<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/NCT02224508</url>
  </required_header>
  <id_info>
    <org_study_id>PCORI-1306-02198</org_study_id>
    <nct_id>NCT02224508</nct_id>
  </id_info>
  <brief_title>Evaluation of a Health Plan Initiative to Mitigate Chronic Opioid Therapy Risks</brief_title>
  <acronym>CARE</acronym>
  <official_title>Evaluation of a Health Plan Initiative to Mitigate Chronic Opioid Therapy Risks</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaiser Permanente</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kaiser Permanente</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Sixty million American adults suffer from moderate to severe chronic pain. Of&#xD;
      these, 5 to 8 million currently use opioids long-term. With increased opioid prescribing for&#xD;
      chronic pain, an epidemic of prescription opioid addiction and overdose has arisen. This&#xD;
      necessitates action to stem opioid-related morbidity and mortality. Group Health (GH), a&#xD;
      large nonprofit health plan, developed and implemented opioid risk reduction strategies for&#xD;
      doctors and patients in some, but not all, of its clinics. The risk reduction initiative&#xD;
      achieved large opioid dose reductions, near universal documentation of care plans, and marked&#xD;
      increases in patient monitoring. Rigorous evaluation of patient outcomes resulting from the&#xD;
      opioid risk reduction initiative, incorporating patient perspectives, is needed to guide&#xD;
      health care improvement efforts to reduce opioid risks regionally and nationally.&#xD;
&#xD;
      Research goal: The investigators will evaluate a major health plan initiative to reduce risks&#xD;
      of long-term opioid use for chronic pain. Starting in 2008, some GH clinics reduced&#xD;
      prescribing of high opioid doses. In 2010 the same clinics increased care planning and&#xD;
      monitoring of chronic opioid therapy (COT) patients. Our research goal is to evaluate effects&#xD;
      of this initiative on health and safety outcomes of COT patients. We will test whether the&#xD;
      initiative influenced pain outcomes; patient-reported opioid benefits and problems; and&#xD;
      opioid-related adverse events.&#xD;
&#xD;
      Design and Outcomes: The investigators will assess effects of GH's opioid risk reduction&#xD;
      initiative among COT patients using opioids long-term. The investigators will compare COT&#xD;
      patients from clinics that implemented the initiative with COT patients from care settings&#xD;
      that did not implement the initiative. The investigators will use survey data to assess&#xD;
      patient-reported outcomes including pain severity, depressive symptoms, and patient&#xD;
      perceptions of opioid benefits and problems, including validated measures of prescription&#xD;
      opioid use disorder. They will interview and compare 800 COT patients using opioids long-term&#xD;
      from clinics that implemented the risk reduction initiative and 800 COT patients from care&#xD;
      settings that did not.&#xD;
&#xD;
      Impact: This research will provide an urgently needed, rigorous evaluation of a major risk&#xD;
      reduction initiative among COT patients. Evaluation results will guide efforts of health&#xD;
      plans, clinicians and patients nationwide to ensure safe, effective and compassionate chronic&#xD;
      pain care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Detailed description not provided&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion With Prescription Opioid Use Disorder (Defined by DSM5 Criteria).</measure>
    <time_frame>1 year prior to interview</time_frame>
    <description>Proportion with Prescription Opioid Use Disorder, which is defined by multiple indicators of opioid abuse and addiction from 9 criteria in the DSM5 manual of the American Psychiatric Association. In this research, it will be assessed using the Psychiatric Research Interview for Substance and Mental Disorders (PRISM5, Columbia University). Estimates were weighted to account for non-response, with weights based on baseline patient characteristics assessed with electronic health care data available for all chronic opioid therapy patients sampled for the survey. The number analyzed differs from the Participant Flow module due to persons with missing item data who were dropped from this analysis. The numbers with missing items were deemed too few to justify item imputation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Severity (Intensity, Interference With Activities, Enjoyment): PEG Scale</measure>
    <time_frame>1 week prior to interview</time_frame>
    <description>PEG (Pain - Enjoyment - Interference with General Activities) pain scale consisting of the average of 3 0-10 ratings of pain intensity, interference with activities due to pain, and reduced enjoyment of life due to pain. Estimates were weighted to account for non-response, with weights based on baseline patient characteristics assessed with electronic health care data available for all chronic opioid therapy patients sampled for the survey. The PEG score ranges from 0 to 30, with higher scores indicating greater pain severity. The number analyzed differs from the Participant Flow module due to persons with missing item data who were dropped from this analysis. The numbers with missing items were deemed too few to justify item imputation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive Symptoms</measure>
    <time_frame>2 weeks prior to interview</time_frame>
    <description>Patient Health Questionnaire (PHQ-8) depression scale. The PHQ-8 is estimated by summing the 8 scale items. The total score ranges from 0 to 24, with higher scores indicating greater depression severity. Estimates were weighted to account for non-response, with weights based on baseline patient characteristics assessed with electronic health care data available for all chronic opioid therapy patients sampled for the survey. The number analyzed differs from the Participant Flow module due to persons with missing item data who were dropped from this analysis. The numbers with missing items were deemed too few to justify item imputation.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">1588</enrollment>
  <condition>Drug Use Disorders</condition>
  <condition>Drug Abuse</condition>
  <condition>Drug Addiction</condition>
  <condition>Drug Dependence</condition>
  <condition>Drug Habituation</condition>
  <condition>Pain</condition>
  <condition>Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>Opioid Risk Reduction Initiative</arm_group_label>
    <description>Opioid risk reduction initiative for chronic opioid therapy patients implemented in Group Health integrated group practice clinics.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <description>Usual care for management of chronic opioid therapy patients implemented in Group Health network care settings.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The study population is prevalent Chronic Opioid Therapy (COT) patients from Group Health&#xD;
        clinics. Our initial goals was to interview and compare 800 COT patients using opioids&#xD;
        long-term from clinics that implemented the risk reduction initiative and 800 COT patients&#xD;
        from care settings that did not. sample size targets were revised to enroll 950 COT&#xD;
        patients from the clinics that implemented the risk reduction initiatives and 650 from the&#xD;
        clinics that did not implement the risk reduction initiatives.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Enrolled for at least one year prior to sampling for survey&#xD;
&#xD;
          -  Received 70+ days supply of opioids in 2 of 4 quarters, including the most recent 90&#xD;
             days&#xD;
&#xD;
          -  Received 45+ days supply of opioids in the other 2 quarters&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Received cancer diagnoses, other than non-melanoma skin cancer, at least twice in the&#xD;
             prior year&#xD;
&#xD;
          -  Received any skilled nursing facility care in the prior year&#xD;
&#xD;
          -  Received any hospice care or&#xD;
&#xD;
          -  Received any opioids from an oncologist&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael R VonKorff, ScD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Group Health Research Institute</affiliation>
  </overall_official>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 15, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <results_first_submitted>February 2, 2017</results_first_submitted>
  <results_first_submitted_qc>March 27, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">May 5, 2017</results_first_posted>
  <last_update_submitted>October 11, 2017</last_update_submitted>
  <last_update_submitted_qc>October 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 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>Substance-Related Disorders</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>A complete, cleaned, de-identified copy of the final dataset used in conducting the final analyses will be made available to other qualified researchers within nine months of the end of the final year of funding upon approval by the Group Health Human Subject's Review Committee.&#xD;
Given the complexity of the final dataset, our expectation would be that other researchers using the data would require technical assistance from our research team to understand the data and to employ appropriate methods of data analysis. Or, other researchers may prefer to have us analyze the study data to produce analyses according to their specifications. Since use of the dataset by other investigators, or analyses carried out by us for other researchers, would occur after the grant award period has ended, we will expect necessary funding of technical support, data transfers and/or data analyses to be obtained by the research team requesting access to the final dataset.</ipd_description>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Opioid Risk Reduction Initiative</title>
          <description>Opioid risk reduction initiative for chronic opioid therapy patients implemented in Group Health integrated group practice clinics.</description>
        </group>
        <group group_id="P2">
          <title>Usual Care</title>
          <description>Usual care for management of chronic opioid therapy patients implemented in Group Health network care settings.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="935">Number of patients surveyed in intervention segment of the health plan (group practice).</participants>
                <participants group_id="P2" count="653">Number of patients surveyed in the control segment of the health plan (contracted care).</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="935"/>
                <participants group_id="P2" count="653"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Opioid Risk Reduction Initiative</title>
          <description>Opioid risk reduction initiatives (dose reduction and then risk stratification and monitoring) for chronic opioid therapy patients implemented in Group Health integrated group practice clinics.</description>
        </group>
        <group group_id="B2">
          <title>Usual Care</title>
          <description>Usual care for management of chronic opioid therapy patients implemented in Group Health network care settings.</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="935"/>
            <count group_id="B2" value="653"/>
            <count group_id="B3" value="1588"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="507"/>
                    <measurement group_id="B2" value="415"/>
                    <measurement group_id="B3" value="922"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="428"/>
                    <measurement group_id="B2" value="238"/>
                    <measurement group_id="B3" value="666"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="62.6" spread="12.1"/>
                    <measurement group_id="B2" value="61.0" spread="12.1"/>
                    <measurement group_id="B3" value="62.0" spread="12.1"/>
                  </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="589"/>
                    <measurement group_id="B2" value="420"/>
                    <measurement group_id="B3" value="1009"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="346"/>
                    <measurement group_id="B2" value="233"/>
                    <measurement group_id="B3" value="579"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Caucasian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="804"/>
                    <measurement group_id="B2" value="576"/>
                    <measurement group_id="B3" value="1380"/>
                  </measurement_list>
                </category>
                <category>
                  <title>African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian/Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Multiple or other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="137"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>High school graduate or less</title>
                  <measurement_list>
                    <measurement group_id="B1" value="243"/>
                    <measurement group_id="B2" value="203"/>
                    <measurement group_id="B3" value="446"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Some college or technical school</title>
                  <measurement_list>
                    <measurement group_id="B1" value="436"/>
                    <measurement group_id="B2" value="296"/>
                    <measurement group_id="B3" value="732"/>
                  </measurement_list>
                </category>
                <category>
                  <title>College graduate or post-college graduate</title>
                  <measurement_list>
                    <measurement group_id="B1" value="255"/>
                    <measurement group_id="B2" value="152"/>
                    <measurement group_id="B3" value="407"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Mental disorder diagnosis past 36 months</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="312"/>
                    <measurement group_id="B2" value="230"/>
                    <measurement group_id="B3" value="542"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="623"/>
                    <measurement group_id="B2" value="423"/>
                    <measurement group_id="B3" value="1046"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Alcohol use disorder, past 36 months</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="885"/>
                    <measurement group_id="B2" value="621"/>
                    <measurement group_id="B3" value="1506"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Non-opioid drug use disorder diagnosis past 36 months</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="846"/>
                    <measurement group_id="B2" value="619"/>
                    <measurement group_id="B3" value="1465"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="89"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Opioid drug use disorder diagnosis, past 36 months</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="834"/>
                    <measurement group_id="B2" value="577"/>
                    <measurement group_id="B3" value="1411"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="101"/>
                    <measurement group_id="B2" value="76"/>
                    <measurement group_id="B3" value="177"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Tobacco use disorder diagnosis, past 36 months</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="711"/>
                    <measurement group_id="B2" value="502"/>
                    <measurement group_id="B3" value="1213"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="224"/>
                    <measurement group_id="B2" value="151"/>
                    <measurement group_id="B3" value="375"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Location in Washington State</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Eastern Washington</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="242"/>
                    <measurement group_id="B2" value="295"/>
                    <measurement group_id="B3" value="537"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Western Washington</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="693"/>
                    <measurement group_id="B2" value="358"/>
                    <measurement group_id="B3" value="1051"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Marital status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Not married</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="318"/>
                    <measurement group_id="B2" value="214"/>
                    <measurement group_id="B3" value="532"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Married</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="615"/>
                    <measurement group_id="B2" value="438"/>
                    <measurement group_id="B3" value="1053"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Missing</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Charlson Comorbidity Score (past 12 months)</title>
          <description>The Charlson Comorbidity Score (Romano version) is assessed from electronic health care data for the year prior to the index date. There are 19 sets of conditions, which prior research has shown predict mortality, that are assessed to develop the Charlson Comorbidity Score. Each set of conditions is assigned a weighted score, depending on the estimated risk of subsequent mortality. The Charlson Comorbidity Score also predicts hospitalization risk. The possible total score ranges from 0 to 37, with higher scores indicating greater comorbidity and higher risk of dying.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>0</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="426"/>
                    <measurement group_id="B2" value="307"/>
                    <measurement group_id="B3" value="733"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="75"/>
                    <measurement group_id="B2" value="73"/>
                    <measurement group_id="B3" value="148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="144"/>
                    <measurement group_id="B2" value="107"/>
                    <measurement group_id="B3" value="251"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3-5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="195"/>
                    <measurement group_id="B2" value="127"/>
                    <measurement group_id="B3" value="322"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 or greater</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="95"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="134"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hepatitis C or cirrhosis diagnosis</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="851"/>
                    <measurement group_id="B2" value="607"/>
                    <measurement group_id="B3" value="1458"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="84"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Received excess days supply of 20% or greater in any of past 4 quarters</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>No</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="734"/>
                    <measurement group_id="B2" value="493"/>
                    <measurement group_id="B3" value="1227"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Yes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="201"/>
                    <measurement group_id="B2" value="160"/>
                    <measurement group_id="B3" value="361"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Average daily opioid dose in morphine equivalents</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>No opioid use</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Less than 15 milligrams</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="232"/>
                    <measurement group_id="B2" value="94"/>
                    <measurement group_id="B3" value="326"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>15 to less than 50 milligrams</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="432"/>
                    <measurement group_id="B2" value="296"/>
                    <measurement group_id="B3" value="728"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>50 to less than 120 milligrams</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="199"/>
                    <measurement group_id="B2" value="150"/>
                    <measurement group_id="B3" value="349"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120 milligrams or greater</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                    <measurement group_id="B2" value="111"/>
                    <measurement group_id="B3" value="183"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Continuously enrolled in health plan for past 24 months</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="98"/>
                    <measurement group_id="B3" value="146"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="887"/>
                    <measurement group_id="B2" value="555"/>
                    <measurement group_id="B3" value="1442"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Employment status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Employed full time/part time</title>
                  <measurement_list>
                    <measurement group_id="B1" value="314"/>
                    <measurement group_id="B2" value="223"/>
                    <measurement group_id="B3" value="537"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Disabled</title>
                  <measurement_list>
                    <measurement group_id="B1" value="182"/>
                    <measurement group_id="B2" value="170"/>
                    <measurement group_id="B3" value="352"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Retired</title>
                  <measurement_list>
                    <measurement group_id="B1" value="410"/>
                    <measurement group_id="B2" value="245"/>
                    <measurement group_id="B3" value="655"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Missing</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Proportion With Prescription Opioid Use Disorder (Defined by DSM5 Criteria).</title>
        <description>Proportion with Prescription Opioid Use Disorder, which is defined by multiple indicators of opioid abuse and addiction from 9 criteria in the DSM5 manual of the American Psychiatric Association. In this research, it will be assessed using the Psychiatric Research Interview for Substance and Mental Disorders (PRISM5, Columbia University). Estimates were weighted to account for non-response, with weights based on baseline patient characteristics assessed with electronic health care data available for all chronic opioid therapy patients sampled for the survey. The number analyzed differs from the Participant Flow module due to persons with missing item data who were dropped from this analysis. The numbers with missing items were deemed too few to justify item imputation.</description>
        <time_frame>1 year prior to interview</time_frame>
        <population>Prevalent chronic opioid therapy (COT) patients defined as having received at least 70 days supply of opioids in the 90 days prior to sample selection, at least 70 days supply of opioids in at least one of the 3 other quarters in the preceding year, and at least 45 days supply of opioids in the other two quarters.</population>
        <group_list>
          <group group_id="O1">
            <title>Opioid Risk Reduction Initiative</title>
            <description>Opioid risk reduction initiatives (dose reduction and then risk stratification and monitoring) for chronic opioid therapy patients implemented in Group Health integrated group practice clinics.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care for management of chronic opioid therapy patients implemented in Group Health network care settings.</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion With Prescription Opioid Use Disorder (Defined by DSM5 Criteria).</title>
          <description>Proportion with Prescription Opioid Use Disorder, which is defined by multiple indicators of opioid abuse and addiction from 9 criteria in the DSM5 manual of the American Psychiatric Association. In this research, it will be assessed using the Psychiatric Research Interview for Substance and Mental Disorders (PRISM5, Columbia University). Estimates were weighted to account for non-response, with weights based on baseline patient characteristics assessed with electronic health care data available for all chronic opioid therapy patients sampled for the survey. The number analyzed differs from the Participant Flow module due to persons with missing item data who were dropped from this analysis. The numbers with missing items were deemed too few to justify item imputation.</description>
          <population>Prevalent chronic opioid therapy (COT) patients defined as having received at least 70 days supply of opioids in the 90 days prior to sample selection, at least 70 days supply of opioids in at least one of the 3 other quarters in the preceding year, and at least 45 days supply of opioids in the other two quarters.</population>
          <units>proportion of COT patients</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="934"/>
                <count group_id="O2" value="652"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.215" lower_limit="0.189" upper_limit="0.244"/>
                    <measurement group_id="O2" value="0.239" lower_limit="0.205" upper_limit="0.276"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Severity (Intensity, Interference With Activities, Enjoyment): PEG Scale</title>
        <description>PEG (Pain - Enjoyment - Interference with General Activities) pain scale consisting of the average of 3 0-10 ratings of pain intensity, interference with activities due to pain, and reduced enjoyment of life due to pain. Estimates were weighted to account for non-response, with weights based on baseline patient characteristics assessed with electronic health care data available for all chronic opioid therapy patients sampled for the survey. The PEG score ranges from 0 to 30, with higher scores indicating greater pain severity. The number analyzed differs from the Participant Flow module due to persons with missing item data who were dropped from this analysis. The numbers with missing items were deemed too few to justify item imputation.</description>
        <time_frame>1 week prior to interview</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Opioid Risk Reduction Initiative</title>
            <description>Opioid risk reduction initiative for chronic opioid therapy patients implemented in Group Health integrated group practice clinics.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care for management of chronic opioid therapy patients implemented in Group Health network care settings.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Severity (Intensity, Interference With Activities, Enjoyment): PEG Scale</title>
          <description>PEG (Pain - Enjoyment - Interference with General Activities) pain scale consisting of the average of 3 0-10 ratings of pain intensity, interference with activities due to pain, and reduced enjoyment of life due to pain. Estimates were weighted to account for non-response, with weights based on baseline patient characteristics assessed with electronic health care data available for all chronic opioid therapy patients sampled for the survey. The PEG score ranges from 0 to 30, with higher scores indicating greater pain severity. The number analyzed differs from the Participant Flow module due to persons with missing item data who were dropped from this analysis. The numbers with missing items were deemed too few to justify item imputation.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="929"/>
                <count group_id="O2" value="647"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.79" lower_limit="5.65" upper_limit="5.93"/>
                    <measurement group_id="O2" value="5.82" lower_limit="5.65" upper_limit="5.99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Depressive Symptoms</title>
        <description>Patient Health Questionnaire (PHQ-8) depression scale. The PHQ-8 is estimated by summing the 8 scale items. The total score ranges from 0 to 24, with higher scores indicating greater depression severity. Estimates were weighted to account for non-response, with weights based on baseline patient characteristics assessed with electronic health care data available for all chronic opioid therapy patients sampled for the survey. The number analyzed differs from the Participant Flow module due to persons with missing item data who were dropped from this analysis. The numbers with missing items were deemed too few to justify item imputation.</description>
        <time_frame>2 weeks prior to interview</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Opioid Risk Reduction Initiative</title>
            <description>Opioid risk reduction initiatives (dose reduction and then risk stratification and monitoring) for chronic opioid therapy patients implemented in Group Health integrated group practice clinics.</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Usual care for management of chronic opioid therapy patients implemented in Group Health network care settings.</description>
          </group>
        </group_list>
        <measure>
          <title>Depressive Symptoms</title>
          <description>Patient Health Questionnaire (PHQ-8) depression scale. The PHQ-8 is estimated by summing the 8 scale items. The total score ranges from 0 to 24, with higher scores indicating greater depression severity. Estimates were weighted to account for non-response, with weights based on baseline patient characteristics assessed with electronic health care data available for all chronic opioid therapy patients sampled for the survey. The number analyzed differs from the Participant Flow module due to persons with missing item data who were dropped from this analysis. The numbers with missing items were deemed too few to justify item imputation.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="932"/>
                <count group_id="O2" value="652"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.39" lower_limit="7.04" upper_limit="7.74"/>
                    <measurement group_id="O2" value="7.91" lower_limit="7.45" upper_limit="8.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The survey was cross-sectional. The prevalent Chronic Opioid Therapy (COT) patients were assessed at the time they were interviewed. The time frame was the year prior to the interview for prescription opioid use disorder, the two weeks prior to the interview for the depressive symptom scale (PHQ-8), and the prior week for the pain severity scale (PEG).</time_frame>
      <desc>Since study subjects were not tracked over time, we did not assess adverse events occurring over time. The survey assessment did assess prevalent adverse outcomes relevant to chronic opioid therapy (prescription opioid use disorder, depressive symptoms, pain severity).</desc>
      <group_list>
        <group group_id="E1">
          <title>Opioid Risk Reduction Initiative</title>
          <description>Opioid risk reduction initiatives (dose reduction and then risk stratification and monitoring) for chronic opioid therapy patients implemented in Group Health integrated group practice clinics.</description>
        </group>
        <group group_id="E2">
          <title>Usual Care</title>
          <description>Usual care for management of chronic opioid therapy patients implemented in Group Health network care settings.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="935"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="653"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="935"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="653"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="935"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="653"/>
              </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>
    <limitations_and_caveats>This phase of the evaluation reports after-only survey data comparing prevalent chronic opioid therapy patients who had been exposed or not exposed to the health plan opioid risk reduction initiatives for at least one year.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Michael Von Korff, ScD</name_or_title>
      <organization>Group Health Research Institute</organization>
      <phone>206-287-2874</phone>
      <email>vonkorff.m@ghc.org</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/NCT02224508
org study id: PCORI-1306-02198
nct id: NCT02224508
lead sponsor: 
has dmc: No
Background: Sixty million American adults suffer from moderate to severe chronic pain. Of
      these, 5 to 8 million currently use opioids long-term. With increased opioid prescribing for
      chronic pain, an epidemic of prescription opioid addiction and overdose has arisen. This
      necessitates action to stem opioid-related morbidity and mortality. Group Health (GH), a
      large nonprofit health plan, developed and implemented opioid risk reduction strategies for
      doctors and patients in some, but not all, of its clinics. The risk reduction initiative
      achieved large opioid dose reductions, near universal documentation of care plans, and marked
      increases in patient monitoring. Rigorous evaluation of patient outcomes resulting from the
      opioid risk reduction initiative, incorporating patient perspectives, is needed to guide
      health care improvement efforts to reduce opioid risks regionally and nationally.

      Research goal: The investigators will evaluate a major health plan initiative to reduce risks
      of long-term opioid use for chronic pain. Starting in 2008, some GH clinics reduced
      prescribing of high opioid doses. In 2010 the same clinics increased care planning and
      monitoring of chronic opioid therapy (COT) patients. Our research goal is to evaluate effects
      of this initiative on health and safety outcomes of COT patients. We will test whether the
      initiative influenced pain outcomes; patient-reported opioid benefits and problems; and
      opioid-related adverse events.

      Design and Outcomes: The investigators will assess effects of GH's opioid risk reduction
      initiative among COT patients using opioids long-term. The investigators will compare COT
      patients from clinics that implemented the initiative with COT patients from care settings
      that did not implement the initiative. The investigators will use survey data to assess
      patient-reported outcomes including pain severity, depressive symptoms, and patient
      perceptions of opioid benefits and problems, including validated measures of prescription
      opioid use disorder. They will interview and compare 800 COT patients using opioids long-term
      from clinics that implemented the risk reduction initiative and 800 COT patients from care
      settings that did not.

      Impact: This research will provide an urgently needed, rigorous evaluation of a major risk
      reduction initiative among COT patients. Evaluation results will guide efforts of health
      plans, clinicians and patients nationwide to ensure safe, effective and compassionate chronic
      pain care.
Detailed description not provided
observational model: Cohort
time perspective: Cross-Sectional
measure: Proportion With Prescription Opioid Use Disorder (Defined by DSM5 Criteria).
time frame: 1 year prior to interview
description: Proportion with Prescription Opioid Use Disorder, which is defined by multiple indicators of opioid abuse and addiction from 9 criteria in the DSM5 manual of the American Psychiatric Association. In this research, it will be assessed using the Psychiatric Research Interview for Substance and Mental Disorders (PRISM5, Columbia University). Estimates were weighted to account for non-response, with weights based on baseline patient characteristics assessed with electronic health care data available for all chronic opioid therapy patients sampled for the survey. The number analyzed differs from the Participant Flow module due to persons with missing item data who were dropped from this analysis. The numbers with missing items were deemed too few to justify item imputation.
measure: Pain Severity (Intensity, Interference With Activities, Enjoyment): PEG Scale
time frame: 1 week prior to interview
description: PEG (Pain - Enjoyment - Interference with General Activities) pain scale consisting of the average of 3 0-10 ratings of pain intensity, interference with activities due to pain, and reduced enjoyment of life due to pain. Estimates were weighted to account for non-response, with weights based on baseline patient characteristics assessed with electronic health care data available for all chronic opioid therapy patients sampled for the survey. The PEG score ranges from 0 to 30, with higher scores indicating greater pain severity. The number analyzed differs from the Participant Flow module due to persons with missing item data who were dropped from this analysis. The numbers with missing items were deemed too few to justify item imputation.
measure: Depressive Symptoms
time frame: 2 weeks prior to interview
description: Patient Health Questionnaire (PHQ-8) depression scale. The PHQ-8 is estimated by summing the 8 scale items. The total score ranges from 0 to 24, with higher scores indicating greater depression severity. Estimates were weighted to account for non-response, with weights based on baseline patient characteristics assessed with electronic health care data available for all chronic opioid therapy patients sampled for the survey. The number analyzed differs from the Participant Flow module due to persons with missing item data who were dropped from this analysis. The numbers with missing items were deemed too few to justify item imputation.
arm group label: Opioid Risk Reduction Initiative
description: Opioid risk reduction initiative for chronic opioid therapy patients implemented in Group Health integrated group practice clinics.
arm group label: Usual Care
description: Usual care for management of chronic opioid therapy patients implemented in Group Health network care settings.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michael R VonKorff, ScD
role: Principal Investigator
affiliation: Group Health Research Institute
responsible party type: Sponsor
mesh term: Substance-Related Disorders
mesh term: Depressive Disorder
sharing ipd: Yes
ipd description: A complete, cleaned, de-identified copy of the final dataset used in conducting the final analyses will be made available to other qualified researchers within nine months of the end of the final year of funding upon approval by the Group Health Human Subject's Review Committee.
Given the complexity of the final dataset, our expectation would be that other researchers using the data would require technical assistance from our research team to understand the data and to employ appropriate methods of data analysis. Or, other researchers may prefer to have us analyze the study data to produce analyses according to their specifications. Since use of the dataset by other investigators, or analyses carried out by us for other researchers, would occur after the grant award period has ended, we will expect necessary funding of technical support, data transfers and/or data analyses to be obtained by the research team requesting access to the final dataset.
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This phase of the evaluation reports after-only survey data comparing prevalent chronic opioid therapy patients who had been exposed or not exposed to the health plan opioid risk reduction initiatives for at least one year.
point of contact: 