NCT05277207

Tobacco Cessation Treatment Preferences Among Veteran Smokers

Tobacco Cessation Treatment Preferences Among Veteran Smokers (CDA 17-005)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Tobacco Use

Interventions

Type	Name	Description
BEHAVIORAL	Personalized Smoking Cessation Facilitation Meetings	Participants will participate in 5-7 meetings in which they will receive cognitive-behavioral therapy for tobacco cessation.
DRUG	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.
BEHAVIORAL	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.
BEHAVIORAL	SmokefreeVET	Participants will receive a referral to SmokefreeVET, a text-messaging intervention designed to help veterans prepare for and attempt quitting smoking.
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.
OTHER	Education about pharmacotherapy	Participants will receive a handout that provides them with information about pharmacotherapies for tobacco cessation.

Timeline

• Start date: 2022-05-02
• Primary completion: 2023-09-27
• Completion: 2023-09-27
• First posted: 2022-03-14
• Last updated: 2024-05-07
• Results posted: 2024-05-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study