<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/NCT02220686</url>
  </required_header>
  <id_info>
    <org_study_id>D14197</org_study_id>
    <nct_id>NCT02220686</nct_id>
  </id_info>
  <brief_title>Vascular Physician Offer and Report (VAPOR) Trial</brief_title>
  <acronym>VAPOR</acronym>
  <official_title>Vascular Physician Offer and Report (VAPOR) Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dartmouth-Hitchcock Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Society for Vascular Surgery</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dartmouth-Hitchcock Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to see if vascular physicians (your provider) using a combination&#xD;
      of proven smoking cessation tools in an organized way can help vascular patients quit smoking&#xD;
      better than usual.&#xD;
&#xD;
      The doctors where you are being treated have been chosen to either provide:&#xD;
&#xD;
      the combination therapy of giving you advice, considering prescribing medications to help you&#xD;
      quit smoking, and referring you to a phone quitline, or to continue their usual smoking&#xD;
      cessation practices (which may include all, some, or none of the treatments above).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of the &quot;Offer and Report&quot; protocol for change in smoking status from Baseline Visit to 3 Month Visit</measure>
    <time_frame>Change in smoking status from Baseline Visit to 3 Month Visit</time_frame>
    <description>To assess the efficacy of the &quot;Offer and Report&quot; protocol (standardized (1) &quot;very brief advice,&quot; (2) referral to telephone-based smoking cessation counseling, and (3) consideration of prescribing nicotine replacement therapy (NRT)) as compared to usual smoking cessation care by vascular physicians in biochemically-validated 3 month smoking cessation rates. A questionnaire will be completed by the patient at the Baseline visit and another questionnaire will be completed at the 3 month visit to assess the change in smoking status.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">156</enrollment>
  <condition>Peripheral Artery Disease (PAD)</condition>
  <arm_group>
    <arm_group_label>Offer and Report Protocol</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Physician advice to stop smoking, referral to state Quitline, and physician considers prescribing nicotine replacement therapy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Physician will follow their institution's standard of care for smoking cessation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Offer and Report Protocol</intervention_name>
    <description>Physician advice to stop smoking, referral to state Quitline, and physician considers prescribing nicotine replacement therapy.</description>
    <arm_group_label>Offer and Report Protocol</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;18&#xD;
&#xD;
          -  Current smoker&#xD;
&#xD;
          -  Plan to have a Vascular Quality Initiative (VQI) procedure in &gt; 7 days&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant Women, Fetuses and Neonates&#xD;
&#xD;
          -  Children&#xD;
&#xD;
          -  People with impaired decision-making capacity&#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>Philip Goodney, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dartmouth-Hitchcock Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alik Farber, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UF Health</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610-0128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern Memorial</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Health</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <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>
    <facility>
      <name>UMASS Memorial Medical Center</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dartmouth-Hitchcock Medical Center</name>
      <address>
        <city>Lebanon</city>
        <state>New Hampshire</state>
        <zip>03766</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Roper Hospital</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah Hospital</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>August 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2014</study_first_posted>
  <last_update_submitted>July 25, 2017</last_update_submitted>
  <last_update_submitted_qc>July 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>VAPOR</keyword>
  <keyword>smoking cessation</keyword>
  <keyword>PAD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peripheral Arterial Disease</mesh_term>
  </condition_browse>
  <!-- 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/NCT02220686
org study id: D14197
nct id: NCT02220686
lead sponsor: 
collaborator: 
has dmc: No
The purpose of the study is to see if vascular physicians (your provider) using a combination
      of proven smoking cessation tools in an organized way can help vascular patients quit smoking
      better than usual.

      The doctors where you are being treated have been chosen to either provide:

      the combination therapy of giving you advice, considering prescribing medications to help you
      quit smoking, and referring you to a phone quitline, or to continue their usual smoking
      cessation practices (which may include all, some, or none of the treatments above).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Efficacy of the "Offer and Report" protocol for change in smoking status from Baseline Visit to 3 Month Visit
time frame: Change in smoking status from Baseline Visit to 3 Month Visit
description: To assess the efficacy of the "Offer and Report" protocol (standardized (1) "very brief advice," (2) referral to telephone-based smoking cessation counseling, and (3) consideration of prescribing nicotine replacement therapy (NRT)) as compared to usual smoking cessation care by vascular physicians in biochemically-validated 3 month smoking cessation rates. A questionnaire will be completed by the patient at the Baseline visit and another questionnaire will be completed at the 3 month visit to assess the change in smoking status.
arm group label: Offer and Report Protocol
arm group type: Experimental
description: Physician advice to stop smoking, referral to state Quitline, and physician considers prescribing nicotine replacement therapy.
arm group label: Usual Care
arm group type: No Intervention
description: Physician will follow their institution's standard of care for smoking cessation.
intervention type: Behavioral
intervention name: Offer and Report Protocol
description: Physician advice to stop smoking, referral to state Quitline, and physician considers prescribing nicotine replacement therapy.
arm group label: Offer and Report Protocol
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Philip Goodney, MD, MS
role: Principal Investigator
affiliation: Dartmouth-Hitchcock Medical Center
last name: Alik Farber, MD
role: Principal Investigator
affiliation: Boston Medical Center
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Peripheral Arterial Disease