NCT07455526 · VA Office of Research and Development
Facilitation to Increase Tobacco Treatment
(FITT)
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Multi-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.
Primary outcome measures
Semi-structured, one-on-one interviews
Time frame: 12 months after start of implementation at each site
Acceptability 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 tracker
Time frame: Weekly 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- None Veterans receiving direct letters:
- Active prescription for bupropion, varenicline, or any nicotine replacement therapy
Where
- Baltimore, Maryland
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 15, 2026 · Source of record for eligibility and locations