Enhanced E-cigarette Coaching Intervention for Dual Users of Cigarettes and E-cigarettes

Study Overview
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Brief Summary
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The purpose of this study is to develop and pilot test an enhanced behavioral coaching intervention for dual users of cigarettes and electronic nicotine delivery systems (ENDS) who call tobacco quitlines for help quitting smoking.

Detailed Description
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The specific aims of this research are to: Develop an Enhanced ENDS Coaching (EEC) intervention to improve standard quitline treatment for dual users who contact the quitline for help quitting smoking and are using ENDS, and train tobacco cessation coaches to deliver the intervention. Phase 1 (n=10): Assess preliminary EEC acceptability and feasibility, and refine the intervention with 10 dual users. Hypothesis 1: ENDS users will rate the helpfulness and usability of EEC positively and will exhibit increased knowledge about ENDS and cessation aids. Phase 2 (n=100): Evaluate the feasibility and acceptability of EEC compared to quitline treatment as usual (TAU) in a randomized pilot study of 100 smokers who use ENDS and are seeking help with quitting smoking. Hypothesis 2a (engagement): EEC participants will complete as many or more coaching calls than TAU. Hypothesis 2b (acceptability, satisfaction; assessed via 3-month survey): EEC will have satisfaction at least as high as the TAU group and rate their quit plan development experience more positively. Hypothesis 2c (beliefs; assessed at 3-month survey): EEC participants will report more accurate knowledge and beliefs about ENDS, smoking, and FDA-approved cessation medications.

Official Title
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Enhanced E-cigarette Coaching Intervention for Dual Users of Cigarettes and E-cigarettes

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Enhanced E-cigarette Coaching
* Behavioral: Quitline treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Requested quitline coaching services and enrolled in 5 call Oklahoma Tobacco Helpline (OKHL) program Currently using e-cigarettes Indicated plan to use e-cigarettes in the next 30 days English Speaking 18+ years old Willing to quit cigarettes in the next 30 days Consented to receive automated phone outreach via the quitline (TCPA consented) Has an Android smartphone with an operating system of 6.0 or higher and comfort downloading and using apps on phone Has regular access to email Callback best time between the hours of 6:00 am - 3:00 pm Pacific Standard Time Exclusion Criteria: • Pregnant or Planning pregnancy within 3 months Reported Schizophrenia diagnosis history during registration Heart attack past 2 weeks Stroke/Transient Ischemic Attack past 2 weeks Rapid Irregular heart beat past 6 months Angina or heart pain past 6 months Currently taking Varenicline (also known as Chantix) or Bupropion (also known as Wellbutrin or Zyban) Previously screened for study Enrolled via proxy (i.e., did not self-enroll)

