Clinical trial NCT04316260: Smoking Cessation E-Visit
Official title: Development and Testing of a Smoking Cessation E-Visit for Implementation in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2020-03-20
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

None

Primary outcomes:
measure: Number of Participants Who Utilized Smoking Cessation Treatment
timeFrame: Month 1
measure: Number of Participants Who Utilized Smoking Cessation Treatment
timeFrame: Month 3
measure: Cigarettes Smoking
timeFrame: Month 1
measure: Cigarettes Smoking
timeFrame: Month 3
measure: Quit Attempts
timeFrame: Month 1
measure: Quit Attempts
timeFrame: Month 3
measure: 24-hour Quit Attempt
timeFrame: Month 1
measure: 24-hour Quit Attempt
timeFrame: Month 3
measure: Seven-day Point Prevalence Abstinence
timeFrame: Month 1
measure: Seven-day Point Prevalence Abstinence
timeFrame: Month 3
measure: Floating Abstinence
timeFrame: Month 1
measure: Floating Abstinence
timeFrame: Month 3
Secondary outcomes:
measure: E-visit Completion
timeFrame: Month 1
measure: Provider Fidelity
timeFrame: Month 1
measure: E-visit Ease of Use
timeFrame: Month 1
measure: Time to Complete the E-visit
timeFrame: Month 1
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
citation: 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.