<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/NCT04462289</url>
  </required_header>
  <id_info>
    <org_study_id>CDX 20-001</org_study_id>
    <nct_id>NCT04462289</nct_id>
  </id_info>
  <brief_title>Electronic Proactive Outreach for Smokers With COPD</brief_title>
  <official_title>Electronic Proactive Outreach for Smokers With COPD: Engaging Patients to Quit (CDA 19-081)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic obstructive pulmonary disease (COPD) is one of the most common respiratory diseases,&#xD;
      with 90% of cases directly attributable to smoking. Unfortunately, many patients continue to&#xD;
      smoke and have an urgent need to quit. Proactive tobacco treatment programs identify patients&#xD;
      outside of a routine clinical appointment and engage them in making a supported quit attempt.&#xD;
&#xD;
      Most previous research of proactive tobacco treatment has used telephone outreach, which can&#xD;
      be resource intensive. Electronic methods (texting, secure messaging) may be effective while&#xD;
      requiring fewer resources.&#xD;
&#xD;
      In this study, a previously tested telephone outreach intervention will be adapted for&#xD;
      electronic delivery, with content tailored to smokers with COPD. First, information will be&#xD;
      gathered from smokers with COPD and the medical staff who care for them to adapt the program&#xD;
      for electronic delivery. Then, the program will be pilot-tested. Smokers with COPD will be&#xD;
      randomly assigned to either usual medical care or the outreach intervention, with goals to&#xD;
      increase participation in smoking cessation programs, quit attempts, and successful&#xD;
      cessation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic obstructive pulmonary disease (COPD) is one of the most common respiratory conditions&#xD;
      and the 4th leading cause of death in the US. 90% of cases are directly attributable to&#xD;
      smoking. Quitting smoking is the most important intervention for these patients, who continue&#xD;
      to smoke at rates double the national average. Smokers with COPD remain undertreated for&#xD;
      tobacco use. Proactive tobacco treatment programs identify patients outside of a routine&#xD;
      clinic visit, engage them in making a quit attempt and connect them with treatment. These&#xD;
      programs may be particularly beneficial for smokers with COPD. Previous phone-based programs&#xD;
      are resource intensive to deliver. Electronic methods for delivering proactive outreach for&#xD;
      tobacco cessation may be effective and cost-effective, and can be tailored to the target&#xD;
      population.&#xD;
&#xD;
      Hypothesis: A proactive tobacco treatment program adapted to electronic delivery and tailored&#xD;
      to smokers with COPD will be effective and cost effective for increasing quit engagement&#xD;
      among smokers with COPD.&#xD;
&#xD;
      Study design: Multi-aim implementation study with randomized pilot. Aim 1: Mixed methods&#xD;
      (survey and interview) assessment of current use of health information technology among&#xD;
      smokers with COPD with a focus on the impact of the chronic disease state on tobacco&#xD;
      cessation.&#xD;
&#xD;
      Aim 2: Qualitative assessment of barriers and facilitators to implementation of proactive&#xD;
      tobacco treatment programs for patients with COPD among staff and leadership.&#xD;
&#xD;
      Aim 3: Randomized pilot of a proactive tobacco treatment program for smokers with COPD&#xD;
      delivered through phone and text messaging.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Anticipated">July 15, 2025</completion_date>
  <primary_completion_date type="Anticipated">July 15, 2024</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>
    <intervention_model_description>Patient-level randomized pilot</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Response to outreach intervention</measure>
    <time_frame>60 days</time_frame>
    <description>Proportion of participants who respond to the proactive offer, feasibility outcome</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Participation in tobacco cessation treatment</measure>
    <time_frame>6 months</time_frame>
    <description>Any participation in tobacco cessation treatment (medication use, counseling)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Smoking cessation</measure>
    <time_frame>6 months</time_frame>
    <description>Self-reported and biochemically confirmed smoking cessation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Quit attempts</measure>
    <time_frame>6 months</time_frame>
    <description>Self-reported attempts to quit smoking</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Marginal Cost</measure>
    <time_frame>6 months</time_frame>
    <description>Cost associated with the proactive program, encompassing both direct costs and indirect costs related to increased use of quit resources and medications</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <condition>Smoking</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Randomly assigned sample who will receive usual care for tobacco cessation treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Proactive Outreach</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Randomly assigned sample who will receive a proactive offer of tobacco treatment with connection to motivational texting program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Proactive Outreach</intervention_name>
    <description>Motivational electronic offer of tobacco cessation support via motivational texting program with care connection to patient's choice of smoking cessation programs</description>
    <arm_group_label>Proactive Outreach</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Veterans active in clinical care (at least one primary care or pulmonary visit within&#xD;
             the past year)&#xD;
&#xD;
          -  Past-year smoking status in the electronic health record indicating current smoking,&#xD;
             confirmed on enrollment call&#xD;
&#xD;
          -  Diagnosed with COPD (2 ICD-10 diagnoses of COPD within the past 2 years)&#xD;
&#xD;
          -  Currently enrolled in MyHealtheVet secure messaging&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Already enrolled in behavioral VA tobacco treatment&#xD;
&#xD;
          -  Enrolled in hospice&#xD;
&#xD;
          -  Undergoing active cancer treatment&#xD;
&#xD;
          -  Advanced dementia&#xD;
&#xD;
          -  Unable to communicate in English&#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>Anne C. Melzer, MD MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Minneapolis VA Health Care System, Minneapolis, MN</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Minneapolis VA Health Care System, Minneapolis, MN</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55417-2309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>May 16, 2023</last_update_submitted>
  <last_update_submitted_qc>May 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>smoking cessation</keyword>
  <keyword>Pulmonary Disease, Chronic Obstructive</keyword>
  <keyword>implementation science</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Chronic Disease</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/NCT04462289
org study id: CDX 20-001
nct id: NCT04462289
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Chronic obstructive pulmonary disease (COPD) is one of the most common respiratory diseases,
      with 90% of cases directly attributable to smoking. Unfortunately, many patients continue to
      smoke and have an urgent need to quit. Proactive tobacco treatment programs identify patients
      outside of a routine clinical appointment and engage them in making a supported quit attempt.