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced E-cigarette Coaching (EEC)<br>The EEC intervention calls will include assessment of e-cigarette use and discussion about how and why e-cigarettes are being used on every call. In addition to the standard quitline cessation program, the enhanced program will include education (via quit coaches and two tailored quit guides), behavioral support tailored to dual users, and shared decision making strategies to address how and why FDA-approved quitting aids and ENDS are being used and to develop an integrated quit plan based on callers' decisions. | Behavioral: Enhanced E-cigarette Coaching<br>* The EEC intervention calls will include assessment of e-cigarette use and discussion about how and why e-cigarettes are being used on every call. In addition to the standard quitline cessation program, the enhanced program will include education (via quit coaches and two tailored quit guides), behavioral support tailored to dual users, and shared decision making strategies to address how and why FDA-approved quitting aids and ENDS are being used and to develop an integrated quit plan based on callers' decisions.<br>* Other names: EEC;|
| Active Comparator: Quitline treatment as usual (TAU)<br>The standard tobacco quitline program is a proactive 5-call intervention grounded in social cognitive theory and the U.S. Public Health Service clinical practices guidelines for treating tobacco use and dependence. All enrollees in the study are eligible for 2-8 weeks of nicotine replacement therapy (depending on their standard quitline benefit offering), if they medically qualify and/or return a medical override letter from their doctor. | Behavioral: Quitline treatment as usual<br>* The standard tobacco quitline program is a proactive 5-call intervention grounded in social cognitive theory and the U.S. Public Health Service clinical practices guidelines for treating tobacco use and dependence. All enrollees in the study are eligible for 2-8 weeks of nicotine replacement therapy (depending on their standard quitline benefit offering), if they medically qualify and/or return a medical override letter from their doctor.<br>* Other names: TAU;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Satisfaction and Acceptability Measured on a Scale From 1-6 (Very Satisfied to Very Dissatisfied) | In Phase 2, average treatment satisfaction and acceptability rating will be compared for EEC and TAU participants. Full 1-6 scale description: 1 - very satisfied; 2 - satisfied; 3 - somewhat satisfied; 4 - somewhat dissatisfied; 5 - dissatisfied; 6 - very dissatisfied. Participants can also respond I don't know or I prefer not to answer. On scale 1-6, 1 is the best outcome. | 3 months after baseline | 
| Treatment Engagement: Call Completion | In Phase 2, call completion (captured via standard quitline data systems) will be compared for EEC and TAU participants. There is no limit to number of calls that can be completed, although participants are called to complete 5 scheduled calls (best outcome). | Phase 2 time frame: 3 months after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quit Plan Development Experience | In Phase 2, quit plan development experience will be compared for EEC and TAU participants. Quit plan development experience will be measured with an adapted version of the CollaboRATE (not an abbreviation) shared decision making assessment measure. The adapted CollaboRATE measure included 3 questions (on a 5-point scale from no effort (0) to every effort was made (4)): How much effort was made to help you understand your options for quitting smoking?, How much effort was made to listen to the things that matter most to you about your plan for quitting smoking?, and How much effort was made to include what matters most to you in creating your plan for quitting smoking?. Higher total scores indicate greater utilization of a shared decision-making approach during quit plan development. Scale minimum equals 0 and maximum equals 12. | 3 months after baseline | 
| Knowledge and Beliefs- Relative Risk of ENDS and Cigarettes | In Phase 2, Knowledge and Beliefs about ENDS, Smoking, and FDA-approved Cessation Medications was assessed via 3 relative risk questions about ENDS, Smoking, and FDA-approved Cessation Medications designed for this study, and compared for EEC and TAU participants. Responses to individual items will be described. To assess the relative risk of ENDS and cigarettes, the following question was asked, Compared to cigarettes, how harmful are e-cigarettes to a person's health? Answer responses included: less harmful, about the same, more harmful, and I prefer not to answer. | Phase 2 time frame: 3 months after baseline | 
| Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and Cigarettes | In Phase 2, Knowledge and Beliefs about ENDS, Smoking, and FDA-approved Cessation Medications was assessed via 3 relative risk questions about ENDS, Smoking, and FDA-approved Cessation Medications designed for this study, and compared for EEC and TAU participants. Responses to individual items will be described. To assess the relative risk of FDA-approved Cessation Medications and cigarettes, the following question was asked, Compared to cigarettes, how harmful are quit medications like the nicotine patch to a person's health? Answer responses included: less harmful, about the same, more harmful, and I prefer not to answer. | Phase 2 time frame: 3 months after baseline | 
| Knowledge and Beliefs- Relative Risk of FDA-approved Cessation Medications and ENDS | In Phase 2, Knowledge and Beliefs about ENDS, Smoking, and FDA-approved Cessation Medications was assessed via 3 relative risk questions about ENDS, Smoking, and FDA-approved Cessation Medications designed for this study, and compared for EEC and TAU participants. Responses to individual items will be described. To assess the relative risk of FDA-approved Cessation Medications and ENDS, the following question was asked, Compared to quit medications like the nicotine patch, how harmful are e-cigarettes to a person's health? Answer responses included: less harmful, about the same, more harmful, and I prefer not to answer. | Phase 2 time frame: 3 months after baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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e-cigarette, vaping, electronic nicotine delivery system (ENDS), smoking cessation