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Facilitating MAT Acceptance & Implementation in Problem Solving & Felony Courts

Primary Purpose

Improving Treatment for Opioid Use Disorder in Courts

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
eLearning Modules
Change Team Intervention
Sponsored by
National Development and Research Institutes, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Improving Treatment for Opioid Use Disorder in Courts

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Over 18 years of age
  • Court Personnel

Exclusion Criteria:

  • Under 18 years of age
  • Not employed by court

Sites / Locations

  • National Development and Research Institutes, Inc.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

E-learning intervention

Change Team Intervention

Arm Description

The E-learning intervention consists of two 20-minute e-learning modules that combine a didactic component with testimonials from respected professionals in the fields of addiction treatment and criminal justice. Module 1 describes the nature of opioid addiction and treatment modalities. Module 2 addresses specific criminal justice concerns of cost, acceptance, usefulness, and diversion, perceived obstacles to providing MAT access as described to us by Ohio criminal justice professionals in formative phase. All courts recruited for the study are exposed to E-Learning.

Half of the courts exposed to e-learning will be randomly assigned to a change team intervention. The change team will reinforce the information in the modules and provide instrumental assistance in linking courts to MAT providers and financial resources.

Outcomes

Primary Outcome Measures

Enrollment in Medication Assisted Treatment
Pre-post intervention comparison of enrollment in MAT among opioid-dependent supervisees. Using an online survey, investigators compare court-reported data for MAT enrollment.

Secondary Outcome Measures

MAT referrals
Pre-post intervention comparison of referral to MAT for opioid-dependent supervisees. Using an online survey, investigators compare court-reported data for MAT referrals.
MAT knowledge/attitudes
Via online survey, MAT knowledge and attitude scale will be used to test pre-post changes in both knowledge of and attitudes toward MAT.
Willingness to refer clients to MAT
Courts asked how receptive they are to refer clients to MAT. Using an online survey, investigators ask judges to elaborate upon their willingness to refer clients to MAT.
Barriers to MAT
Courts complete a checklist of structural barriers such as cost, policy opposition, availability. Using an online survey, investigators compare court-reported data for barriers to MAT referral.

Full Information

First Posted
July 14, 2017
Last Updated
July 21, 2017
Sponsor
National Development and Research Institutes, Inc.
Collaborators
Treatment Alternatives for Safe Communities
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1. Study Identification

Unique Protocol Identification Number
NCT03229447
Brief Title
Facilitating MAT Acceptance & Implementation in Problem Solving & Felony Courts
Official Title
Facilitating MAT Acceptance & Implementation in Problem Solving & Felony Courts
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 15, 2016 (Actual)
Primary Completion Date
April 2018 (Anticipated)
Study Completion Date
April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Development and Research Institutes, Inc.
Collaborators
Treatment Alternatives for Safe Communities

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study compares two methodologies for improving access to medication assisted treatment (MAT) in Ohio courts where MAT is currently restricted or prohibited. All participating courts are asked to view two educational modules. Module 1 addresses the nature of opioid addiction and treatment. Module 2 addresses concerns specific to criminal justice such as misuse and diversion of medications. Courts selected for the experimental group also receive a hands-on change team initiative in which specially trained professionals work with court staff to provide education and instrumental assistance in order to improve access to MAT for court supervisees who are opioid-dependent.
Detailed Description
Although there is robust evidence for the efficacy of medication assisted treatment (MAT), e.g., buprenorphine, extended-release naltrexone, methadone, this evidence-based treatment (EBT) is not available for the majority of opioid dependent clients (ODCs) in the criminal justice (CJ) population. In a recent survey of drug courts our group found that less than half include MAT as a treatment option for their ODCs. Moreover among the minority of courts that do permit MAT, it is typically restricted. Responses by drug court personnel revealed serious concerns about diversion, misuse, and uncertainty about the efficacy of MAT, especially among courts in which MAT was unavailable. Despite these barriers, 70% of the courts indicated that with proper evidence MAT could be considered or expanded as a treatment option. To increase court professionals' understanding of MAT and facilitate decisions on whether MAT would be an appropriate treatment, we proposed a Stage I study to develop and test the feasibility of using an eLearning and an eLearning + a behavioral change team intervention, an Addiction Technology Transfer Center - ATTC - Technology Transfer [TT] model, to advance knowledge and facilitate inclusion of MAT as a treatment option in the criminal justice system (CJS) for ODCs. To enhance the eLearning modality we included testimonials from opinion leaders/early adopters of MAT (e.g., a drug court judge, a representative from the National Association of Drug Court Professionals, and treatment providers) who addressed specific concerns such as methods to identify qualified MAT providers, appraise treatment plans, and prevent and minimize negative effects of diversion and misuse. The behavioral change intervention will be based on a model of process improvement developed by the ATTC Network5 to expand treatment options for the management of opioid dependence, in this case MAT. The planned program represents the first study to: 1) include testimonials by opinion leaders in conjunction with an eLearning approach to spur inclusion of an evidence-based intervention for the treatment of opioid dependence within a criminal justice (CJ) setting and; 2) adapt the ATTC TT model to the specific goal of facilitating inclusion of MAT as a treatment option. Specific aims of the study are: Aim 1. Develop an eLearning (web-based) intervention that will provide information about risks and benefits of MAT to help drug and felony court staff determine whether MAT is suitable for their clients. The protocol will include group discussions with both MAT-friendly and MAT-averse court personnel and inclusion of a MAT Advisory Panel (MAP), a team of experts in the implementation of MAT in CJ settings. Through an iterative process (review/revisions by MAT experts and court staff) we will develop a consensual outline representing topics that would be addressed by our web-based intervention. The objective will be to provide a balanced, thorough presentation of both benefits and risks of MAT provision and will specifically seek to address concerns about MAT provision such as diversion and misuse. Informed by diffusion of innovations theory, the eLearning modules will be enhanced by including testimony of criminal justice professionals about their experiences with MAT in their courtrooms, what their concerns had been prior to MAT adoption by their court, and how these concerns (and other obstacles that emerged) were addressed.  Aim 2. Develop a TT intervention to facilitate Courts' readiness and resources to engage in case-by-case inquiries to determine whether and under what circumstances to permit MAT. Working with ATTC TT experts we will develop a change team (CT) intervention for court representatives and treatment providers (including Judge, coordinator, administrator, and case-managers). The objective of the proposed CT intervention will be to: 1) Broker relationships between MAT providers and courts; ensuring that MAT providers will accept court referred individuals; 2) Reinforce the educational objectives - including addressing in substantive ways issues of availability, access (including cost), misuse, and diversion - with court personnel in order to expand policy and practice to include MAT; 3) Work with local MAT and other treatment providers to help create an environment in which MAT is accepted as part of the constellation of available treatments; 4) help develop protocols such as assertive ongoing monitoring and support to assure that MAT benefits are sustained once a client has been referred to treatment. Aim 3. Conduct a small-scale trial to evaluate the preliminary effectiveness of the eLearning intervention, and the eLearning + change team intervention (TT-intervention). Targeting courts that either do not place their ODCs in MAT or tightly restrict MAT access, 24 courts will be randomly assigned to 1 of 2 treatment conditions: 1. Treatment as usual, followed by the eLearning intervention, or 2. eLearning intervention followed by the CT intervention. Outcomes include 1) the rate of enrollment of clients in MAT; 2) rate of referral of clients to MAT; 3) MAT Knowledge, 4) Willingness to use MAT, and 5) Barriers to MAT. We expect this development/pilot project will lead to a protocol to implement an EBT in the CJS; a setting with high numbers of ODCs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Improving Treatment for Opioid Use Disorder in Courts

