Feasibility of a Decision Aid for E-Cigarettes in Primary Care
Condition: Smoking, Cigarette; Smoking Cessation
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Smoking Cessation iPad Decision Aid Tool
Intervention type(s): Behavioral
Intervention description(s): 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.
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.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: E-cigarettes; Nicotine Replacement Therapy