Not Yet RecruitingNot Applicable

Facilitation to Increase Tobacco Treatment

United States65 participantsStarted 2026-10-01

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Semi-structured, one-on-one interviews

Timeframe: 12 months after start of implementation at each site

Implementation tracker

Timeframe: Weekly for the duration of the implementation at each site (12 months)

Trial details

NCT IDNCT07455526

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2030-06-30

Contact for this trial

Corinne N Kacmarek, PhD

(410) 340-0727 corinne.kacmarek2@va.gov

View on ClinicalTrials.gov More Serious Mental Illness trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.