<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/NCT03793894</url>
  </required_header>
  <id_info>
    <org_study_id>H-38353</org_study_id>
    <secondary_id>LCD-507875</secondary_id>
    <nct_id>NCT03793894</nct_id>
  </id_info>
  <brief_title>Inpatient Smokers and LDCT Screening Part 2</brief_title>
  <official_title>Engaging Low SES Inpatient Smokers in LDCT Lung Cancer Screening: Enhanced Interventions That Include CHWs to Address SDH Barriers</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>
      Lung cancer suffers from large racial and socioeconomic disparities. Yet those at the highest&#xD;
      risk of lung cancer death - current smokers, blacks, and individuals with low socioeconomic&#xD;
      status (SES) and negative social determinants of health (SDH) - are less likely to receive&#xD;
      preventive health services, including the two most effective interventions to reduce lung&#xD;
      cancer mortality: tobacco dependence treatment and lung cancer screening (LCS) with low-dose&#xD;
      computed tomography (LDCT). At Boston Medical Center (BMC) these preventive services are&#xD;
      grossly underutilized, in part due to barriers our patients face in accessing these&#xD;
      outpatient programs. Innovative approaches are needed to guide high-risk smokers to&#xD;
      post-discharge early lung cancer detection services.&#xD;
&#xD;
      The overarching goal of this study is to reduce disparities in lung cancer morbidity and&#xD;
      mortality by using hospitalization at an urban safety net hospital as an opportunity to&#xD;
      connect high-risk smokers to both LDCT lung cancer screening and tobacco dependence&#xD;
      treatment.&#xD;
&#xD;
      In addition to inpatient shared decision making [SDM] by an NP using a decision aid,&#xD;
      screen-eligible smokers will also be connected with a community health worker (CHW) to&#xD;
      facilitate access to outpatient smoking cessation counseling and LCS (CHW navigation).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a randomized controlled trial (RCT) among 128 hospitalized smokers at BMC (64&#xD;
      participants in each of two arms), to assess the effect of inpatient SDM + CHW Navigation&#xD;
      (AHRQ LDCT screening decision aid + CHW + SDM discussion + smoking cessation counseling)&#xD;
      compared to Enhanced Usual Care (smoking cessation counseling + decision aid) on LDCT&#xD;
      screening completion at 3 months, patient knowledge, and smoking cessation at 6 months.&#xD;
&#xD;
      The research will meet two specific aims (SA1 and SA2).&#xD;
&#xD;
      SA1: To address barriers to engaging smokers in prevention and early detection of lung&#xD;
      cancer, a pilot RCT (Pilot Study 2) will be conducted in which screen-eligible hospitalized&#xD;
      smokers will be randomized to receive inpatient sdm + CHW navigation (inpatient SDM during&#xD;
      smoking cessation counseling visits + CHW navigation to coordinate outpatient tobacco&#xD;
      treatment, referral to LCS, and resources to address negative social determinant of health&#xD;
      that present barriers to these preventive services) or Enhanced usual care (furnishing of&#xD;
      LDCT screening decision aid during inpatient smoking cessation counseling visits). Compared&#xD;
      to Enhanced Usual Care, it is hypothesized that inpatient sdm + CHW navigation will increase&#xD;
      the number of patients completing LCS (1° outcome) and LCS knowledge, and biochemically&#xD;
      validated smoking cessation at 6 months (2° outcome).&#xD;
&#xD;
      SA2: To collect stakeholder input to inform future implementation, Fifteen primary care&#xD;
      providers (PCPs) will be interviewed to assess their impressions of the intervention,&#xD;
      integration into workflow, and barriers to adoption. Fifteen smokers who received the&#xD;
      intervention will be interviewed to learn their impressions of its utility and suggestions&#xD;
      for improvement.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 12, 2019</start_date>
  <completion_date type="Actual">June 4, 2020</completion_date>
  <primary_completion_date type="Actual">January 28, 2020</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>LDCT screening within 3 months post randomization</measure>
    <time_frame>3 months</time_frame>
    <description>Data will be collected from the electronic health record (EHR) and the BMC lung cancer screening (LDCT) database.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Knowledge of LDCT screening</measure>
    <time_frame>baseline, 24 hours post enrollment</time_frame>
    <description>Knowledge about LDCT screening will be measured with a 23-item instrument developed by Lau and colleagues and modified for a low health literacy population by Crothers. 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>Self-report smoking cessation</measure>
    <time_frame>6 months</time_frame>
    <description>Participants will be asked during telephone interview if they are smoking.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biochemical validated smoking cessation</measure>
    <time_frame>6 months</time_frame>
    <description>Participants who self-report quitting will be invited to complete the CO test for biochemical verification. This dichotomous outcome will be defined by biochemically verified 7-day point prevalence abstinence at 6 months. At study end, participants will be identified as smokers who 1) self-report abstinence, but are identified as smokers via biochemical validation (CO level &gt;10 ppm), or 2) self-report abstinence, but refuse biochemical verification.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Lung Cancer Screening</condition>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>Enhanced usual care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All trial participants will receive smoking cessation counseling (standard of care) and will be given the AHRQ &quot;Is Lung Cancer Screening Right for me?&quot; patient decision aid to review independently while in the hospital.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Inpatient SDM + CHW Navigation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to the smoking cessation counseling and decision aid received by all subjects, intervention subjects will receive shared decision making (SDM) + CHW navigation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Smoking Cessation Counseling</intervention_name>
    <description>All participants will receive inpatient smoking cessation counseling by the tobacco-trained NP. Inpatient smoking cessation counseling is the standard of care at BMC.</description>
    <arm_group_label>Enhanced usual care</arm_group_label>
    <arm_group_label>Inpatient SDM + CHW Navigation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Decision Aid</intervention_name>
    <description>The AHRQ &quot;Is Lung Cancer Screening Right for me?&quot; patient 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 tradeoffs; 3) clear quit smoking messaging and resources (1-800-QUIT-NOW)</description>
    <arm_group_label>Enhanced usual care</arm_group_label>
    <arm_group_label>Inpatient SDM + CHW Navigation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Shared decision making (SDM)</intervention_name>
    <description>During the smoking cessation consultation, the nurse practitioner (NP) will conduct SDM, using the 4-page AHRQ &quot;Is Lung Cancer Screening Right for me?&quot; decision aid as a guide. The purpose of SDM is three-fold: 1) conduct a tailored discussion on tradeoffs of LDCT screening, consistent with Centers for Medicare &amp; Medicaid Services (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>Inpatient SDM + CHW Navigation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CHW Navigation</intervention_name>
    <description>The CHW will meet with the participant after the SDM to initiate the coordination of outpatient tobacco treatment, referral to LCS, and resources to address the barriers to preventive services. The CHW will follow patients subjects in the intervention arm for 3 months to help navigate and address negative social determinants of health that are barriers to LCS and tobacco treatment. For patients who agree to screening, the CHW will schedule the appointment, arrange the transportation to appointment, and meet participant at the appointment to facilitate the screening.</description>
    <arm_group_label>Inpatient SDM + CHW Navigation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Hospitalized smoker at BMC&#xD;
&#xD;
          2. Meeting LDCT screening eligibility criteria: (age 55-80 years; ≥30-pack years smoking)&#xD;
&#xD;
          3. Current smoker (&gt; 1 cigarette per day)&#xD;
&#xD;
          4. Able to speak, read, and understand English&#xD;
&#xD;
          5. Able and willing to comply with all study protocols and procedures&#xD;
&#xD;
          6. Having a PCP in the BMC network or one of the affiliated health centers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inability to tolerate surgical resection of a lung cancer, as defined by home oxygen&#xD;
             therapy (an indicator of severe lung cancer or heart disease)&#xD;
&#xD;
          2. Active cancer (receiving treatment/new diagnosis) in prior 3 months or advanced stage&#xD;
             cancer&#xD;
&#xD;
          3. Signs and symptoms of lung cancer or prior diagnosis of lung cancer&#xD;
&#xD;
          4. Already had chest CT (LDCT screening or other chest CT) in the past year&#xD;
&#xD;
          5. Pregnant&#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>Boston Medical Center</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 2020</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>July 6, 2020</last_update_submitted>
  <last_update_submitted_qc>July 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Community health worker (CHW)</keyword>
  <keyword>Shared decision making (SDM)</keyword>
  <keyword>Low-dose computed tomography (LDCT)</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/NCT03793894
org study id: H-38353
secondary id: LCD-507875
nct id: NCT03793894
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Lung cancer suffers from large racial and socioeconomic disparities. Yet those at the highest
      risk of lung cancer death - current smokers, blacks, and individuals with low socioeconomic
      status (SES) and negative social determinants of health (SDH) - are less likely to receive
      preventive health services, including the two most effective interventions to reduce lung
      cancer mortality: tobacco dependence treatment and lung cancer screening (LCS) with low-dose
      computed tomography (LDCT). At Boston Medical Center (BMC) these preventive services are
      grossly underutilized, in part due to barriers our patients face in accessing these
      outpatient programs. Innovative approaches are needed to guide high-risk smokers to
      post-discharge early lung cancer detection services.

      The overarching goal of this study is to reduce disparities in lung cancer morbidity and
      mortality by using hospitalization at an urban safety net hospital as an opportunity to
      connect high-risk smokers to both LDCT lung cancer screening and tobacco dependence
      treatment.

      In addition to inpatient shared decision making [SDM] by an NP using a decision aid,
      screen-eligible smokers will also be connected with a community health worker (CHW) to
      facilitate access to outpatient smoking cessation counseling and LCS (CHW navigation).
This study is a randomized controlled trial (RCT) among 128 hospitalized smokers at BMC (64
      participants in each of two arms), to assess the effect of inpatient SDM + CHW Navigation
      (AHRQ LDCT screening decision aid + CHW + SDM discussion + smoking cessation counseling)
      compared to Enhanced Usual Care (smoking cessation counseling + decision aid) on LDCT
      screening completion at 3 months, patient knowledge, and smoking cessation at 6 months.

      The research will meet two specific aims (SA1 and SA2).

      SA1: To address barriers to engaging smokers in prevention and early detection of lung
      cancer, a pilot RCT (Pilot Study 2) will be conducted in which screen-eligible hospitalized
      smokers will be randomized to receive inpatient sdm + CHW navigation (inpatient SDM during
      smoking cessation counseling visits + CHW navigation to coordinate outpatient tobacco
      treatment, referral to LCS, and resources to address negative social determinant of health
      that present barriers to these preventive services) or Enhanced usual care (furnishing of
      LDCT screening decision aid during inpatient smoking cessation counseling visits). Compared
      to Enhanced Usual Care, it is hypothesized that inpatient sdm + CHW navigation will increase
      the number of patients completing LCS (1° outcome) and LCS knowledge, and biochemically
      validated smoking cessation at 6 months (2° outcome).

      SA2: To collect stakeholder input to inform future implementation, Fifteen primary care
      providers (PCPs) will be interviewed to assess their impressions of the intervention,
      integration into workflow, and barriers to adoption. Fifteen smokers who received the
      intervention will be interviewed to learn their impressions of its utility and suggestions
      for improvement.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: LDCT screening within 3 months post randomization
time frame: 3 months
description: Data will be collected from the electronic health record (EHR) and the BMC lung cancer screening (LDCT) database.
measure: Knowledge of LDCT screening
time frame: baseline, 24 hours post enrollment
description: Knowledge about LDCT screening will be measured with a 23-item instrument developed by Lau and colleagues and modified for a low health literacy population by Crothers. The instrument includes true/false and multiple choice questions that will be used to determine a total score representing knowledge of LDCT screening.
measure: Self-report smoking cessation
time frame: 6 months
description: Participants will be asked during telephone interview if they are smoking.
measure: Biochemical validated smoking cessation
time frame: 6 months
description: Participants who self-report quitting will be invited to complete the CO test for biochemical verification. This dichotomous outcome will be defined by biochemically verified 7-day point prevalence abstinence at 6 months. At study end, participants will be identified as smokers who 1) self-report abstinence, but are identified as smokers via biochemical validation (CO level >10 ppm), or 2) self-report abstinence, but refuse biochemical verification.
arm group label: Enhanced usual care
arm group type: Active Comparator
description: All trial participants will receive smoking cessation counseling (standard of care) and will be given the AHRQ "Is Lung Cancer Screening Right for me?" patient decision aid to review independently while in the hospital.
arm group label: Inpatient SDM + CHW Navigation
arm group type: Experimental
description: In addition to the smoking cessation counseling and decision aid received by all subjects, intervention subjects will receive shared decision making (SDM) + CHW navigation.
intervention type: Behavioral
intervention name: Smoking Cessation Counseling
description: All participants will receive inpatient smoking cessation counseling by the tobacco-trained NP. Inpatient smoking cessation counseling is the standard of care at BMC.
arm group label: Enhanced usual care
arm group label: Inpatient SDM + CHW Navigation
intervention type: Behavioral
intervention name: Decision Aid
description: The AHRQ "Is Lung Cancer Screening Right for me?" patient 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 tradeoffs; 3) clear quit smoking messaging and resources (1-800-QUIT-NOW)
arm group label: Enhanced usual care
arm group label: Inpatient SDM + CHW Navigation
intervention type: Behavioral
intervention name: Shared decision making (SDM)
description: During the smoking cessation consultation, the nurse practitioner (NP) will conduct SDM, using the 4-page AHRQ "Is Lung Cancer Screening Right for me?" decision aid as a guide. The purpose of SDM is three-fold: 1) conduct a tailored discussion on tradeoffs of LDCT screening, consistent with Centers for Medicare & Medicaid Services (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: Inpatient SDM + CHW Navigation
intervention type: Behavioral
intervention name: CHW Navigation
description: The CHW will meet with the participant after the SDM to initiate the coordination of outpatient tobacco treatment, referral to LCS, and resources to address the barriers to preventive services. The CHW will follow patients subjects in the intervention arm for 3 months to help navigate and address negative social determinants of health that are barriers to LCS and tobacco treatment. For patients who agree to screening, the CHW will schedule the appointment, arrange the transportation to appointment, and meet participant at the appointment to facilitate the screening.
arm group label: Inpatient SDM + CHW Navigation
criteria: 
gender: All
minimum age: 55 Years
maximum age: 80 Years
healthy volunteers: No
last name: Hasmeena Kathuria, MD
role: Principal Investigator
affiliation: Boston Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Neoplasms
sharing ipd: No