Implementation Strategies to Improve Access to and Use of MAT for Defendants in Opioid Courts
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04216719|
Recruitment Status : Recruiting
First Posted : January 3, 2020
Last Update Posted : September 2, 2020
|First Submitted Date ICMJE||December 19, 2019|
|First Posted Date ICMJE||January 3, 2020|
|Last Update Posted Date||September 2, 2020|
|Actual Study Start Date ICMJE||September 1, 2020|
|Estimated Primary Completion Date||July 2024 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Pre-specified Outcome Measures
|Original Other Pre-specified Outcome Measures||Same as current|
|Brief Title ICMJE||Implementation Strategies to Improve Access to and Use of MAT for Defendants in Opioid Courts|
|Official Title ICMJE||Facilitating Opioid Care Connections: System Level Strategies to Improve Use of Medication-Assisted Treatment (MAT) and Movement Through the Opioid Care Cascade for Defendants in a New Opioid Court System|
|Brief Summary||In response to the opioid crisis in New York State (NYS), where the propose project will take place, the Unified Court System (UCS) developed a new treatment court model - the opioid court model (OCM) - designed around 10 practice guidelines to address the flaws of existing drug courts and reduce overdose (OD), opioid use disorder (OUD), and recidivism via rapid screening and linkage to medication for opioid use disorder (MOUD). In 2018, NYS began to expand the OCM across NYS. Yet, given the innovation of the OCM, the exact barriers to implementation in disparate counties with a range of resources - and the strategies to overcome them - are largely unknown. The research team proposes to integrate evidence-based implementation strategies to refine and evaluate the Opioid Court Model Rigorous Implementation Science for Effectiveness (OCM RISE) intervention, an implementation intervention that will allow the OCM, as framed by the 10 practice guidelines, to be scaled up across NYS.|
Aims. Guided by Exploration Preparation Implementation Sustainment (EPIS) model and Social Cognitive Theory (SCT), Specific Aims are: 1) To refine OCM-RISE using mixed-method formative work with 5 NYS "initial adopter" counties, who established opioid courts before 2019, that (a) identifies gaps in service provision by documenting OCM/opioid cascade outcomes; (b) identifies successes/challenges in operationalizing guidelines; and (c) characterizes the working relationships between county opioid court and treatment systems. 2). In a cluster-randomized, stepped-wedge design in 10 "new adopter" counties, which includes some counties who established opioid courts in 2019, compared to baseline treatment as usual (drug courts), test, (a) the implementation impact of OCM RISE in improving implementation outcomes along the opioid cascade (screening/identification, referral, treatment enrollment, MOUD initiation); and (b) the clinical and cost effectiveness of OCM RISE in improving public health (treatment retention/court graduation) and public safety (recidivism) outcomes, exploring moderators: defendant gender, age, charge; county urbanicity and county OD rates. 3) To characterize and compare advancement through the stages of implementation of the OCM in the 10 counties, elucidating the inner- and outer-level EPIS- and SCT-derived factors that influence delivery of implementation strategies to inform OCM scale up; and (b) to explore the relationship between implementation stage completion and all opioid cascade, public health and public safety outcomes.
Setting.The research team will leverage the real-world roll-out of the OCM by the NYS UCS to provide implementation strategies that will optimize the ability of diverse counties to effectively adopt this innovative model. Between 2017 and 2019, several counties have scaled up these courts, and the research team will use their experiences and outcomes in intervention refinement. The team will then evaluate OCM RISE in 10 "new adopter" counties, some if which have established opioid courts in 2019, that all have an existing adult drug (non-opioid) court. Counties are varied in their experience of opioid "burden" as well as the stage of the development of their court.
Design, Sample Size and Randomization. In the proposed cluster randomized stepped-wedge design, 10 new adopter counties will be randomized - stratified by population density/urbanicity (as a proxy for staffing and resource availability), (a metric developed by NYS Department of Health (DOH) that encompasses non-fatal ER visits and hospital discharges involving opioid use, OD deaths, which will be used as a proxy for treatment need), and county court activity (newly established versus not)- to one of 5 waves of OCM RISE at 2-month intervals. The 2-month intervals for randomization reflect the real world need for counties to meet the UCS mandate to establish opioid courts as well as our experience with managing multiple start-ups across NYS. The research team will examine the differences between matched defendants with opioid use (OU) or OUD at baseline (county drug court outcomes in the 3 months prior to randomization) with those after OCM RISE on opioid cascade outcomes and on recidivism. By randomizing sites across time, the control group is taken to be counties that have not yet been randomized by a particular time, i.e., treatment as usual (TAU), allowing us to control for secular changes over time. During the pre-randomization period the opioid cascade outcomes will be collected on defendants with OU or OUD who enter into the existing county drug courts. The team expects that introduction of the OCM will identify a broader case-mix of defendants with OU than those currently identified for drug courts.
Hence, the research team will take into account defendant level differences (e.g. heroin vs prescription drug use, age, OUD severity) when testing the effect of OCM by using propensity score matching. There are two limitations to cluster randomized deigns: potential of uneven distribution of potentially confounding variables within a cluster (i.e. county) as well as interrelationship between variables. Our proposed stratification plan and use of propensity matching will address issues related to confounding. The team calculated our ability to detect an effect of the OCM (i.e. power) using a conservative intraclass correlation coefficient (ICC) of 0.05 denoting a moderate positive correlation between outcomes within a county to address issues of interrelationship between variables at the county level
Participants. Participants will be court and treatment staff who participate in 1) staff surveys, 2) in-depth interviews, 3) focus groups, 4) the interagency change team (IACT) and/or 5) preparation activities (e.g. leadership meeting, orientation meeting). Approximately n=10 court and n=10 treatment staff will be recruited in each county for a total of 200 participants. Main study outcome data are to be drawn from court records of defendants, who are not considered human subjects and will not be enrolled in the study.
Formative Phase (with "initial adopter" counties). Convene expert stakeholder OCM Advisory Panel with "initial adopter" counties. At the outset of the grant, the team will convene an OCM Advisory Panel of stakeholders involved in OCM implementation in 5 counties who implemented opioid courts before 2019. In a half-day meeting at each county, the research team will lead discussion of facilitators and barriers relevant to each step of the opioid care cascade. Stakeholders will discuss experiences, facilitators, and barriers in operationalizing the UCS OCM practice guidelines (and meeting benchmarks if set) in their counties. This discussion will inform development of a set of benchmarks for the 10 OCM RISE guidelines. These data will contribute to identifying specific areas of focus for the proposed implementation intervention (OCM RISE) and informing needed changes or refinements.
Intervention Phases (with "new adopter" counties). OCM RISE will comprise four phases (Exploratory, Preparation, Implementation, and Sustainment) that a new adopter county will use to roll out the OCM. OCM RISE implementation strategies, grouped to achieve three implementation goals, have been well documented in projects that involve interagency collaboration and/or delivery of evidence-based guidelines, and use of data to guide decision- making and improve current practices has been successfully implemented in justice (e.g., JJTRIALS), health, education, and business settings. In the Exploratory Phase (5 months), research staff will conduct readiness surveys, system mapping exercises, focus groups and in-depth interviews to assess county context to allow specific content of implementation strategies to be tailored to that county's needs and capabilities. The research team will integrate these data to prepare a needs assessment report to be presented to each county's court and treatment leadership in the Preparation Phase (7 months) and be used by the Inter Agency Change Team (IACT), with guidance from external facilitators, to create an implementation plan for the county. Guided facilitation during this phase will include court development planning for counties without opioid courts and practice and process improvement planning to help all IACTs operationalize the 10 OCM guidelines and achieve a balance between fidelity to the guideline and fit to the local context; and training on data-driven decision-making (DDDM) to allow IACTs to use data to inform continued process improvement and practice changes to optimize OCM delivery. DDDM is a process, frequently used in the justice system, by which key system stakeholders collect, analyze, and interpret data to inform decisions that will help improve a range of outcomes/practices. In the Implementation Phase (18 months), the county will roll out the OCM for 18 months with data feedback, support, and facilitation from the research team. Each IACT will be provided with data on performance of its county OCM following implementation, and complete two plan-do-study-act (PDSA) cycles. PDSA is an evidence-based, rapid-cycle change model for testing organizational enhancements on a small scale before incorporating them on a larger scale. It is a flexible modality that can be used to achieve sustainable quality improvement and may be particularly useful in a court system that requires evidence before policy or procedures are altered. In the Sustainment Phase (6-18 months depending on the study wave), OCM implementation and feedback reports will continue but without other external facilitation.
