<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/NCT02210936</url>
  </required_header>
  <id_info>
    <org_study_id>14047</org_study_id>
    <nct_id>NCT02210936</nct_id>
  </id_info>
  <brief_title>SCOSI-M: Preventing Prescription Drug Problems</brief_title>
  <official_title>Preventing Prescription Drug Problems: A Pilot Military Opioid Safety Initiative</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brandeis University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Moncrief Army Community Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>William Jennings Bryan Dorn VA Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Brandeis University</source>
  <brief_summary>
    <textblock>
      Brandeis University and University of South Carolina (USC) have joined together to develop&#xD;
      the South Carolina Opioid Safety Initiative - Military (SCOSI-M), to develop an academic&#xD;
      detailing (medical education) intervention for physicians and evaluate its effectiveness in a&#xD;
      pilot study. The goal of the intervention is to increase the use of safe prescribing and&#xD;
      prescription monitoring practices among primary care physicians. The research team will&#xD;
      design and pilot an educational intervention for physicians who treat military personnel,&#xD;
      veterans, and their families with prescription opioids. The overall aim of SCOSI-M is to&#xD;
      prevent the onset or progression of prescription drug problems among Iraq and Afghanistan&#xD;
      veterans, military members, and their families who are at high risk for developing problems&#xD;
      if their treatment involves long-term use of an opioid.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">May 2019</completion_date>
  <primary_completion_date type="Actual">May 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Use of SCRIPTS</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Primary outcomes, or effectiveness, will be measured first by the use of SCRIPTS when prescribing opioids (e.g., % of new patients the physician queried; % of patients with long-term use the physician queried).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">93</enrollment>
  <condition>Prescription Drug Problems</condition>
  <arm_group>
    <arm_group_label>PDMP Data</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational Intervention</intervention_name>
    <description>The design is primarily a pre-post, non-equivalent comparison group test of program effectiveness. If final sample size permits, we will examine program effects for each practice environment separately. For measures that require interview data there will be no comparison group data.&#xD;
We will construct matched comparison groups of physicians for each environment for which only secondary data analysis will be conducted. The matched comparison group will be constructed using prescription data from the DoD's pharmacy data transaction system (MACH and DORN VAMC) and from SCRIPTS (community-based physicians and VA prescribers).</description>
    <arm_group_label>PDMP Data</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. a physician within one of the 3 practice environments;&#xD;
&#xD;
          2. typically prescribes Schedule II opioids to 10 or more non-cancer pain patients each&#xD;
             month;&#xD;
&#xD;
          3. if community office-based, a substantial number of patients must have TRICARE (e.g.,&#xD;
             20%); and d) willing to provide written consent for data collection and release of own&#xD;
             SCRIPTS data.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. non-physician providers who report data to the SCRIPTS (dentist, veterinarians,&#xD;
             nurses),&#xD;
&#xD;
          2. surgeons, pediatricians, or physicians predominately treating pain in cancer or&#xD;
             surgical patients, and,&#xD;
&#xD;
          3. not eligible to register as authorized SCRIPTS user.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Brandeis University</name>
      <address>
        <city>Waltham</city>
        <state>Massachusetts</state>
        <zip>02454</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>August 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>July 8, 2020</last_update_submitted>
  <last_update_submitted_qc>July 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02210936
org study id: 14047
nct id: NCT02210936
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
Brandeis University and University of South Carolina (USC) have joined together to develop
      the South Carolina Opioid Safety Initiative - Military (SCOSI-M), to develop an academic
      detailing (medical education) intervention for physicians and evaluate its effectiveness in a
      pilot study. The goal of the intervention is to increase the use of safe prescribing and
      prescription monitoring practices among primary care physicians. The research team will
      design and pilot an educational intervention for physicians who treat military personnel,
      veterans, and their families with prescription opioids. The overall aim of SCOSI-M is to
      prevent the onset or progression of prescription drug problems among Iraq and Afghanistan
      veterans, military members, and their families who are at high risk for developing problems
      if their treatment involves long-term use of an opioid.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Use of SCRIPTS
time frame: Up to 12 months
description: Primary outcomes, or effectiveness, will be measured first by the use of SCRIPTS when prescribing opioids (e.g., % of new patients the physician queried; % of patients with long-term use the physician queried).
arm group label: PDMP Data
arm group type: Other
intervention type: Other
intervention name: Educational Intervention
description: The design is primarily a pre-post, non-equivalent comparison group test of program effectiveness. If final sample size permits, we will examine program effects for each practice environment separately. For measures that require interview data there will be no comparison group data.
We will construct matched comparison groups of physicians for each environment for which only secondary data analysis will be conducted. The matched comparison group will be constructed using prescription data from the DoD's pharmacy data transaction system (MACH and DORN VAMC) and from SCRIPTS (community-based physicians and VA prescribers).
arm group label: PDMP Data
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor