Recruiting

Tobacco Medication

Sponsor:

VA Office of Research and Development

Code:

NCT07455526

Conditions

Serious Mental Illness

Tobacco Use Disorder

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Multi-component facilitation

Study Details

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.

Conditions

Serious Mental Illness

Tobacco Use Disorder

Study ID

NCT07455526

Start date

Aug 3, 2026

Status verified date

Oct, 2026

Completion date

May 1, 2031

Anticipated

Primary completion date

Jan 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

65 participants

Anticipated

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Multi-component external facilitation

The facilitation strategy will involve an external facilitator who will support other implementation activities: educational outreach, auditing performance and providing feedback, training, Veteran outreach, champions, and implementation team meetings.

Interventions

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 measure

  • Semi-structured, one-on-one interviews [ Time Frame: 12 months after start of implementation at each site ]
  • Implementation tracker [ Time Frame: Weekly for the duration of the implementation at each site (12 months) ]

Central Contacts and Locations

Central contacts

Corinne N Kacmarek, PhD

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

Frederick M Ivey, PhD

(410) 605-7000Frederick.Ivey@va.gov

Locations

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

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Corinne N Kacmarek, PhD

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

Frederick M Ivey, PhD

(410) 605-7000Frederick.Ivey@va.gov

Principal Investigator:

Corinne N Kacmarek, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Oct 15, 2026

Last verified

Oct, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-16. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-10-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.