Clinical trial NCT05868421: Veteran Social Support for Enhancing Use of Smoking Cessation Treatment
Official title: Veteran Social Support Intervention for Enhancing Smoking Treatment Utilization and Cessation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking Cessation
Veterans Health
Keywords: Smoking cessation
Social support
Veterans health
Tobacco cessation
Support persons
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2023-05-22
Enrollment: 2376
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: pragmatic randomized controlled trial that will randomize Smoker-Support Person dyads with 1:1 allocation
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study is recruiting Veterans who currently smoke cigarettes and support persons who are nominated by the Veterans. The purpose of this study is to assist Veterans with smoking cessation by asking Veterans to choose a support person who will assist them with the quitting process, or who may assist them with the quitting process once the Veteran is ready to quit smoking sometime in the future. Study staff will assess how much or how little social support during the Veteran's quitting process is helpful to the Veteran. This information will help us come up with new ways to help Veterans quit smoking that are better tailored to their needs.

Detailed description: Background: 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, 29% of women and 21% of male Veterans reported current cigarette smoking. Evidence-based cessation treatments (EBCTs) such as, tobacco quitlines, behavioral counseling, and pharmacotherapy, are greatly underutilized by Veteran smokers. Gaps remain in reaching women Veterans and use of existing social support networks to enhance use of EBCTs and cessation among Veterans.

Specific Aims. Aim 1: To evaluate the impact of the social support intervention on Veteran smokers' use of EBCT. Aim 2: To examine the effectiveness of the social support intervention on the biochemically confirmed 7-day point prevalence cigarette smoking abstinence. Aim 3: To explore potential moderators (e.g., smoker gender, SP tobacco use status) of intervention effects on study outcomes. Aim 4: To conduct a process evaluation assessing implementation outcomes (reach, adoption, fidelity) of the social support intervention and multilevel factors that may influence implementation.

Methods: The investigators will conduct a pragmatic randomized controlled trial (RCT) within the national VHA health system to evaluate the effectiveness of a social support intervention compared with a control condition on utilization of EBCT among VHA-enrolled smokers. Veteran smokers, regardless of level of readiness to quit, will be identified nationally using the VHA electronic health record and proactively recruited. Interested smokers will be asked to identify a support person (SP) who will enroll. Participants will be randomized as smoker-SP dyads to the intervention (n= 594 dyads) or control condition (n= 594 dyads). All smokers will receive written resources and information on EBCTs. 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, 3-, and 6-months post-randomization.

Innovation and Impact: This 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, the 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. It is expected to be especially beneficial for Veteran smokers who might not otherwise access cessation treatment. Because the prior VHA trials enrolled about 94% men and the higher smoking rates among women, the investigators will oversample women to enroll an equal number of men and women smokers. This study contributes to VA HSR\&D's priority initiatives for enhancing treatment access and women's health and is significant because it will advance research on the role of partnering with Veterans' families and/or important others to enhance access to VA healthcare and population-specific treatments, especially women Veterans. The potential reach and public health impact of an effective social support intervention for the Veteran tobacco user population is considerable.

Implementation/Next Steps: Next steps depend on the actual results, but the investigators expect findings to be important to VA leaders, the VA Women's Health Research Consortium and the Veteran community. The investigators will maintain communication throughout the project with VA program partners to share findings in a timely manner. The investigators will collaborate with CCDOR's Veteran Engagement Panel on development of patient-centered dissemination approaches and recommendations for future intervention adaptations and/or implementation.

Eligibility criteria: Inclusion Criteria:

Veteran Inclusion Criteria

* Smoked 1 cigarettes over the past 30 days, even a puff
* If using other tobacco or nicotine products, cigarettes are the main product used
* Able to identify one adult family member or friend (SP) with whom they have contact (of any form) at least 3 times per week who will enroll Veteran Support Person Inclusion Criteria
* Willing to support the Veteran smoker
* Have to have access to any type of phone (or tablet for video call) for delivery of the SP intervention

Exclusion Criteria:

Veteran Exclusion Criteria

* Have used cessation medications or a stop smoking program within the past 3 months
* Have no valid phone contact information

Primary outcomes:
measure: Use of Any Evidence-Based Cessation Treatments (EBCTs)
timeFrame: 6 months
Secondary outcomes:
measure: Biochemically confirmed 7-day point prevalence cigarette smoking abstinence
timeFrame: 6 months
measure: Use of Any Evidence-Based Cessation Treatments (EBCTs)
timeFrame: 3 months
measure: Self-reported 7-day point prevalence cigarette smoking abstinence
timeFrame: 6 months
measure: Self-reported 7-day point prevalence cigarette smoking abstinence
timeFrame: 3 months
measure: Prolonged smoking abstinence
timeFrame: 6 months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System, Minneapolis, MN
state: Minnesota
Study officials:
affiliation: Minneapolis VA Health Care System, Minneapolis, MN
name: Steven S. Fu, MD MSCE
role: PRINCIPAL_INVESTIGATOR
References: