- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03229447
Facilitating MAT Acceptance & Implementation in Problem Solving & Felony Courts
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: Andrew Rosenblum, PhD
- Phone Number: 2128454258
- Email: rosenblum@ndri.org
Study Contact Backup
- Name: Harlan Matusow, PhD
- Phone Number: 2128454445
- Email: matusow@ndri.orgm
Study Locations
-
-
New York
-
New York, New York, United States, 10010
- Recruiting
- National Development and Research Institutes, Inc.
-
Contact:
- Andrew Rosenblum, PhD
- Phone Number: 212-845-4528
- Email: Rosenblum@ndr.org
-
Contact:
- Harlan Matusow, PhD
- Phone Number: 212-845-4445
- Email: Matusow@ndri.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Over 18 years of age
- Court Personnel
Exclusion Criteria:
- Under 18 years of age
- Not employed by court
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: E-learning intervention
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.
|
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.
|
Experimental: Change Team Intervention
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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Enrollment in Medication Assisted Treatment
Time Frame: 9 months
|
Pre-post intervention comparison of enrollment in MAT among opioid-dependent supervisees.
Using an online survey, investigators compare court-reported data for MAT enrollment.
|
9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MAT referrals
Time Frame: 9 months
|
Pre-post intervention comparison of referral to MAT for opioid-dependent supervisees.
Using an online survey, investigators compare court-reported data for MAT referrals.
|
9 months
|
MAT knowledge/attitudes
Time Frame: 9 months
|
Via online survey, MAT knowledge and attitude scale will be used to test pre-post changes in both knowledge of and attitudes toward MAT.
|
9 months
|
Willingness to refer clients to MAT
Time Frame: 9 months
|
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.
|
9 months
|
Barriers to MAT
Time Frame: 9 months
|
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.
|
9 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Andrew Rosenblum, Executive Director
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NationalDRI
- R34DA038799 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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