<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/NCT03026790</url>
  </required_header>
  <id_info>
    <org_study_id>OPD-1511-33052</org_study_id>
    <nct_id>NCT03026790</nct_id>
  </id_info>
  <brief_title>Veterans' Pain Care Organizational Improvement Comparative Effectiveness Study</brief_title>
  <acronym>VOICE</acronym>
  <official_title>Comparative Effectiveness of Patient-Centered Strategies to Improve Pain Management and Opioid Safety for Veterans</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Minnesota</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background and significance: Treatment with opioid pain medications (like hydrocodone and&#xD;
      morphine) is common for severe pain, but studies show these medications may not always help&#xD;
      and can cause serious problems. High daily doses of opioids can be especially unsafe. To help&#xD;
      patients with chronic pain have better quality of life and avoid medication toxicity, health&#xD;
      care teams need to manage pain while helping patients reduce opioid medication doses to safer&#xD;
      levels.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study aims: This study will test which of two pain treatment strategies is better for&#xD;
      managing pain and helping patients improve safety of opioid medication. For patients on high&#xD;
      opioid doses who want to reduce, this study will also test whether offering an extra option&#xD;
      for tapering (buprenorphine-naloxone) helps them succeed. Finally, the study will examine&#xD;
      patients' and clinicians' experiences with the interventions.&#xD;
&#xD;
      Study description: The study will compare two treatment strategies among patients with pain&#xD;
      who are taking long-term opioid pain medications prescribed by VA healthcare facilities&#xD;
      across the country. Patients who wish to enter the study will be assigned by chance to&#xD;
      telecare collaborative management (TCM) or integrated pain team (IPT). TCM involves a&#xD;
      pharmacist and supervising physician working together to find the best medication options for&#xD;
      each individual patient. In IPT, a team of clinicians focuses on non-medication pain&#xD;
      management options, in addition to pain medication.&#xD;
&#xD;
      All participants will be asked to stay in the study for 12 months. Patients for whom it would&#xD;
      be unsafe to participate will not be invited to join. With either treatment strategy, TCM or&#xD;
      IPT, participants will have individualized pain care tailored to their needs and preferences.&#xD;
      Participants on high opioid medication doses who want to reduce their opioid medication dose&#xD;
      will be assigned by chance to get either a regular step-wise taper or a choice between a&#xD;
      regular taper or switching to a different medication (buprenorphine-naloxone).&#xD;
&#xD;
      At the end of the study, the two treatment strategies will be compared to see which worked&#xD;
      better to (1) decrease pain severity and (2) reduce opioid medication dose. Other outcomes&#xD;
      important to patients will also be tracked. These include quality of life, sleep, fatigue,&#xD;
      depression, anxiety, and side effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 19, 2017</start_date>
  <completion_date type="Actual">October 30, 2022</completion_date>
  <primary_completion_date type="Actual">March 17, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Response</measure>
    <time_frame>12 months</time_frame>
    <description>Binary response variable defined by reduction of at least 30% in Brief Pain Inventory (BPI) total score from baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>50% Reduction in Opioid Daily Dose</measure>
    <time_frame>12 months</time_frame>
    <description>Binary response variable defined by reduction of at least 50% in opioid daily dose (morphine-equivalent mg) from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite Response</measure>
    <time_frame>12 months</time_frame>
    <description>Binary composite response variable defined by achieving at least a 30% reduction in BPI total score and at least 50% reduction in opioid daily dose from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Pain Inventory (BPI) Total Score</measure>
    <time_frame>12 months</time_frame>
    <description>Brief Pain Inventory (BPI) total score calculated as average of 11 items (range 0-10; higher is worse)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>VR-12 Physical Component Score</measure>
    <time_frame>12 months</time_frame>
    <description>Veterans RAND 12-item health survey (VR-12) Physical Component Score (range 0-100; higher is better)</description>
  </other_outcome>
  <other_outcome>
    <measure>Symptom Checklist</measure>
    <time_frame>12 months</time_frame>
    <description>Medication-related adverse symptoms count (0-19; higher is worse)</description>
  </other_outcome>
  <other_outcome>
    <measure>PODS Problems</measure>
    <time_frame>12 months</time_frame>
    <description>Prescribed Opioids Difficulty Scale (PODS) Problems score (range 0-32; higher is worse)</description>
  </other_outcome>
  <other_outcome>
    <measure>PHQ-8</measure>
    <time_frame>12 months</time_frame>
    <description>Patient Health Questionnaire 8-item (PHQ-8) depression scale score (range 0-24; higher is worse)</description>
  </other_outcome>
  <other_outcome>
    <measure>GAD-7</measure>
    <time_frame>12 months</time_frame>
    <description>General Anxiety Disorders 7-item questionnaire (GAD-7) score (range 0-21; higher is worse)</description>
  </other_outcome>
  <other_outcome>
    <measure>PROMIS Sleep Disturbance</measure>
    <time_frame>12 months</time_frame>
    <description>Patient Reported Outcomes Measurement Information System (PROMIS) sleep disturbance short-form 4a T-score (higher is worse). Raw scores were rescaled into standardized T-scores with a mean of 50 representing the average for the US population and a standard deviation (SD) of 10. A person with a T-score of 40 is one SD below the mean.</description>
  </other_outcome>
  <other_outcome>
    <measure>PROMIS Fatigue</measure>
    <time_frame>12 months</time_frame>
    <description>Patient Reported Outcomes Measurement Information System (PROMIS) fatigue short-form 4a T-score (higher is worse). Raw scores were rescaled into standardized T-scores with a mean of 50 representing the average for the US population and a standard deviation (SD) of 10. A person with a T-score of 40 is one SD below the mean.</description>
  </other_outcome>
  <other_outcome>
    <measure>Headache Impact Test</measure>
    <time_frame>12 months</time_frame>
    <description>Headache Impact Test score (range 36-78; higher is worse)</description>
  </other_outcome>
  <other_outcome>
    <measure>VR-12 Mental Component Score</measure>
    <time_frame>12 months</time_frame>
    <description>Veterans RAND 12-item health survey (VR-12) Mental Component Score (range 0-100; higher is better)</description>
  </other_outcome>
  <other_outcome>
    <measure>PODS Concerns</measure>
    <time_frame>12 months</time_frame>
    <description>Prescribed Opioids Difficulty Scale (PODS) Concerns score (range 0-28; higher is worse)</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">820</enrollment>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>Telecare collaborative management (TCM)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Integrated pain team (IPT)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard taper options</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The standard taper options arm uses patient education and shared decision-making to guide opioid medication management.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Expanded taper options</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The expanded taper options arm uses patient education and shared decision-making to guide opioid medication management and includes the additional option of rotation to buprenorphine-naloxone.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Medication management</intervention_name>
    <description>Individualized management of medications for pain</description>
    <arm_group_label>Expanded taper options</arm_group_label>
    <arm_group_label>Integrated pain team (IPT)</arm_group_label>
    <arm_group_label>Standard taper options</arm_group_label>
    <arm_group_label>Telecare collaborative management (TCM)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non-pharmacological pain management</intervention_name>
    <description>Individualized management of non-medication pain treatment approaches</description>
    <arm_group_label>Integrated pain team (IPT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Buprenorphine-Naloxone</intervention_name>
    <description>Option of using buprenorphine-naloxone to assist with opioid dose reduction or discontinuation</description>
    <arm_group_label>Expanded taper options</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Moderate or high-dose long-term opioid therapy (≥ 20 ME mg daily for at least 3&#xD;
             months) for chronic pain&#xD;
&#xD;
          -  Chronic pain of at least moderate severity (defined as pain that is present every or&#xD;
             nearly every day for ≥ 6 months and with a score on the PEG 3-item pain measure of ≥&#xD;
             5)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dementia diagnosis&#xD;
&#xD;
          -  Unstable or severe untreated psychiatric disorder, including severe untreated&#xD;
             substance use disorder or active suicidal ideation&#xD;
&#xD;
          -  Unstable or end-stage medical disease that would interfere with participation,&#xD;
             including cancer requiring active treatment and life expectancy &lt; 12 months&#xD;
&#xD;
          -  Documentation of suspected controlled substance diversion&#xD;
&#xD;
          -  Inability to communicate by telephone&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Minneapolis VA Health Care System</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55417</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 1, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <results_first_submitted>March 31, 2023</results_first_submitted>
  <results_first_submitted_qc>May 7, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">June 5, 2023</results_first_posted>
  <last_update_submitted>May 7, 2023</last_update_submitted>
  <last_update_submitted_qc>May 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Opioid analgesics</keyword>
  <keyword>Opioid partial agonists</keyword>
  <keyword>Health care delivery</keyword>
  <keyword>Back pain</keyword>
  <keyword>Osteoarthritis</keyword>
  <keyword>Veterans health</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Buprenorphine</mesh_term>
    <mesh_term>Buprenorphine, Naloxone Drug Combination</mesh_term>
