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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 : Not yet recruiting
First Posted : January 3, 2020
Last Update Posted : April 20, 2020
Sponsor:
Collaborators:
Center for Court Innovation
New York State Unified Court System
Center on Addiction
Columbia University
Weill Medical College of Cornell University
Information provided by (Responsible Party):
Katherine Elkington, New York State Psychiatric Institute

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.

Condition or disease Intervention/treatment Phase
Opioid Court Model Medication to Treat Opioid Use Disorder Opioid Use Behavioral: OCM-RISE Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Stepped-wedge design
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: 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
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2024

Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. Number of participants who are retained in treatment for at least 60 days [ Time Frame: Through study completion, an average of 30 months ]
    Derived from Unified Court Management System (UCMS)

  2. Number of participants who graduate from court [ Time Frame: Through study completion, an average of 30 months ]
    Derived from Unified Court Management System (UCMS)

  3. Number of participants who are abstinent from opioid use [ Time Frame: Through study completion, an average of 30 months ]
    Derived from Unified Court Management System (UCMS)

  4. Number of participants who recidivate within 12 months following court completion [ Time Frame: Through study completion, an average of 30 months ]
    Derived from Unified Court Management System (UCMS)


Secondary Outcome Measures :
  1. Number of defendants who are screened for opioid use after arrest [ Time Frame: Through study completion, an average of 30 months ]
    Derived from Unified Court Management System (UCMS)

  2. Number of court participants who are referred for opioid treatment [ Time Frame: Through study completion, an average of 30 months ]
    Unified Court System Management Information System (UCMS)

  3. Number of court participants who are provided medication for Opioid Use Disorder (MOUD) Initiation [ Time Frame: Through study completion, an average of 30 months ]
    Unified Court System Management Information System; UCMS data field

  4. Acceptability of the opioid court [ Time Frame: At study completion ]
    Opinions of acceptability of OCM RISE as derived from a focus group with interagency change team members

  5. Adoption of OCM RISE [ Time Frame: Through study completion, an average of 30 months ]
    Number of implementation stages (as determined by EPIS: exploration, preparation, implementation, sustainment) completed measured by the Stages if Implementation Completion (SIC) tool

  6. Sustainability of OCM RISE [ Time Frame: Through study completion, an average of 30 months ]
    Continued screening, referral, treatment enrollment, MOUD initiation 12m post Implementation phase ends


Other Outcome Measures:
  1. Knowledge, Attitudes towards MOUD [ Time Frame: Through study completion, an average of 30 months ]
    Court and Treatment Staff Survey

  2. Self-Efficacy to address Opioid Use Disorder [ Time Frame: Through study completion, an average of 30 months ]
    Court and Treatment Staff Survey

  3. Perceived Importance of Cascade Behaviors [ Time Frame: Through study completion, an average of 30 months ]
    Court and Treatment Staff Survey

  4. Perceived Potential Sustainability of OCM [ Time Frame: Through study completion, an average of 30 months ]
    Court and Treatment Staff Survey

  5. Practice change [ Time Frame: Through study completion, an average of 30 months ]
    Training quiz

  6. Organizational climate, support, and functioning [ Time Frame: Through study completion, an average of 30 months ]
    Court and Treatment Staff Survey

  7. Leadership innovation [ Time Frame: Through study completion, an average of 30 months ]
    Court and Treatment Staff Survey

  8. Inter-agency Organizational Features [ Time Frame: Through study completion, an average of 30 months ]
    Court and Treatment Staff Survey

  9. Structural Organizational Characteristics [ Time Frame: Through study completion, an average of 30 months ]
    Bi-Monthly check-ins; Readiness Survey

  10. Defendant Characteristics [ Time Frame: Through study completion, an average of 30 months ]
    Unified Court System Management Information System; UCMS data field;



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Court Staff

Inclusion Criteria:

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

Exclusion Criteria:

- None

County Treatment Staff Inclusion Criteria

  • Employed at substance use (SU) treatment agency
  • Age 18+
  • Understands and speaks English

Exclusion Criteria:

- None


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04216719


Contacts
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Contact: Katherine S Elkington, PhD 6467746965 ke2143@cumc.columbia.edu
Contact: Margaret Ryan, MS 6467745945 margaret.ryan@nyspi.columbia.edu

Sponsors and Collaborators
New York State Psychiatric Institute
Center for Court Innovation
New York State Unified Court System
Center on Addiction
Columbia University
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Katherine S Elkington, PhD Columbia University/NYSPI
Principal Investigator: Edward Nunes, MD Columbia University/NYSPI
Principal Investigator: Milton L Wainberg, MD Columbia University/NYSPI
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Responsible Party: Katherine Elkington, 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, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT04216719    
Other Study ID Numbers: 7872
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No