Enhancing Smoking Cessation Via Telehealth Options in Primary Care

Smoking Cessation Clinical Trial

— E-STOP  

Official title:

Hybrid Type 1 Effectiveness-Implementation Trial of a Proactive Smoking Cessation Electronic Visit for Scalable Delivery Via Primary Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05493254
• Other study ID #: Pro00113308
• Secondary ID: R01CA258669
• Status: Recruiting
• Phase: N/A
• Start date: August 31, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2023
• Source: Medical University of South Carolina
• Contact: Noelle E Natale
• Phone: 843-876-2426
• Email: natalen[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 672
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. current smoking, defined as 5+ cigarettes/day, for 20+ days out of the last 30 for the last 6+ months

2. age 18+

3. enrolled in MyChart or willing to enroll

4. possess a valid e-mail address that is checked daily

5. owner of an iOS or Android smartphone to provide remote CO

6. have a valid mailing address

7. English fluency Exclusion Criteria: 1) Use of an FDA-approved cessation medication in the last 7 days

Related Conditions & MeSH terms

• Smoking Cessation

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 (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Cancer Institute (NCI)

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	Number of participants who utilized smoking cessation treatment	Number of participants who utilized smoking cessation treatment since last assessment.	Month 6
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	Cigarettes smoking	Cigarettes per day reduction greater than 50%	Month 6
Primary	Quit attempts	Quit attempts since last contact	Month 1
Primary	Quit attempts	Quit attempts since last contact	Month 3
Primary	Quit attempts	Quit attempts since last contact	Month 6
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	Seven-day point prevalence abstinence	Participant has not had a cigarette in the past 7 days	Month 6
Primary	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
Primary	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
Primary	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
Primary	E-visit Adoption	Patients prescribed a medication who obtain their medication	Month 1
Primary	E-visit Adoption	Patients prescribed a medication who obtain their medication	Month 3
Primary	E-visit Adoption	Patients prescribed a medication who obtain their medication	Month 6