Tobacco Cessation Treatment Preferences Among Veteran Smokers (MESH)

VA Office of Research and Development

Status and phase: Completed; Phase 4

Conditions: Tobacco Use

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

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT05277207

CDX 22-005

Details and patient eligibility

About

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.

Full 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).

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

MESH

Experimental group

Description:

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.

Treatment:

Behavioral: Personalized Text Messaging Support

Drug: Personalized Smoking Cessation Pharmacotherapy

Behavioral: Personalized Smoking Cessation Facilitation Meetings

Best Practice Telehealth Group

Active Comparator group

Description:

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.

Treatment:

Other: Education about pharmacotherapy

Behavioral: VA Quitline

Behavioral: SmokefreeVET