

KY JCOIN is guided by the following specific aims:

  • Compare the effectiveness of (1) MOUD pretreatment telehealth alone and (2) MOUD pretreatment telehealth with peer navigation to (3) services as usual (SAU) to increase MOUD initiation among justice-involved women post-release;

  • Estimate the incremental cost and cost-effectiveness of MOUD pretreatment telehealth (alone and with peer navigation) relative to SAU; and

  • Examine changes in constructs hypothesized by the exploration, preparation, implementation, and sustainment (EPIS) framework as being associated with successful innovation implementation.

2. Methods: Participants, interventions, and outcomes

2.1. Study setting

This project builds on long-standing partnerships with the Kentucky Department of Corrections and the Kentucky Department for Behavioral Health. Kentucky has 76 jails across 120 counties that daily house nearly 24,500 inmates, an incarceration rate that is 8% higher than the national average (Kaeble & Cowhig, 2018); the female incarceration rate nearly doubles the national average (Cheves, 2017). Kentucky JCOIN includes jails in nine geographically distinct counties. The study selected jails based on existing substance use disorder (SUD) treatment programs, the medical infrastructure and leadership support for MOUD, daily census of incarcerated women to ensure adequate power, county-level indicators for opioid overdose, and identification of a community MOUD provider. Of the nine sites, only three include jails with SUD programs serving women, which the study includes as comparison sites.

2.2. Eligibility criteria

For the effectiveness trial, incarcerated women in the study jails are randomly selected from daily census reports and screened for eligibility based on: 1) positive screen for OUD on the Diagnostic Statistical Manual (DSM-5) checklist (2+ criteria) or the NIDA-modified (NM) Alcohol Smoking Substance Involved Screening Test (ASSIST; score of 4+ for street or prescription opioids); 2) willingness to participate in MOUD pretreatment; 3) no evidence of cognitive impairment; 4) no evidence of active psychosis; and 5) remaining incarceration period between 7 and 30 days.

2.3. Participant timeline

Incarcerated women are randomly selected, consented, screened for eligibility, and participate in a baseline interview. From six experimental sites, eligible women are randomly assigned to either pretreatment telehealth alone or in combination with peer navigation services (see Fig. 1).

Figure 1.

Figure 1.

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Study participant timeline

2.4. Recruitment

Within each jail site, women who anticipate being released within 7–30 days are randomly selected each month from the daily jail roster. Random sampling helps to reduce bias that might occur under an open-enrollment or voluntary response sampling. A private screening session initially identifies incarcerated women with OUD, includes informed consent (screening procedure only), and emphasizes the voluntary nature of study participation. Following consent, participants are administered the NM-ASSIST and the DSM-5 OUD checklist. Study staff ask women who screen OUD-positive on either assessment to complete the full screening session (including biological measures).

2.5. Sample size

A total of 900 participants will be recruited, 600 will be randomized at the individual level to two experimental conditions, and 300 will be in the nonrandomized comparison group. Within a traditional randomized controlled trial, a chi-square test has approximately 80% power to detect a difference in MOUD initiation rates of 10% (MOUD pretreatment telehealth alone) versus 20% (MOUD pretreatment telehealth with peer navigation) when the sample size is 420 (210 per group). Thus, the proposed sample size provides enough power to detect group difference even after some sample attrition at follow-up.

2.6. Interventions

The project incorporates random assignment to one of two study conditions in the experimental conditions: 1) MOUD pretreatment telehealth or 2) MOUD pretreatment telehealth with peer navigation.

