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

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Smoking, Cigarette
• Intervention / Treatment: Behavioral: Smoking Cessation iPad Decision Aid Tool

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
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • UF Health at the University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• non smokers
• pregnant women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cigarettes smoked per day	Change in number of cigarettes smoked per day between the groups.	Baseline, Week 1, Month 3

Collaborators and Investigators

• Sponsor: University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2019
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): August 1, 2019

Study Registration Dates

• First Submitted: February 8, 2019
• First Submitted That Met QC Criteria: February 8, 2019
• First Posted (Actual): February 11, 2019

Study Record Updates

• Last Update Posted (Actual): August 22, 2019
• Last Update Submitted That Met QC Criteria: August 20, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Nicotine Replacement Therapy; E-cigarettes
• Other Study ID Numbers: IRB201803056; ID00023035 (Other Identifier: University of Florida); OCR19859 (Other Identifier: UF OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No