<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/NCT01714323</url>
  </required_header>
  <id_info>
    <org_study_id>1R01HL111821</org_study_id>
    <nct_id>NCT01714323</nct_id>
  </id_info>
  <brief_title>Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers</brief_title>
  <acronym>Helping HAND2</acronym>
  <official_title>Comparative Effectiveness of Post-Discharge Strategies for Hospitalized Smokers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>North Shore Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cigarette smoking is the leading preventable cause of death in the U.S. The 2008 US Public&#xD;
      Health Service Smoking Cessation Guideline recommends offering effective treatment to smokers&#xD;
      in all health care settings, including hospitals. Nearly 4 million smokers are hospitalized&#xD;
      each year, and hospital admission offers a &quot;teachable moment&quot; for intervention.&#xD;
      Hospital-initiated smoking cessation intervention is effective, but only if contact continues&#xD;
      for more than 1 month after discharge. The challenge is to translate this research into&#xD;
      clinical practice by identifying an evidence-based cost-effective model that U.S. hospitals&#xD;
      can adopt. The major barrier is sustaining contact after discharge. This project tests an&#xD;
      innovative strategy to streamline the delivery and maximize the uptake of post-discharge&#xD;
      smoking interventions.&#xD;
&#xD;
      Specific Aim: To test the effectiveness of an innovative strategy to maximize smokers' use of&#xD;
      evidence-based tobacco treatment (counseling and medication) after hospital discharge,&#xD;
      thereby increasing the proportion of smokers who achieve long-term (6-month) tobacco&#xD;
      abstinence.&#xD;
&#xD;
      Study Design: A multi-site randomized controlled comparative effectiveness trial will enroll&#xD;
      1350 adult smokers admitted to 3 acute care hospitals in Massachusetts and Pennsylvania. All&#xD;
      subjects will receive a brief in-hospital smoking intervention and be randomly assigned at&#xD;
      discharge to either Standard Care (passive referral to their state quitline) or Extended&#xD;
      Care, a 3-month program consisting of (1) Free Medication: A 30-day supply of FDA-approved&#xD;
      medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and&#xD;
      refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive&#xD;
      Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider. IVR&#xD;
      aims to encourage medication adherence and enhance counseling efficiency by identifying&#xD;
      smokers who need post-discharge support. Immediate transfer of a patient from automated IVR&#xD;
      call to live telephone counselor will facilitate a successful connection to counseling.&#xD;
&#xD;
      Outcomes, assessed at 1, 3, and 6 months after hospital discharge, are: (1) intervention&#xD;
      effectiveness (cotinine-validated 7-day point-prevalence tobacco abstinence rate at 6 month&#xD;
      follow-up [primary outcome] and other tobacco abstinence measures); (2) treatment&#xD;
      utilization, and (3) cost-effectiveness (cost per quit). Exploratory analyses will examine&#xD;
      the intervention's effect on hospital readmissions and mortality in the 6 months after&#xD;
      discharge.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tobacco Abstinence - 6 Month Follow-up</measure>
    <time_frame>6 months</time_frame>
    <description>Cotinine-validated 7-day point prevalence tobacco abstinence at 6 month follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Continuous Tobacco Abstinence</measure>
    <time_frame>1 month, 3 months, 6 months</time_frame>
    <description>Continuous tobacco abstinence after hospital discharge assessed by self-report at 1, 3, and 6 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Point Prevalence Tobacco Abstinence</measure>
    <time_frame>1 month, 3 months, 6 months</time_frame>
    <description>7-day point prevalence tobacco abstinence after hospital discharge, assessed by self-report</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Tobacco Abstinence After Hospital Discharge</measure>
    <time_frame>1 month, 3 months, 6 months</time_frame>
    <description>Self-reported number of days in which a participant was abstinent from tobacco after hospital discharge, by self-report, obtained from surveys done at 1 month, 3 months, and 6 months. Patient can only relapse once but it can occur at any point up to 6 months after discharge. Therefore, the data point can come from either the 1 or 3 or 6 month follow-up depending on when relapse occurred.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of Smoking Cessation Treatment After Hospital Discharge</measure>
    <time_frame>1 month, 3 months, 6 months</time_frame>
    <description>Use of either FDA-approved pharmacotherapy for tobacco dependence (nicotine replacement therapy, bupropion, or varenicline), or psychosocial support (including telephone counseling, in person counseling, web-based counseling, physician counseling).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>All-cause Hospitalizations</measure>
    <time_frame>12 months</time_frame>
    <description>Self-reported admission to a hospital in the 12 months after the index hospitalization.</description>
  </other_outcome>
  <other_outcome>
    <measure>All-cause Mortality</measure>
    <time_frame>6 months</time_frame>
    <description>Death from any cause in the 6 months after hospital discharge</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1359</enrollment>
  <condition>Cigarette Smoking</condition>
  <condition>Tobacco Smoking</condition>
  <condition>Tobacco Use Disorder</condition>
  <arm_group>
    <arm_group_label>Standard care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>At discharge, the participant receives the standard care provided by the hospital. This consists of a handout with information to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sustained Care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A 3-month program after hospital discharge with these 2 components: (1) Free Medication and (2) Interactive Voice Response (IVR) Triage to Telephone Counseling.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Sustained Care</intervention_name>
    <description>A 3-month program after hospital discharge with these 2 components: (1) Free Medication - A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider (Alere Wellbeing, Inc., previously Free &amp; Clear). IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling.</description>
    <arm_group_label>Sustained Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard Care</intervention_name>
    <description>Standard care consists of a handout with information about how to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.</description>
    <arm_group_label>Standard care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cigarette smoker (smoked at least 1 cigarette in the month before hospital admission&#xD;
             and at least 1 cigarette per day when smoking at baseline rate in the month before&#xD;
             hospital admission)&#xD;
&#xD;
          -  Counseled by hospital smoking counselor during hospital stay&#xD;
&#xD;
          -  Plans to stop smoking tobacco products after hospital discharge&#xD;
&#xD;
          -  Agrees to take home a supply of smoking cessation medication after discharge&#xD;
&#xD;
          -  Agrees to and able to accept telephone calls after hospital discharge&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No access to a telephone or unable to communicate by telephone&#xD;
&#xD;
          -  Severe psychiatric or neurologic disease precluding ability to provide informed&#xD;
             consent and to be counseled&#xD;
&#xD;
          -  Pregnant, nursing, or planning to become pregnant in next 3 months&#xD;
&#xD;
          -  Unable to speak English&#xD;
&#xD;
          -  Medical instability precluding study participation&#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>Nancy A Rigotti, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Shore Medical Center</name>
      <address>
        <city>Salem</city>
        <state>Massachusetts</state>
        <zip>01970</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Medical Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>October 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 25, 2012</study_first_posted>
  <results_first_submitted>November 23, 2016</results_first_submitted>
  <results_first_submitted_qc>May 11, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">June 8, 2018</results_first_posted>
  <last_update_submitted>May 11, 2018</last_update_submitted>
  <last_update_submitted_qc>May 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Nancy A. Rigotti</investigator_full_name>
    <investigator_title>Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>Cigarette smoking</keyword>
  <keyword>Tobacco smoking</keyword>
  <keyword>Tobacco use disorder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tobacco Use Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment of eligible daily smokers admitted to 3 hospitals (Massachusetts General Hospital, Boston, MA; University of Pittsburgh Medical Center, Pittsburgh, PA; and North Shore Medical Center, Salem, MA) occurred during the period 12/3/2012 - 7/18/2014</recruitment_details>
      <pre_assignment_details>1359 patients were enrolled in the study and randomized to Sustained Care (n=681) or Standard Care (n=678). Two patients, 1 in each group, were excluded post-randomization but before hospital discharge (when intervention began) because they were not eligible. ITT analysis was conducted on 1357 patients (Standard Care n=677, Sustained Care n=680).</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Standard Care</title>
          <description>At discharge, the participant receives the standard care provided by the hospital. This consists of a handout with information to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.&#xD;
Standard Care: Standard care consists of a handout with information about how to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.</description>
        </group>
        <group group_id="P2">
          <title>Sustained Care</title>
          <description>A 3-month program after hospital discharge with these 2 components: (1) Free Medication and (2) Interactive Voice Response (IVR) Triage to Telephone Counseling.&#xD;
Sustained Care: A 3-month program after hospital discharge with these 2 components: (1) Free Medication - A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider (Alere Wellbeing, Inc., previously Free &amp; Clear). IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="677"/>
                <participants group_id="P2" count="680"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="513"/>
                <participants group_id="P2" count="508"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="164"/>
                <participants group_id="P2" count="172"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Standard Care</title>
          <description>At discharge, the participant receives the standard care provided by the hospital. This consists of a handout with information to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.&#xD;
Standard Care: Standard care consists of a handout with information about how to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.</description>
        </group>
        <group group_id="B2">
          <title>Sustained Care</title>
          <description>A 3-month program after hospital discharge with these 2 components: (1) Free Medication and (2) Interactive Voice Response (IVR) Triage to Telephone Counseling.&#xD;
Sustained Care: A 3-month program after hospital discharge with these 2 components: (1) Free Medication - A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider (Alere Wellbeing, Inc., previously Free &amp; Clear). IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling.</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="677"/>
            <count group_id="B2" value="680"/>
            <count group_id="B3" value="1357"/>
          </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="49.8" spread="12.4"/>
                    <measurement group_id="B2" value="49.6" spread="12.8"/>
                    <measurement group_id="B3" value="49.7" spread="12.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="336"/>
                    <measurement group_id="B2" value="332"/>
                    <measurement group_id="B3" value="668"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="341"/>
                    <measurement group_id="B2" value="348"/>
                    <measurement group_id="B3" value="689"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="677"/>
                    <measurement group_id="B2" value="680"/>
                    <measurement group_id="B3" value="1357"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Tobacco Abstinence - 6 Month Follow-up</title>
        <description>Cotinine-validated 7-day point prevalence tobacco abstinence at 6 month follow-up</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>At discharge, the participant receives the standard care provided by the hospital. This consists of a handout with information to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.&#xD;
Standard Care: Standard care consists of a handout with information about how to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.</description>
          </group>
          <group group_id="O2">
            <title>Sustained Care</title>
            <description>A 3-month program after hospital discharge with these 2 components: (1) Free Medication and (2) Interactive Voice Response (IVR) Triage to Telephone Counseling.&#xD;
Sustained Care: A 3-month program after hospital discharge with these 2 components: (1) Free Medication - A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider (Alere Wellbeing, Inc., previously Free &amp; Clear). IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling.</description>
          </group>
        </group_list>
        <measure>
          <title>Tobacco Abstinence - 6 Month Follow-up</title>
          <description>Cotinine-validated 7-day point prevalence tobacco abstinence at 6 month follow-up</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="677"/>
                <count group_id="O2" value="680"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="105"/>
                    <measurement group_id="O2" value="113"/>
                  </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>
            <groups_desc>Data from all three sites were combined after determining that outcomes did not vary by hospital using Breslow-Day tests. The proportion abstinent by treatment arm was assessed using chi-square test.</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&gt;0.05</p_value>
            <method>Chi-squared</method>
            <param_type>Risk Ratio (RR)</param_type>
            <param_value>1.07</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.84</ci_lower_limit>
            <ci_upper_limit>1.37</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Continuous Tobacco Abstinence</title>
        <description>Continuous tobacco abstinence after hospital discharge assessed by self-report at 1, 3, and 6 months.</description>
        <time_frame>1 month, 3 months, 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>At discharge, the participant receives the standard care provided by the hospital. This consists of a handout with information to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.&#xD;
Standard Care: Standard care consists of a handout with information about how to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.</description>
          </group>
          <group group_id="O2">
            <title>Sustained Care</title>
            <description>A 3-month program after hospital discharge with these 2 components: (1) Free Medication and (2) Interactive Voice Response (IVR) Triage to Telephone Counseling.&#xD;
Sustained Care: A 3-month program after hospital discharge with these 2 components: (1) Free Medication - A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider (Alere Wellbeing, Inc., previously Free &amp; Clear). IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling.</description>
          </group>
        </group_list>
        <measure>
          <title>Continuous Tobacco Abstinence</title>
          <description>Continuous tobacco abstinence after hospital discharge assessed by self-report at 1, 3, and 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="677"/>
                <count group_id="O2" value="680"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1 month follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="179"/>
                    <measurement group_id="O2" value="211"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 month follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="122"/>
                    <measurement group_id="O2" value="147"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 month follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="101"/>
                    <measurement group_id="O2" value="121"/>
                  </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 or Other</non_inferiority_type>
            <p_value>&gt;0.05</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Point Prevalence Tobacco Abstinence</title>
        <description>7-day point prevalence tobacco abstinence after hospital discharge, assessed by self-report</description>
        <time_frame>1 month, 3 months, 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>At discharge, the participant receives the standard care provided by the hospital. This consists of a handout with information to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.&#xD;
