<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/NCT03836573</url>
  </required_header>
  <id_info>
    <org_study_id>IRB201803056</org_study_id>
    <secondary_id>ID00023035</secondary_id>
    <secondary_id>OCR19859</secondary_id>
    <nct_id>NCT03836573</nct_id>
  </id_info>
  <brief_title>Feasibility of a Decision Aid for E-Cigarettes in Primary Care</brief_title>
  <official_title>Patient Decision Aid About E-cigarettes: A Feasibility Test</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Florida</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>
      The study team will use a pre-post study design, in which data will be collected from 60&#xD;
      patients under &quot;control&quot; conditions (Phase I), whereby an iPad-delivered decision aid is&#xD;
      implemented in the clinic to address only standard smoking cessation options (i.e., nicotine&#xD;
      replacement therapy and approved prescription medications) with patients who are current&#xD;
      smokers. After that, the iPad-delivered decision aid will be implemented with an additional&#xD;
      60 patients for the &quot;intervention&quot; condition (Phase II), whereby the decision aid will also&#xD;
      address e-cigarettes, in addition to standard smoking cessation options.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This portion of the project will take place at the UF Health Family Medicine Main Street&#xD;
      clinic. The investigators will use a pre-post study design, in which data will be collected&#xD;
      from 60 patients under &quot;control&quot; conditions (Phase I), whereby an iPad-delivered decision aid&#xD;
      is implemented in the clinic to address only standard smoking cessation options (i.e.,&#xD;
      nicotine replacement therapy and approved prescription medications) with patients who are&#xD;
      current smokers. After that, the iPad-delivered decision aid will be implemented with an&#xD;
      additional 60 patients for the &quot;intervention&quot; condition (Phase II), whereby the decision aid&#xD;
      will also address e-cigarettes, in addition to standard smoking cessation options. In each&#xD;
      phase, patients visiting the clinic will be asked upon check-in to the facility if they smoke&#xD;
      cigarettes and, if so, whether they would like to participate in research regarding smoking.&#xD;
      Those who are interested would be directed to a research assistant in the waiting room who&#xD;
      would present them with the study description and informed consent document, responding to&#xD;
      any questions that they might have. Those who consent in the initial phase of the control&#xD;
      conditions will undergo standard counseling practices their physician provides after viewing&#xD;
      the iPad-delivered decision aid. Once the clinical visit ends, the research assistant will&#xD;
      administer a brief survey and provide information about the two follow-up surveys, which will&#xD;
      take place one week and 3 months after the clinical encounter.&#xD;
&#xD;
      In the intervention phase of the study (Phase II), after consenting to participate, patients&#xD;
      will be provided with the iPad-delivered decision aid. The patient will answer a series of&#xD;
      questions and based on their responses be shown information based on the group of which they&#xD;
      are a member: 1. Uninterested in quitting cigarettes (harm-reduction group); 2. Interested in&#xD;
      quitting and using e-cigarettes (e-cigarette cessation group); 3. Interested in quitting but&#xD;
      does not use e-cigarettes (standard smoking cessation).&#xD;
&#xD;
      In both phases, after viewing the decision aid slides, patients will answer another series of&#xD;
      questions on: value clarification; quitting readiness, interest in using e-cigarettes;&#xD;
      interest in using other cessation methods.&#xD;
&#xD;
      Patient responses will be printed by the research assistant and provided to the nurse who is&#xD;
      rooming the patient. While the rooming process takes place, the nurse would then place the&#xD;
      printed decision aid paperwork in the folder outside the patient's exam room with a visual&#xD;
      and/or verbal reminder to the physician. Upon visiting the patient, the physician would&#xD;
      address smoking cessation with the patient incorporating the provided decision aid results.&#xD;
      After the clinical encounter and completing check-out, the patient would return to the&#xD;
      research assistant and conclude the experience with a short satisfaction survey that would&#xD;
      gather information about the encounter. Participants will be followed up by preferred method&#xD;
      (e.g., telephone, email) one week and three months after the encounter to determine changes&#xD;
      in tobacco use perceptions and behaviors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 6, 2019</start_date>
  <completion_date type="Actual">August 1, 2019</completion_date>
  <primary_completion_date type="Actual">July 31, 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>
    <intervention_model_description>The patient will answer a series of questions and based on their responses be shown information based on the group of which they are a member.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Participant satisfaction with decision aid</measure>
    <time_frame>Day 1 post visit</time_frame>
    <description>A satisfaction survey will be administered to participants after the clinical encounter. Questions assess satisfaction and perceived effectiveness of the intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in cigarettes smoked per day</measure>
    <time_frame>Baseline, Week 1, Month 3</time_frame>
    <description>Change in number of cigarettes smoked per day between the groups.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Smoking, Cigarette</condition>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>E-cigarette only decision aid</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be provided with the Smoking Cessation iPad Decision Aid Tool consisting of information on e-cigarettes only. Patients will only be enrolled in this group in phase II if they self-identify as 'uninterested in quitting cigarettes'. During the physician encounter will be given harm-reduction guidance.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>E-cigarette and Standard Smoking Cessation Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be provided with the Smoking Cessation iPad Decision Aid Tool consisting of standard smoking cessation and e-cigarette options. Patients will only be enrolled in this group in phase II if they self identify as 'interested in quitting and using e-cigarettes'. During the physician encounter will be given e-cigarette cessation guidance.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Smoking Cessation Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be provided with the Smoking Cessation iPad Decision Aid Tool consisting of standard smoking cessation and e-cigarette options. All patients in phase I will be enrolled in this group. In addition, patients in phase II who self-identify as 'interested in quitting but do not use e-cigarettes' will also be enrolled in this group. During the physician encounter will be given standard smoking cessation guidance.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Smoking Cessation iPad Decision Aid Tool</intervention_name>
    <description>Patients will be provided with the iPad-delivered decision aid. The patient will answer a series of questions and based on their responses be shown information based on the group of which they are a member: 1. Uninterested in quitting cigarettes (Harm-reduction Group); 2. Interested in quitting and using e-cigarettes (E-cigarette Cessation Group); 3. Interested in quitting but does not use e-cigarettes (Standard Smoking Cessation Group). Upon visiting the patient, the physician will address smoking cessation with the patient incorporating the provided decision aid results.</description>
    <arm_group_label>E-cigarette and Standard Smoking Cessation Group</arm_group_label>
    <arm_group_label>E-cigarette only decision aid</arm_group_label>
    <arm_group_label>Standard Smoking Cessation Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult smokers&#xD;
&#xD;
          -  people who have smoked regular cigarettes at least once in the last month&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  non smokers&#xD;
&#xD;
          -  pregnant women&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ramzi Salloum, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UF Health at the University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>February 8, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>August 20, 2019</last_update_submitted>
  <last_update_submitted_qc>August 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>E-cigarettes</keyword>
  <keyword>Nicotine Replacement Therapy</keyword>
  <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/NCT03836573
org study id: IRB201803056
secondary id: ID00023035
secondary id: OCR19859
nct id: NCT03836573
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study team will use a pre-post study design, in which data will be collected from 60
      patients under "control" conditions (Phase I), whereby an iPad-delivered decision aid is
      implemented in the clinic to address only standard smoking cessation options (i.e., nicotine
      replacement therapy and approved prescription medications) with patients who are current
      smokers. After that, the iPad-delivered decision aid will be implemented with an additional
      60 patients for the "intervention" condition (Phase II), whereby the decision aid will also
      address e-cigarettes, in addition to standard smoking cessation options.
This portion of the project will take place at the UF Health Family Medicine Main Street
      clinic. The investigators will use a pre-post study design, in which data will be collected
      from 60 patients under "control" conditions (Phase I), whereby an iPad-delivered decision aid
      is implemented in the clinic to address only standard smoking cessation options (i.e.,
      nicotine replacement therapy and approved prescription medications) with patients who are
      current smokers. After that, the iPad-delivered decision aid will be implemented with an
      additional 60 patients for the "intervention" condition (Phase II), whereby the decision aid
      will also address e-cigarettes, in addition to standard smoking cessation options. In each
      phase, patients visiting the clinic will be asked upon check-in to the facility if they smoke
      cigarettes and, if so, whether they would like to participate in research regarding smoking.
