Tobacco Cessation Treatment Preferences Among Veteran Smokers
MESH
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started May 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 2, 2022
CompletedFirst Posted
Study publicly available on registry
March 14, 2022
CompletedStudy Start
First participant enrolled
May 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 27, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 27, 2023
CompletedResults Posted
Study results publicly available
May 7, 2024
CompletedMay 7, 2024
April 1, 2024
1.4 years
March 2, 2022
April 10, 2024
April 10, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Who Report Post-treatment Satisfaction
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.
Post-treatment 3-month follow-up visit (approximately three months after enrollment)
Secondary Outcomes (3)
Treatment Attendance
Post-treatment, approximately eight weeks after baseline visit
Therapist-rated Treatment Acceptability in Active Treatment Group
Post-treatment 3-month follow-up visit (approximately three months after enrollment)
Proportion of Participants Who Completed Treatment in the Active Treatment Group
Post-treatment, approximately eight weeks after baseline visit
Study Arms (2)
MESH
EXPERIMENTALParticipants 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.
Best Practice Telehealth Group
ACTIVE COMPARATORParticipants 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.
Interventions
Participants will participate in 5-7 meetings in which they will receive cognitive-behavioral therapy for tobacco cessation.
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.
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.
Participants will receive a referral to SmokefreeVET, a text-messaging intervention designed to help veterans prepare for and attempt quitting smoking.
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.
Participants will receive a handout that provides them with information about pharmacotherapies for tobacco cessation.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Angela Kirby
- Organization
- Durham VA Health Care System
Study Officials
- PRINCIPAL INVESTIGATOR
Sarah M. Wilson, PhD
Durham VA Medical Center, Durham, NC
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 2, 2022
First Posted
March 14, 2022
Study Start
May 2, 2022
Primary Completion
September 27, 2023
Study Completion
September 27, 2023
Last Updated
May 7, 2024
Results First Posted
May 7, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share
De-identified data sets will be available upon written FOIA request. Final data sets will also be maintained locally until enterprise-level resources become available for broader long-term storage and access unless the relevant ORD or VA Program Office Funding Announcement states otherwise.