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

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Estimated): 672
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Noelle E Natale; Phone Number: 843-876-2426; Email: natalen@musc.edu

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Recruiting
      • Medical University of South Carolina
      • Contact: Noelle Natale; Phone Number: 843-876-2426; Email: natalen@musc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. current smoking, defined as 1+ 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

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 (TAU); 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
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

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Cancer Institute (NCI)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 5, 2022
• First Submitted That Met QC Criteria: August 5, 2022
• First Posted (Actual): August 9, 2022

Study Record Updates

• Last Update Posted (Actual): March 5, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Health Behavior; Smoking Cessation; Therapeutics
• Other Study ID Numbers: Pro00113308; R01CA258669 (U.S. NIH Grant/Contract)

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