Smoking Cessation E-Visit
Development and Testing of a Smoking Cessation E-Visit for Implementation in Primary Care
1 other identifier
interventional
51
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2020
CompletedFirst Submitted
Initial submission to the registry
March 18, 2020
CompletedFirst Posted
Study publicly available on registry
March 20, 2020
CompletedResults Posted
Study results publicly available
December 8, 2020
CompletedDecember 8, 2020
December 1, 2020
6 months
March 18, 2020
November 5, 2020
December 4, 2020
Conditions
Outcome Measures
Primary Outcomes (12)
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 Outcomes (4)
E-visit Completion
Month 1
Provider Fidelity
Month 1
E-visit Ease of Use
Month 1
Time to Complete the E-visit
Month 1
Study Arms (2)
Smoking cessation electronic visit (e-visit)
EXPERIMENTALThis 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
ACTIVE COMPARATORThis 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.
Interventions
electronic visits (e-visits) for smoking cessation
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
Eligibility Criteria
You may qualify if:
- current smoking, defined as smoking 5+ cigarettes/day, for 20+ days out of the last 30, for the last 6+ months
- age 18+
- enrolled in Epic's MyChart program or willing to sign up for MyChart
- possess a valid e-mail address that is checked daily to access follow-up assessments and MyChart messages
- English fluency
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Related Publications (1)
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.
PMID: 33085578DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Noelle Natale
- Organization
- Medical University of South Carolina
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 18, 2020
First Posted
March 20, 2020
Study Start
May 1, 2019
Primary Completion
October 31, 2019
Study Completion
February 28, 2020
Last Updated
December 8, 2020
Results First Posted
December 8, 2020
Record last verified: 2020-12
Data Sharing
- IPD Sharing
- Will not share