      Most previous research of proactive tobacco treatment has used telephone outreach, which can
      be resource intensive. Electronic methods (texting, secure messaging) may be effective while
      requiring fewer resources.

      In this study, a previously tested telephone outreach intervention will be adapted for
      electronic delivery, with content tailored to smokers with COPD. First, information will be
      gathered from smokers with COPD and the medical staff who care for them to adapt the program
      for electronic delivery. Then, the program will be pilot-tested. Smokers with COPD will be
      randomly assigned to either usual medical care or the outreach intervention, with goals to
      increase participation in smoking cessation programs, quit attempts, and successful
      cessation.
Chronic obstructive pulmonary disease (COPD) is one of the most common respiratory conditions
      and the 4th leading cause of death in the US. 90% of cases are directly attributable to
      smoking. Quitting smoking is the most important intervention for these patients, who continue
      to smoke at rates double the national average. Smokers with COPD remain undertreated for
      tobacco use. Proactive tobacco treatment programs identify patients outside of a routine
      clinic visit, engage them in making a quit attempt and connect them with treatment. These
      programs may be particularly beneficial for smokers with COPD. Previous phone-based programs
      are resource intensive to deliver. Electronic methods for delivering proactive outreach for
      tobacco cessation may be effective and cost-effective, and can be tailored to the target
      population.

      Hypothesis: A proactive tobacco treatment program adapted to electronic delivery and tailored
      to smokers with COPD will be effective and cost effective for increasing quit engagement
      among smokers with COPD.

      Study design: Multi-aim implementation study with randomized pilot. Aim 1: Mixed methods
      (survey and interview) assessment of current use of health information technology among
      smokers with COPD with a focus on the impact of the chronic disease state on tobacco
      cessation.

      Aim 2: Qualitative assessment of barriers and facilitators to implementation of proactive
      tobacco treatment programs for patients with COPD among staff and leadership.

      Aim 3: Randomized pilot of a proactive tobacco treatment program for smokers with COPD
      delivered through phone and text messaging.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patient-level randomized pilot
primary purpose: Health Services Research
masking: Single (Outcomes Assessor)
measure: Response to outreach intervention
time frame: 60 days
description: Proportion of participants who respond to the proactive offer, feasibility outcome
measure: Participation in tobacco cessation treatment
time frame: 6 months
description: Any participation in tobacco cessation treatment (medication use, counseling)
measure: Rate of Smoking cessation
time frame: 6 months
description: Self-reported and biochemically confirmed smoking cessation
measure: Number of Quit attempts
time frame: 6 months
description: Self-reported attempts to quit smoking
measure: Marginal Cost
time frame: 6 months
description: Cost associated with the proactive program, encompassing both direct costs and indirect costs related to increased use of quit resources and medications
arm group label: Usual Care
arm group type: No Intervention
description: Randomly assigned sample who will receive usual care for tobacco cessation treatment
arm group label: Proactive Outreach
arm group type: Experimental
description: Randomly assigned sample who will receive a proactive offer of tobacco treatment with connection to motivational texting program.
intervention type: Behavioral
intervention name: Proactive Outreach
description: Motivational electronic offer of tobacco cessation support via motivational texting program with care connection to patient's choice of smoking cessation programs
arm group label: Proactive Outreach
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anne C. Melzer, MD MS
role: Principal Investigator
affiliation: Minneapolis VA Health Care System, Minneapolis, MN
facility: 
country: United States
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Chronic Disease
sharing ipd: No