Clinical trial NCT03229447: Facilitating MAT Acceptance & Implementation in Problem Solving & Felony Courts
Official title: Facilitating MAT Acceptance & Implementation in Problem Solving & Felony Courts
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Improving Treatment for Opioid Use Disorder in Courts
Lead sponsor: National Development and Research Institutes, Inc.
Sponsor class: OTHER
Collaborators: name: Treatment Alternatives for Safe Communities
First posted: 2017-07-25
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Over 18 years of age
* Court Personnel

Exclusion Criteria:

* Under 18 years of age
* Not employed by court

Primary outcomes:
measure: Enrollment in Medication Assisted Treatment
timeFrame: 9 months
Secondary outcomes:
measure: MAT referrals
timeFrame: 9 months
measure: MAT knowledge/attitudes
timeFrame: 9 months
measure: Willingness to refer clients to MAT
timeFrame: 9 months
measure: Barriers to MAT
timeFrame: 9 months
Other outcomes:
Locations:
city: New York
country: United States
facility: National Development and Research Institutes, Inc.
state: New York
Study officials:
affiliation: Executive Director
name: Andrew Rosenblum
role: PRINCIPAL_INVESTIGATOR
References: