Facilitation Strategy for Tobacco Use Disorder

(FITT Trial)

Overseen By Cynthia Y Giron-Hernandez

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must not be taking: Bupropion, Varenicline, Nicotine replacement

Disqualifiers: Serious mental illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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 Is on the Research Team?

Corinne N Kacmarek, PhD

Principal Investigator

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

Are You a Good Fit for This Trial?

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

Veterans receiving direct letters: Diagnosed with a serious mental illness

Exclusion Criteria

I am currently prescribed medication or therapy to help me quit smoking.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

External facilitation strategy is implemented to improve tobacco treatment delivery in VA SMI clinics

12 months

Weekly implementation activities

Follow-up

Participants are monitored for changes in tobacco use and prescription rates

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Multi-component facilitation

How Is the Trial Designed?

Group I: Multi-component external facilitation Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+