    <mesh_term>Naloxone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data sharing procedures have not been finalized. At a minimum, a complete, cleaned, de-identified copy of the final dataset used in conducting the final analyses of the study will be created and made available within one year after the completion of the study, pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. Depending on feasibility and guidance from VA Office of Research Oversight, a Limited Dataset (LDS) may be created and shared. We have not yet determined how to operationalize data sharing for this study. In the interim, contact the PI for questions or requests.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>February 1, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/90/NCT03026790/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>October 23, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/90/NCT03026790/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Active Comparator: Telecare Collaborative Management (TCM)</title>
          <description>Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.</description>
        </group>
        <group group_id="P2">
          <title>Active Comparator: Integrated Pain Team (IPT)</title>
          <description>Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="411"/>
                <participants group_id="P2" count="409"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="358"/>
                <participants group_id="P2" count="363"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
                <participants group_id="P2" count="46"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Active Comparator: Telecare Collaborative Management (TCM)</title>
          <description>Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.</description>
        </group>
        <group group_id="B2">
          <title>Active Comparator: Integrated Pain Team (IPT)</title>
          <description>Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="411"/>
            <count group_id="B2" value="409"/>
            <count group_id="B3" value="820"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62.1" spread="10.8"/>
                    <measurement group_id="B2" value="62.2" spread="10.4"/>
                    <measurement group_id="B3" value="62.2" spread="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                    <measurement group_id="B2" value="51"/>
                    <measurement group_id="B3" value="111"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="351"/>
                    <measurement group_id="B2" value="358"/>
                    <measurement group_id="B3" value="709"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="130"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="312"/>
                    <measurement group_id="B2" value="297"/>
                    <measurement group_id="B3" value="609"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Pain Response</title>
        <description>Binary response variable defined by reduction of at least 30% in Brief Pain Inventory (BPI) total score from baseline</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Active Comparator: Telecare Collaborative Management (TCM)</title>
            <description>Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.</description>
          </group>
          <group group_id="O2">
            <title>Active Comparator: Integrated Pain Team (IPT)</title>
            <description>Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Response</title>
          <description>Binary response variable defined by reduction of at least 30% in Brief Pain Inventory (BPI) total score from baseline</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="350"/>
                <count group_id="O2" value="362"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58"/>
                    <measurement group_id="O2" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>50% Reduction in Opioid Daily Dose</title>
        <description>Binary response variable defined by reduction of at least 50% in opioid daily dose (morphine-equivalent mg) from baseline</description>
        <time_frame>12 months</time_frame>
        <population>All participants who were alive at 12 months</population>
        <group_list>
          <group group_id="O1">
            <title>Active Comparator: Telecare Collaborative Management (TCM)</title>
            <description>Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.</description>
          </group>
          <group group_id="O2">
            <title>Active Comparator: Integrated Pain Team (IPT)</title>
            <description>Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.</description>
          </group>
        </group_list>
        <measure>
          <title>50% Reduction in Opioid Daily Dose</title>
          <description>Binary response variable defined by reduction of at least 50% in opioid daily dose (morphine-equivalent mg) from baseline</description>
          <population>All participants who were alive at 12 months</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="403"/>
                <count group_id="O2" value="399"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="102"/>
                    <measurement group_id="O2" value="98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Composite Response</title>
        <description>Binary composite response variable defined by achieving at least a 30% reduction in BPI total score and at least 50% reduction in opioid daily dose from baseline.</description>
        <time_frame>12 months</time_frame>
        <population>All participants who completed the measure at 12 months</population>
        <group_list>
          <group group_id="O1">
            <title>Active Comparator: Telecare Collaborative Management (TCM)</title>
            <description>Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.</description>
          </group>
          <group group_id="O2">
            <title>Active Comparator: Integrated Pain Team (IPT)</title>
            <description>Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.</description>
          </group>
        </group_list>
        <measure>
          <title>Composite Response</title>
          <description>Binary composite response variable defined by achieving at least a 30% reduction in BPI total score and at least 50% reduction in opioid daily dose from baseline.</description>
          <population>All participants who completed the measure at 12 months</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="350"/>
                <count group_id="O2" value="362"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                    <measurement group_id="O2" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Brief Pain Inventory (BPI) Total Score</title>
        <description>Brief Pain Inventory (BPI) total score calculated as average of 11 items (range 0-10; higher is worse)</description>
        <time_frame>12 months</time_frame>
        <population>All participants who completed the measure at 12 months</population>
        <group_list>
          <group group_id="O1">
            <title>Active Comparator: Telecare Collaborative Management (TCM)</title>
            <description>Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.</description>
          </group>
          <group group_id="O2">
            <title>Active Comparator: Integrated Pain Team (IPT)</title>
            <description>Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.</description>
          </group>
        </group_list>
        <measure>
          <title>Brief Pain Inventory (BPI) Total Score</title>
          <description>Brief Pain Inventory (BPI) total score calculated as average of 11 items (range 0-10; higher is worse)</description>
          <population>All participants who completed the measure at 12 months</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="351"/>
                <count group_id="O2" value="362"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.07" spread="1.81"/>
                    <measurement group_id="O2" value="6.01" spread="1.91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>VR-12 Physical Component Score</title>
        <description>Veterans RAND 12-item health survey (VR-12) Physical Component Score (range 0-100; higher is better)</description>
        <time_frame>12 months</time_frame>
        <population>All participants who completed the measure at 12 months</population>
        <group_list>
          <group group_id="O1">
            <title>Active Comparator: Telecare Collaborative Management (TCM)</title>
            <description>Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.</description>
          </group>
          <group group_id="O2">
            <title>Active Comparator: Integrated Pain Team (IPT)</title>
            <description>Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.</description>
          </group>
        </group_list>
        <measure>
          <title>VR-12 Physical Component Score</title>
          <description>Veterans RAND 12-item health survey (VR-12) Physical Component Score (range 0-100; higher is better)</description>
          <population>All participants who completed the measure at 12 months</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="357"/>
                <count group_id="O2" value="363"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.9" spread="12.9"/>
                    <measurement group_id="O2" value="42.5" spread="13.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Symptom Checklist</title>
        <description>Medication-related adverse symptoms count (0-19; higher is worse)</description>
        <time_frame>12 months</time_frame>
        <population>All participants who completed the measure at 12 months</population>
        <group_list>
          <group group_id="O1">
            <title>Active Comparator: Telecare Collaborative Management (TCM)</title>
            <description>Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.</description>
          </group>
          <group group_id="O2">
            <title>Active Comparator: Integrated Pain Team (IPT)</title>
            <description>Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.</description>
          </group>
        </group_list>
        <measure>
          <title>Symptom Checklist</title>
          <description>Medication-related adverse symptoms count (0-19; higher is worse)</description>
          <population>All participants who completed the measure at 12 months</population>
          <units>symptom count</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="270"/>
                <count group_id="O2" value="278"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4" spread="3.7"/>
                    <measurement group_id="O2" value="3.5" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>PODS Problems</title>
        <description>Prescribed Opioids Difficulty Scale (PODS) Problems score (range 0-32; higher is worse)</description>
        <time_frame>12 months</time_frame>
        <population>All participants who completed the measure at 12 months</population>
        <group_list>
          <group group_id="O1">
            <title>Active Comparator: Telecare Collaborative Management (TCM)</title>
            <description>Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.</description>
          </group>
          <group group_id="O2">
            <title>Active Comparator: Integrated Pain Team (IPT)</title>
            <description>Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.</description>
          </group>
        </group_list>
        <measure>
          <title>PODS Problems</title>
          <description>Prescribed Opioids Difficulty Scale (PODS) Problems score (range 0-32; higher is worse)</description>
          <population>All participants who completed the measure at 12 months</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="234"/>
                <count group_id="O2" value="245"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="6.2"/>
                    <measurement group_id="O2" value="2.5" spread="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>PHQ-8</title>
        <description>Patient Health Questionnaire 8-item (PHQ-8) depression scale score (range 0-24; higher is worse)</description>
        <time_frame>12 months</time_frame>
        <population>All participants who completed the measure at 12 months</population>
        <group_list>
          <group group_id="O1">
            <title>Active Comparator: Telecare Collaborative Management (TCM)</title>
            <description>Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.</description>
          </group>
          <group group_id="O2">
            <title>Active Comparator: Integrated Pain Team (IPT)</title>
            <description>Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.</description>
          </group>
        </group_list>
        <measure>
          <title>PHQ-8</title>
          <description>Patient Health Questionnaire 8-item (PHQ-8) depression scale score (range 0-24; higher is worse)</description>
          <population>All participants who completed the measure at 12 months</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="320"/>
                <count group_id="O2" value="327"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.79" spread="5.84"/>
                    <measurement group_id="O2" value="5.2" spread="5.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>GAD-7</title>
        <description>General Anxiety Disorders 7-item questionnaire (GAD-7) score (range 0-21; higher is worse)</description>
        <time_frame>12 months</time_frame>
        <population>All participants who completed the measure at 12 months</population>
        <group_list>
          <group group_id="O1">
            <title>Active Comparator: Telecare Collaborative Management (TCM)</title>
            <description>Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.</description>
          </group>
          <group group_id="O2">
            <title>Active Comparator: Integrated Pain Team (IPT)</title>
            <description>Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.</description>
          </group>
        </group_list>
        <measure>
          <title>GAD-7</title>
          <description>General Anxiety Disorders 7-item questionnaire (GAD-7) score (range 0-21; higher is worse)</description>
          <population>All participants who completed the measure at 12 months</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="319"/>
                <count group_id="O2" value="326"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.01" spread="5.61"/>
                    <measurement group_id="O2" value="5.55" spread="5.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>PROMIS Sleep Disturbance</title>
        <description>Patient Reported Outcomes Measurement Information System (PROMIS) sleep disturbance short-form 4a T-score (higher is worse). Raw scores were rescaled into standardized T-scores with a mean of 50 representing the average for the US population and a standard deviation (SD) of 10. A person with a T-score of 40 is one SD below the mean.</description>
        <time_frame>12 months</time_frame>
        <population>All participants who completed the measure at 12 months</population>
        <group_list>
          <group group_id="O1">
            <title>Active Comparator: Telecare Collaborative Management (TCM)</title>
            <description>Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.</description>
          </group>
          <group group_id="O2">
            <title>Active Comparator: Integrated Pain Team (IPT)</title>
            <description>Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.</description>
          </group>
        </group_list>
        <measure>
          <title>PROMIS Sleep Disturbance</title>
          <description>Patient Reported Outcomes Measurement Information System (PROMIS) sleep disturbance short-form 4a T-score (higher is worse). Raw scores were rescaled into standardized T-scores with a mean of 50 representing the average for the US population and a standard deviation (SD) of 10. A person with a T-score of 40 is one SD below the mean.</description>
          <population>All participants who completed the measure at 12 months</population>
