<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/NCT01691105</url>
  </required_header>
  <id_info>
    <org_study_id>1205010297</org_study_id>
    <secondary_id>R18HL108788</secondary_id>
    <nct_id>NCT01691105</nct_id>
  </id_info>
  <brief_title>Implementation of HIT-Enhanced Tobacco Treatment for Hospitalized Smokers</brief_title>
  <official_title>Implementation of HIT-Enhanced Tobacco Treatment for Hospitalized Smokers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will implement and test the effectiveness and cost-effectiveness of a tobacco&#xD;
      cessation intervention (Academic Detailing + Integrated Tobacco Order Set - AD + ITOS) for&#xD;
      adults admitted to the hospital. The intervention will begin during the hospital stay and&#xD;
      continue after discharge. The intervention will use resources easily available to most acute&#xD;
      care hospitals: computerized physician order entry, physician and nurse education, staff&#xD;
      meetings for physicians, nurses and allied health professionals, online learning&#xD;
      capabilities, faxing to primary care providers (PCPs), and the telephone counseling and&#xD;
      support available from a state smokers' quitline (QL).&#xD;
&#xD;
      The investigators hypothesize that the subjects in the intervention arm (AD + ITOS) will be&#xD;
      more likely to achieve tobacco abstinence at 12 months post hospital stay than subjects in&#xD;
      the control arm (Academic Detailing - AD). Tobacco abstinence will be assessed by self report&#xD;
      and biochemical verification (exhaled carbon monoxide reading).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cigarette smoking remains the leading cause of preventable death and illness in the United&#xD;
      States. In 2008, 20.6% of all American adults smoked, and 435,000 died from smoking-related&#xD;
      illnesses. Economic costs of smoking dependence are estimated at $193 billion/year and have&#xD;
      far-reaching implications for the individual, workplace, society and the healthcare system.&#xD;
      However, treatment is associated with significant individual and society benefits, and both&#xD;
      counseling and pharmacotherapy have been demonstrated to be effective treatments. Along with&#xD;
      poverty and low education, smoking causes a greater loss of quality-adjusted life years than&#xD;
      race, uninsurance, overweight, or binge drinking.&#xD;
&#xD;
      Smokers are admitted to acute care hospital more than nonsmokers. Using estimates from a&#xD;
      number of sources, we estimate that approximately 6.1-12.5 million hospitalizations occur&#xD;
      annually among adult smokers. This represents 20-41% of the 29.8 million annual inpatient&#xD;
      stays in US acute care hospitals among adults age 18 and older unrelated to pregnancy or&#xD;
      childbirth. Put another way, the nation's 46 million smokers represent 20% of the adult&#xD;
      population, but account for 20-40% of all hospitalizations unrelated to pregnancy. Given that&#xD;
      US hospitals are now smoke-free (per Joint Commission regulations), and many of these&#xD;
      admissions are for tobacco-related conditions, the hospital admission represents a profound&#xD;
      opportunity-a &quot;teachable moment&quot;-for tobacco control.&#xD;
&#xD;
      Recent &quot;core measure&quot; regulations by the Joint Commission and the Centers for Medicare and&#xD;
      Medicaid Services require hospitals to report publicly their tobacco screening for patients&#xD;
      admitted with acute myocardial infarction, congestive heart failure, and pneumonia. Although&#xD;
      many hospitals have improved their performance considerably on these smoking measures,&#xD;
      sometimes this has resulted from &quot;gaming,&quot; e.g. giving all discharged patients a preprinted&#xD;
      instruction sheet that includes boilerplate text about smoking cessation. Thus, although most&#xD;
      hospitals assess inpatients for tobacco use (either through a nursing assessment or the&#xD;
      physician's initial history and physical examination), there are often no systems in place to&#xD;
      initiate or sustain tobacco treatment for smokers. This gap in service delivery prevents&#xD;
      millions of smokers from accessing the many effective, evidence-based treatments for tobacco&#xD;
      dependence during a period in which they may be particularly receptive to an intervention.&#xD;
&#xD;
      Hence, the overarching goal of this project is to implement and study the effectiveness and&#xD;
      cost-effectiveness of a tobacco intervention for hospitalized adults that begins during&#xD;
      inpatient treatment and continues after discharge. To enhance dissemination, we will use&#xD;
      resources currently available to most acute care hospitals: computerized physician order&#xD;
      entry, physician and nurse education, staff meetings for physicians, nurses, and allied&#xD;
      health professionals, online learning capabilities, faxing to primary care providers (PCPs),&#xD;
      and the telephone counseling and support available from a state smokers' quitline (QL). In&#xD;
      the final year, a toolkit will be disseminated by professional societies. We hypothesize that&#xD;
      the proposed intervention is clinically effective, cost effective, sustainable, and&#xD;
      generalizable. All interventions are evidence-based and consistent with the 2008 Public&#xD;
      Health Service clinical practice guideline for tobacco dependence treatment.&#xD;
&#xD;
      The Specific Aims of the proposed project are to:&#xD;
&#xD;
      Primary Aims:&#xD;
&#xD;
        1. Determine whether Academic Detailing (AD) and an Integrated Tobacco Order Set (ITOS)&#xD;
           compared to AD alone improves biologically verified smoking cessation at 12 months&#xD;
           post-quit in a cohort of 960 smokers age &gt; 18 years admitted to Yale New Haven Hospital&#xD;
           (YNHH).&#xD;
&#xD;
           Secondary Aims:&#xD;
&#xD;
        2. Study ITOS's ability to encourage smokers to use treatment services and reduce&#xD;
           consumption.&#xD;
&#xD;
        3. Study ITOS's ability to enhance provider delivery of tobacco screening and treatment.&#xD;
&#xD;
        4. Conduct an incremental cost-effectiveness analysis of the intervention.&#xD;
&#xD;
      Our associated hypotheses are:&#xD;
&#xD;
        1. Subjects treated by physicians in the AD+ITOS arm will have a higher rate of&#xD;
           biochemically verified 7-day point prevalence smoking abstinence at 12 months post-quit&#xD;
           than subjects treated by physicians in the AD arm, in a cohort of adult smokers admitted&#xD;
           to the inpatient units of Yale-New Haven Hospital.&#xD;
&#xD;
        2. Subjects treated by AD+ITOS physicians will have made more quit attempts, and&#xD;
           experienced greater reduction in daily cigarette consumption, than smokers treated by AD&#xD;
           physicians.&#xD;
&#xD;
        3. A higher proportion of patients treated by AD+ITOS physicians will have tobacco&#xD;
           treatment initiated in hospital than patients treated by AD physicians.&#xD;
&#xD;
        4. Societal costs of AD+ITOS, per abstinent smoker, will be cost-effective relative to AD.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2013</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Exhaled Carbon Monoxide Confirmed Abstinence</measure>
    <time_frame>12 months post enrollment</time_frame>
    <description>Tobacco abstinence will be assessed by obtaining an exhaled carbon monoxide reading for all subjects self-reporting tobacco abstinence at 12 month follow-up. Consistent with manufacturer's recommendations, a cutoff of 10 ppm will indicate current smoking.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 12 Months</measure>
    <time_frame>12 months post enrollment</time_frame>
    <description>Self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use. The Time Line Follow Back technique will be used to assess 7-day point prevalence abstinence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 6 Months</measure>
    <time_frame>6 months post enrollment</time_frame>
    <description>Self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use. The Time Line Follow Back technique will be used to assess 7-day point prevalence abstinence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 1 Month</measure>
    <time_frame>1 month post enrollment</time_frame>
    <description>Self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use. The Time Line Follow Back technique will be used to assess 7-day point prevalence abstinence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Self-Reporting Use of Cessation Medications - 1 Month</measure>
    <time_frame>1 month post enrollment</time_frame>
    <description>Nicotine replacement therapy (NRT) use and use of other pharmacotherapies will be assessed by self-report. A Treatment Services Review (TSR) will be administered during follow-up assessments at 1, 6, and 12 months post enrollment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Self-Reporting Use of Cessation Medications - 6 Months</measure>
    <time_frame>6 months post enrollment</time_frame>
    <description>NRT use and use of other pharmacotherapies will be assessed by self-report. A Treatment Services Review (TSR) will be administered during follow-up assessments at 6 months post enrollment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Self-Reporting Use of Cessation Medications - 12 Months</measure>
    <time_frame>12 months post enrollment</time_frame>
    <description>NRT use and use of other pharmacotherapies will be assessed by self-report. A Treatment Services Review (TSR) will be administered during follow-up assessments at 1, 6, and 12 months post enrollment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants Self-Reporting Treatment Engagement - 1 Month</measure>
    <time_frame>1 month post enrollment</time_frame>
    <description>Treatment engagement will be assessed by subject self-report during the 1 month follow-up interview. Subjects will be considered engaged in treatment if at 30 days after randomization the subject reports currently receiving care for the Quitline or another treatment program that addresses the subject's nicotine dependence.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1044</enrollment>
  <condition>Tobacco Use Cessation</condition>
  <condition>Smoking Cessation</condition>
  <condition>Smoking</condition>
  <condition>Tobacco Use Disorder</condition>
  <arm_group>
    <arm_group_label>Academic Detailing (AD)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard of care for patients who are smokers and admitted to the hospital.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AD + Integrated Tobacco Order Set</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Access to the Integrated Tobacco Order Set (ITOS) Nicotine Replacement Therapy with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>AD + Integrated Tobacco Order Set</intervention_name>
    <description>Physician will have access to:&#xD;
NRT with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center</description>
    <arm_group_label>AD + Integrated Tobacco Order Set</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  admitted to any medical ward, telemetry or cardiac care unit&#xD;
&#xD;
          -  identified as a smoker by the nurse or physician in the admitting EMR&#xD;
&#xD;
          -  treated by a study physician&#xD;
&#xD;
          -  able to give written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  inability to read or understand English or Spanish&#xD;
&#xD;
          -  lacks capacity to give informed consent&#xD;
&#xD;
          -  currently receiving formal tobacco dependence treatment&#xD;
&#xD;
          -  current suicide or homicide risk&#xD;
&#xD;
          -  current psychotic disorder or life-threatening or unstable medical or psychiatric&#xD;
             condition within past 6 months&#xD;
&#xD;
          -  unable to provide 2 telephone contact numbers&#xD;
&#xD;
          -  unwilling to follow up per study protocol, including release of information to assess&#xD;
             treatment engagement at 30-days&#xD;
&#xD;
          -  live outside of New Haven County&#xD;
&#xD;
          -  leaving the hospital against medical advice&#xD;
&#xD;
          -  history of clinically significant allergic reaction to nicotine replacement therapies,&#xD;
             varenicline or bupropion&#xD;
&#xD;
          -  use of an investigational drug within 30 days&#xD;
&#xD;
          -  use of tobacco products other than cigarettes&#xD;
&#xD;
          -  women of childbearing potential who are pregnant, nursing, or sexually active and not&#xD;
             practicing effective contraception (oral injectable, or implantable contraceptives,&#xD;
             intrauterine device, or barrier method with spermicide)&#xD;
&#xD;
          -  do not have access to a phone with a CT area code (required to use the CT Tobacco&#xD;
             Quitline)&#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>Steven L Bernstein, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale University</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <results_first_submitted>September 17, 2018</results_first_submitted>
  <results_first_submitted_qc>October 25, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">November 23, 2018</results_first_posted>
  <last_update_submitted>August 11, 2021</last_update_submitted>
  <last_update_submitted_qc>August 11, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tobacco Use Cessation</keyword>
  <keyword>Smoking Cessation</keyword>
  <keyword>Nicotine Replacement Therapy</keyword>
  <keyword>Hospitalized Smokers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tobacco Use Disorder</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Academic Detailing (AD)</title>
          <description>Standard of care for patients who are smokers and admitted to the hospital.</description>
        </group>
        <group group_id="P2">
          <title>AD + Integrated Tobacco Order Set</title>
          <description>Access to the Integrated Tobacco Order Set (ITOS) Nicotine Replacement Therapy with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center&#xD;
AD + Integrated Tobacco Order Set: Physician will have access to:&#xD;
NRT with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Baseline</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="477"/>
                <participants group_id="P2" count="567"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="477"/>
                <participants group_id="P2" count="567"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>1 Month Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="477"/>
                <participants group_id="P2" count="567"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="434"/>
                <participants group_id="P2" count="526"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="43"/>
                <participants group_id="P2" count="41"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="41"/>
                <participants group_id="P2" count="38"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>6 Month Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="477"/>
                <participants group_id="P2" count="567"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="425"/>
                <participants group_id="P2" count="496"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="52"/>
                <participants group_id="P2" count="71"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
                <participants group_id="P2" count="58"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>12 Month Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="477"/>
                <participants group_id="P2" count="567"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="405"/>
                <participants group_id="P2" count="466"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="72"/>
                <participants group_id="P2" count="101"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="71"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>12 Month Biochemical Verification</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="477"/>
                <participants group_id="P2" count="567"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="53"/>
                <participants group_id="P2" count="65"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="424"/>
                <participants group_id="P2" count="502"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="71"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>subject did not self-report abstinence</title>
              <participants_list>
                <participants group_id="P1" count="352"/>
                <participants group_id="P2" count="401"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Academic Detailing (AD)</title>
          <description>Standard of care for patients who are smokers and admitted to the hospital.</description>
        </group>
        <group group_id="B2">
          <title>AD + Integrated Tobacco Order Set</title>
          <description>Access to the Integrated Tobacco Order Set (ITOS) Nicotine Replacement Therapy with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center&#xD;
AD + Integrated Tobacco Order Set: Physician will have access to:&#xD;
NRT with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center</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="477"/>
            <count group_id="B2" value="567"/>
            <count group_id="B3" value="1044"/>
          </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="49.3" spread="12.6"/>
                    <measurement group_id="B2" value="49.3" spread="11.7"/>
                    <measurement group_id="B3" value="49.3" spread="12.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="238"/>
                    <measurement group_id="B2" value="286"/>
                    <measurement group_id="B3" value="524"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="239"/>
                    <measurement group_id="B2" value="281"/>
                    <measurement group_id="B3" value="520"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="112"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="426"/>
                    <measurement group_id="B2" value="506"/>
                    <measurement group_id="B3" value="932"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="157"/>
                    <measurement group_id="B2" value="170"/>
                    <measurement group_id="B3" value="327"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="303"/>
                    <measurement group_id="B2" value="372"/>
                    <measurement group_id="B3" value="675"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="29"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="3"/>
                    <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>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="477"/>
                    <measurement group_id="B2" value="567"/>
                    <measurement group_id="B3" value="1044"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cigarettes/day</title>
          <units>cigarettes per day</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10.0" lower_limit="8" upper_limit="20"/>
                    <measurement group_id="B2" value="10.5" lower_limit="8" upper_limit="20"/>
                    <measurement group_id="B3" value="10.0" lower_limit="8" upper_limit="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Heavy Smoking Index &gt;= 4, N (%)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="208"/>
                    <measurement group_id="B2" value="210"/>
                    <measurement group_id="B3" value="418"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Exhaled Carbon Monoxide Confirmed Abstinence</title>
        <description>Tobacco abstinence will be assessed by obtaining an exhaled carbon monoxide reading for all subjects self-reporting tobacco abstinence at 12 month follow-up. Consistent with manufacturer's recommendations, a cutoff of 10 ppm will indicate current smoking.</description>
        <time_frame>12 months post enrollment</time_frame>
        <population>Only participants self-reporting abstinence during the 12 month follow-up call were asked to provide biochemical verification.</population>
        <group_list>
          <group group_id="O1">
            <title>Academic Detailing (AD)</title>
            <description>Standard of care for patients who are smokers and admitted to the hospital.</description>
          </group>
          <group group_id="O2">
            <title>AD + Integrated Tobacco Order Set</title>
            <description>Access to the Integrated Tobacco Order Set (ITOS) Nicotine Replacement Therapy with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center&#xD;
AD + Integrated Tobacco Order Set: Physician will have access to:&#xD;
NRT with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Exhaled Carbon Monoxide Confirmed Abstinence</title>
          <description>Tobacco abstinence will be assessed by obtaining an exhaled carbon monoxide reading for all subjects self-reporting tobacco abstinence at 12 month follow-up. Consistent with manufacturer's recommendations, a cutoff of 10 ppm will indicate current smoking.</description>
          <population>Only participants self-reporting abstinence during the 12 month follow-up call were asked to provide biochemical verification.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="78"/>
                <count group_id="O2" value="86"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="53"/>
                    <measurement group_id="O2" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 12 Months</title>
        <description>Self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use. The Time Line Follow Back technique will be used to assess 7-day point prevalence abstinence.</description>
        <time_frame>12 months post enrollment</time_frame>
        <population>Only includes participants who completed the 12 month follow-up appointment.</population>
        <group_list>
          <group group_id="O1">
            <title>Academic Detailing (AD)</title>
            <description>Standard of care for patients who are smokers and admitted to the hospital.</description>
          </group>
          <group group_id="O2">
            <title>AD + Integrated Tobacco Order Set</title>
            <description>Access to the Integrated Tobacco Order Set (ITOS) Nicotine Replacement Therapy with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center&#xD;
AD + Integrated Tobacco Order Set: Physician will have access to:&#xD;
NRT with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 12 Months</title>
          <description>Self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use. The Time Line Follow Back technique will be used to assess 7-day point prevalence abstinence.</description>
          <population>Only includes participants who completed the 12 month follow-up appointment.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="405"/>
                <count group_id="O2" value="466"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78"/>
                    <measurement group_id="O2" value="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 6 Months</title>
        <description>Self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use. The Time Line Follow Back technique will be used to assess 7-day point prevalence abstinence.</description>
        <time_frame>6 months post enrollment</time_frame>
        <population>Includes only participants who completed the 6 month follow-up appointment.</population>
        <group_list>
          <group group_id="O1">
            <title>Academic Detailing (AD)</title>
            <description>Standard of care for patients who are smokers and admitted to the hospital.</description>
          </group>
          <group group_id="O2">
            <title>AD + Integrated Tobacco Order Set</title>
            <description>Access to the Integrated Tobacco Order Set (ITOS) Nicotine Replacement Therapy with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center&#xD;
AD + Integrated Tobacco Order Set: Physician will have access to:&#xD;
NRT with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 6 Months</title>
          <description>Self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use. The Time Line Follow Back technique will be used to assess 7-day point prevalence abstinence.</description>
          <population>Includes only participants who completed the 6 month follow-up appointment.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="425"/>
                <count group_id="O2" value="496"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68"/>
                    <measurement group_id="O2" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 1 Month</title>
        <description>Self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use. The Time Line Follow Back technique will be used to assess 7-day point prevalence abstinence.</description>
        <time_frame>1 month post enrollment</time_frame>
        <population>Includes only participants who completed 1 month follow-up appointment.</population>
        <group_list>
          <group group_id="O1">
            <title>Academic Detailing (AD)</title>
            <description>Standard of care for patients who are smokers and admitted to the hospital.</description>
          </group>
          <group group_id="O2">
            <title>AD + Integrated Tobacco Order Set</title>
            <description>Access to the Integrated Tobacco Order Set (ITOS) Nicotine Replacement Therapy with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center&#xD;
AD + Integrated Tobacco Order Set: Physician will have access to:&#xD;
NRT with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 1 Month</title>
          <description>Self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use. The Time Line Follow Back technique will be used to assess 7-day point prevalence abstinence.</description>
          <population>Includes only participants who completed 1 month follow-up appointment.</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="434"/>
                <count group_id="O2" value="526"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="72"/>
                    <measurement group_id="O2" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Self-Reporting Use of Cessation Medications - 1 Month</title>
        <description>Nicotine replacement therapy (NRT) use and use of other pharmacotherapies will be assessed by self-report. A Treatment Services Review (TSR) will be administered during follow-up assessments at 1, 6, and 12 months post enrollment.</description>
        <time_frame>1 month post enrollment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Academic Detailing (AD)</title>
            <description>Standard of care for patients who are smokers and admitted to the hospital.</description>
          </group>
          <group group_id="O2">
            <title>AD + Integrated Tobacco Order Set</title>
            <description>Access to the Integrated Tobacco Order Set (ITOS) Nicotine Replacement Therapy with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center&#xD;
AD + Integrated Tobacco Order Set: Physician will have access to:&#xD;
NRT with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Self-Reporting Use of Cessation Medications - 1 Month</title>
          <description>Nicotine replacement therapy (NRT) use and use of other pharmacotherapies will be assessed by self-report. A Treatment Services Review (TSR) will be administered during follow-up assessments at 1, 6, and 12 months post enrollment.</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="434"/>
                <count group_id="O2" value="526"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="126"/>
                    <measurement group_id="O2" value="187"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Self-Reporting Use of Cessation Medications - 6 Months</title>
        <description>NRT use and use of other pharmacotherapies will be assessed by self-report. A Treatment Services Review (TSR) will be administered during follow-up assessments at 6 months post enrollment.</description>
        <time_frame>6 months post enrollment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Academic Detailing (AD)</title>
            <description>Standard of care for patients who are smokers and admitted to the hospital.</description>
          </group>
          <group group_id="O2">
            <title>AD + Integrated Tobacco Order Set</title>
            <description>Access to the Integrated Tobacco Order Set (ITOS) Nicotine Replacement Therapy with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center&#xD;
AD + Integrated Tobacco Order Set: Physician will have access to:&#xD;
NRT with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Self-Reporting Use of Cessation Medications - 6 Months</title>
          <description>NRT use and use of other pharmacotherapies will be assessed by self-report. A Treatment Services Review (TSR) will be administered during follow-up assessments at 6 months post enrollment.</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="425"/>
                <count group_id="O2" value="496"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="146"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Self-Reporting Use of Cessation Medications - 12 Months</title>
        <description>NRT use and use of other pharmacotherapies will be assessed by self-report. A Treatment Services Review (TSR) will be administered during follow-up assessments at 1, 6, and 12 months post enrollment.</description>
        <time_frame>12 months post enrollment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Academic Detailing (AD)</title>
            <description>Standard of care for patients who are smokers and admitted to the hospital.</description>
          </group>
          <group group_id="O2">
            <title>AD + Integrated Tobacco Order Set</title>
            <description>Access to the Integrated Tobacco Order Set (ITOS) Nicotine Replacement Therapy with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center&#xD;
AD + Integrated Tobacco Order Set: Physician will have access to:&#xD;
NRT with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Self-Reporting Use of Cessation Medications - 12 Months</title>
          <description>NRT use and use of other pharmacotherapies will be assessed by self-report. A Treatment Services Review (TSR) will be administered during follow-up assessments at 1, 6, and 12 months post enrollment.</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="405"/>
                <count group_id="O2" value="466"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="136"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants Self-Reporting Treatment Engagement - 1 Month</title>
        <description>Treatment engagement will be assessed by subject self-report during the 1 month follow-up interview. Subjects will be considered engaged in treatment if at 30 days after randomization the subject reports currently receiving care for the Quitline or another treatment program that addresses the subject's nicotine dependence.</description>
        <time_frame>1 month post enrollment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Academic Detailing (AD)</title>
            <description>Standard of care for patients who are smokers and admitted to the hospital.</description>
          </group>
          <group group_id="O2">
            <title>AD + Integrated Tobacco Order Set</title>
            <description>Access to the Integrated Tobacco Order Set (ITOS) Nicotine Replacement Therapy with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center&#xD;
AD + Integrated Tobacco Order Set: Physician will have access to:&#xD;
NRT with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Self-Reporting Treatment Engagement - 1 Month</title>
          <description>Treatment engagement will be assessed by subject self-report during the 1 month follow-up interview. Subjects will be considered engaged in treatment if at 30 days after randomization the subject reports currently receiving care for the Quitline or another treatment program that addresses the subject's nicotine dependence.</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="434"/>
                <count group_id="O2" value="526"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32"/>
                    <measurement group_id="O2" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed.</desc>
      <group_list>
        <group group_id="E1">
          <title>Academic Detailing (AD)</title>
          <description>Standard of care for patients who are smokers and admitted to the hospital.</description>
        </group>
        <group group_id="E2">
          <title>AD + Integrated Tobacco Order Set</title>
          <description>Access to the Integrated Tobacco Order Set (ITOS) Nicotine Replacement Therapy with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center&#xD;
AD + Integrated Tobacco Order Set: Physician will have access to:&#xD;
NRT with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center</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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </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="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Dr. Steven Bernstein</name_or_title>
      <organization>Yale School of Medicine</organization>
      <phone>203-737-3574</phone>
      <email>steven.bernstein@yale.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/NCT01691105
org study id: 1205010297
secondary id: R18HL108788
nct id: NCT01691105
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This study will implement and test the effectiveness and cost-effectiveness of a tobacco
      cessation intervention (Academic Detailing + Integrated Tobacco Order Set - AD + ITOS) for
      adults admitted to the hospital. The intervention will begin during the hospital stay and
      continue after discharge. The intervention will use resources easily available to most acute
      care hospitals: computerized physician order entry, physician and nurse education, staff
      meetings for physicians, nurses and allied health professionals, online learning
      capabilities, faxing to primary care providers (PCPs), and the telephone counseling and
      support available from a state smokers' quitline (QL).

      The investigators hypothesize that the subjects in the intervention arm (AD + ITOS) will be
      more likely to achieve tobacco abstinence at 12 months post hospital stay than subjects in
      the control arm (Academic Detailing - AD). Tobacco abstinence will be assessed by self report
      and biochemical verification (exhaled carbon monoxide reading).
Cigarette smoking remains the leading cause of preventable death and illness in the United
      States. In 2008, 20.6% of all American adults smoked, and 435,000 died from smoking-related
      illnesses. Economic costs of smoking dependence are estimated at $193 billion/year and have
      far-reaching implications for the individual, workplace, society and the healthcare system.
      However, treatment is associated with significant individual and society benefits, and both
      counseling and pharmacotherapy have been demonstrated to be effective treatments. Along with
      poverty and low education, smoking causes a greater loss of quality-adjusted life years than
      race, uninsurance, overweight, or binge drinking.

      Smokers are admitted to acute care hospital more than nonsmokers. Using estimates from a
      number of sources, we estimate that approximately 6.1-12.5 million hospitalizations occur
      annually among adult smokers. This represents 20-41% of the 29.8 million annual inpatient
      stays in US acute care hospitals among adults age 18 and older unrelated to pregnancy or
      childbirth. Put another way, the nation's 46 million smokers represent 20% of the adult
      population, but account for 20-40% of all hospitalizations unrelated to pregnancy. Given that
      US hospitals are now smoke-free (per Joint Commission regulations), and many of these
      admissions are for tobacco-related conditions, the hospital admission represents a profound
      opportunity-a "teachable moment"-for tobacco control.

      Recent "core measure" regulations by the Joint Commission and the Centers for Medicare and
      Medicaid Services require hospitals to report publicly their tobacco screening for patients
      admitted with acute myocardial infarction, congestive heart failure, and pneumonia. Although
      many hospitals have improved their performance considerably on these smoking measures,
      sometimes this has resulted from "gaming," e.g. giving all discharged patients a preprinted
      instruction sheet that includes boilerplate text about smoking cessation. Thus, although most
      hospitals assess inpatients for tobacco use (either through a nursing assessment or the
      physician's initial history and physical examination), there are often no systems in place to
      initiate or sustain tobacco treatment for smokers. This gap in service delivery prevents
      millions of smokers from accessing the many effective, evidence-based treatments for tobacco
      dependence during a period in which they may be particularly receptive to an intervention.

      Hence, the overarching goal of this project is to implement and study the effectiveness and
      cost-effectiveness of a tobacco intervention for hospitalized adults that begins during
      inpatient treatment and continues after discharge. To enhance dissemination, we will use
      resources currently available to most acute care hospitals: computerized physician order
      entry, physician and nurse education, staff meetings for physicians, nurses, and allied
      health professionals, online learning capabilities, faxing to primary care providers (PCPs),
      and the telephone counseling and support available from a state smokers' quitline (QL). In
      the final year, a toolkit will be disseminated by professional societies. We hypothesize that
      the proposed intervention is clinically effective, cost effective, sustainable, and
      generalizable. All interventions are evidence-based and consistent with the 2008 Public
      Health Service clinical practice guideline for tobacco dependence treatment.

      The Specific Aims of the proposed project are to:

      Primary Aims:

        1. Determine whether Academic Detailing (AD) and an Integrated Tobacco Order Set (ITOS)
           compared to AD alone improves biologically verified smoking cessation at 12 months
           post-quit in a cohort of 960 smokers age > 18 years admitted to Yale New Haven Hospital
           (YNHH).

           Secondary Aims:

        2. Study ITOS's ability to encourage smokers to use treatment services and reduce
           consumption.

        3. Study ITOS's ability to enhance provider delivery of tobacco screening and treatment.

        4. Conduct an incremental cost-effectiveness analysis of the intervention.

      Our associated hypotheses are:

        1. Subjects treated by physicians in the AD+ITOS arm will have a higher rate of
           biochemically verified 7-day point prevalence smoking abstinence at 12 months post-quit
           than subjects treated by physicians in the AD arm, in a cohort of adult smokers admitted
           to the inpatient units of Yale-New Haven Hospital.

        2. Subjects treated by AD+ITOS physicians will have made more quit attempts, and
           experienced greater reduction in daily cigarette consumption, than smokers treated by AD
           physicians.

        3. A higher proportion of patients treated by AD+ITOS physicians will have tobacco
           treatment initiated in hospital than patients treated by AD physicians.

        4. Societal costs of AD+ITOS, per abstinent smoker, will be cost-effective relative to AD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Number of Participants With Exhaled Carbon Monoxide Confirmed Abstinence
time frame: 12 months post enrollment
description: Tobacco abstinence will be assessed by obtaining an exhaled carbon monoxide reading for all subjects self-reporting tobacco abstinence at 12 month follow-up. Consistent with manufacturer's recommendations, a cutoff of 10 ppm will indicate current smoking.
measure: Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 12 Months
time frame: 12 months post enrollment
description: Self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use. The Time Line Follow Back technique will be used to assess 7-day point prevalence abstinence.
measure: Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 6 Months
time frame: 6 months post enrollment
description: Self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use. The Time Line Follow Back technique will be used to assess 7-day point prevalence abstinence.
measure: Number of Participants With Self-Reported Tobacco Reduction or Abstinence - 1 Month
time frame: 1 month post enrollment
description: Self-report questionnaires are completed over the phone to assess reduction in cigarette use or abstinence from cigarette use. The Time Line Follow Back technique will be used to assess 7-day point prevalence abstinence.
measure: Number of Participants Self-Reporting Use of Cessation Medications - 1 Month
time frame: 1 month post enrollment
description: Nicotine replacement therapy (NRT) use and use of other pharmacotherapies will be assessed by self-report. A Treatment Services Review (TSR) will be administered during follow-up assessments at 1, 6, and 12 months post enrollment.
measure: Number of Participants Self-Reporting Use of Cessation Medications - 6 Months
time frame: 6 months post enrollment
description: NRT use and use of other pharmacotherapies will be assessed by self-report. A Treatment Services Review (TSR) will be administered during follow-up assessments at 6 months post enrollment.
measure: Number of Participants Self-Reporting Use of Cessation Medications - 12 Months
time frame: 12 months post enrollment
description: NRT use and use of other pharmacotherapies will be assessed by self-report. A Treatment Services Review (TSR) will be administered during follow-up assessments at 1, 6, and 12 months post enrollment.
measure: Number of Participants Self-Reporting Treatment Engagement - 1 Month
time frame: 1 month post enrollment
description: Treatment engagement will be assessed by subject self-report during the 1 month follow-up interview. Subjects will be considered engaged in treatment if at 30 days after randomization the subject reports currently receiving care for the Quitline or another treatment program that addresses the subject's nicotine dependence.
arm group label: Academic Detailing (AD)
arm group type: No Intervention
description: Standard of care for patients who are smokers and admitted to the hospital.
arm group label: AD + Integrated Tobacco Order Set
arm group type: Experimental
description: Access to the Integrated Tobacco Order Set (ITOS) Nicotine Replacement Therapy with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center
intervention type: Other
intervention name: AD + Integrated Tobacco Order Set
description: Physician will have access to:
NRT with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center
arm group label: AD + Integrated Tobacco Order Set
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Steven L Bernstein, MD
role: Principal Investigator
affiliation: Yale University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Tobacco Use Disorder
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 