Tobacco Cessation Treatment Preferences Among Veteran Smokers

Tobacco Use Clinical Trial

— MESH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05277207
• Other study ID #: CDX 22-005
• Status: Completed
• Phase: Phase 4
• Start date: May 2, 2022
• Est. completion date: September 27, 2023

Study information

• Verified date: April 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 27, 2023
• Est. primary completion date: September 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Use

Intervention

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

Locations

Country	Name	City	State
United States	Durham VA Medical Center, Durham, NC	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Treatment Attendance	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).	Post-treatment, approximately eight weeks after baseline visit
Secondary	Therapist-rated Treatment Acceptability in Active Treatment Group	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.	Post-treatment 3-month follow-up visit (approximately three months after enrollment)
Secondary	Proportion of Participants Who Completed Treatment in the Active Treatment Group	The investigators will provide the proportion of participants assigned to the active treatment group who complete treatment.	Post-treatment, approximately eight weeks after baseline visit