NCT05764759

Brief Summary

The purpose of this research study is to evaluate an electronic visit (e-visit) for smoking cessation across rural primary care settings. Participants will be randomly assigned to receive either the smoking cessation e-visit or not. The e-visit will look similar to an online questionnaire asking about smoking history, motivation to quit, and preferences for medications for quitting smoking. Participants may receive a prescription for a smoking cessation medication as an outcome of the e-visit, if randomized to the e-visit group, but there is no requirement to take any medication. This study consists of questionnaires and breath samples provided at 4 separate time points throughout the study. Participation in this study will take about 24 weeks.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P75+ for not_applicable

Timeline
15mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Mar 2023Aug 2027

First Submitted

Initial submission to the registry

February 17, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

March 7, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2027

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

4 years

First QC Date

February 17, 2023

Last Update Submit

March 3, 2026

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (6)

  • Smoking Cessation

    Self-reported smoking via Timeline Follow Back will be biochemically verified via breath CO, with abstinence defined as CO of ≤ 4 ppm. Self-report and CO data will be utilized together to determine 7-day PPA.

    Month 1

  • Smoking Cessation

    Self-reported smoking via Timeline Follow Back will be biochemically verified via breath CO, with abstinence defined as CO of ≤ 4 ppm. Self-report and CO data will be utilized together to determine 7-day PPA.

    Month 3

  • Smoking Cessation

    Self-reported smoking via Timeline Follow Back will be biochemically verified via breath CO, with abstinence defined as CO of ≤ 4 ppm. Self-report and CO data will be utilized together to determine 7-day PPA.

    Month 6

  • Reduction in Cigarettes Per Day

    Reduction in cigarettes per day of 50% via self-report timeline follow back assessment.

    Month 1

  • Reduction in Cigarettes Per Day

    Reduction in cigarettes per day of 50% via self-report timeline follow back assessment.

    Month 3

  • Reduction in Cigarettes Per Day

    Reduction in cigarettes per day of 50% via self-report timeline follow back assessment.

    Month 6

Study Arms (2)

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.

Behavioral: Smoking cessation e-visit

Treatment as usual (TAU)

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.

Behavioral: Treatment as usual

Interventions

Smoking cessation e-visitBEHAVIORAL

electronic visits (e-visits) for smoking cessation

Smoking cessation electronic visit (e-visit)
Treatment as usualBEHAVIORAL

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.

Treatment as usual (TAU)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current cigarette smoking, defined as smoking 1+ cigarettes per 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 enroll
  • Possess a valid e-mail address that is checked daily to access study assessments and MyChart messages
  • Owner of an iOS or Android compatible smartphone to provide remote CO readings
  • Have a valid address at which mail can be received (for mailing iCO™)
  • English fluency

You may not qualify if:

  • \- Current engagement in cessation treatment, defined as use of an FDA-approved cessation medication within the last 7 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Smoking Cessation

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Central Study Contacts

Noelle E Natale

CONTACT

843-876-9457natalen@musc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 17, 2023

First Posted

March 13, 2023

Study Start

March 7, 2023

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

August 15, 2027

Last Updated

March 5, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)