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Facilitation to Increase Tobacco Treatment

External Facilitation to Expand Reach of Tobacco Treatment to SMI Veterans

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07455526
Acronym
FITT
Enrollment
65
Registered
2026-03-06
Start date
2026-10-01
Completion date
2031-10-01
Last updated
2026-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Serious Mental Illness, Tobacco Use Disorder

Keywords

veterans health services, mental health services, tobacco use disorder, delivery of health care, integrated, attitude of health personnel, qualitative research, implementation science, mental disorders

Brief summary

Smoking disproportionally impacts Veterans, and VA spends $2.7 billion annually on smoking-related health conditions. Veterans with serious mental illness (SMI) smoke tobacco products at triple the rate of Veterans without any mental illness and die 10-15 years earlier as a result. SMI Veterans who smoke want to quit and FDA-approved tobacco cessation medications are safe, effective, and readily available in VA. However, mental health providers are hesitant to treat smoking and just 11-18% of Veterans with SMI who smoke receive tobacco medication. External facilitation is an effective implementation strategy that can overcome barriers to integrating evidence-based treatment into routine clinical practice. In collaboration with local and operational partners, the proposed CDA-2 will evaluate and refine an external facilitation strategy to improve tobacco medication prescribing in VA SMI clinics. This proposal aligns with VA priorities to enhance timely access to care and improve Veteran outcomes.

Detailed description

Tobacco smoking and its health consequences disproportionally impact Veterans. Veterans with serious mental illness (SMI Veterans; schizophrenia spectrum, bipolar spectrum, and other psychotic disorders) have among the highest rates of smoking in VA and die 10-15 years earlier than those without SMI, largely due to smoking-related conditions. Seven FDA-approved tobacco medications are available in VA that are low-cost, safe, and effective for SMI Veterans when combined with brief behavioral counseling: nicotine replacement therapies (lozenge, gum, patch, nasal spray), bupropion, and varenicline. Nearly 70% of SMI Veterans who smoke want to quit, but they are 26% less likely to be prescribed tobacco medication (10.9% vs. 14.3% prescription rate) and also less likely to be advised to quit by physicians. SMI providers face numerous barriers to treating smoking. Implementation activities like external facilitation can address these barriers by coordinating other evidence-based implementation activities, such as academic detailing and auditing with feedback, that are tailored to local needs and show promise for improving tobacco treatment delivery in VA mental health clinics. Despite the availability of tobacco treatment in VA, smoking-related conditions remain the leading cause of death for SMI Veterans and account for nearly 8% of VA health care expenditures: $2.7 billion annually. Using external facilitation and other implementation strategies can help integrate tobacco treatment into routine mental health care and, in turn, reduce a critical health disparity between veterans with and without SMI and maximize the VA's use of existing resources. The primary purpose of this study is to evaluate the acceptability and feasibility of this multi-component implementation strategy designed to improve tobacco treatment delivery in VAMHCS SMI clinics.

Interventions

OTHERMulti-component facilitation

Facilitation includes identifying multilevel barriers to change, selecting implementation activities to address known barriers, tailoring implementation activities to the local context, providing social support, problem-solving challenges, conducting administrative duties, and refining implementation activities over time in response to data-driven needs for improvement. Facilitation will support multiple other evidence-based implementation activities like auditing performance with feedback and engaging patients. The proposed study will use an external facilitator - someone outside the clinic with expertise in implementation science and tobacco treatment - to partner with clinic representatives and operational leaders who share a commitment to increasing adoption of tobacco medication.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Multi-component external facilitation strategy

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

Providers: * VA Maryland Health Care System patient care providers serving Veterans in Critical Time Intervention, Psychosocial Rehabilitation and Recovery Center, Mental Health Integrative Case Management, or outpatient psychiatry clinics Veterans receiving direct letters: * Had an appointment in VA Maryland Health Care System, Critical Time Intervention, Psychosocial Rehabilitation and Recovery Center, Mental Health Integrative Case Management, or outpatient psychiatry clinics in the last 30 days * Diagnosed with a serious mental illness * Positive tobacco use screen * Appointment scheduled with an outpatient psychiatric prescriber in the next 30 days * Of note, study staff are not directly recruiting Veterans for this implementation intervention component Veteran chart review: * All Veterans actively enrolled in VAMHCS medical facilities with at least one encounter during a given period with available smoking health factor data * Of note, study staff are not directly recruiting veterans for this data analysis

Exclusion criteria

Providers: * None Veterans receiving direct letters: * Active prescription for bupropion, varenicline, or any nicotine replacement therapy

Design outcomes

Primary

MeasureTime frameDescription
Semi-structured, one-on-one interviews12 months after start of implementation at each siteAcceptability and feasibility: Interviews will gauge provider satisfaction with the implementation strategy (acceptability) and provider perceptions of the actual fit of the implementation strategy with the clinical setting (feasibility). This qualitative data will be analyzed for common themes. The number of providers endorsing each theme will be quantified.
Implementation trackerWeekly for the duration of the implementation at each site (12 months)Based on observation, the investigators will track provider attendance at trainings (number of providers attending divided by total number of eligible providers) and number of academic detailing sessions completed per provider (minimum = 1, maximum = 3) in an excel spreadsheet as benchmarks of feasibility to inform refinements to the implementation strategy.

Countries

United States

Contacts

CONTACTCorinne N Kacmarek, PhD
corinne.kacmarek2@va.gov(410) 340-0727
CONTACTCynthia Y Giron-Hernandez
cynthia.giron-hernandez@va.gov(805) 478-7948
PRINCIPAL_INVESTIGATORCorinne N Kacmarek, PhD

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026