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OpenTrials
Completed

NCT Number: NCT05277207

Tobacco Cessation Treatment Preferences Among Veteran Smokers

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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Key information

Conditions

Tobacco Use Behavior Smoking

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Durham VA Medical Center, Durham, NC

Durham, North Carolina, 27705-3875, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Personalized Smoking Cessation Facilitation Meetings

Behavioral

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

Personalized Smoking Cessation Pharmacotherapy

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

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.

Other names: Annie

SmokefreeVET

Behavioral

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

VA Quitline

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

Other

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

Primary outcomes

  1. 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

  1. Treatment Attendance

    Time frame: 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).

  2. Therapist-rated Treatment Acceptability in Active Treatment Group

    Time frame: 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.

  3. Proportion of Participants Who Completed Treatment in the Active Treatment Group

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Acronym: MESH

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 14, 2022
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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