Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04216719 |
| Other study ID # |
7872 |
| Secondary ID |
UG1DA050071 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 18, 2020 |
| Est. completion date |
December 1, 2025 |
Study information
| Verified date |
August 2023 |
| Source |
New York State Psychiatric Institute |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
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.
