Enhancing Smoking Cessation Via Telehealth Options in Primary Care
E-STOP
Hybrid Type 1 Effectiveness-Implementation Trial of a Proactive Smoking Cessation Electronic Visit for Scalable Delivery Via Primary Care
2 other identifiers
interventional
672
1 country
1
Brief Summary
The purpose of this research study is to evaluate an electronic visit (e-visit) for smoking cessation. Participants will be randomly assigned to receive either the smoking cessation e-visit or not. The e-visit will look similar to an online questionnaire asking about smoking history, motivation to quit, and preferences for medications for quitting smoking. Participants may receive a prescription for a smoking cessation medication as an outcome of the e-visit, if randomized to the e-visit group, but there is no requirement to take any medication. This study consists of questionnaires and breath samples provided at 4 separate time points throughout the study. Participation in this study will take about 24 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2022
CompletedFirst Posted
Study publicly available on registry
August 9, 2022
CompletedStudy Start
First participant enrolled
August 31, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
March 5, 2026
March 1, 2026
4.3 years
August 5, 2022
March 3, 2026
Conditions
Outcome Measures
Primary Outcomes (18)
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
Number of participants who utilized smoking cessation treatment
Number of participants who utilized smoking cessation treatment since last assessment.
Month 6
Cigarettes smoking
Cigarettes per day reduction greater than 50%
Month 1
Cigarettes smoking
Cigarettes per day reduction greater than 50%
Month 3
Cigarettes smoking
Cigarettes per day reduction greater than 50%
Month 6
Quit attempts
Quit attempts since last contact
Month 1
Quit attempts
Quit attempts since last contact
Month 3
Quit attempts
Quit attempts since last contact
Month 6
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
Seven-day point prevalence abstinence
Participant has not had a cigarette in the past 7 days
Month 6
E-visit Acceptability
The e-visit will be considered acceptable if the average score on the Acceptability of Intervention Measure (AIM) is greater than or equal to 4.
Month 1
E-visit Acceptability
The e-visit will be considered acceptable if the average score on the Acceptability of Intervention Measure (AIM) is greater than or equal to 4.
Month 3
E-visit Acceptability
The e-visit will be considered acceptable if the average score on the Acceptability of Intervention Measure (AIM) is greater than or equal to 4.
Month 6
E-visit Adoption
Patients prescribed a medication who obtain their medication
Month 1
E-visit Adoption
Patients prescribed a medication who obtain their medication
Month 3
E-visit Adoption
Patients prescribed a medication who obtain their medication
Month 6
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 (TAU)
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 1+ cigarettes/day, for 20+ days out of the last 30 for the last 6+ months
- age 18+
- enrolled in MyChart or willing to enroll
- possess a valid e-mail address that is checked daily
- owner of an iOS or Android smartphone to provide remote CO
- have a valid mailing address
- English fluency
You may not qualify if:
- \) Use of an FDA-approved cessation medication in the last 7 days
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)
Fahey MC, Wahlquist AE, Diaz VA, Player MS, Natale N, Sterba KR, Chen BK, Hermes EDA, Carpenter MJ, Dahne J. Rationale, design, and protocol for a hybrid type 1 effectiveness-implementation trial of a proactive smoking cessation electronic visit for scalable delivery via primary care: the E-STOP trial. BMC Prim Care. 2023 Nov 29;24(1):254. doi: 10.1186/s12875-023-02205-3.
PMID: 38030991DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
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
- Associate Professor
Study Record Dates
First Submitted
August 5, 2022
First Posted
August 9, 2022
Study Start
August 31, 2022
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
March 5, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share