Enhancing Smoking Cessation Via Telehealth Options in Primary Care

Study Overview
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Brief Summary
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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.

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

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Smoking cessation e-visit
* Behavioral: Treatment As Usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: current smoking, defined as 5+ 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 Exclusion Criteria: 1) Use of an FDA-approved cessation medication in the last 7 days

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smoking cessation electronic visit (e-visit)<br>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<br>* electronic visits (e-visits) for smoking cessation<br>|
| Active Comparator: Treatment as usual (TAU)<br>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<br>* 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.<br>|

What is the study measuring?
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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 |