<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03229447</url>
  </required_header>
  <id_info>
    <org_study_id>NationalDRI</org_study_id>
    <secondary_id>R34DA038799</secondary_id>
    <nct_id>NCT03229447</nct_id>
  </id_info>
  <brief_title>Facilitating MAT Acceptance &amp; Implementation in Problem Solving &amp; Felony Courts</brief_title>
  <official_title>Facilitating MAT Acceptance &amp; Implementation in Problem Solving &amp; Felony Courts</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Development and Research Institutes, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Treatment Alternatives for Safe Communities</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Development and Research Institutes, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study compares two methodologies for improving access to medication assisted treatment&#xD;
      (MAT) in Ohio courts where MAT is currently restricted or prohibited. All participating&#xD;
      courts are asked to view two educational modules. Module 1 addresses the nature of opioid&#xD;
      addiction and treatment. Module 2 addresses concerns specific to criminal justice such as&#xD;
      misuse and diversion of medications. Courts selected for the experimental group also receive&#xD;
      a hands-on change team initiative in which specially trained professionals work with court&#xD;
      staff to provide education and instrumental assistance in order to improve access to MAT for&#xD;
      court supervisees who are opioid-dependent.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Although there is robust evidence for the efficacy of medication assisted treatment (MAT),&#xD;
      e.g., buprenorphine, extended-release naltrexone, methadone, this evidence-based treatment&#xD;
      (EBT) is not available for the majority of opioid dependent clients (ODCs) in the criminal&#xD;
      justice (CJ) population.&#xD;
&#xD;
      In a recent survey of drug courts our group found that less than half include MAT as a&#xD;
      treatment option for their ODCs. Moreover among the minority of courts that do permit MAT, it&#xD;
      is typically restricted. Responses by drug court personnel revealed serious concerns about&#xD;
      diversion, misuse, and uncertainty about the efficacy of MAT, especially among courts in&#xD;
      which MAT was unavailable. Despite these barriers, 70% of the courts indicated that with&#xD;
      proper evidence MAT could be considered or expanded as a treatment option. To increase court&#xD;
      professionals' understanding of MAT and facilitate decisions on whether MAT would be an&#xD;
      appropriate treatment, we proposed a Stage I study to develop and test the feasibility of&#xD;
      using an eLearning and an eLearning + a behavioral change team intervention, an Addiction&#xD;
      Technology Transfer Center - ATTC - Technology Transfer [TT] model, to advance knowledge and&#xD;
      facilitate inclusion of MAT as a treatment option in the criminal justice system (CJS) for&#xD;
      ODCs. To enhance the eLearning modality we included testimonials from opinion leaders/early&#xD;
      adopters of MAT (e.g., a drug court judge, a representative from the National Association of&#xD;
      Drug Court Professionals, and treatment providers) who addressed specific concerns such as&#xD;
      methods to identify qualified MAT providers, appraise treatment plans, and prevent and&#xD;
      minimize negative effects of diversion and misuse. The behavioral change intervention will be&#xD;
      based on a model of process improvement developed by the ATTC Network5 to expand treatment&#xD;
      options for the management of opioid dependence, in this case MAT. The planned program&#xD;
      represents the first study to: 1) include testimonials by opinion leaders in conjunction with&#xD;
      an eLearning approach to spur inclusion of an evidence-based intervention for the treatment&#xD;
      of opioid dependence within a criminal justice (CJ) setting and; 2) adapt the ATTC TT model&#xD;
      to the specific goal of facilitating inclusion of MAT as a treatment option. Specific aims of&#xD;
      the study are:&#xD;
&#xD;
      Aim 1. Develop an eLearning (web-based) intervention that will provide information about&#xD;
      risks and benefits of MAT to help drug and felony court staff determine whether MAT is&#xD;
      suitable for their clients. The protocol will include group discussions with both&#xD;
      MAT-friendly and MAT-averse court personnel and inclusion of a MAT Advisory Panel (MAP), a&#xD;
      team of experts in the implementation of MAT in CJ settings. Through an iterative process&#xD;
      (review/revisions by MAT experts and court staff) we will develop a consensual outline&#xD;
      representing topics that would be addressed by our web-based intervention. The objective will&#xD;
      be to provide a balanced, thorough presentation of both benefits and risks of MAT provision&#xD;
      and will specifically seek to address concerns about MAT provision such as diversion and&#xD;
      misuse. Informed by diffusion of innovations theory, the eLearning modules will be enhanced&#xD;
      by including testimony of criminal justice professionals about their experiences with MAT in&#xD;
      their courtrooms, what their concerns had been prior to MAT adoption by their court, and how&#xD;
      ￼these concerns (and other obstacles that emerged) were addressed.&#xD;
&#xD;
      ￼ Aim 2. Develop a TT intervention to facilitate Courts' readiness and resources to engage in&#xD;
      case-by-case inquiries to determine whether and under what circumstances to permit MAT.&#xD;
      Working with ATTC TT experts we will develop a change team (CT) intervention for court&#xD;
      representatives and treatment providers (including Judge, coordinator, administrator, and&#xD;
      case-managers). The objective of the proposed CT intervention will be to: 1) Broker&#xD;
      relationships between MAT providers and courts; ensuring that MAT providers will accept court&#xD;
      referred individuals; 2) Reinforce the educational objectives - including addressing in&#xD;
      substantive ways issues of availability, access (including cost), misuse, and diversion -&#xD;
      with court personnel in order to expand policy and practice to include MAT; 3) Work with&#xD;
      local MAT and other treatment providers to help create an environment in which MAT is&#xD;
      accepted as part of the constellation of available treatments; 4) help develop protocols such&#xD;
      as assertive ongoing monitoring and support to assure that MAT benefits are sustained once a&#xD;
      client has been referred to treatment.&#xD;
&#xD;
      Aim 3. Conduct a small-scale trial to evaluate the preliminary effectiveness of the eLearning&#xD;
      intervention, and the eLearning + change team intervention (TT-intervention). Targeting&#xD;
      courts that either do not place their ODCs in MAT or tightly restrict MAT access, 24 courts&#xD;
      will be randomly assigned to 1 of 2 treatment conditions: 1. Treatment as usual, followed by&#xD;
      the eLearning intervention, or 2. eLearning intervention followed by the CT intervention.&#xD;
      Outcomes include 1) the rate of enrollment of clients in MAT; 2) rate of referral of clients&#xD;
      to MAT; 3) MAT Knowledge, 4) Willingness to use MAT, and 5) Barriers to MAT. We expect this&#xD;
      development/pilot project will lead to a protocol to implement an EBT in the CJS; a setting&#xD;
      with high numbers of ODCs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 15, 2016</start_date>
  <completion_date type="Anticipated">April 2018</completion_date>
  <primary_completion_date type="Anticipated">April 2018</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Enrollment in Medication Assisted Treatment</measure>
    <time_frame>9 months</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MAT referrals</measure>
    <time_frame>9 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MAT knowledge/attitudes</measure>
    <time_frame>9 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Willingness to refer clients to MAT</measure>
    <time_frame>9 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Barriers to MAT</measure>
    <time_frame>9 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">96</enrollment>
  <condition>Improving Treatment for Opioid Use Disorder in Courts</condition>
  <arm_group>
    <arm_group_label>E-learning intervention</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Change Team Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>eLearning Modules</intervention_name>
    <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.</description>
    <arm_group_label>Change Team Intervention</arm_group_label>
    <arm_group_label>E-learning intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Change Team Intervention</intervention_name>
    <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.</description>
    <arm_group_label>Change Team Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Over 18 years of age&#xD;
&#xD;
          -  Court Personnel&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under 18 years of age&#xD;
&#xD;
          -  Not employed by court&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew Rosenblum</last_name>
    <role>Principal Investigator</role>
    <affiliation>Executive Director</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Andrew Rosenblum, PhD</last_name>
    <phone>2128454258</phone>
    <email>rosenblum@ndri.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Harlan Matusow, PhD</last_name>
    <phone>2128454445</phone>
    <email>matusow@ndri.orgm</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>National Development and Research Institutes, Inc.</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrew Rosenblum, PhD</last_name>
      <phone>212-845-4528</phone>
      <email>Rosenblum@ndr.org</email>
    </contact>
    <contact_backup>
      <last_name>Harlan Matusow, PhD</last_name>
      <phone>212-845-4445</phone>
      <email>Matusow@ndri.org</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 14, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>July 21, 2017</last_update_submitted>
  <last_update_submitted_qc>July 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Opioid-Related Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03229447
org study id: NationalDRI
secondary id: R34DA038799
nct id: NCT03229447
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
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
masking: None (Open Label)
measure: Enrollment in Medication Assisted Treatment
time frame: 9 months
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.
measure: MAT referrals
time frame: 9 months
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.
measure: MAT knowledge/attitudes
time frame: 9 months
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.
measure: Willingness to refer clients to MAT
time frame: 9 months
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.
measure: Barriers to MAT
time frame: 9 months
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.
arm group label: E-learning intervention
arm group type: Active Comparator
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 group label: Change Team Intervention
arm group type: Experimental
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: eLearning Modules
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.
arm group label: Change Team Intervention
arm group label: E-learning intervention
intervention type: Behavioral
intervention name: Change Team 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.
arm group label: Change Team Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Andrew Rosenblum
role: Principal Investigator
affiliation: Executive Director
last name: Andrew Rosenblum, PhD
phone: 2128454258
email: rosenblum@ndri.org
last name: Harlan Matusow, PhD
phone: 2128454445
email: matusow@ndri.orgm
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
mesh term: Opioid-Related Disorders
sharing ipd: No