<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/NCT04473482</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00174946</org_study_id>
    <secondary_id>5K23AA026333-02</secondary_id>
    <nct_id>NCT04473482</nct_id>
  </id_info>
  <brief_title>Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Trial</brief_title>
  <acronym>MAIN-ART</acronym>
  <official_title>Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Alcohol Abuse and Alcoholism (NIAAA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to determine if providing participants with alcohol-related liver&#xD;
      disease with tailored alcohol use treatment options is feasible and acceptable in order to&#xD;
      increase their engagement with treatment and reduce alcohol use. This is an important area to&#xD;
      study to help create ways to increase participants' knowledge about different treatment&#xD;
      options as well as increase likelihood of seeking and participating in alcohol use disorder&#xD;
      treatments.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 23, 2020</start_date>
  <completion_date type="Actual">June 30, 2022</completion_date>
  <primary_completion_date type="Actual">June 30, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility of MAIN-ART Tool as Measured by Recruitment Rates</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Feasibility of administration of the MAIN-ART tool will be determined by recruitment rates and retention rates (as measured at 6 months after recruitment). Study recruitment started on 23 September, 2020 and concluded on 10 January 2022. The results reflect the number and percent of those patients who were approached, were determined to be eligible, and were consented.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of MAIN-ART Tool as Measured by Retention Rates</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Feasibility of administration of the MAIN-ART tool will be determined by recruitment rates and retention rates (as measured at 6 months after recruitment). Retention rate is shown by the number of participants who continued in the study for 6 months, and the percentage that it represents compared to those who began it but did not follow through to the end of the study (6 months).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability of the MAIN-ART Tool as Measured by Post-intervention Surveys</measure>
    <time_frame>Up to 1 hour</time_frame>
    <description>On the day the participants engage with the MAIN-ART tool, acceptability will be determined by patient-level surveys. The System usability Survey (SUS) consists of 10 questions ranging from 1 (strongly disagree) to 5 (strongly agree). A scoring algorithm which produces a range from 0 to 100 was used. Current literature suggests that a score above 68 for mean SUS is considered &quot;above average.&quot; By &quot;intervention,&quot; this measure means interaction with the MAIN-ART tool, which occurs only at the participant's initial visit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Alcohol Use Frequency as Measured by the Alcohol Timeline Follow-back (TLFB) Interview</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Alcohol use will be defined according to World Health Organization (WHO) risk drinking level. WHO drinking risk levels were derived from patient reports of the number of standard drinks (defined as 0.6 ounces of absolute alcohol) consumed, which were converted to grams of pure alcohol (0.6 ounces = 14 grams). Ranging from abstinence (0 grams) to very high risk (101+ males / 61+ females grams).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol Treatment Engagement as Measured by Number of Participants Who Engaged in Any Alcohol Cessation or Reduction Visit as Measured by Self-report.</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>Alcohol treatment engagement will be defined as at least one visit with formal, external assistance in alcohol cessation or reduction including inpatient rehabilitation services, out patient alcohol cessation programs, engagement in therapy of any kind tailored for alcohol cessation, and engagement in any group therapy or support groups for alcohol cessation including alcoholics anonymous, 12 step facilitation and etc.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Alcohol-Related Disorders</condition>
  <condition>Liver Diseases</condition>
  <arm_group>
    <arm_group_label>MAIN-ART Behavior Tool</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Tool (MAIN-ART) behavioral intervention is an online web application with two modules: misconception correction and tailored, preference-sensitive alcohol use disorder (AUD) treatment matching.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients randomized to usual care will receive a pamphlet for alcohol treatment referral to the University of Michigan Addiction Treatment Services, but will receive no further education from the research team.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Michigan Alcohol Improvement Network-Alcohol Reduction and Treatment tool</intervention_name>
    <description>The intervention corrects misconceptions about alcohol use, liver disease, and alcohol treatment and matches patients to their top three choices of treatment while providing them with brief explanations of each treatment option.</description>
    <arm_group_label>MAIN-ART Behavior Tool</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Enrolled at University of Michigan general hepatology clinics or inpatient wards&#xD;
&#xD;
          -  Documented diagnosis of alcohol-associated cirrhosis or alcoholic hepatitis or&#xD;