      Those who are interested would be directed to a research assistant in the waiting room who
      would present them with the study description and informed consent document, responding to
      any questions that they might have. Those who consent in the initial phase of the control
      conditions will undergo standard counseling practices their physician provides after viewing
      the iPad-delivered decision aid. Once the clinical visit ends, the research assistant will
      administer a brief survey and provide information about the two follow-up surveys, which will
      take place one week and 3 months after the clinical encounter.

      In the intervention phase of the study (Phase II), after consenting to participate, patients
      will be provided with the iPad-delivered decision aid. The patient will answer a series of
      questions and based on their responses be shown information based on the group of which they
      are a member: 1. Uninterested in quitting cigarettes (harm-reduction group); 2. Interested in
      quitting and using e-cigarettes (e-cigarette cessation group); 3. Interested in quitting but
      does not use e-cigarettes (standard smoking cessation).

      In both phases, after viewing the decision aid slides, patients will answer another series of
      questions on: value clarification; quitting readiness, interest in using e-cigarettes;
      interest in using other cessation methods.

      Patient responses will be printed by the research assistant and provided to the nurse who is
      rooming the patient. While the rooming process takes place, the nurse would then place the
      printed decision aid paperwork in the folder outside the patient's exam room with a visual
      and/or verbal reminder to the physician. Upon visiting the patient, the physician would
      address smoking cessation with the patient incorporating the provided decision aid results.
      After the clinical encounter and completing check-out, the patient would return to the
      research assistant and conclude the experience with a short satisfaction survey that would
      gather information about the encounter. Participants will be followed up by preferred method
      (e.g., telephone, email) one week and three months after the encounter to determine changes
      in tobacco use perceptions and behaviors.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The patient will answer a series of questions and based on their responses be shown information based on the group of which they are a member.
primary purpose: Supportive Care
masking: None (Open Label)
measure: Participant satisfaction with decision aid
time frame: Day 1 post visit
description: A satisfaction survey will be administered to participants after the clinical encounter. Questions assess satisfaction and perceived effectiveness of the intervention.
measure: Change in cigarettes smoked per day
time frame: Baseline, Week 1, Month 3
description: Change in number of cigarettes smoked per day between the groups.
arm group label: E-cigarette only decision aid
arm group type: Experimental
description: Patients will be provided with the Smoking Cessation iPad Decision Aid Tool consisting of information on e-cigarettes only. Patients will only be enrolled in this group in phase II if they self-identify as 'uninterested in quitting cigarettes'. During the physician encounter will be given harm-reduction guidance.
arm group label: E-cigarette and Standard Smoking Cessation Group
arm group type: Experimental
description: Patients will be provided with the Smoking Cessation iPad Decision Aid Tool consisting of standard smoking cessation and e-cigarette options. Patients will only be enrolled in this group in phase II if they self identify as 'interested in quitting and using e-cigarettes'. During the physician encounter will be given e-cigarette cessation guidance.
arm group label: Standard Smoking Cessation Group
arm group type: Experimental
description: Patients will be provided with the Smoking Cessation iPad Decision Aid Tool consisting of standard smoking cessation and e-cigarette options. All patients in phase I will be enrolled in this group. In addition, patients in phase II who self-identify as 'interested in quitting but do not use e-cigarettes' will also be enrolled in this group. During the physician encounter will be given standard smoking cessation guidance.
intervention type: Behavioral
intervention name: Smoking Cessation iPad Decision Aid Tool
description: Patients will be provided with the iPad-delivered decision aid. The patient will answer a series of questions and based on their responses be shown information based on the group of which they are a member: 1. Uninterested in quitting cigarettes (Harm-reduction Group); 2. Interested in quitting and using e-cigarettes (E-cigarette Cessation Group); 3. Interested in quitting but does not use e-cigarettes (Standard Smoking Cessation Group). Upon visiting the patient, the physician will address smoking cessation with the patient incorporating the provided decision aid results.
arm group label: E-cigarette and Standard Smoking Cessation Group
arm group label: E-cigarette only decision aid
arm group label: Standard Smoking Cessation Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ramzi Salloum, PhD
role: Principal Investigator
affiliation: University of Florida
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No