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OpenTrials
Completed

NCT Number: NCT04316260

Smoking Cessation E-Visit

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.

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Key information

Conditions

Smoking Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

None

Treatment and study plan

Smoking cessation e-visit

Behavioral

electronic visits (e-visits) for smoking cessation

Treatment as Usual

Behavioral

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

Primary outcomes

  1. Number of Participants Who Utilized Smoking Cessation Treatment

    Time frame: Month 1

    Number of participants who utilized smoking cessation treatment since last assessment.

  2. Number of Participants Who Utilized Smoking Cessation Treatment

    Time frame: Month 3

    Number of participants who utilized smoking cessation treatment since last assessment.

  3. Cigarettes Smoking

    Time frame: Month 1

    Cigarettes per day reduction greater than 50%

  4. Cigarettes Smoking

    Time frame: Month 3

    Cigarettes per day reduction greater than 50%

  5. Quit Attempts

    Time frame: Month 1

    Quit attempts since last contact

  6. Quit Attempts

    Time frame: Month 3

    Quit attempts since last contact

  7. 24-hour Quit Attempt

    Time frame: Month 1

    Quit attempt lasting 24 hours since last contact

  8. 24-hour Quit Attempt

    Time frame: Month 3

    Quit attempt lasting 24 hours since last contact

  9. Seven-day Point Prevalence Abstinence

    Time frame: Month 1

    Participant has not had a cigarette in the past 7 days

  10. Seven-day Point Prevalence Abstinence

    Time frame: Month 3

    Participant has not had a cigarette in the past 7 days

  11. Floating Abstinence

    Time frame: Month 1

    Participant has gone 7+ days without a cigarette since last contact.

  12. Floating Abstinence

    Time frame: Month 3

    Participant has gone 7+ days without a cigarette since last contact.

Secondary outcomes

  1. E-visit Completion

    Time frame: Month 1

    Number of participants that completed the e-visit

  2. Provider Fidelity

    Time frame: Month 1

    Reviewing within Epic whether the provider administered treatment consistent with e-visit recommendations

  3. E-visit Ease of Use

    Time frame: Month 1

    Participants reported Agree or Strongly Agree to finding the e-visit easy to use question

  4. Time to Complete the E-visit

    Time frame: Month 1

    Time (days) to complete the e-visit among participants that completed the e-visit.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Mar 20, 2020
Registry last updated
Dec 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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