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
This study will develop and test the feasibility of an interactive eLearning modality and an eLearning + an organizational approach (change team intervention; a Technology Transfer model) to advance knowledge and facilitate inclusion of MAT in the criminal justice system for opioid-addicted clients. Courts recruited for the study will receive eLearning and half of these courts will be randomly assigned to the change team.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
E-learning intervention
Arm Type
Active Comparator
Arm Description
The E-learning intervention consists of two 20-minute e-learning modules that combine a didactic component with testimonials from respected professionals in the fields of addiction treatment and criminal justice. Module 1 describes the nature of opioid addiction and treatment modalities. Module 2 addresses specific criminal justice concerns of cost, acceptance, usefulness, and diversion, perceived obstacles to providing MAT access as described to us by Ohio criminal justice professionals in formative phase. All courts recruited for the study are exposed to E-Learning.
Arm Title
Change Team Intervention
Arm Type
Experimental
Arm Description
Half of the courts exposed to e-learning will be randomly assigned to a change team intervention. The change team will reinforce the information in the modules and provide instrumental assistance in linking courts to MAT providers and financial resources.
Intervention Type
Behavioral
Intervention Name(s)
eLearning Modules
Intervention Description
All participating courts will view two eLearning modules. Module one discusses opioid addiction and treatment; module two discusses specific concerns of criminal justice with regard to MAT and ways in which those concerns may be addressed.
Intervention Type
Behavioral
Intervention Name(s)
Change Team Intervention
Intervention Description
Courts selected for the experimental condition will participate in a hands-on change team intervention to provide instrumental assistance and to reinforce the information contained in the eLearning modules.
Primary Outcome Measure Information:
Title
Enrollment in Medication Assisted Treatment
Description
Pre-post intervention comparison of enrollment in MAT among opioid-dependent supervisees. Using an online survey, investigators compare court-reported data for MAT enrollment.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
MAT referrals
Description
Pre-post intervention comparison of referral to MAT for opioid-dependent supervisees. Using an online survey, investigators compare court-reported data for MAT referrals.
Time Frame
9 months
Title
MAT knowledge/attitudes
Description
Via online survey, MAT knowledge and attitude scale will be used to test pre-post changes in both knowledge of and attitudes toward MAT.
Time Frame
9 months
Title
Willingness to refer clients to MAT
Description
Courts asked how receptive they are to refer clients to MAT. Using an online survey, investigators ask judges to elaborate upon their willingness to refer clients to MAT.
Time Frame
9 months
Title
Barriers to MAT
Description
Courts complete a checklist of structural barriers such as cost, policy opposition, availability. Using an online survey, investigators compare court-reported data for barriers to MAT referral.
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Over 18 years of age Court Personnel Exclusion Criteria: Under 18 years of age Not employed by court
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrew Rosenblum, PhD
Phone
2128454258
Email
rosenblum@ndri.org
First Name & Middle Initial & Last Name or Official Title & Degree
Harlan Matusow, PhD
Phone
2128454445
Email
matusow@ndri.orgm
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Rosenblum
Organizational Affiliation
Executive Director
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Development and Research Institutes, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Rosenblum, PhD
Phone
212-845-4528
Email
Rosenblum@ndr.org
First Name & Middle Initial & Last Name & Degree
Harlan Matusow, PhD
Phone
212-845-4445
Email
Matusow@ndri.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Facilitating MAT Acceptance & Implementation in Problem Solving & Felony Courts

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