<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/NCT01702142</url>
  </required_header>
  <id_info>
    <org_study_id>Molfenter_2012_0008</org_study_id>
    <secondary_id>1R01DA030431-01A1</secondary_id>
    <nct_id>NCT01702142</nct_id>
  </id_info>
  <brief_title>To Test a Payer/Treatment Agency Intervention to Increase Use of Buprenorphine</brief_title>
  <official_title>To Test a Payer/Treatment Agency Intervention to Increase Use of Buprenorphine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A team of researchers from the University of Wisconsin-Madison College of Engineering and&#xD;
      Oregon Health &amp; Science University will test whether clinician training and the use of&#xD;
      organizational change strategies are sufficient for disseminating an evidence-based practice&#xD;
      (EBP), or if changes to both organizational systems and payer policy results in greater EBP&#xD;
      use. Demonstrating the role of payment policy as a driver in the adoption of evidence-based&#xD;
      practices could provide a contribution to dissemination and implementation science. This&#xD;
      study will employ an intervention that was developed through the Robert Wood Johnson&#xD;
      Foundation-funded Advancing Recovery (AR) program. In AR, payer/treatment organization&#xD;
      partnerships in 12 states collaborated to remove systemic barriers to the adoption of EBPs&#xD;
      such as medication-assisted treatment for substance abuse disorders. The resulting &quot;AR&#xD;
      Framework&quot; of payer and organizational change strategies will be tested against its ability&#xD;
      to increase the use of the addiction medication buprenorphine as compared to organizational&#xD;
      change strategies alone. Buprenorphine is an EBP for treating people addicted to heroin or&#xD;
      opioid-based pain medications for non-medical use. Buprenorphine has experienced low adoption&#xD;
      rates and is not a standard part of addiction treatment. In Ohio, the location of the study,&#xD;
      deaths to due to accidental overdoses of opioids has increased by 304% over the past decade&#xD;
      and surpassed auto accidents as the leading cause of accidental deaths in 2006. Ohio was&#xD;
      selected for the study because of the public health significance of opioid abuse and because&#xD;
      each county in Ohio acts as a stand-alone payer, offering 48 unique eligible payer&#xD;
      environments. This trial will develop a deeper understanding of the role payers and treatment&#xD;
      organizations play in implementing and disseminating EBPs and will focus on the public health&#xD;
      issue of rising opioid abuse.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Buprenorphine (EBP) use data will be collected from November, 2012 to May, 2016 through&#xD;
      administrative databases located at the state of Ohio. Participants will be followed for the&#xD;
      duration of Buprenorphine use that is an average of 5-7 months. Organizational and Payer data&#xD;
      will be collected from January, 2013 to January, 2015. The data from the study will be&#xD;
      analyzed and reported during January 2015 to February 2017.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">February 28, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Buprenorphine Use</measure>
    <time_frame>Five Years</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">14</enrollment>
  <condition>Addiction</condition>
  <arm_group>
    <arm_group_label>NIATx Only</arm_group_label>
    <description>NIATx (Network for the Improvement of Addiction Treatment) organization change model only</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NIATx and Advancing Recovery</arm_group_label>
    <description>Organizational and system changes</description>
  </arm_group>
  <biospec_retention>None Retained</biospec_retention>
  <biospec_descr>
    <textblock>
      Biospecimens are not part of this study.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Treatment agencies and Ohio County Boards&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Treatment agencies with greater than 75 admissions per year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Todd D Molfenter, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ohio Department of Addiction Services</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>October 4, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>November 28, 2018</last_update_submitted>
  <last_update_submitted_qc>November 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Addiction Treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Behavior, Addictive</mesh_term>
  </condition_browse>
  <!-- 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/NCT01702142
org study id: Molfenter_2012_0008
secondary id: 1R01DA030431-01A1
nct id: NCT01702142
lead sponsor: 
collaborator: 
has dmc: Yes
A team of researchers from the University of Wisconsin-Madison College of Engineering and
      Oregon Health & Science University will test whether clinician training and the use of
      organizational change strategies are sufficient for disseminating an evidence-based practice
      (EBP), or if changes to both organizational systems and payer policy results in greater EBP
      use. Demonstrating the role of payment policy as a driver in the adoption of evidence-based
      practices could provide a contribution to dissemination and implementation science. This
      study will employ an intervention that was developed through the Robert Wood Johnson
      Foundation-funded Advancing Recovery (AR) program. In AR, payer/treatment organization
      partnerships in 12 states collaborated to remove systemic barriers to the adoption of EBPs
      such as medication-assisted treatment for substance abuse disorders. The resulting "AR
      Framework" of payer and organizational change strategies will be tested against its ability
      to increase the use of the addiction medication buprenorphine as compared to organizational
      change strategies alone. Buprenorphine is an EBP for treating people addicted to heroin or
      opioid-based pain medications for non-medical use. Buprenorphine has experienced low adoption
      rates and is not a standard part of addiction treatment. In Ohio, the location of the study,
      deaths to due to accidental overdoses of opioids has increased by 304% over the past decade
      and surpassed auto accidents as the leading cause of accidental deaths in 2006. Ohio was
      selected for the study because of the public health significance of opioid abuse and because
      each county in Ohio acts as a stand-alone payer, offering 48 unique eligible payer
      environments. This trial will develop a deeper understanding of the role payers and treatment
      organizations play in implementing and disseminating EBPs and will focus on the public health
      issue of rising opioid abuse.
Buprenorphine (EBP) use data will be collected from November, 2012 to May, 2016 through
      administrative databases located at the state of Ohio. Participants will be followed for the
      duration of Buprenorphine use that is an average of 5-7 months. Organizational and Payer data
      will be collected from January, 2013 to January, 2015. The data from the study will be
      analyzed and reported during January 2015 to February 2017.
observational model: Case-Only
time perspective: Prospective
measure: Buprenorphine Use
time frame: Five Years
arm group label: NIATx Only
description: NIATx (Network for the Improvement of Addiction Treatment) organization change model only
arm group label: NIATx and Advancing Recovery
description: Organizational and system changes
Biospecimens are not part of this study.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 17 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Todd D Molfenter, Ph.D.
role: Principal Investigator
affiliation: University of Wisconsin, Madison
facility: 
country: United States
responsible party type: Sponsor
mesh term: Behavior, Addictive