Smoking Cessation E-Visit

Not Applicable

Completed

• Conditions: Smoking

• Registration Number: NCT04316260
• Lead Sponsor: Medical University of South Carolina

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-01
• Primary Completion: 2019-10-31
• Study Completion: 2020-02-28
• Study First Submitted: 2020-03-18
• Study First Submitted QC: 2020-03-19
• Study First Posted: 2020-03-20
• Results First Submitted: 2020-11-05
• Status Verified: 2020-12
• Results First Submitted QC: 2020-12-04
• Last Update Submitted: 2020-12-04
• Results First Posted: 2020-12-08
• Last Update Posted: 2020-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States