Smoking Cessation E-Visit

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

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.

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Behavioral: Smoking cessation e-visit; Behavioral: Treatment As Usual

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smoking cessation electronic visit (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.	Behavioral: Smoking cessation e-visit; electronic visits (e-visits) for smoking cessation
Active Comparator: 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.	Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Utilized Smoking Cessation Treatment	Number of participants who utilized smoking cessation treatment since last assessment.	Month 1
Number of Participants Who Utilized Smoking Cessation Treatment	Number of participants who utilized smoking cessation treatment since last assessment.	Month 3
Cigarettes Smoking	Cigarettes per day reduction greater than 50%	Month 1
Cigarettes Smoking	Cigarettes per day reduction greater than 50%	Month 3
Quit Attempts	Quit attempts since last contact	Month 1
Quit Attempts	Quit attempts since last contact	Month 3
24-hour Quit Attempt	Quit attempt lasting 24 hours since last contact	Month 1
24-hour Quit Attempt	Quit attempt lasting 24 hours since last contact	Month 3
Seven-day Point Prevalence Abstinence	Participant has not had a cigarette in the past 7 days	Month 1
Seven-day Point Prevalence Abstinence	Participant has not had a cigarette in the past 7 days	Month 3
Floating Abstinence	Participant has gone 7+ days without a cigarette since last contact.	Month 1
Floating Abstinence	Participant has gone 7+ days without a cigarette since last contact.	Month 3

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): February 28, 2020

Study Registration Dates

• First Submitted: March 18, 2020
• First Submitted That Met QC Criteria: March 19, 2020
• First Posted (Actual): March 20, 2020

Study Record Updates

• Last Update Posted (Actual): December 8, 2020
• Last Update Submitted That Met QC Criteria: December 4, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Pro00078077

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No