Standard Care: Standard care consists of a handout with information about how to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.</description>
          </group>
          <group group_id="O2">
            <title>Sustained Care</title>
            <description>A 3-month program after hospital discharge with these 2 components: (1) Free Medication and (2) Interactive Voice Response (IVR) Triage to Telephone Counseling.&#xD;
Sustained Care: A 3-month program after hospital discharge with these 2 components: (1) Free Medication - A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider (Alere Wellbeing, Inc., previously Free &amp; Clear). IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling.</description>
          </group>
        </group_list>
        <measure>
          <title>Point Prevalence Tobacco Abstinence</title>
          <description>7-day point prevalence tobacco abstinence after hospital discharge, assessed by self-report</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="677"/>
                <count group_id="O2" value="680"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1 month follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="217"/>
                    <measurement group_id="O2" value="295"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 month follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="206"/>
                    <measurement group_id="O2" value="253"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 month follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="180"/>
                    <measurement group_id="O2" value="209"/>
                  </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>
            <groups_desc>This compares at Month 1</groups_desc>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>This is analysis for Month 3</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <method>Chi-squared</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>This is for Month 6</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.09</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Tobacco Abstinence After Hospital Discharge</title>
        <description>Self-reported number of days in which a participant was abstinent from tobacco after hospital discharge, by self-report, obtained from surveys done at 1 month, 3 months, and 6 months. Patient can only relapse once but it can occur at any point up to 6 months after discharge. Therefore, the data point can come from either the 1 or 3 or 6 month follow-up depending on when relapse occurred.</description>
        <time_frame>1 month, 3 months, 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>At discharge, the participant receives the standard care provided by the hospital. This consists of a handout with information to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.&#xD;
Standard Care: Standard care consists of a handout with information about how to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.</description>
          </group>
          <group group_id="O2">
            <title>Sustained Care</title>
            <description>A 3-month program after hospital discharge with these 2 components: (1) Free Medication and (2) Interactive Voice Response (IVR) Triage to Telephone Counseling.&#xD;
Sustained Care: A 3-month program after hospital discharge with these 2 components: (1) Free Medication - A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider (Alere Wellbeing, Inc., previously Free &amp; Clear). IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling.</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Tobacco Abstinence After Hospital Discharge</title>
          <description>Self-reported number of days in which a participant was abstinent from tobacco after hospital discharge, by self-report, obtained from surveys done at 1 month, 3 months, and 6 months. Patient can only relapse once but it can occur at any point up to 6 months after discharge. Therefore, the data point can come from either the 1 or 3 or 6 month follow-up depending on when relapse occurred.</description>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="677"/>
                <count group_id="O2" value="680"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7" lower_limit="2" upper_limit="75"/>
                    <measurement group_id="O2" value="14" lower_limit="3" upper_limit="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Use of Smoking Cessation Treatment After Hospital Discharge</title>
        <description>Use of either FDA-approved pharmacotherapy for tobacco dependence (nicotine replacement therapy, bupropion, or varenicline), or psychosocial support (including telephone counseling, in person counseling, web-based counseling, physician counseling).</description>
        <time_frame>1 month, 3 months, 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>At discharge, the participant receives the standard care provided by the hospital. This consists of a handout with information to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.&#xD;
Standard Care: Standard care consists of a handout with information about how to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.</description>
          </group>
          <group group_id="O2">
            <title>Sustained Care</title>
            <description>A 3-month program after hospital discharge with these 2 components: (1) Free Medication and (2) Interactive Voice Response (IVR) Triage to Telephone Counseling.&#xD;
Sustained Care: A 3-month program after hospital discharge with these 2 components: (1) Free Medication - A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider (Alere Wellbeing, Inc., previously Free &amp; Clear). IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling.</description>
          </group>
        </group_list>
        <measure>
          <title>Use of Smoking Cessation Treatment After Hospital Discharge</title>
          <description>Use of either FDA-approved pharmacotherapy for tobacco dependence (nicotine replacement therapy, bupropion, or varenicline), or psychosocial support (including telephone counseling, in person counseling, web-based counseling, physician counseling).</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="677"/>
                <count group_id="O2" value="680"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>1 month follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="306"/>
                    <measurement group_id="O2" value="491"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 month follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="404"/>
                    <measurement group_id="O2" value="554"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 month follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="448"/>
                    <measurement group_id="O2" value="580"/>
                  </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 or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <p_value_desc>This is the p value for the comparison at each follow up point: 1 mo, 3 mo, and 6 mo.</p_value_desc>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>All-cause Hospitalizations</title>
        <description>Self-reported admission to a hospital in the 12 months after the index hospitalization.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>At discharge, the participant receives the standard care provided by the hospital. This consists of a handout with information to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.&#xD;
Standard Care: Standard care consists of a handout with information about how to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.</description>
          </group>
          <group group_id="O2">
            <title>Sustained Care</title>
            <description>A 3-month program after hospital discharge with these 2 components: (1) Free Medication and (2) Interactive Voice Response (IVR) Triage to Telephone Counseling.&#xD;
Sustained Care: A 3-month program after hospital discharge with these 2 components: (1) Free Medication - A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider (Alere Wellbeing, Inc., previously Free &amp; Clear). IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling.</description>
          </group>
        </group_list>
        <measure>
          <title>All-cause Hospitalizations</title>
          <description>Self-reported admission to a hospital in the 12 months after the index hospitalization.</description>
          <units>hospital admissions</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="677"/>
                <count group_id="O2" value="680"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="224"/>
                    <measurement group_id="O2" value="216"/>
                  </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 or Other</non_inferiority_type>
            <p_value>&gt;0.05</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>All-cause Mortality</title>
        <description>Death from any cause in the 6 months after hospital discharge</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard Care</title>
            <description>At discharge, the participant receives the standard care provided by the hospital. This consists of a handout with information to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.&#xD;
Standard Care: Standard care consists of a handout with information about how to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.</description>
          </group>
          <group group_id="O2">
            <title>Sustained Care</title>
            <description>A 3-month program after hospital discharge with these 2 components: (1) Free Medication and (2) Interactive Voice Response (IVR) Triage to Telephone Counseling.&#xD;
Sustained Care: A 3-month program after hospital discharge with these 2 components: (1) Free Medication - A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider (Alere Wellbeing, Inc., previously Free &amp; Clear). IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling.</description>
          </group>
        </group_list>
        <measure>
          <title>All-cause Mortality</title>
          <description>Death from any cause in the 6 months after hospital discharge</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="677"/>
                <count group_id="O2" value="680"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="13"/>
                  </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 or Other</non_inferiority_type>
            <p_value>&gt;0.05</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year (hospital readmissions); 6 months (deaths)</time_frame>
      <desc>Hospital admissions for 1 year after index hospitalization were obtained by chart review of admissions to the network of hospitals affiliated with Partners HealthCare and University of Pittsburgh Medical Center. Deaths in the first 6 months were systematically identified at patient assessments (1, 3, and 6 months). No systematic assessment of other adverse events during the trial was done due to the intervention's minimal risk.</desc>
      <group_list>
        <group group_id="E1">
          <title>Standard Care</title>
          <description>At discharge, the participant receives the standard care provided by the hospital. This consists of a handout with information to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.&#xD;
Standard Care: Standard care consists of a handout with information about how to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.</description>
        </group>
        <group group_id="E2">
          <title>Sustained Care</title>
          <description>A 3-month program after hospital discharge with these 2 components: (1) Free Medication and (2) Interactive Voice Response (IVR) Triage to Telephone Counseling.&#xD;
Sustained Care: A 3-month program after hospital discharge with these 2 components: (1) Free Medication - A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider (Alere Wellbeing, Inc., previously Free &amp; Clear). IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling.</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="224" subjects_at_risk="677"/>
                <counts group_id="E2" subjects_affected="216" subjects_at_risk="680"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Hospital Readmission</sub_title>
                <counts group_id="E1" subjects_affected="19" subjects_at_risk="677"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="680"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Hospital Readmission</sub_title>
                <counts group_id="E1" subjects_affected="50" subjects_at_risk="677"/>
                <counts group_id="E2" subjects_affected="48" subjects_at_risk="680"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="677"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="680"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hospital Readmission</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="677"/>
                <counts group_id="E2" subjects_affected="25" subjects_at_risk="680"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Hospital Readmission</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="677"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="680"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hospital Readmission</sub_title>
                <counts group_id="E1" subjects_affected="66" subjects_at_risk="677"/>
                <counts group_id="E2" subjects_affected="70" subjects_at_risk="680"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Hospital Readmission</sub_title>
                <counts group_id="E1" subjects_affected="22" subjects_at_risk="677"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="680"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hospital Readmisson</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="677"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="680"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="677"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="680"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Hospital Readmission</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="677"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="680"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="677"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="680"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Hospital Readmission</sub_title>
                <counts group_id="E1" subjects_affected="44" subjects_at_risk="677"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="680"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="677"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="680"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hospital Readmission</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="677"/>
                <counts group_id="E2" subjects_affected="35" subjects_at_risk="680"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hospital Readmission</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="677"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="680"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Hospital Readmission</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="677"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="680"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="677"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="680"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Hospital Readmission</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="677"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="680"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Hospital Readmission</sub_title>
                <counts group_id="E1" subjects_affected="29" subjects_at_risk="677"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="680"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hospital Readmission</sub_title>
                <counts group_id="E1" subjects_affected="26" subjects_at_risk="677"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="680"/>
              </event>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="677"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="680"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Hospital Readmission</sub_title>
                <counts group_id="E1" subjects_affected="21" subjects_at_risk="677"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="680"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hospital Readmission</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="677"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="680"/>
              </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="677"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="680"/>
              </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>Nancy Rigotti, MD</name_or_title>
      <organization>Massachusetts General Hospital</organization>
      <phone>617-724-4709</phone>
      <email>nrigotti@partners.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/NCT01714323
org study id: 1R01HL111821
nct id: NCT01714323
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Cigarette smoking is the leading preventable cause of death in the U.S. The 2008 US Public
      Health Service Smoking Cessation Guideline recommends offering effective treatment to smokers
      in all health care settings, including hospitals. Nearly 4 million smokers are hospitalized
      each year, and hospital admission offers a "teachable moment" for intervention.
      Hospital-initiated smoking cessation intervention is effective, but only if contact continues
      for more than 1 month after discharge. The challenge is to translate this research into
      clinical practice by identifying an evidence-based cost-effective model that U.S. hospitals
      can adopt. The major barrier is sustaining contact after discharge. This project tests an
      innovative strategy to streamline the delivery and maximize the uptake of post-discharge
      smoking interventions.

      Specific Aim: To test the effectiveness of an innovative strategy to maximize smokers' use of
      evidence-based tobacco treatment (counseling and medication) after hospital discharge,
      thereby increasing the proportion of smokers who achieve long-term (6-month) tobacco
      abstinence.

      Study Design: A multi-site randomized controlled comparative effectiveness trial will enroll
      1350 adult smokers admitted to 3 acute care hospitals in Massachusetts and Pennsylvania. All
      subjects will receive a brief in-hospital smoking intervention and be randomly assigned at
      discharge to either Standard Care (passive referral to their state quitline) or Extended
      Care, a 3-month program consisting of (1) Free Medication: A 30-day supply of FDA-approved
      medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and
      refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive
      Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider. IVR
      aims to encourage medication adherence and enhance counseling efficiency by identifying
      smokers who need post-discharge support. Immediate transfer of a patient from automated IVR
      call to live telephone counselor will facilitate a successful connection to counseling.

      Outcomes, assessed at 1, 3, and 6 months after hospital discharge, are: (1) intervention
      effectiveness (cotinine-validated 7-day point-prevalence tobacco abstinence rate at 6 month
      follow-up [primary outcome] and other tobacco abstinence measures); (2) treatment
      utilization, and (3) cost-effectiveness (cost per quit). Exploratory analyses will examine
      the intervention's effect on hospital readmissions and mortality in the 6 months after
      discharge.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Tobacco Abstinence - 6 Month Follow-up
time frame: 6 months
description: Cotinine-validated 7-day point prevalence tobacco abstinence at 6 month follow-up
measure: Continuous Tobacco Abstinence
time frame: 1 month, 3 months, 6 months
description: Continuous tobacco abstinence after hospital discharge assessed by self-report at 1, 3, and 6 months.
measure: Point Prevalence Tobacco Abstinence
time frame: 1 month, 3 months, 6 months
description: 7-day point prevalence tobacco abstinence after hospital discharge, assessed by self-report
measure: Duration of Tobacco Abstinence After Hospital Discharge
time frame: 1 month, 3 months, 6 months
description: Self-reported number of days in which a participant was abstinent from tobacco after hospital discharge, by self-report, obtained from surveys done at 1 month, 3 months, and 6 months. Patient can only relapse once but it can occur at any point up to 6 months after discharge. Therefore, the data point can come from either the 1 or 3 or 6 month follow-up depending on when relapse occurred.
measure: Use of Smoking Cessation Treatment After Hospital Discharge
time frame: 1 month, 3 months, 6 months
description: Use of either FDA-approved pharmacotherapy for tobacco dependence (nicotine replacement therapy, bupropion, or varenicline), or psychosocial support (including telephone counseling, in person counseling, web-based counseling, physician counseling).
measure: All-cause Hospitalizations
time frame: 12 months
description: Self-reported admission to a hospital in the 12 months after the index hospitalization.
measure: All-cause Mortality
time frame: 6 months
description: Death from any cause in the 6 months after hospital discharge
arm group label: Standard care
arm group type: Other
description: At discharge, the participant receives the standard care provided by the hospital. This consists of a handout with information to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.
arm group label: Sustained Care
arm group type: Experimental
description: A 3-month program after hospital discharge with these 2 components: (1) Free Medication and (2) Interactive Voice Response (IVR) Triage to Telephone Counseling.
intervention type: Behavioral
intervention name: Sustained Care
description: A 3-month program after hospital discharge with these 2 components: (1) Free Medication - A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider (Alere Wellbeing, Inc., previously Free & Clear). IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling.
arm group label: Sustained Care
intervention type: Behavioral
intervention name: Standard Care
description: Standard care consists of a handout with information about how to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.
arm group label: Standard care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nancy A Rigotti, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Nancy A. Rigotti
investigator title: Professor of Medicine
mesh term: Tobacco Use Disorder
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 