2.6.1. MOUD pretreatment telehealth (n=300).

PreTreatment telehealth is the process along the MOUD cascade of care (Socías et al., 2016) to determine eligibility for MOUD following jail release. Following the initial study screening, determination of OUD, and collection of biological indicators (urine drug screens, pregnancy tests, HIV/HCV tests), research staff prepare a referral packet for review by the community MOUD provider prior to the intake session. The telehealth-based MOUD staff assessment involves DSM-5 OUD criteria, a psychosocial assessment, and MOUD education. MOUD staff may make a recommendation for the course of medication (extended-release naltrexone [XR-NTX], buprenorphine, or methadone), and final determinations are made following the medical evaluation with the agency provider after release. Each of the targeted MOUD providers offer FDA-approved MOUD. At the end of the pretreatment telehealth session, the participant and the MOUD community provider develop a reentry plan for ongoing care, which includes insurance coverage. The participant will be in a private room within the jail with no jail staff during the telehealth session to ensure confidentiality and privacy.

2.6.2. MOUD pretreatment telehealth + peer navigation (n=300).

Following the initial pretreatment telehealth session, women in this condition have an additional telehealth session with their peer navigator (a woman in recovery certified as a peer support specialist). The session includes an assessment of recovery capital, goals for recovery, and plans for engaging in MOUD and other recovery services postrelease. Participants in this condition also engage in weekly telephone recovery services with the peer navigator for 12 weeks postrelease, which include identifying personal goals and strength-based, practical strategies for success. In addition to MOUD linkages, peer navigators suggest strategies to maintain recovery/remission, including safe housing, financial counseling, employment skills, and sober social activities. While participants will engage in a minimum of 12 weekly peer navigation sessions, study staff will encourage additional interactions and each contact will be documented in the study database.

2.6.3. SAU (n=300).

Women in this condition are not randomized, but receive state-supported SUD treatment as usual in three jail comparison sites. These treatment programs operate as modified therapeutic communities with transitional support following release. XR-NTX is available for treatment participants with two injections prior to release, as well as referrals to community-based treatment for ongoing injections postrelease. These jails provide the opportunity to compare JCOIN interventions to the state corrections standard of care.

2.7. Outcomes

The primary outcomes for the effectiveness trial are assessed at 3, 6, and 12 months and include community MOUD initiation, medication type, and community treatment retention. The study will also monitor public health outcomes (relapse and overdose) and public safety outcomes (criminal activity and recidivism) as secondary outcomes.

3. Methods: Assignment of interventions

3.1. Allocation

This project incorporates random assignment to experimental study conditions: (1) MOUD pretreatment telehealth alone or (2) MOUD pretreatment telehealth + peer navigation using a randomized block design. The random assignment sequence allocation is determined a priori and is stored in a password protected database accessible only to the principal investigator and project director. Women in the experimental conditions are stratified by the six sites, and the project director maintains the notification file for random assignment, which is concealed from research staff until after completion of the baseline interview. The three comparison sites are not randomized, but we will include them in planned analyses.

3.2. Blinding

The Kentucky JCOIN study is an unblinded trial.

4. Methods: Data collection, management, and analysis

4.1. Effectiveness trial

Effectiveness trial outcomes are based on face-to-face data collection at baseline (see Fig. 1, considered study “entry”) and follow-up in the community. Research staff are located regionally in study field offices, trained in the study protocol and jail visitation procedures, and travel to each jail in the nine counties for data collection. All participants remain in the study regardless of their decision to enroll in MOUD treatment following release, and follow-up data are collected with all study participants at 3, 6, and 12 months postrelease. Data collection takes place face-to-face with all study participants (at a mutually agreed upon location), as well as through monthly data reports from community MOUD providers on medication compliance. Tracking procedures include letters, telephone calls, Internet searches, social media (particularly Facebook), and field visits.

The primary analysis will be the overall comparison of MOUD pretreatment alone versus MOUD pretreatment telehealth with peer navigators (as randomized) on MOUD initiation (yes/no) using a chi-square test of independence. Any differences between groups will be addressed within analyses by including potential confounders in logistic regression models. Odds ratio estimates (unadjusted and adjusted) will be provided with 95% confidence intervals. The combined effects of MOUD pretreatment (with or without peer navigation) will be compared to SAU. To evaluate the trajectory of MOUD use patterns during the follow-up, the study will use a repeated measures approach to determine whether randomized groups change differently over time. The study will also treat secondary public health and safety outcomes as a cumulative measure, aggregating any events over the study period as well as a dichotomous indicator by time point.