             alcohol-related liver disease of any stage&#xD;
&#xD;
          -  Drinking of any amount of alcohol within the 6 months prior to recruitment&#xD;
&#xD;
          -  No alcohol use treatment within the past 1 month&#xD;
&#xD;
          -  Access to a phone for purposes of follow-up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active alcohol use treatment&#xD;
&#xD;
          -  Undergoing active evaluation for liver transplantation, is listed for liver&#xD;
             transplant, or is post-transplantation.&#xD;
&#xD;
          -  Is enrolled in the multidisciplinary alcohol-related liver disease clinic at Michigan&#xD;
             Medicine&#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>Jessica Mellinger, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <results_first_submitted>July 7, 2023</results_first_submitted>
  <results_first_submitted_qc>August 7, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">August 30, 2023</results_first_posted>
  <last_update_submitted>August 7, 2023</last_update_submitted>
  <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Jessica Mellinger</investigator_full_name>
    <investigator_title>Assistant Professor of Internal Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
    <mesh_term>Alcohol-Related Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ethanol</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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>June 18, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT04473482/Prot_SAP_001.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>December 21, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT04473482/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>MAIN-ART Behavior Tool</title>
          <description>The Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Tool (MAIN-ART) behavioral intervention is an online web application with two modules: misconception correction and tailored, preference-sensitive alcohol use disorder (AUD) treatment matching.&#xD;
Michigan Alcohol Improvement Network-Alcohol Reduction and Treatment tool: The intervention corrects misconceptions about alcohol use, liver disease, and alcohol treatment and matches patients to their top three choices of treatment while providing them with brief explanations of each treatment option.</description>
        </group>
        <group group_id="P2">
          <title>Routine Care</title>
          <description>Patients randomized to usual care will receive a pamphlet for alcohol treatment referral to the University of Michigan Addiction Treatment Services, but will receive no further education from the research team.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>3-month Post Intervention Phone Call</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>6-month Post Intervention Phone Call</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="19"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>MAIN-ART Behavior Tool</title>
          <description>The Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Tool (MAIN-ART) behavioral intervention is an online web application with two modules: misconception correction and tailored, preference-sensitive alcohol use disorder (AUD) treatment matching.&#xD;
Michigan Alcohol Improvement Network-Alcohol Reduction and Treatment tool: The intervention corrects misconceptions about alcohol use, liver disease, and alcohol treatment and matches patients to their top three choices of treatment while providing them with brief explanations of each treatment option.</description>
        </group>
        <group group_id="B2">
          <title>Routine Care</title>
          <description>Patients randomized to usual care will receive a pamphlet for alcohol treatment referral to the University of Michigan Addiction Treatment Services, but will receive no further education from the research team.</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="30"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="60"/>
          </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="46.8" spread="11.3"/>
                    <measurement group_id="B2" value="50.0" spread="13.4"/>
                    <measurement group_id="B3" value="48.4" spread="12.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Gender</title>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="30"/>
                  </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>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native American</title>
              <category_list>
                <category>
                  <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>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown/Declined to Answer</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>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Alcohol-Related Liver Disease (ALD) Severity</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Alcohol related cirrhosis or acute alcohol related hepatitis or both</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Alcohol-related Steatosis</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cirrhosis Diagnosis</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Compensated Cirrhosis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Decompensated Cirrhosis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alcohol-Related Liver Disease (ALD), No Cirrhosis</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Self-reported last drink</title>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60" spread="11.2"/>
                    <measurement group_id="B2" value="61" spread="12.4"/>
                    <measurement group_id="B3" value="60.5" spread="11.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Feasibility of MAIN-ART Tool as Measured by Recruitment Rates</title>
        <description>Feasibility of administration of the MAIN-ART tool will be determined by recruitment rates and retention rates (as measured at 6 months after recruitment). Study recruitment started on 23 September, 2020 and concluded on 10 January 2022. The results reflect the number and percent of those patients who were approached, were determined to be eligible, and were consented.</description>
        <time_frame>Up to 6 months</time_frame>
        <population>This population is prior to consent and includes the patients who were ultimately excluded due to not meeting study criteria, cancellation, not showing up to appointments, being unreachable via phone, or for declining participation in the study.</population>
        <group_list>
          <group group_id="O1">
            <title>Clinical Population</title>
            <description>Patients in hepatology and the University of Michigan Hospital's inpatient ward who were approached about possible participation in this study.</description>
          </group>
        </group_list>
        <measure>
          <title>Feasibility of MAIN-ART Tool as Measured by Recruitment Rates</title>
          <description>Feasibility of administration of the MAIN-ART tool will be determined by recruitment rates and retention rates (as measured at 6 months after recruitment). Study recruitment started on 23 September, 2020 and concluded on 10 January 2022. The results reflect the number and percent of those patients who were approached, were determined to be eligible, and were consented.</description>
          <population>This population is prior to consent and includes the patients who were ultimately excluded due to not meeting study criteria, cancellation, not showing up to appointments, being unreachable via phone, or for declining participation in the study.</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="276"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Feasibility of MAIN-ART Tool as Measured by Retention Rates</title>
        <description>Feasibility of administration of the MAIN-ART tool will be determined by recruitment rates and retention rates (as measured at 6 months after recruitment). Retention rate is shown by the number of participants who continued in the study for 6 months, and the percentage that it represents compared to those who began it but did not follow through to the end of the study (6 months).</description>
        <time_frame>Up to 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>MAIN-ART Behavior Tool</title>
            <description>The Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Tool (MAIN-ART) behavioral intervention is an online web application with two modules: misconception correction and tailored, preference-sensitive alcohol use disorder (AUD) treatment matching.&#xD;
Michigan Alcohol Improvement Network-Alcohol Reduction and Treatment tool: The intervention corrects misconceptions about alcohol use, liver disease, and alcohol treatment and matches patients to their top three choices of treatment while providing them with brief explanations of each treatment option.</description>
          </group>
          <group group_id="O2">
            <title>Routine Care</title>
            <description>Patients randomized to usual care will receive a pamphlet for alcohol treatment referral to the University of Michigan Addiction Treatment Services, but will receive no further education from the research team.</description>
          </group>
        </group_list>
        <measure>
          <title>Feasibility of MAIN-ART Tool as Measured by Retention Rates</title>
          <description>Feasibility of administration of the MAIN-ART tool will be determined by recruitment rates and retention rates (as measured at 6 months after recruitment). Retention rate is shown by the number of participants who continued in the study for 6 months, and the percentage that it represents compared to those who began it but did not follow through to the end of the study (6 months).</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="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Acceptability of the MAIN-ART Tool as Measured by Post-intervention Surveys</title>
        <description>On the day the participants engage with the MAIN-ART tool, acceptability will be determined by patient-level surveys. The System usability Survey (SUS) consists of 10 questions ranging from 1 (strongly disagree) to 5 (strongly agree). A scoring algorithm which produces a range from 0 to 100 was used. Current literature suggests that a score above 68 for mean SUS is considered &quot;above average.&quot; By &quot;intervention,&quot; this measure means interaction with the MAIN-ART tool, which occurs only at the participant's initial visit.</description>
        <time_frame>Up to 1 hour</time_frame>
        <population>Only subjects randomized to the intervention MAIN-ART behavioral tool were assessed in the intervention group. Because this intervention was given at the initial visit, all participants who were randomized to the MAIN-ART tool arm are available for analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>MAIN-ART Behavior Tool</title>
            <description>The Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Tool (MAIN-ART) behavioral intervention is an online web application with two modules: misconception correction and tailored, preference-sensitive alcohol use disorder (AUD) treatment matching.&#xD;
Michigan Alcohol Improvement Network-Alcohol Reduction and Treatment tool: The intervention corrects misconceptions about alcohol use, liver disease, and alcohol treatment and matches patients to their top three choices of treatment while providing them with brief explanations of each treatment option.</description>
          </group>
        </group_list>
        <measure>
          <title>Acceptability of the MAIN-ART Tool as Measured by Post-intervention Surveys</title>
          <description>On the day the participants engage with the MAIN-ART tool, acceptability will be determined by patient-level surveys. The System usability Survey (SUS) consists of 10 questions ranging from 1 (strongly disagree) to 5 (strongly agree). A scoring algorithm which produces a range from 0 to 100 was used. Current literature suggests that a score above 68 for mean SUS is considered &quot;above average.&quot; By &quot;intervention,&quot; this measure means interaction with the MAIN-ART tool, which occurs only at the participant's initial visit.</description>
          <population>Only subjects randomized to the intervention MAIN-ART behavioral tool were assessed in the intervention group. Because this intervention was given at the initial visit, all participants who were randomized to the MAIN-ART tool arm are available for analysis.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70" lower_limit="47.5" upper_limit="95"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alcohol Use Frequency as Measured by the Alcohol Timeline Follow-back (TLFB) Interview</title>
        <description>Alcohol use will be defined according to World Health Organization (WHO) risk drinking level. WHO drinking risk levels were derived from patient reports of the number of standard drinks (defined as 0.6 ounces of absolute alcohol) consumed, which were converted to grams of pure alcohol (0.6 ounces = 14 grams). Ranging from abstinence (0 grams) to very high risk (101+ males / 61+ females grams).</description>
        <time_frame>Baseline and 6 months</time_frame>
        <population>Baseline measure data includes all participants whose data was collected at baseline. The participants at 6 months includes only those who completed the study.</population>
        <group_list>
          <group group_id="O1">
            <title>MAIN-ART Behavior Tool</title>
            <description>The Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Tool (MAIN-ART) behavioral intervention is an online web application with two modules: misconception correction and tailored, preference-sensitive alcohol use disorder (AUD) treatment matching.&#xD;
Michigan Alcohol Improvement Network-Alcohol Reduction and Treatment tool: The intervention corrects misconceptions about alcohol use, liver disease, and alcohol treatment and matches patients to their top three choices of treatment while providing them with brief explanations of each treatment option.</description>
          </group>
          <group group_id="O2">
            <title>Routine Care</title>
            <description>Patients randomized to usual care will receive a pamphlet for alcohol treatment referral to the University of Michigan Addiction Treatment Services, but will receive no further education from the research team.</description>
          </group>
        </group_list>
        <measure>
          <title>Alcohol Use Frequency as Measured by the Alcohol Timeline Follow-back (TLFB) Interview</title>
          <description>Alcohol use will be defined according to World Health Organization (WHO) risk drinking level. WHO drinking risk levels were derived from patient reports of the number of standard drinks (defined as 0.6 ounces of absolute alcohol) consumed, which were converted to grams of pure alcohol (0.6 ounces = 14 grams). Ranging from abstinence (0 grams) to very high risk (101+ males / 61+ females grams).</description>
          <population>Baseline measure data includes all participants whose data was collected at baseline. The participants at 6 months includes only those who completed the study.</population>
          <units>Grams per day</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="30"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="87" spread="192"/>
                    <measurement group_id="O2" value="72" spread="191"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="19"/>
                    <count group_id="O2" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13" spread="33"/>
                    <measurement group_id="O2" value="29" spread="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Generalized estimating equations with robust sandwich estimators used with Wald 95% confidence intervals and conversion to odds ratios</non_inferiority_desc>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.25</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>Generalized estimating equations with robust sandwich estimators used with Wald 95% confidence intervals and conversion to odds ratios</estimate_desc>
            <other_analysis_desc>Generalized estimating equations with robust sandwich estimators used with Wald 95% confidence intervals</other_analysis_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Alcohol Treatment Engagement as Measured by Number of Participants Who Engaged in Any Alcohol Cessation or Reduction Visit as Measured by Self-report.</title>
        <description>Alcohol treatment engagement will be defined as at least one visit with formal, external assistance in alcohol cessation or reduction including inpatient rehabilitation services, out patient alcohol cessation programs, engagement in therapy of any kind tailored for alcohol cessation, and engagement in any group therapy or support groups for alcohol cessation including alcoholics anonymous, 12 step facilitation and etc.</description>
        <time_frame>Up to 6 months</time_frame>
        <population>All participants involved in the initial use of the MAIN-ART tool or who received routine care are analyzed to evaluate what percent engaged with alcohol treatment by the end of the study.</population>
        <group_list>
          <group group_id="O1">
            <title>MAIN-ART Behavior Tool</title>
            <description>The Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Tool (MAIN-ART) behavioral intervention is an online web application with two modules: misconception correction and tailored, preference-sensitive alcohol use disorder (AUD) treatment matching.&#xD;
Michigan Alcohol Improvement Network-Alcohol Reduction and Treatment tool: The intervention corrects misconceptions about alcohol use, liver disease, and alcohol treatment and matches patients to their top three choices of treatment while providing them with brief explanations of each treatment option.</description>
          </group>
          <group group_id="O2">
            <title>Routine Care</title>
            <description>Patients randomized to usual care will receive a pamphlet for alcohol treatment referral to the University of Michigan Addiction Treatment Services, but will receive no further education from the research team.</description>
          </group>
        </group_list>
        <measure>
          <title>Alcohol Treatment Engagement as Measured by Number of Participants Who Engaged in Any Alcohol Cessation or Reduction Visit as Measured by Self-report.</title>
          <description>Alcohol treatment engagement will be defined as at least one visit with formal, external assistance in alcohol cessation or reduction including inpatient rehabilitation services, out patient alcohol cessation programs, engagement in therapy of any kind tailored for alcohol cessation, and engagement in any group therapy or support groups for alcohol cessation including alcoholics anonymous, 12 step facilitation and etc.</description>
          <population>All participants involved in the initial use of the MAIN-ART tool or who received routine care are analyzed to evaluate what percent engaged with alcohol treatment by the end of the study.</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="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>2.31</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <estimate_desc>GEEs with robust sandwich estimators and Wald 95% CIs with conversion to Odds Ratios</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 6 months.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>MAIN-ART Behavior Tool</title>
          <description>The Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Tool (MAIN-ART) behavioral intervention is an online web application with two modules: misconception correction and tailored, preference-sensitive alcohol use disorder (AUD) treatment matching.&#xD;
Michigan Alcohol Improvement Network-Alcohol Reduction and Treatment tool: The intervention corrects misconceptions about alcohol use, liver disease, and alcohol treatment and matches patients to their top three choices of treatment while providing them with brief explanations of each treatment option.</description>
        </group>
        <group group_id="E2">
          <title>Routine Care</title>
          <description>Patients randomized to usual care will receive a pamphlet for alcohol treatment referral to the University of Michigan Addiction Treatment Services, but will receive no further education from the research team.</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="30"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </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="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </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>Jessica Mellinger</name_or_title>
      <organization>University of Michigan</organization>
      <phone>734-232-0284</phone>
      <email>jmelling@umich.edu</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/NCT04473482
org study id: HUM00174946
secondary id: 5K23AA026333-02
nct id: NCT04473482
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to determine if providing participants with alcohol-related liver
      disease with tailored alcohol use treatment options is feasible and acceptable in order to
      increase their engagement with treatment and reduce alcohol use. This is an important area to
      study to help create ways to increase participants' knowledge about different treatment
      options as well as increase likelihood of seeking and participating in alcohol use disorder
      treatments.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Feasibility of MAIN-ART Tool as Measured by Recruitment Rates
time frame: Up to 6 months
description: Feasibility of administration of the MAIN-ART tool will be determined by recruitment rates and retention rates (as measured at 6 months after recruitment). Study recruitment started on 23 September, 2020 and concluded on 10 January 2022. The results reflect the number and percent of those patients who were approached, were determined to be eligible, and were consented.
measure: Feasibility of MAIN-ART Tool as Measured by Retention Rates
time frame: Up to 6 months
description: Feasibility of administration of the MAIN-ART tool will be determined by recruitment rates and retention rates (as measured at 6 months after recruitment). Retention rate is shown by the number of participants who continued in the study for 6 months, and the percentage that it represents compared to those who began it but did not follow through to the end of the study (6 months).
measure: Acceptability of the MAIN-ART Tool as Measured by Post-intervention Surveys
time frame: Up to 1 hour
description: On the day the participants engage with the MAIN-ART tool, acceptability will be determined by patient-level surveys. The System usability Survey (SUS) consists of 10 questions ranging from 1 (strongly disagree) to 5 (strongly agree). A scoring algorithm which produces a range from 0 to 100 was used. Current literature suggests that a score above 68 for mean SUS is considered "above average." By "intervention," this measure means interaction with the MAIN-ART tool, which occurs only at the participant's initial visit.
measure: Alcohol Use Frequency as Measured by the Alcohol Timeline Follow-back (TLFB) Interview
time frame: Baseline and 6 months
description: Alcohol use will be defined according to World Health Organization (WHO) risk drinking level. WHO drinking risk levels were derived from patient reports of the number of standard drinks (defined as 0.6 ounces of absolute alcohol) consumed, which were converted to grams of pure alcohol (0.6 ounces = 14 grams). Ranging from abstinence (0 grams) to very high risk (101+ males / 61+ females grams).
measure: Alcohol Treatment Engagement as Measured by Number of Participants Who Engaged in Any Alcohol Cessation or Reduction Visit as Measured by Self-report.
time frame: Up to 6 months
description: Alcohol treatment engagement will be defined as at least one visit with formal, external assistance in alcohol cessation or reduction including inpatient rehabilitation services, out patient alcohol cessation programs, engagement in therapy of any kind tailored for alcohol cessation, and engagement in any group therapy or support groups for alcohol cessation including alcoholics anonymous, 12 step facilitation and etc.
arm group label: MAIN-ART Behavior Tool
arm group type: Experimental
description: The Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Tool (MAIN-ART) behavioral intervention is an online web application with two modules: misconception correction and tailored, preference-sensitive alcohol use disorder (AUD) treatment matching.
arm group label: Routine care
arm group type: No Intervention
description: Patients randomized to usual care will receive a pamphlet for alcohol treatment referral to the University of Michigan Addiction Treatment Services, but will receive no further education from the research team.
intervention type: Behavioral
intervention name: Michigan Alcohol Improvement Network-Alcohol Reduction and Treatment tool
description: The intervention corrects misconceptions about alcohol use, liver disease, and alcohol treatment and matches patients to their top three choices of treatment while providing them with brief explanations of each treatment option.
arm group label: MAIN-ART Behavior Tool
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jessica Mellinger, MD, MSc
role: Principal Investigator
affiliation: University of Michigan
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Jessica Mellinger
investigator title: Assistant Professor of Internal Medicine
mesh term: Liver Diseases
mesh term: Alcohol-Related Disorders
mesh term: Ethanol
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 