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Feasibility of a Decision Aid for E-Cigarettes in Primary Care

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ClinicalTrials.gov Identifier: NCT03836573
Recruitment Status : Not yet recruiting
First Posted : February 11, 2019
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief 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.

Condition or disease Intervention/treatment Phase
Smoking, Cigarette Smoking Cessation Behavioral: Smoking Cessation iPad Decision Aid Tool Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
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
Official Title: Patient Decision Aid About E-cigarettes: A Feasibility Test
Estimated Study Start Date : March 6, 2019
Estimated Primary Completion Date : March 6, 2020
Estimated Study Completion Date : December 15, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: E-cigarette only decision aid
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.
Behavioral: Smoking Cessation iPad Decision Aid Tool
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.

Experimental: E-cigarette and Standard Smoking Cessation Group
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.
Behavioral: Smoking Cessation iPad Decision Aid Tool
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.

Experimental: Standard Smoking Cessation Group
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.
Behavioral: Smoking Cessation iPad Decision Aid Tool
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.




Primary Outcome Measures :
  1. Participant satisfaction with decision aid [ Time Frame: Day 1 post visit ]
    A satisfaction survey will be administered to participants after the clinical encounter. Questions assess satisfaction and perceived effectiveness of the intervention.


Secondary Outcome Measures :
  1. Change in cigarettes smoked per day [ Time Frame: Baseline, Week 1, Month 3 ]
    Change in number of cigarettes smoked per day between the groups.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adult smokers
  • people who have smoked regular cigarettes at least once in the last month

Exclusion Criteria:

  • non smokers
  • pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03836573


Contacts
Contact: Ramzi Salloum, PhD 352-295-4997 rsalloum@ufl.edu

Locations
United States, Florida
UF Health at the University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Ramzi Salloum, PhD University of Florida

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT03836573     History of Changes
Other Study ID Numbers: IRB201803056
ID00023035 ( Other Identifier: University of Florida )
OCR19859 ( Other Identifier: UF OnCore )
First Posted: February 11, 2019    Key Record Dates
Last Update Posted: February 11, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
E-cigarettes
Nicotine Replacement Therapy