          <units>T-score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="310"/>
                <count group_id="O2" value="322"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.2" spread="9.1"/>
                    <measurement group_id="O2" value="55.5" spread="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>PROMIS Fatigue</title>
        <description>Patient Reported Outcomes Measurement Information System (PROMIS) fatigue short-form 4a T-score (higher is worse). Raw scores were rescaled into standardized T-scores with a mean of 50 representing the average for the US population and a standard deviation (SD) of 10. A person with a T-score of 40 is one SD below the mean.</description>
        <time_frame>12 months</time_frame>
        <population>All participants who completed the measure at 12 months</population>
        <group_list>
          <group group_id="O1">
            <title>Active Comparator: Telecare Collaborative Management (TCM)</title>
            <description>Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.</description>
          </group>
          <group group_id="O2">
            <title>Active Comparator: Integrated Pain Team (IPT)</title>
            <description>Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.</description>
          </group>
        </group_list>
        <measure>
          <title>PROMIS Fatigue</title>
          <description>Patient Reported Outcomes Measurement Information System (PROMIS) fatigue short-form 4a T-score (higher is worse). Raw scores were rescaled into standardized T-scores with a mean of 50 representing the average for the US population and a standard deviation (SD) of 10. A person with a T-score of 40 is one SD below the mean.</description>
          <population>All participants who completed the measure at 12 months</population>
          <units>T-score</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="310"/>
                <count group_id="O2" value="321"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.1" spread="10.9"/>
                    <measurement group_id="O2" value="55.7" spread="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Headache Impact Test</title>
        <description>Headache Impact Test score (range 36-78; higher is worse)</description>
        <time_frame>12 months</time_frame>
        <population>All participants who completed the measure at 12 months</population>
        <group_list>
          <group group_id="O1">
            <title>Active Comparator: Telecare Collaborative Management (TCM)</title>
            <description>Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.</description>
          </group>
          <group group_id="O2">
            <title>Active Comparator: Integrated Pain Team (IPT)</title>
            <description>Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.</description>
          </group>
        </group_list>
        <measure>
          <title>Headache Impact Test</title>
          <description>Headache Impact Test score (range 36-78; higher is worse)</description>
          <population>All participants who completed the measure at 12 months</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="289"/>
                <count group_id="O2" value="303"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.77" spread="12.26"/>
                    <measurement group_id="O2" value="49.84" spread="11.54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>VR-12 Mental Component Score</title>
        <description>Veterans RAND 12-item health survey (VR-12) Mental Component Score (range 0-100; higher is better)</description>
        <time_frame>12 months</time_frame>
        <population>All participants who completed the measure at 12 months</population>
        <group_list>
          <group group_id="O1">
            <title>Active Comparator: Telecare Collaborative Management (TCM)</title>
            <description>Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.</description>
          </group>
          <group group_id="O2">
            <title>Active Comparator: Integrated Pain Team (IPT)</title>
            <description>Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.</description>
          </group>
        </group_list>
        <measure>
          <title>VR-12 Mental Component Score</title>
          <description>Veterans RAND 12-item health survey (VR-12) Mental Component Score (range 0-100; higher is better)</description>
          <population>All participants who completed the measure at 12 months</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="356"/>
                <count group_id="O2" value="363"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.9" spread="12.9"/>
                    <measurement group_id="O2" value="42.5" spread="13.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>PODS Concerns</title>
        <description>Prescribed Opioids Difficulty Scale (PODS) Concerns score (range 0-28; higher is worse)</description>
        <time_frame>12 months</time_frame>
        <population>All participants who completed the measure at 12 months</population>
        <group_list>
          <group group_id="O1">
            <title>Active Comparator: Telecare Collaborative Management (TCM)</title>
            <description>Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.</description>
          </group>
          <group group_id="O2">
            <title>Active Comparator: Integrated Pain Team (IPT)</title>
