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



Status:Recruiting
Conditions:Smoking Cessation
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 100
Updated:3/23/2019
Start Date:March 6, 2019
End Date:December 15, 2020
Contact:Ramzi Salloum, PhD
Email:rsalloum@ufl.edu
Phone:352-295-4997

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Patient Decision Aid About E-cigarettes: A Feasibility Test

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.

Inclusion Criteria:

- adult smokers

- people who have smoked regular cigarettes at least once in the last month

Exclusion Criteria:

- non smokers

- pregnant women
We found this trial at
1
site
2033 Mowry Road
Gainesville, Florida 32610
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Gainesville, FL
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