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

NCT03836573 | Completed

• 3 other identifiers: IRB201803056ID00023035OCR19859
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking, Cigarette; Smoking Cessation

Keywords

E-cigarettes; Nicotine Replacement Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in cigarettes smoked per day

  Baseline, Week 1, Month 3

Study Arms (3)

E-cigarette only decision aid

EXPERIMENTAL

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

E-cigarette and Standard Smoking Cessation Group

EXPERIMENTAL

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

Standard Smoking Cessation Group

EXPERIMENTAL

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

Interventions

Smoking Cessation iPad Decision Aid Tool BEHAVIORAL

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.

E-cigarette and Standard Smoking Cessation Group; E-cigarette only decision aid; Standard Smoking Cessation Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• non smokers
• pregnant women

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

UF Health at the University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Cigarette Smoking; Smoking Cessation; Vaping

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use; Health Behavior

Study Officials

• Ramzi Salloum, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: February 11, 2019
• Study Start: March 6, 2019
• Primary Completion: July 31, 2019
• Study Completion: August 1, 2019
• Last Updated: August 22, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)