Smoking, CigaretteNCT03836573
Feasibility of a Decision Aid for E-Cigarettes in Primary Care
A study testing Smoking Cessation iPad Decision Aid Tool in people with Smoking, Cigarette and Smoking Cessation, run by University of Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Cigarette, Smoking Cessation
- What is being tested?
- Smoking Cessation iPad Decision Aid Tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2019to 1 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adult smokers
- people who have smoked regular cigarettes at least once in the last month
Who cannot join
- non smokers
- pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
UF Health at the University of Florida
Gainesville, Florida, 32610
About this study
Official title: 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.
Read the 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.
- Conditions
- Smoking, Cigarette, Smoking Cessation
- Being tested
- Smoking Cessation iPad Decision Aid Tool
- Keywords
- E-cigarettes, Nicotine Replacement Therapy
- Medical subject headings
- Cigarette Smoking, Smoking Cessation, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking Cessation iPad Decision Aid ToolBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Smoking Cessation iPad Decision Aid Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 post visit
Secondary outcomes (1)
Change in cigarettes smoked per day
Change in number of cigarettes smoked per day between the groups.
Measured: Baseline, Week 1, Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2019
- Study start6 Mar 2019
- Primary completion31 Jul 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking, CigaretteStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ramzi Salloum, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03836573
- Sponsor's protocol ID
- IRB201803056
- Other IDs
- ID00023035, OCR19859
- Status last verified
- Aug 2019
- First submitted
- 8 Feb 2019
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Decision Aid About E-cigarettes: A Feasibility Test
- ClinicalTrials.gov ID
- NCT03836573
- Acronym / sponsor ID
- IRB201803056
- Conditions
- Smoking, Cigarette, Smoking Cessation
- Keywords
- E-cigarettes, Nicotine Replacement Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 31 Jul 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 11 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| E-cigarette only decision aid | Experimental | Behavioral: Smoking Cessation iPad Decision Aid ToolPatients 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. |
| E-cigarette and Standard Smoking Cessation Group | Experimental | Behavioral: Smoking Cessation iPad Decision Aid ToolPatients 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. |
| Standard Smoking Cessation Group | Experimental | Behavioral: Smoking Cessation iPad Decision Aid ToolPatients 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adult smokers
- people who have smoked regular cigarettes at least once in the last month
Key exclusion criteria (2 listed)
- non smokers
- pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking Cessation iPad Decision Aid ToolPatients 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. | Behavioural | E-cigarette and Standard Smoking Cessation Group, E-cigarette only decision aid, Standard Smoking Cessation Group |
Primary outcome
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.
1 secondary outcome
Change in cigarettes smoked per day
Time frame: Baseline, Week 1, Month 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramzi Salloum, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking Cessation iPad Decision Aid Tool in people with Smoking, Cigarette and Smoking Cessation, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant satisfaction with decision aid (time frame: Day 1 post visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2019.