NCT04840108

Veteran Support for Smoking Cessation Pilot Project (VAntage Pilot)

Veteran Social Support Intervention for Enhancing Smoking Treatment Utilization and Cessation Pilot Project

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (estimated)
• Sponsor: Minneapolis Veterans Affairs Medical Center · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Smoking Cessation

Interventions

Type	Name	Description
BEHAVIORAL	Support Person Coaching Intervention	The intervention condition will include, for the SPs, a manualized, 1-session coaching intervention delivered by a research coach. The call will be delivered by phone using VA-permitted remote audio or video communication technology (e.g., doximity dialer, Zoom, or VA Video Connect if a Veteran). Coaches will use behavior change strategies delivered with a MI style.
BEHAVIORAL	Support Person Written Materials	Support persons will receive existing written materials on effective social support strategies for smoking cessation. Materials will be sent via postal mail.

Timeline

• Start date: 2021-04-12
• Primary completion: 2024-09-01
• Completion: 2024-12-01
• First posted: 2021-04-09
• Last updated: 2024-03-19

Locations

1 site across 1 country: United States