Smoking Cessation E-Visit

Not Applicable

Completed

• Conditions: Smoking
• Interventions: Behavioral: Smoking cessation e-visit; Behavioral: Treatment As Usual

• 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

Arm && Interventions

Group	Intervention	Description
Smoking cessation electronic visit (e-visit)	Smoking cessation e-visit	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.
Treatment As Usual	Treatment As Usual	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.

Primary Outcome Measures

Name	Time	Method
Cigarettes Smoking	Month 3	Cigarettes per day reduction greater than 50%
Quit Attempts	Month 3	Quit attempts since last contact
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

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