Clinical trial NCT04840108: Veteran Support for Smoking Cessation Pilot Project (VAntage Pilot)
Official title: Veteran Social Support Intervention for Enhancing Smoking Treatment Utilization and Cessation Pilot Project
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking Cessation
Keywords: Smoking cessation
Support Person
Lead sponsor: Minneapolis Veterans Affairs Medical Center
Sponsor class: FED
First posted: 2021-04-09
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a proposal to conduct a pilot study to assess the feasibility of recruitment of Veteran smoker and support person (SP) dyads and study procedures in preparation for a large randomized pragmatic trial.

Detailed description: This is a proposal to conduct a pilot study to assess the feasibility of recruitment of Veteran smoker and support person (SP) dyads and study procedures in preparation for a large randomized pragmatic trial. Enhancing access and use of evidence-based tobacco cessation treatments and eliminating tobacco-related health disparities are top national and VA health services priorities. The prevalence of tobacco use is greater among Veterans compared to non-Veterans. From 2010-2015, 28.9% of women and 21.1% of male Veterans reported current cigarette smoking. Because our prior VHA trials enrolled about 94% men and the higher smoking rates among women, we will examine the feasibility of recruitment of an equal number of men and women Veteran smokers in this pilot study. Evidence-based cessation treatments (EBCTs) such as, tobacco quitlines, behavioral counseling, and pharmacotherapy, are greatly underutilized by Veteran smokers. This pilot project is innovative for evaluating social support networks as a proactive outreach approach to enhance cessation treatment utilization among Veteran smokers. The role of social network influences and social support on successful smoking cessation is established. Based on Cohen's theory of social support, our team developed a social support intervention for diverse family members, friends, and other adults who wanted to help a smoker quit. The intervention consists of written materials and a 1-call, 15-25 minute coaching session. The intervention goal is for support persons (SPs) to encourage their smoker to use EBCT.

We will conduct a randomized pilot trial within the national VHA health system to evaluate the feasibility of recruitment of smoker-SP dyads and other study procedures. Veteran smokers, regardless of level of readiness to quit, will be identified nationally using the VHA electronic health record (EHR) data base and proactively recruited. Interested smokers will be asked to identify a SP who will enroll. Participants will be randomized as smoker-SP dyads to the intervention (n= 15 dyads) or control condition (n= 15 dyads). All smoker participants will receive written resources and information on evidence-based cessation treatments. All SP participants will receive written materials. SP participants assigned to the intervention group will additionally receive a 1-call coaching session. Assessments for dyads in both study groups will be conducted at baseline and at 3-months post-randomization.

Our specific aims are to: (Aim 1) To assess the feasibility of recruitment of 30 Veteran smoker-SP dyads including enrollment of an equal number of men and women Veterans; and (Aim 2) To evaluate the feasibility of biochemical verification of the smoker's abstinence at 1-month follow-up using a remote collection method.

If the project is successful, we will have a blueprint for conducting a large randomized pragmatic trial. Preliminary data will be incorporated in a grant resubmission to the VA HSR\& D to support the feasibility of recruitment and other study procedures.

Eligibility criteria: Inclusion Criteria:

* Veteran: Veteran has to be current tobacco user (past month) and and has smoked greater than 1 cigarette in the past 30 days, aged 18 years or older, cigarettes are the main tobacco product being used, are able to identify a support person to volunteer in the study with them who they have contact with (of any form) at least 3 times per week, and the Veteran has to have access to a smartphone or tablet device.
* Support Person: Has to be 18 years or older, willing to participate in the study and support the Veteran smoker, and have access to any type of phone they are able to complete the screener and coaching intervention call with.

Exclusion Criteria:

* Veteran: Does not use cigarettes as may tobacco use, does not smoke, is younger than 18 years of age, does not have a support person to have participate with them in the study, does not have access to a smartphone or tablet device.
* Support Person: Does not have access to a phone, is not willing to support the Veteran and participate in the study, or is younger than 18 years of age.

Primary outcomes:
measure: Recruitment Feasibility
timeFrame: Duration of project, one year
Secondary outcomes:
measure: Smoking abstinence: feasibility of biochemical confirmation using a remote collection method
timeFrame: One-month after randomization
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis Veterans Administration Health Care System
state: Minnesota
Study officials:
affiliation: MinnepolisVAMC
name: Steven Fu, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: