Facilitating Opioid Care Connections

NCT04216719 | Enrolling By Invitation DMC

• 2 other identifiers: 7872UG1DA050071
• Study Type: interventional
• Target: 3,440
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Court Model; Medication to Treat Opioid Use Disorder; Opioid Use

Outcome Measures

Primary Outcomes (4)

• Number of participants who are retained in treatment for at least 60 days

  Derived from Unified Court Management System (UCMS)

  Through study completion, an average of 30 months

• Number of participants who graduate from court

  Derived from Unified Court Management System (UCMS)

  Through study completion, an average of 30 months

• Number of participants who are abstinent from opioid use

  Derived from Unified Court Management System (UCMS)

  Through study completion, an average of 30 months

• Number of participants who recidivate within 12 months following court completion

  Derived from Unified Court Management System (UCMS)

  Through study completion, an average of 30 months

Secondary Outcomes (6)

• Number of defendants who are screened for opioid use after arrest

  Through study completion, an average of 30 months

• Number of court participants who are referred for opioid treatment

  Through study completion, an average of 30 months

• Number of court participants who are provided medication for Opioid Use Disorder (MOUD) Initiation

  Through study completion, an average of 30 months

• Acceptability of the opioid court

  At study completion

• Adoption of OCM RISE

  Through study completion, an average of 30 months

Other Outcomes (10)

• Knowledge, Attitudes towards MOUD

  Through study completion, an average of 30 months

• Self-Efficacy to address Opioid Use Disorder

  Through study completion, an average of 30 months

• Perceived Importance of Cascade Behaviors

  Through study completion, an average of 30 months

Study Arms (1)

OCM-RISE

EXPERIMENTAL

Opioid court team provided external facilitation to generate action plans to develop and roll out or improve practice of the county opioid court.

Behavioral: OCM-RISE

Interventions

OCM-RISE BEHAVIORAL

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.

OCM-RISE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Employed by the Unified Court System/County Court in participating county
• Age 18+
• Understands and speaks English

You may not qualify if:

• \- None
• Employed at substance use (SU) treatment agency
• Age 18+
• Understands and speaks English
• \- None

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• Center for Court Innovation: collaborator
• Center on Addiction: collaborator
• New York State Unified Court System: collaborator
• Columbia University: collaborator
• Weill Medical College of Cornell University: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Study Officials

• Katherine S Elkington, PhD

  Columbia University/NYSPI

  PRINCIPAL INVESTIGATOR

• Edward Nunes, MD

  Columbia University/NYSPI

  PRINCIPAL INVESTIGATOR

• Milton L Wainberg, MD

  Columbia University/NYSPI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Medical Psychology, in Psychiatry, Co-Director, Center for the Promotion of Mental Health in Juvenile Justice, Division of Child and Adolescent Psychiatry

Model Details: Stepped-wedge design

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: January 3, 2020
• Study Start: March 18, 2020
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (1)