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NCT Number: NCT07455526

Facilitation to Increase Tobacco Treatment

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Baltimore, Maryland, 21201, United States

Location contact

Corinne N Kacmarek, PhD

CONTACT

[email protected]

410-340-0727

Corinne N Kacmarek, PhD

PRINCIPAL_INVESTIGATOR

Cynthia Y Giron-Hernandez

CONTACT

[email protected]

(805) 478-7948

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multi-component facilitation

Other

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 outcomes

  1. 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.

  2. 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.

Other outcomes

  1. Smoking Knowledge, Attitudes, and Practices Scale: Practices subscale only

    Time frame: Before implementation, at end of implementation (12 months), and 12 months after end of implementation (24 months)

    Adoption: The survey will inquire about provider frequency of delivering evidence-based tobacco treatment to Veterans.

    Minimum = 0 (never), maximum = 4 (always). A higher score is desired because it suggests frequent tobacco treatment delivery.

  2. Prescriptions of tobacco cessation medication

    Time frame: Monthly 12 months before through 12 months after the end of implementation (36 months)

    Reach: Change in the proportion of eligible Veterans prescribed a medication for tobacco use from the VHA corporate data warehouse.

  3. Changes in tobacco use

    Time frame: Monthly 12 months before through 12 months after the end of implementation (36 months)

    Effectiveness: Changes in the proportion of Veterans quitting tobacco from the VHA corporate data warehouse.

Study contacts

Contact information is provided by the study sponsor or research team.

Corinne N Kacmarek, PhD

CONTACT

[email protected]

(410) 340-0727

Cynthia Y Giron-Hernandez

CONTACT

[email protected]

(805) 478-7948

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

External Facilitation to Expand Reach of Tobacco Treatment to SMI Veterans

Acronym: FITT

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Mar 6, 2026
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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