SmokingNCT04316260

Smoking Cessation E-Visit

A study testing Smoking cessation e-visit and Treatment As Usual in people with Smoking, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Smoking
What is being tested?: Smoking cessation e-visit and Treatment As Usual
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 1 siteUnited States
Study dates: 1 May 2019to 28 Feb 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

current smoking, defined as smoking 5+ cigarettes/day, for 20+ days out of the last 30, for the last 6+ months
age 18+
enrolled in Epic's MyChart program or willing to sign up for MyChart
possess a valid e-mail address that is checked daily to access follow-up assessments and MyChart messages
English fluency

Who cannot join

None

Trial locations and contacts

1 site in 1 country.

United States1 site

Medical University of South Carolina
Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: Development and Testing of a Smoking Cessation E-Visit for Implementation in Primary Care

The goal of this study is to develop, refine, and complete preliminary feasibility testing of a smoking cessation electronic visit (e-visit) for implementation in primary care/family medicine. The investigators will conduct a feasibility RCT (N=51) of the smoking cessation e-visit as compared to treatment as usual (TAU), delivered via primary care, with primary objective to provide effect size estimates for a larger RCT. Primary outcomes cluster around: 1) treatment feasibility, 2) treatment acceptability, 3) treatment satisfaction, 4) evidence-based cessation treatment utilization, and 5) cessation-related outcomes (quit attempt incidence, abstinence). It is hypothesized that participants randomized to the e-visit condition as compared to those randomized to the TAU condition will have higher rates of cessation treatment utilization (medications, counseling) and superior cessation-related outcomes.

Conditions: Smoking
Being tested: Smoking cessation e-visit, Treatment As Usual
Medical subject headings: Smoking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Smoking cessation e-visitBehavioural
electronic visits (e-visits) for smoking cessation
Treatment As UsualBehavioural
Information about the state quitline and about the importance of quitting smoking and a recommendation to contact one's PCP to schedule a medical visit to discuss quitting smoking

Study groups in NCT04316260
Study group	Role	What they receive
Smoking cessation electronic visit (e-visit)	Experimental	This group will be sent 1) an invitation to complete an electronic visit (e-visit) focused on cigarette smoking and 2) an invitation to complete a follow-up e-visit one-month after the initial e-visit. Receives: Behavioral: Smoking cessation e-visit
Treatment As Usual	Active comparator	This group will be provided information about the state quitline and about the importance of quitting smoking and it will be recommended that they contact their PCP to schedule a medical visit to discuss quitting smoking. Receives: Behavioral: Treatment As Usual

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Utilized Smoking Cessation Treatment
Number of participants who utilized smoking cessation treatment since last assessment.
Measured: Month 1
Number of Participants Who Utilized Smoking Cessation Treatment
Number of participants who utilized smoking cessation treatment since last assessment.
Measured: Month 3
Cigarettes Smoking
Cigarettes per day reduction greater than 50%
Measured: Month 1
Cigarettes Smoking
Cigarettes per day reduction greater than 50%
Measured: Month 3
Quit Attempts
Quit attempts since last contact
Measured: Month 1
Quit Attempts
Quit attempts since last contact
Measured: Month 3
24-hour Quit Attempt
Quit attempt lasting 24 hours since last contact
Measured: Month 1
24-hour Quit Attempt
Quit attempt lasting 24 hours since last contact
Measured: Month 3
Seven-day Point Prevalence Abstinence
Participant has not had a cigarette in the past 7 days
Measured: Month 1
Seven-day Point Prevalence Abstinence
Participant has not had a cigarette in the past 7 days
Measured: Month 3
Floating Abstinence
Participant has gone 7+ days without a cigarette since last contact.
Measured: Month 1
Floating Abstinence
Participant has gone 7+ days without a cigarette since last contact.
Measured: Month 3

Secondary outcomes (4)

E-visit Completion
Number of participants that completed the e-visit
Measured: Month 1
Provider Fidelity
Reviewing within Epic whether the provider administered treatment consistent with e-visit recommendations
Measured: Month 1
E-visit Ease of Use
Participants reported Agree or Strongly Agree to finding the e-visit easy to use question
Measured: Month 1
Time to Complete the E-visit
Time (days) to complete the e-visit among participants that completed the e-visit.
Measured: Month 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 201928 Feb 2020

First posted20 Mar 2020
Study start1 May 2019
Primary completion31 Oct 2019
Study completion28 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SmokingStudies of the same condition, open and under way.
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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04316260
Sponsor's protocol ID: Pro00078077
Status last verified: Dec 2020
First submitted: 18 Mar 2020
Last updated: 8 Dec 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Dahne J, Player M, Carpenter MJ, Ford DW, Diaz VA. Evaluation of a Proactive Smoking Cessation Electronic Visit to Extend the Reach of Evidence-Based Cessation Treatment via Primary Care. Telemed J E Health. 2021 Mar;27(3):347-354. doi: 10.1089/tmj.2020.0167. Epub 2020 Oct 20.
PubMed 33085578

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Smoking trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Development and Testing of a Smoking Cessation E-Visit for Implementation in Primary Care
ClinicalTrials.gov ID: NCT04316260
Acronym / sponsor ID: Pro00078077
Conditions: Smoking
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Medical University of South CarolinaUniversity, hospital or other
Study start: 1 May 2019 (actual)
Primary completion: 31 Oct 2019 (actual)
Study completion: 28 Feb 2020 (actual)
First posted: 20 Mar 2020 (actual)
Results: Posted 8 Dec 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Smoking cessation electronic visit (e-visit)	Experimental	Behavioral: Smoking cessation e-visitThis group will be sent 1) an invitation to complete an electronic visit (e-visit) focused on cigarette smoking and 2) an invitation to complete a follow-up e-visit one-month after the initial e-visit.
Treatment As Usual	Active comparator	Behavioral: Treatment As UsualThis group will be provided information about the state quitline and about the importance of quitting smoking and it will be recommended that they contact their PCP to schedule a medical visit to discuss quitting smoking.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

current smoking, defined as smoking 5+ cigarettes/day, for 20+ days out of the last 30, for the last 6+ months
age 18+
enrolled in Epic's MyChart program or willing to sign up for MyChart
possess a valid e-mail address that is checked daily to access follow-up assessments and MyChart messages
English fluency

Key exclusion criteria (1 listed)

None

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 e-visitelectronic visits (e-visits) for smoking cessation	Behavioural	Smoking cessation electronic visit (e-visit)
Treatment As UsualInformation about the state quitline and about the importance of quitting smoking and a recommendation to contact one's PCP to schedule a medical visit to discuss quitting smoking	Behavioural	Treatment As Usual

Primary outcome

Number of Participants Who Utilized Smoking Cessation Treatment
Time frame: Month 1
Number of participants who utilized smoking cessation treatment since last assessment.
Number of Participants Who Utilized Smoking Cessation Treatment
Time frame: Month 3
Number of participants who utilized smoking cessation treatment since last assessment.
Cigarettes Smoking
Time frame: Month 1
Cigarettes per day reduction greater than 50%
Cigarettes Smoking
Time frame: Month 3
Cigarettes per day reduction greater than 50%
Quit Attempts
Time frame: Month 1
Quit attempts since last contact
Quit Attempts
Time frame: Month 3
Quit attempts since last contact
24-hour Quit Attempt
Time frame: Month 1
Quit attempt lasting 24 hours since last contact
24-hour Quit Attempt
Time frame: Month 3
Quit attempt lasting 24 hours since last contact
Seven-day Point Prevalence Abstinence
Time frame: Month 1
Participant has not had a cigarette in the past 7 days
Seven-day Point Prevalence Abstinence
Time frame: Month 3
Participant has not had a cigarette in the past 7 days
Floating Abstinence
Time frame: Month 1
Participant has gone 7+ days without a cigarette since last contact.
Floating Abstinence
Time frame: Month 3
Participant has gone 7+ days without a cigarette since last contact.

4 secondary outcomes

E-visit Completion
Time frame: Month 1
Provider Fidelity
Time frame: Month 1
E-visit Ease of Use
Time frame: Month 1
Time to Complete the E-visit
Time frame: Month 1

Results and safety

Results posted to the registry on 8 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Smoking Cessation Electronic Visit (E-visit)	34	34
Treatment As Usual	17	17

Primary outcome: Number of Participants Who Utilized Smoking Cessation Treatment

Time frame: Month 1. Count of participants. Unit: Participants

Measure	Smoking Cessation Electronic Visit (E-visit) n = 28	Treatment As Usual n = 17
Value	15	3

Population analysed: The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information.

Primary outcome: Number of Participants Who Utilized Smoking Cessation Treatment

Time frame: Month 3. Count of participants. Unit: Participants

Measure	Smoking Cessation Electronic Visit (E-visit) n = 23	Treatment As Usual n = 16
Value	14	4

Population analysed: The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information.

Primary outcome: Cigarettes Smoking

Time frame: Month 1. Count of participants. Unit: Participants

Measure	Smoking Cessation Electronic Visit (E-visit) n = 28	Treatment As Usual n = 17
Value	9	3

Population analysed: The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information.

Primary outcome: Cigarettes Smoking

Time frame: Month 3. Count of participants. Unit: Participants

Measure	Smoking Cessation Electronic Visit (E-visit) n = 23	Treatment As Usual n = 16
Value	15	5

Population analysed: The number of participants analyzed differs from the total participants in each group because not everyone completed the questionnaire that assessed this information.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 month and 3 month assessments (3 total months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Smoking Cessation Electronic Visit (E-visit)	0 of 34 (0%)	4 of 34 (11.8%)	0 of 34
Treatment As Usual	0 of 17 (0%)	3 of 17 (17.6%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33085578Dahne J, Player M, Carpenter MJ, Ford DW, Diaz VA. Evaluation of a Proactive Smoking Cessation Electronic Visit to Extend the Reach of Evidence-Based Cessation Treatment via Primary Care. Telemed J E Health. 2021 Mar;27(3):347-354. doi: 10.1089/tmj.2020.0167. Epub 2020 Oct 20.
Individual participant dataSharing planned: No

Related trials for Smoking

Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruiting
Flavored Electronic Nicotine Delivery Systems to Lower Smoking and Exposure to Tobacco Toxicants Among Cigarette Smokers Interested in Quitting, REFLECT Trial
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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.

The record lists no contact. Use the official record to reach the sponsor.

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 e-visit and Treatment As Usual in people with Smoking, run by Medical University of South Carolina 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 5 inclusion and 1 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 8 Dec 2020. 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?

Yes. Results are posted in the registry (first posted 8 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants Who Utilized Smoking Cessation Treatment (time frame: Month 1). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04316260, which also lists 1 linked publication.

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 8 Dec 2020.