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

Patient Decision Aid About E-cigarettes: A Feasibility Test

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03836573
Enrollment
120
Registered
2019-02-11
Start date
2019-03-06
Completion date
2019-08-01
Last updated
2019-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation, Smoking, Cigarette

Keywords

E-cigarettes, Nicotine Replacement Therapy

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.

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.

Interventions

BEHAVIORALSmoking 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.

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* non smokers * pregnant women

Design outcomes

Primary

MeasureTime frameDescription
Participant satisfaction with decision aidDay 1 post visitA satisfaction survey will be administered to participants after the clinical encounter. Questions assess satisfaction and perceived effectiveness of the intervention.

Secondary

MeasureTime frameDescription
Change in cigarettes smoked per dayBaseline, Week 1, Month 3Change in number of cigarettes smoked per day between the groups.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026