Enhanced E-cigarette Coaching Intervention for Dual Users of Cigarettes and E-cigarettes
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Enhanced E-cigarette Coaching (EEC) 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
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.
Other Names:
|
| Active Comparator: Quitline treatment as usual (TAU) 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
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.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Treatment Satisfaction and Acceptability measured on a scale from 1-6 (very satisfied to very dissatisfied) [3 months after baseline]
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.
- Treatment engagement: call completion [Phase 2 time frame: 3 months after baseline]
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).
Secondary Outcome Measures
- Quit plan development experience [3 months after baseline]
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 shared decision making assessment measure (Barr et al, 2014).
- Knowledge and beliefs [Phase 2 time frame: 3 months after baseline]
In Phase 2, Knowledge and Beliefs about ENDS, Smoking, and FDA-approved Cessation Medications will be assessed via 14 belief questions designed for this study, and compared for EEC and TAU participants. Answers are reported on a 4 or 5 point scales (answer scales are tailored to the content of the specific question). Responses to individual items will be described. The questionnaire will be evaluated and refined, if needed, during Phase 1 of the study.
Other Outcome Measures
- 7-Day point prevalence smoking cessation rates [Phase 2 time frame: 3 months after baseline]
In Phase 2 participants will report their quit status during their outcome survey.
- Changes in use of ENDS, Nicotine Replacement Therapy (NRT), and cigarettes [Up to 12 weeks]
A descriptive analysis of how ENDS, NRT, and cigarettes are used during a participant's quit process through diary procedures.
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Optum | Seattle | Washington | United States | 98104 |
Sponsors and Collaborators
- Consumer Wellness Solutions
- University of Oklahoma
- SRI International
- H. Lee Moffitt Cancer Center and Research Institute
Investigators
- Principal Investigator: Katrina Vickerman, PHD, Optum, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1R21DA042960-01A1