4.2. Cost and cost-effectiveness

Incremental cost and cost-effectiveness of the two study interventions (pretreatment telehealth alone and with peer navigation) relative to SAU will be assessed. The economic analysis will be conducted from provider (i.e., key stakeholders being the justice and behavioral health care systems) and societal perspectives (Neumann, Sanders, Russell, Siegel, & Ganiats, 2016). This prospective economic analysis will use an activity-based micro-costing approach to identify, measure, and value all resources invested by providers and agencies, and ultimately link those costs to study outcomes. Standard methods and tools will be used to track resources and costs associated with the development of the MOUD pretreatment telehealth interventions and the specific services and activities that the network provides to increase initiation of MOUD. For each recruitment site, the cost to implement pretreatment telehealth and peer navigation, using the Drug Abuse Treatment Cost Analysis Program (DATCAP; French, Dunlap, Zarkin, McGeary, & McLellan, 1997), will be estimated. Key stakeholders in the nine targeted counties will complete the DATCAP survey, which will be augmented to include questions about implementation resources and costs (e.g., trainings, new equipment needed to offer MOUD pretreatment). Cost data will then be matched with effectiveness outcomes to calculate incremental cost-effectiveness ratios and to conduct cost-effectiveness analyses of the MOUD pretreatment telehealth and peer navigation interventions. For each intervention condition, differences in costs and effects will be estimated using multilevel general linear models.

4.3. Implementation process and outcomes

The implementation process for study interventions is informed by the EPIS framework (Aarons et al., 2011), which considers the multilevel nature of service systems, the organizations within systems, the providers who deliver services, and individuals who engage in services. Additionally, we will use a longitudinal mixed-method approach (Hunter, Ayer, Han, Garner, & Godley, 2014) that examines the implementation process over time, with a focus on intervention sustainability. Key stakeholders (MOUD staff, jail administrators, state-agency administrators) will be asked to participate in web-based Qualtrics surveys to assess core implementation constructs including implementation climate (Jacobs, Weiner, & Bunger, 2014), organizational readiness (Shea, Jacobs, Esserman, Bruce, & Weiner, 2014), and leadership engagement (Aarons, Ehrhart, & Farahnak, 2014) at the beginning of the project (month 3), every six months during the implementation phase (months 9–42), and 3 and 9 months after completion of the implementation phase (months 45 and 51) for a total of eight assessment points. In addition to staff level surveys, aggregate client-level data will be monitored during each of these phases as well to assess the cascade of care, including the number of women screened, identified as eligible, enrolled in the study, completed the telehealth assessment, released from jail, and engaged in MOUD treatment in the community.

Quantitative data will be aggregated by data collection wave, and qualitative focus groups with key stakeholders will be held during months 3, 9, and 15 during the implementation phase to validate consensus in survey responses (Hunter et al., 2014). These focus groups will probe stakeholder and staff perceptions of the acceptability of study interventions, interagency communication during community reentry, perceived barriers and facilitators to telehealth use, and other factors that may support or impede use. The mixed-methods approach provides critical information for disseminating, implementing, and sustaining telehealth within MOUD community provider and jail-based networks.

Implementation analysis will focus on stakeholder perspectives to assess longitudinal changes in key constructs associated with successful implementation within the justice-community treatment partnership (implementation climate, organizational readiness, and leadership). Having a relatively small number of analytic units (e.g., nine site teams) to analyze for the quantitative data collection, we will use the C statistic, developed by Tryon (1982) for use with simplified time series designs. Qualitative focus group data will be transcribed and analyzed.

5. Trial monitoring

The JCOIN Data Safety and Monitoring Board, the University of Kentucky Institutional Review Board, the Office of Human Research Protections, and the Kentucky Department of Corrections Office of Research monitor this trial. This protocol adheres to all conditions for human subjects research with prisoners as a vulnerable population (Nunes et al., 2016).

