Tobacco Cessation Treatment Preferences Among Veteran Smokers

Phase 4

Completed

Conditions: Tobacco Use

Interventions: Behavioral: Personalized Smoking Cessation Facilitation Meetings
Behavioral: SmokefreeVET
Drug: Personalized Smoking Cessation Pharmacotherapy
Behavioral: VA Quitline
Behavioral: Personalized Text Messaging Support
Other: Education about pharmacotherapy

Registration Number: NCT05277207

Lead Sponsor: VA Office of Research and Development

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MESH	Personalized Smoking Cessation Facilitation Meetings	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.
MESH	Personalized Smoking Cessation Pharmacotherapy	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.
MESH	Personalized Text Messaging Support	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.
Best Practice Telehealth Group	SmokefreeVET	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.
Best Practice Telehealth Group	VA Quitline	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.
Best Practice Telehealth Group	Education about pharmacotherapy	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Report Post-treatment Satisfaction	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 Outcome Measures

Name	Time	Method
Treatment Attendance	Post-treatment, approximately eight weeks after baseline visit	Treatment attendance is defined as the proportion of participants who complete at least one treatment session (via self-report for control group, via attendance logs for treatment group).
Therapist-rated Treatment Acceptability in Active Treatment Group	Post-treatment 3-month follow-up visit (approximately three months after enrollment)	The proportion of post-treatment acceptability scores greater than 3.5 will be reported. Post-treatment therapist acceptability will be measured at the 3-month follow-up. Acceptability will be defined as a mean score greater than 3.5 on the acceptability measure.
Proportion of Participants Who Completed Treatment in the Active Treatment Group	Post-treatment, approximately eight weeks after baseline visit	The investigators will provide the proportion of participants assigned to the active treatment group who complete treatment.