Clinical trial NCT05277207: Tobacco Cessation Treatment Preferences Among Veteran Smokers
Official title: Tobacco Cessation Treatment Preferences Among Veteran Smokers (CDA 17-005)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Tobacco Use
Keywords: tobacco use
smoking
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2022-03-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants Who Report Post-treatment Satisfaction
timeFrame: Post-treatment 3-month follow-up visit (approximately three months after enrollment)
Secondary outcomes:
measure: Treatment Attendance
timeFrame: Post-treatment, approximately eight weeks after baseline visit
measure: Therapist-rated Treatment Acceptability in Active Treatment Group
timeFrame: Post-treatment 3-month follow-up visit (approximately three months after enrollment)
measure: Proportion of Participants Who Completed Treatment in the Active Treatment Group
timeFrame: Post-treatment, approximately eight weeks after baseline visit
Other outcomes:
Locations:
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
Study officials:
affiliation: Durham VA Medical Center, Durham, NC
name: Sarah M. Wilson, PhD
role: PRINCIPAL_INVESTIGATOR
References: