Tobacco Cessation Treatment Preferences Among Veteran Smokers (CDA 17-005)
Overview
- Phase
- Phase 4
- Intervention
- Personalized Smoking Cessation Pharmacotherapy
- Conditions
- Tobacco Use
- Sponsor
- VA Office of Research and Development
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Number of Participants Who Report Post-treatment Satisfaction
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
There are significant barriers to tobacco cessation treatment for patients and providers in specialty care clinical settings. Specialty providers cite several barriers to delivering evidence-based tobacco cessation care, including insufficient time and lack of training. In addition, a large proportion of patients who begin tobacco cessation treatment do not quit. Use of healthcare technology (i.e., telehealth, electronic health record, and computerized treatment algorithms based on patient data) to improve patients' ability to quit tobacco use. The purpose of this study is to demonstrate the feasibility of a larger trial, and to evaluate the acceptability of the intervention design. Thirty participants will be assigned to receive either 1) a treatment that includes personalized counseling, tobacco cessation medications, and text messaging; or 2) referral to Department of Veterans Affairs' Quitline program plus SmokefreeVET, a text messaging program.
Detailed Description
There are significant barriers to tobacco cessation treatment for patients and providers in specialty care clinical settings. Specialty providers in general cite several prominent barriers to delivering evidence-based tobacco cessation care, including insufficient time, lack of training, a perception of low motivation in their patients, and concerns about the sensitivity of tobacco cessation discussions. In addition, a large proportion of patients who begin tobacco cessation treatment do not achieve initial abstinence. Use of healthcare technology (i.e., telehealth, electronic health record, and computerized treatment algorithms based on patient data) to personalize treatment has the potential to increase patient engagement and proactively address treatment non-response. The proposed randomized controlled trial is a two-arm experimental design to demonstrate the feasibility of a larger trial and the acceptability of the intervention design. Participants (N = 30) will be stratified by clinic and randomized to either 1) the active treatment, which includes personalized cognitive behavioral treatment, personalized smoking cessation pharmacotherapy, and test messaging support; or 2) standard of care Department of Veterans Affairs' Quitline (telehealth intervention including 5 sessions of CBT) plus SmokefreeVET (text-messaging intervention).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Durham VA patient
- •willing to complete study procedures
- •appointment in Durham VA Infectious Disease (ID) Clinic or Durham VA Cardiology Section within the past 12 months
- •currently smoking 7 times per week (cigarettes, cigars, cigarillos, hookah, etc.) and/or using 1 can of smokeless tobacco per week
Exclusion Criteria
- •participation in Aim 3 (already received the intervention)
- •current hospitalization (recent hospitalization is acceptable)
- •currently not using combustible or smokeless tobacco (vaping only)
- •acute risk for suicide documented in the medical record
- •or inability to complete study procedures
Arms & Interventions
MESH
Participants assigned to this group will receive a treatment that includes personalized smoking cessation facilitation meetings with cognitive-behavioral therapy, personalized smoking cessation pharmacotherapy, and personalized text messaging.
Intervention: Personalized Smoking Cessation Pharmacotherapy
MESH
Participants assigned to this group will receive a treatment that includes personalized smoking cessation facilitation meetings with cognitive-behavioral therapy, personalized smoking cessation pharmacotherapy, and personalized text messaging.
Intervention: Personalized Smoking Cessation Facilitation Meetings
MESH
Participants assigned to this group will receive a treatment that includes personalized smoking cessation facilitation meetings with cognitive-behavioral therapy, personalized smoking cessation pharmacotherapy, and personalized text messaging.
Intervention: Personalized Text Messaging Support
Best Practice Telehealth Group
Participants assigned to this group will be referred to Quit Vet (VA's quitline for stopping tobacco) and SmokefreeVET (a free text messaging program to help you quit), and will receive information about getting quit medications.
Intervention: SmokefreeVET
Best Practice Telehealth Group
Participants assigned to this group will be referred to Quit Vet (VA's quitline for stopping tobacco) and SmokefreeVET (a free text messaging program to help you quit), and will receive information about getting quit medications.
Intervention: VA Quitline
Best Practice Telehealth Group
Participants assigned to this group will be referred to Quit Vet (VA's quitline for stopping tobacco) and SmokefreeVET (a free text messaging program to help you quit), and will receive information about getting quit medications.
Intervention: Education about pharmacotherapy
Outcomes
Primary Outcomes
Number of Participants Who Report Post-treatment Satisfaction
Time Frame: Post-treatment 3-month follow-up visit (approximately three months after enrollment)
Post-treatment satisfaction will be measured at the 3-month follow-up. Satisfaction will be defined as a mean score greater than 3.5 on the satisfaction measure.
Secondary Outcomes
- Treatment Attendance(Post-treatment, approximately eight weeks after baseline visit)
- Therapist-rated Treatment Acceptability in Active Treatment Group(Post-treatment 3-month follow-up visit (approximately three months after enrollment))
- Proportion of Participants Who Completed Treatment in the Active Treatment Group(Post-treatment, approximately eight weeks after baseline visit)