Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05868421
Status:
RECRUITING
Last Update Posted:
2024-02-06
First Post:
2023-05-05
Brief Title:
Veteran Social Support for Enhancing Use of Smoking Cessation Treatment
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Veteran Social Support Intervention for Enhancing Smoking Treatment Utilization and Cessation
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VAntage
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 Veterans 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 eg 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 Cohens 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 HSRDs priority initiatives for enhancing treatment access and womens health and is significant because it will advance research on the role of partnering with Veterans families andor 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
ImplementationNext Steps Next steps depend on the actual results but the investigators expect findings to be important to VA leaders the VA Womens 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 CCDORs Veteran Engagement Panel on development of patient-centered dissemination approaches and recommendations for future intervention adaptations andor implementation
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 eg 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 Cohens 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 HSRDs priority initiatives for enhancing treatment access and womens health and is significant because it will advance research on the role of partnering with Veterans families andor 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
ImplementationNext Steps Next steps depend on the actual results but the investigators expect findings to be important to VA leaders the VA Womens 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 CCDORs Veteran Engagement Panel on development of patient-centered dissemination approaches and recommendations for future intervention adaptations andor implementation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None