Smoking Cessation E-Visit

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04316260
• Other study ID #: Pro00078077
• Status: Completed
• Phase: N/A
• Start date: May 1, 2019
• Est. completion date: February 28, 2020

Study information

• Verified date: December 2020
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: February 28, 2020
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking

Intervention

Behavioral:
• Smoking cessation e-visit
electronic visits (e-visits) for smoking cessation
• Treatment As Usual
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

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Utilized Smoking Cessation Treatment	Number of participants who utilized smoking cessation treatment since last assessment.	Month 1
Primary	Number of Participants Who Utilized Smoking Cessation Treatment	Number of participants who utilized smoking cessation treatment since last assessment.	Month 3
Primary	Cigarettes Smoking	Cigarettes per day reduction greater than 50%	Month 1
Primary	Cigarettes Smoking	Cigarettes per day reduction greater than 50%	Month 3
Primary	Quit Attempts	Quit attempts since last contact	Month 1
Primary	Quit Attempts	Quit attempts since last contact	Month 3
Primary	24-hour Quit Attempt	Quit attempt lasting 24 hours since last contact	Month 1
Primary	24-hour Quit Attempt	Quit attempt lasting 24 hours since last contact	Month 3
Primary	Seven-day Point Prevalence Abstinence	Participant has not had a cigarette in the past 7 days	Month 1
Primary	Seven-day Point Prevalence Abstinence	Participant has not had a cigarette in the past 7 days	Month 3
Primary	Floating Abstinence	Participant has gone 7+ days without a cigarette since last contact.	Month 1
Primary	Floating Abstinence	Participant has gone 7+ days without a cigarette since last contact.	Month 3
Secondary	E-visit Completion	Number of participants that completed the e-visit	Month 1
Secondary	Provider Fidelity	Reviewing within Epic whether the provider administered treatment consistent with e-visit recommendations	Month 1
Secondary	E-visit Ease of Use	Participants reported Agree or Strongly Agree to finding the e-visit easy to use question	Month 1
Secondary	Time to Complete the E-visit	Time (days) to complete the e-visit among participants that completed the e-visit.	Month 1