            <description>Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.</description>
          </group>
        </group_list>
        <measure>
          <title>PODS Concerns</title>
          <description>Prescribed Opioids Difficulty Scale (PODS) Concerns score (range 0-28; higher is worse)</description>
          <population>All participants who completed the measure at 12 months</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="244"/>
                <count group_id="O2" value="254"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" spread="4.7"/>
                    <measurement group_id="O2" value="4" spread="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Active Comparator: Telecare Collaborative Management (TCM)</title>
          <description>Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.</description>
        </group>
        <group group_id="E2">
          <title>Active Comparator: Integrated Pain Team (IPT)</title>
          <description>Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="358"/>
                <counts group_id="E2" subjects_affected="9" subjects_at_risk="363"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="109" subjects_at_risk="358"/>
                <counts group_id="E2" subjects_affected="109" subjects_at_risk="363"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization</sub_title>
                <counts group_id="E1" subjects_affected="109" subjects_at_risk="358"/>
                <counts group_id="E2" subjects_affected="109" subjects_at_risk="363"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="207" subjects_at_risk="358"/>
                <counts group_id="E2" subjects_affected="178" subjects_at_risk="363"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Emergency department visit</sub_title>
                <counts group_id="E1" subjects_affected="207" subjects_at_risk="358"/>
                <counts group_id="E2" subjects_affected="178" subjects_at_risk="363"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Erin Krebs</name_or_title>
      <organization>University of Minnesota</organization>
      <phone>612-629-7558</phone>
      <email>Erin.Krebs@va.gov</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03026790
org study id: OPD-1511-33052
nct id: NCT03026790
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Background and significance: Treatment with opioid pain medications (like hydrocodone and
      morphine) is common for severe pain, but studies show these medications may not always help
      and can cause serious problems. High daily doses of opioids can be especially unsafe. To help
      patients with chronic pain have better quality of life and avoid medication toxicity, health
      care teams need to manage pain while helping patients reduce opioid medication doses to safer
      levels.
Study aims: This study will test which of two pain treatment strategies is better for
      managing pain and helping patients improve safety of opioid medication. For patients on high
      opioid doses who want to reduce, this study will also test whether offering an extra option
      for tapering (buprenorphine-naloxone) helps them succeed. Finally, the study will examine
      patients' and clinicians' experiences with the interventions.

      Study description: The study will compare two treatment strategies among patients with pain
      who are taking long-term opioid pain medications prescribed by VA healthcare facilities
      across the country. Patients who wish to enter the study will be assigned by chance to
      telecare collaborative management (TCM) or integrated pain team (IPT). TCM involves a
      pharmacist and supervising physician working together to find the best medication options for
      each individual patient. In IPT, a team of clinicians focuses on non-medication pain
      management options, in addition to pain medication.

      All participants will be asked to stay in the study for 12 months. Patients for whom it would
      be unsafe to participate will not be invited to join. With either treatment strategy, TCM or
      IPT, participants will have individualized pain care tailored to their needs and preferences.
      Participants on high opioid medication doses who want to reduce their opioid medication dose
      will be assigned by chance to get either a regular step-wise taper or a choice between a
      regular taper or switching to a different medication (buprenorphine-naloxone).

      At the end of the study, the two treatment strategies will be compared to see which worked
      better to (1) decrease pain severity and (2) reduce opioid medication dose. Other outcomes
      important to patients will also be tracked. These include quality of life, sleep, fatigue,
      depression, anxiety, and side effects.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Pain Response
time frame: 12 months
description: Binary response variable defined by reduction of at least 30% in Brief Pain Inventory (BPI) total score from baseline
measure: 50% Reduction in Opioid Daily Dose
time frame: 12 months
description: Binary response variable defined by reduction of at least 50% in opioid daily dose (morphine-equivalent mg) from baseline
measure: Composite Response
time frame: 12 months
description: Binary composite response variable defined by achieving at least a 30% reduction in BPI total score and at least 50% reduction in opioid daily dose from baseline.