Assessments and analysis. Data sources in the proposed study include court system records (Unified Case Management System; UCMS), staff surveys, focus groups and checklists. Staff surveys are administered at 3 timepoints: during baseline data collection (before exploration or preparation being), at the beginning of the implementation phase and at the end of the sustainment phase. Main outcome data will be drawn from the UCMS. The research team will determine the clinical effectiveness of OCM RISE by determining differences between matched defendants with OU or OUD in county drug courts (baseline) with those in the OCM on (i) retention in community treatment for >60 days/court completion (primary outcome) and recidivism 6 months after OCM termination/graduation; cost- effectiveness will also examine abstinence. The research team will examine the implementation impact of OCM RISE by examining differences between matched defendants with OU or OUD in county drug courts (baseline) with those in the OCM on (i) identification of service need; (ii) referral to community-based treatment/MOUD; (iii) enrollment in treatment/MOUD; (iv) MOUD initiation. By randomizing sites to OCM-RISE across time, the control group (which is changing over time) is taken to be the sites that have not yet rolled out the OCM by a particular time, treatment as usual (TAU).
Clinical effectiveness and Implementation impact will be determined using generalized linear mixed effects modeling for stepped-wedge designs. In the event that descriptive analyses identify large differences in the case mix of background characteristics for the defendants during the TAU period prior to OCM implementation as compared to the case-mix after OCM implementation, the team will additionally implement propensity score matching. Cost effectiveness will be determined using multivariable Generalized Linear Mixed Model. The multivariable aspect of the model allows for the control of potentially confounding factors that are unbalanced between arms because they either were not accounted for in the randomization process or became unbalanced due to loss to follow-up. EPIS and SCT derived inner and outer setting factors will be examined as mediators and moderators in clinical effectiveness and implementation impact analysis; data are derived from staff surveys.
To explore the implementation process, the team will characterize the paths through stages of implementation through to sustainability, as measured by the Stages of Implementation Change (SIC) tool, across counties, exploring differences between counties that have recently implemented a new opioid court (within 2019) prior to study participation and counties that had not. Through case studies the team will qualitatively describe how different counties deal with the different barriers they face and progress through the implementation phases. The research team will combine quantitative and qualitative data collected throughout the implementation process from multiple sources, including: in-depth interviews, UCMS data, staff surveys, and county data.
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Not Applicable|
|Study Design ICMJE||Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Stepped-wedge designMasking: None (Open Label)
Primary Purpose: Health Services Research
|Intervention ICMJE||Behavioral: OCM-RISE
OCM RISE will comprise four phases (Exploratory, Preparation, Implementation, and Sustainment). During Exploration, staff will conduct readiness surveys, interviews and system mapping exercises to assess county context. In the Preparation Phase, the needs assessment data will inform county-specific action plans. Guided facilitation during this phase includes court development planning, practice/process improvement strategies, and training on data-driven decision-making to help IACTs operationalize the 10 OCM guidelines, assess performance, and fit the guideline to the local context. In the Implementation Phase, counties will roll out the OCM for 18 months with data feedback, support, and facilitation. Each IACT will receive reports on the performance of its OCM and complete two plan-do-study-act cycles. In the Sustainment Phase, implementation and feedback reports will continue for 6-18 months, but without other external facilitation.
|Study Arms ICMJE||Experimental: OCM-RISE
Opioid court team provided external facilitation to generate action plans to develop and roll out or improve practice of the county opioid court.
Intervention: Behavioral: OCM-RISE
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE
|Original Estimated Enrollment ICMJE||Same as current|
|Estimated Study Completion Date ICMJE||July 2024|
|Estimated Primary Completion Date||July 2024 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
County Treatment Staff Inclusion Criteria
|Ages ICMJE||18 Years and older (Adult, Older Adult)|
|Accepts Healthy Volunteers ICMJE||Yes|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT04216719|
|Other Study ID Numbers ICMJE||7872|
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||
|IPD Sharing Statement ICMJE||Not Provided|
|Responsible Party||Katherine Elkington, New York State Psychiatric Institute|
|Study Sponsor ICMJE||New York State Psychiatric Institute|
|PRS Account||New York State Psychiatric Institute|
|Verification Date||September 2020|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP