<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/NCT03276806</url>
  </required_header>
  <id_info>
    <org_study_id>H-36854</org_study_id>
    <secondary_id>LCD-507875</secondary_id>
    <nct_id>NCT03276806</nct_id>
  </id_info>
  <brief_title>Inpatient Smokers and LDCT Screening RCT</brief_title>
  <official_title>Capitalizing on Hospitalization to Engage Low SES Smokers in LDCT Screening: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>American Lung Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston University</source>
  <oversight_info>
    <has_dmc>No</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>
      Current smokers who undergo annual low dose CT (LDCT) lung cancer screening and successfully&#xD;
      quit smoking derive the greatest reduction in lung cancer mortality. Unfortunately, those at&#xD;
      highest risk of lung cancer death- those with low socioeconomic status, blacks, and current&#xD;
      smokers- are the same individuals that typically have reduced access to preventive healthcare&#xD;
      such as smoking cessation services and screening tests. Furthermore, patients from&#xD;
      underserved communities often have lower health literacy, less awareness of lung cancer&#xD;
      screening, and a poor understanding of the trade-offs of LDCT screening. In 2015 the Center&#xD;
      for Medicare and Medicaid Services began requiring (1) a shared decision-making (SDM)&#xD;
      discussion including use of a patient decision aid and (2) smoking cessation counseling in&#xD;
      order to receive reimbursement for LDCT screening. There is little guidance, however, to help&#xD;
      healthcare systems implement this requirement. Furthermore, primary care physicians (PCPs)&#xD;
      report time constraints, competing demands, and knowledge deficiencies as barriers to&#xD;
      optimizing utilization of LDCT screening.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this study is to create and evaluate an intervention that capitalizes on&#xD;
      hospitalization at an urban safety net hospital as an opportunity to connect high risk&#xD;
      smokers to lung cancer screening and smoking cessation services. Building on the&#xD;
      well-established inpatient tobacco dependence consult service at Boston Medical Center, the&#xD;
      investigators will study the effect of adding a nurse-driven LDCT screening SDM intervention&#xD;
      to inpatient smoking cessation counseling among screen-eligible hospitalized smokers.&#xD;
      Hospitalization may be an ideal time-point for this intervention as it offers 1) a &quot;teachable&#xD;
      moment&quot; for patients, when they may be particularly receptive to interventions to reduce&#xD;
      smoking-related disease, and 2) an opportunity to offload busy PCPs of the obligation to&#xD;
      conduct SDM for LDCT screening.&#xD;
&#xD;
      In Aim 1, screen-eligible patients who are smokers will be randomized into one of the study&#xD;
      arms (n=284, 142 per arm) to receive either inpatient 1) SDM (SDM by a thoracic oncology&#xD;
      nurse using a decision aid) or 2) usual care and a LDCT informational brochure during&#xD;
      inpatient smoking cessation consultation visits. In both arms the thoracic oncology nurse&#xD;
      will counsel patients on smoking cessation. The investigators hypothesize that for&#xD;
      screen-eligible smokers, inpatient SDM will increase (1) LDCT screening rates, (2) patient&#xD;
      knowledge of LDCT screening, and (3) 1 month smoking quit rates compared to usual care.&#xD;
&#xD;
      In Aim 2, the potential for future implementation of the intervention will be evaluated by&#xD;
      incorporating stakeholder impressions of the intervention through qualitative interviews. By&#xD;
      study end, an inpatient intervention will be created to promote both LDCT screening and&#xD;
      smoking cessation among low income and minority smokers. This hybrid study will allow te&#xD;
      investigators to establish not only the effectiveness of the intervention, but also help&#xD;
      inform future implementation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 7, 2017</start_date>
  <completion_date type="Actual">July 1, 2019</completion_date>
  <primary_completion_date type="Actual">April 1, 2019</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Completion of LDCT screening</measure>
    <time_frame>3 months</time_frame>
    <description>The electronic records review and from the Lung Cancer Screening clinical database created by the Department of Pulmonary Disease and Critical Care at BMC will be reviewed to determine which participants have completed LDCT screening designated as yes or no and if yes the date of the LDCT screening will be recorded..</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Knowledge of LDCT screening (experimental group)</measure>
    <time_frame>Baseline, immediately post SDM, 1 month</time_frame>
    <description>A 21 item instrument developed by Lau and colleagues and modified for a low health literacy population by Crothers will be used. The instrument includes true/false and multiple choice questions that will be used to determine a total score representing knowledge of LDCT screening. The mean percentage of correct responses will be measured so higher scores are better suggesting more knowledge about LDCT screening.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knowledge of LDCT screening (active comparator group)</measure>
    <time_frame>Baseline, 1 month</time_frame>
    <description>A 21 item instrument developed by Lau and colleagues and modified for a low health literacy population by Crothers will be used. The instrument includes true/false and multiple choice questions that will be used to determine a total score representing knowledge of LDCT screening.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>smoking cessation</measure>
    <time_frame>4 weeks</time_frame>
    <description>Dichotomous outcome by self-report of prolonged abstinence at 4 weeks and 7-day point prevalence at 4 weeks, as recommended by the Society for Research on Nicotine and Tobacco and the Russell Standard.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>Lung Cancer</condition>
  <condition>Shared Decision Making</condition>
  <arm_group>
    <arm_group_label>SDM + decision aid + tobacco counseling</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive tobacco dependence/smoking cessation counseling by a nurse, SDM and a decision aid.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LDCT brochure + tobacco counseling</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will receive tobacco dependence/smoking cessation counseling by a nurse and a LDCT informational brochure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>tobacco dependence/smoking cessation counseling</intervention_name>
    <description>Standard of care tobacco dependence/smoking cessation counseling offered to all smokers at Boston Medical Center.</description>
    <arm_group_label>LDCT brochure + tobacco counseling</arm_group_label>
    <arm_group_label>SDM + decision aid + tobacco counseling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SDM</intervention_name>
    <description>SDM is three-fold to: 1) conduct a tailored discussion on tradeoffs of LDCT screening, consistent with CMS requirements for SDM using a decision aid; 2) directly connect interested patients to LDCT screening; 3) to empower and motivate patients to quit smoking within the LDCT screening context.</description>
    <arm_group_label>SDM + decision aid + tobacco counseling</arm_group_label>
    <other_name>Shared decision making</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Decision Aid</intervention_name>
    <description>The decision aid is a 4-page paper format with the following features: 1) LDCT screening harms and benefits information, written in plain language and using pictographs, easily understood by those with low health literacy; 2) prompts to clarify patient values and preferences and to stimulate discussion about trade-offs; 3) clear quit smoking messaging and resources (1-800-QUIT-NOW).</description>
    <arm_group_label>SDM + decision aid + tobacco counseling</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>LDCT brochure</intervention_name>
    <description>A informational brochure developed by the BMC screening program about low dose CT screening for lung cancer.</description>
    <arm_group_label>LDCT brochure + tobacco counseling</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  hospitalized smokers at BMC meeting LDCT screening eligible criteria&#xD;
&#xD;
          -  males and females 55-80 years of age&#xD;
&#xD;
          -  ≥30-pack years smoking&#xD;
&#xD;
          -  current smoker&#xD;
&#xD;
          -  able to speak, read, and understand English&#xD;
&#xD;
          -  able and willing to participate and provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe co-morbidities expected to limit life expectancy or ability to tolerate&#xD;
             surgical resection of a lung cancer, including patients requiring home oxygen therapy&#xD;
             (an indicator of severe lung or heart disease), and patients with active cancer&#xD;
&#xD;
          -  patients who have already had LDCT screening in the past year&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hasmeena Kathuria, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistant Professor</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>September 5, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>July 2, 2019</last_update_submitted>
  <last_update_submitted_qc>July 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CT low dose</keyword>
  <keyword>nurse led intervention</keyword>
  <keyword>safety net hospital</keyword>
  <keyword>lung cancer screening with CTLD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03276806
org study id: H-36854
secondary id: LCD-507875
nct id: NCT03276806
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Current smokers who undergo annual low dose CT (LDCT) lung cancer screening and successfully
      quit smoking derive the greatest reduction in lung cancer mortality. Unfortunately, those at
      highest risk of lung cancer death- those with low socioeconomic status, blacks, and current
      smokers- are the same individuals that typically have reduced access to preventive healthcare
      such as smoking cessation services and screening tests. Furthermore, patients from
      underserved communities often have lower health literacy, less awareness of lung cancer
      screening, and a poor understanding of the trade-offs of LDCT screening. In 2015 the Center
      for Medicare and Medicaid Services began requiring (1) a shared decision-making (SDM)
      discussion including use of a patient decision aid and (2) smoking cessation counseling in
      order to receive reimbursement for LDCT screening. There is little guidance, however, to help
      healthcare systems implement this requirement. Furthermore, primary care physicians (PCPs)
      report time constraints, competing demands, and knowledge deficiencies as barriers to
      optimizing utilization of LDCT screening.
The goal of this study is to create and evaluate an intervention that capitalizes on
      hospitalization at an urban safety net hospital as an opportunity to connect high risk
      smokers to lung cancer screening and smoking cessation services. Building on the
      well-established inpatient tobacco dependence consult service at Boston Medical Center, the
      investigators will study the effect of adding a nurse-driven LDCT screening SDM intervention
      to inpatient smoking cessation counseling among screen-eligible hospitalized smokers.
      Hospitalization may be an ideal time-point for this intervention as it offers 1) a "teachable
      moment" for patients, when they may be particularly receptive to interventions to reduce
      smoking-related disease, and 2) an opportunity to offload busy PCPs of the obligation to
      conduct SDM for LDCT screening.

      In Aim 1, screen-eligible patients who are smokers will be randomized into one of the study
      arms (n=284, 142 per arm) to receive either inpatient 1) SDM (SDM by a thoracic oncology
      nurse using a decision aid) or 2) usual care and a LDCT informational brochure during
      inpatient smoking cessation consultation visits. In both arms the thoracic oncology nurse
      will counsel patients on smoking cessation. The investigators hypothesize that for
      screen-eligible smokers, inpatient SDM will increase (1) LDCT screening rates, (2) patient
      knowledge of LDCT screening, and (3) 1 month smoking quit rates compared to usual care.

      In Aim 2, the potential for future implementation of the intervention will be evaluated by
      incorporating stakeholder impressions of the intervention through qualitative interviews. By
      study end, an inpatient intervention will be created to promote both LDCT screening and
      smoking cessation among low income and minority smokers. This hybrid study will allow te
      investigators to establish not only the effectiveness of the intervention, but also help
      inform future implementation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Completion of LDCT screening
time frame: 3 months
description: The electronic records review and from the Lung Cancer Screening clinical database created by the Department of Pulmonary Disease and Critical Care at BMC will be reviewed to determine which participants have completed LDCT screening designated as yes or no and if yes the date of the LDCT screening will be recorded..
measure: Knowledge of LDCT screening (experimental group)
time frame: Baseline, immediately post SDM, 1 month
description: A 21 item instrument developed by Lau and colleagues and modified for a low health literacy population by Crothers will be used. The instrument includes true/false and multiple choice questions that will be used to determine a total score representing knowledge of LDCT screening. The mean percentage of correct responses will be measured so higher scores are better suggesting more knowledge about LDCT screening.
measure: Knowledge of LDCT screening (active comparator group)
time frame: Baseline, 1 month
description: A 21 item instrument developed by Lau and colleagues and modified for a low health literacy population by Crothers will be used. The instrument includes true/false and multiple choice questions that will be used to determine a total score representing knowledge of LDCT screening.
measure: smoking cessation
time frame: 4 weeks
description: Dichotomous outcome by self-report of prolonged abstinence at 4 weeks and 7-day point prevalence at 4 weeks, as recommended by the Society for Research on Nicotine and Tobacco and the Russell Standard.
arm group label: SDM + decision aid + tobacco counseling
arm group type: Experimental
description: Participants will receive tobacco dependence/smoking cessation counseling by a nurse, SDM and a decision aid.
arm group label: LDCT brochure + tobacco counseling
arm group type: Active Comparator
description: Participants will receive tobacco dependence/smoking cessation counseling by a nurse and a LDCT informational brochure.
intervention type: Behavioral
intervention name: tobacco dependence/smoking cessation counseling
description: Standard of care tobacco dependence/smoking cessation counseling offered to all smokers at Boston Medical Center.
arm group label: LDCT brochure + tobacco counseling
arm group label: SDM + decision aid + tobacco counseling
intervention type: Behavioral
intervention name: SDM
description: SDM is three-fold to: 1) conduct a tailored discussion on tradeoffs of LDCT screening, consistent with CMS requirements for SDM using a decision aid; 2) directly connect interested patients to LDCT screening; 3) to empower and motivate patients to quit smoking within the LDCT screening context.
arm group label: SDM + decision aid + tobacco counseling
other name: Shared decision making
intervention type: Other
intervention name: Decision Aid
description: The decision aid is a 4-page paper format with the following features: 1) LDCT screening harms and benefits information, written in plain language and using pictographs, easily understood by those with low health literacy; 2) prompts to clarify patient values and preferences and to stimulate discussion about trade-offs; 3) clear quit smoking messaging and resources (1-800-QUIT-NOW).
arm group label: SDM + decision aid + tobacco counseling
intervention type: Other
intervention name: LDCT brochure
description: A informational brochure developed by the BMC screening program about low dose CT screening for lung cancer.
arm group label: LDCT brochure + tobacco counseling
criteria: 
gender: All
minimum age: 55 Years
maximum age: 80 Years
healthy volunteers: No
last name: Hasmeena Kathuria, MD
role: Principal Investigator
affiliation: Assistant Professor
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Neoplasms
sharing ipd: No