Facilitation to Increase Tobacco Treatment (FITT)

External Facilitation to Expand Reach of Tobacco Treatment to SMI Veterans

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tobacco Use Disorder; Serious Mental Illness
• Intervention / Treatment: Other: Multi-component facilitation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 65
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Corinne N Kacmarek, PhD; Phone Number: (410) 340-0727; Email: corinne.kacmarek2@va.gov
• Study Contact Backup: Name: Cynthia Y Giron-Hernandez; Phone Number: (805) 478-7948; Email: cynthia.giron-hernandez@va.gov

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
      • Contact: Cynthia Y Giron-Hernandez; Phone Number: (805) 478-7948; Email: cynthia.giron-hernandez@va.gov
      • Contact: Corinne N Kacmarek, PhD; Phone Number: 410-340-0727; Email: corinne.kacmarek2@va.gov
      • Principal Investigator: Corinne N Kacmarek, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Semi-structured, one-on-one interviews	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.	12 months after start of implementation at each site
Implementation tracker	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.	Weekly for the duration of the implementation at each site (12 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking Knowledge, Attitudes, and Practices Scale: Practices subscale only	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.	Before implementation, at end of implementation (12 months), and 12 months after end of implementation (24 months)
Prescriptions of tobacco cessation medication	Reach: Change in the proportion of eligible Veterans prescribed a medication for tobacco use from the VHA corporate data warehouse.	Monthly 12 months before through 12 months after the end of implementation (36 months)
Changes in tobacco use	Effectiveness: Changes in the proportion of Veterans quitting tobacco from the VHA corporate data warehouse.	Monthly 12 months before through 12 months after the end of implementation (36 months)

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Corinne N Kacmarek, PhD, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): June 30, 2030
• Study Completion (Estimated): October 1, 2031

Study Registration Dates

• First Submitted: February 24, 2026
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: implementation science; mental disorders; tobacco use disorder; qualitative research; mental health services; attitude of health personnel; veterans health services; delivery of health care, integrated
• Additional Relevant MeSH Terms: Substance-Related Disorders; Chemically-Induced Disorders; Tobacco Use Disorder; Mental Disorders
• Other Study ID Numbers: HSR4-014-25M-T; 1IK2RD000661-01A2 (Other Grant/Funding Number: Veterans Health Administration)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Person-level qualitative data from semi-structured interviews can be provided as a de-identified, anonymized dataset depending on the need of the requester pursuant to a Data Use Agreement appropriately limiting use of the dataset and prohibiting the recipient from identifying, or taking steps to re-identify, any individuals whose data are included in the dataset. Audio recordings of qualitative interviews will not be shared.

For chart review data, a Limited Dataset will be created and shared pursuant to a Data Use Agreement appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.

• IPD Sharing Time Frame: Data will be available for sharing starting 6 months after publication.

IPD Sharing Access Criteria

Person-level qualitative data from semi-structured interviews can be provided as a de-identified, anonymized dataset depending on the need of the requester pursuant to a Data Use Agreement appropriately limiting use of the dataset and prohibiting the recipient from identifying, or taking steps to re-identify, any individuals whose data are included in the dataset. Audio recordings of qualitative interviews will not be shared.

For chart review data, a Limited Dataset will be created and shared pursuant to a Data Use Agreement appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No