Tobacco Cessation Treatment Preferences Among Veteran Smokers

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-02

Study Completion Date

2023-09-27

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Tobacco Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Personalized Smoking Cessation Facilitation Meetings

Intervention Type BEHAVIORAL

Participants will participate in 5-7 meetings in which they will receive cognitive-behavioral therapy for tobacco cessation.

Personalized Smoking Cessation Pharmacotherapy

Intervention Type DRUG

Participants may receive pharmacotherapy for smoking cessation based on VA Pharmacy Benefits Management Services guidelines. Medications may include nicotine-replacement therapy, varenicline, and/or bupropion.

Personalized Text Messaging Support

Intervention Type BEHAVIORAL

If the participant has a working cell phone and is willing to receive text messages, supportive, personalized text messages will be sent to the participant starting after Session 1 and extending through 6 months post-quit using VA's Annie texting capability.

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.

Group Type ACTIVE_COMPARATOR

SmokefreeVET

Intervention Type BEHAVIORAL

Participants will receive a referral to SmokefreeVET, a text-messaging intervention designed to help veterans prepare for and attempt quitting smoking.

VA Quitline

Intervention Type BEHAVIORAL

Participants will receive a referral to VA Quitline, which is a nationally available telehealth intervention that provides assistance to veterans who wish to quit tobacco use. Quitline includes five sessions of cognitive-behavioral treatment.

Education about pharmacotherapy

Intervention Type OTHER

Participants will receive a handout that provides them with information about pharmacotherapies for tobacco cessation.

Interventions

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Personalized Smoking Cessation Facilitation Meetings

Participants will participate in 5-7 meetings in which they will receive cognitive-behavioral therapy for tobacco cessation.

Intervention Type BEHAVIORAL

Personalized Smoking Cessation Pharmacotherapy

Participants may receive pharmacotherapy for smoking cessation based on VA Pharmacy Benefits Management Services guidelines. Medications may include nicotine-replacement therapy, varenicline, and/or bupropion.

Intervention Type DRUG

Personalized Text Messaging Support

If the participant has a working cell phone and is willing to receive text messages, supportive, personalized text messages will be sent to the participant starting after Session 1 and extending through 6 months post-quit using VA's Annie texting capability.

Intervention Type BEHAVIORAL

SmokefreeVET

Participants will receive a referral to SmokefreeVET, a text-messaging intervention designed to help veterans prepare for and attempt quitting smoking.

Intervention Type BEHAVIORAL

VA Quitline

Participants will receive a referral to VA Quitline, which is a nationally available telehealth intervention that provides assistance to veterans who wish to quit tobacco use. Quitline includes five sessions of cognitive-behavioral treatment.

Intervention Type BEHAVIORAL

Education about pharmacotherapy

Participants will receive a handout that provides them with information about pharmacotherapies for tobacco cessation.

Intervention Type OTHER

Other Intervention Names

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Annie

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No