6. Discussion

With the opioid crisis and overdose deaths continuing in U.S. communities (Scholl, Seth, Kariisa, Wilson, & Baldwin, 2019), and signals that overdose rates are rising during the COVID-19 pandemic (Slavova et al., 2020), efforts to increase access to treatment among justice-involved women during community reentry are critical. The overall goal of the Kentucky JCOIN project is to increase MOUD initiation and retention to reduce opioid relapse and overdose among justice-involved women during community reentry. This project is the only JCOIN study focused exclusively on women, examining women’s unique vulnerabilities associated with high-risk opioid use, health-related consequences, and limited access to gender-specific health and behavioral health care. This study is also innovative because of its focus on community reentry following jail release, a risk period for relapse among individuals with a history of OUD (Mital, Wolff, & Carroll, 2020). The focus on the MOUD continuum of care from a pre-release telehealth intake assessment to a community medical evaluation and medication initiation is an innovation for women-specific treatment research, as is peer navigation to increase utilization and maintenance of MOUD following jail.

Challenges remain in linking to and engaging criminal justice-involved women in MOUD postrelease. Despite studies demonstrating the benefits of MOUD, some participants may not be interested in engaging in treatment after jail release, which may be related to logistical challenges or MOUD stigma. Reentry can be a chaotic time and the commitment to participate in MOUD may not come to fruition in the community (Velasquez et al., 2019). This finding may inform strategies to address participation barriers and/or suggest different timing of intervention delivery. In addition, women reentering the community have complex lives that could affect MOUD engagement, including positive influences (care, concern for children) as well as negative (stressful partner or family relationships, limited access to childcare or transportation). Some participants will be reincarcerated, and the study will monitor recidivism across conditions and examine it as a predictor of engagement. Also, issues, such as COVID-19, may impact face-to-face data collection, resulting in the need to conduct additional study activities using a virtual format.

These limitations are offset by project strengths, the potential contribution to science, and the life-saving benefits of MOUD for high-risk, justice-involved women with OUD. The JCOIN network has the potential to broadly impact the OUD treatment field by contributing empirical evidence on the effectiveness, implementation, and sustainability of innovative approaches to increase access to MOUD and expand the capacity of the justice system to respond to the opioid crisis. Furthermore, due to COVID-19 behavioral health systems have been forced to rapidly adapt telehealth capacity; research examining telehealth engagement and retention in treatment services is of critical importance now more than ever.

Highlights.

  • Despite unique vulnerabilities for opioid use disorder (OUD), justice-involved women have been largely neglected in research on medications to treat OUD (MOUD).

  • The Kentucky Justice Community Opioid Innovation Network (JCOIN) will implement a type 1 hybrid effectiveness and implementation trial to examine an innovative MOUD PreTreatment Telehealth model (alone and in combination with peer navigators) for justice-involved women in transition from jail to the community.

  • The overall goal of the project is to increase initiation and maintenance of MOUD among high-risk justice-involved women during community re-entry to reduce opioid relapse and overdose.

  • This project will also address significant gaps in the literature around cost-effectiveness of telehealth as platform to link community treatment to women in justice environments, which will contribute to long-term sustainability.

  • By understanding both the effectiveness and implementation issues in delivering telehealth interventions through a jail/community treatment provider partnership, translating research findings into routine MOUD clinical practice can be accelerated.

Acknowledgement

This research was supported by the National Institutes of Health through the NIH HEAL Initiative under award number UG1DA050069. The contents of this publication are solely the responsibility of the authors and do not necessarily represent the official views of the NIH, the NIH HEAL Initiative, or the participating sites. We would also like to acknowledge the contribution of our partners in the Kentucky Department of Corrections and the Kentucky Department of Behavioral Health.

Footnotes

Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

Trial registration: NCT04069624

Declarations of interest: None to report

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