measure: Brief Pain Inventory (BPI) Total Score
time frame: 12 months
description: Brief Pain Inventory (BPI) total score calculated as average of 11 items (range 0-10; higher is worse)
measure: VR-12 Physical Component Score
time frame: 12 months
description: Veterans RAND 12-item health survey (VR-12) Physical Component Score (range 0-100; higher is better)
measure: Symptom Checklist
time frame: 12 months
description: Medication-related adverse symptoms count (0-19; higher is worse)
measure: PODS Problems
time frame: 12 months
description: Prescribed Opioids Difficulty Scale (PODS) Problems score (range 0-32; higher is worse)
measure: PHQ-8
time frame: 12 months
description: Patient Health Questionnaire 8-item (PHQ-8) depression scale score (range 0-24; higher is worse)
measure: GAD-7
time frame: 12 months
description: General Anxiety Disorders 7-item questionnaire (GAD-7) score (range 0-21; higher is worse)
measure: PROMIS Sleep Disturbance
time frame: 12 months
description: Patient Reported Outcomes Measurement Information System (PROMIS) sleep disturbance short-form 4a T-score (higher is worse). Raw scores were rescaled into standardized T-scores with a mean of 50 representing the average for the US population and a standard deviation (SD) of 10. A person with a T-score of 40 is one SD below the mean.
measure: PROMIS Fatigue
time frame: 12 months
description: Patient Reported Outcomes Measurement Information System (PROMIS) fatigue short-form 4a T-score (higher is worse). Raw scores were rescaled into standardized T-scores with a mean of 50 representing the average for the US population and a standard deviation (SD) of 10. A person with a T-score of 40 is one SD below the mean.
measure: Headache Impact Test
time frame: 12 months
description: Headache Impact Test score (range 36-78; higher is worse)
measure: VR-12 Mental Component Score
time frame: 12 months
description: Veterans RAND 12-item health survey (VR-12) Mental Component Score (range 0-100; higher is better)
measure: PODS Concerns
time frame: 12 months
description: Prescribed Opioids Difficulty Scale (PODS) Concerns score (range 0-28; higher is worse)
arm group label: Telecare collaborative management (TCM)
arm group type: Active Comparator
description: Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.
arm group label: Integrated pain team (IPT)
arm group type: Active Comparator
description: Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.
arm group label: Standard taper options
arm group type: Active Comparator
description: The standard taper options arm uses patient education and shared decision-making to guide opioid medication management.
arm group label: Expanded taper options
arm group type: Active Comparator
description: The expanded taper options arm uses patient education and shared decision-making to guide opioid medication management and includes the additional option of rotation to buprenorphine-naloxone.
intervention type: Other
intervention name: Medication management
description: Individualized management of medications for pain
arm group label: Expanded taper options
arm group label: Integrated pain team (IPT)
arm group label: Standard taper options
arm group label: Telecare collaborative management (TCM)
intervention type: Other
intervention name: Non-pharmacological pain management
description: Individualized management of non-medication pain treatment approaches
arm group label: Integrated pain team (IPT)
intervention type: Drug
intervention name: Buprenorphine-Naloxone
description: Option of using buprenorphine-naloxone to assist with opioid dose reduction or discontinuation
arm group label: Expanded taper options
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Chronic Pain
mesh term: Buprenorphine
mesh term: Buprenorphine, Naloxone Drug Combination
mesh term: Naloxone
sharing ipd: Yes
ipd description: Data sharing procedures have not been finalized. At a minimum, a complete, cleaned, de-identified copy of the final dataset used in conducting the final analyses of the study will be created and made available within one year after the completion of the study, pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset. Depending on feasibility and guidance from VA Office of Research Oversight, a Limited Dataset (LDS) may be created and shared. We have not yet determined how to operationalize data sharing for this study. In the interim, contact the PI for questions or requests.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 