Serious Mental IllnessFITTNCT07455526
Facilitation to Increase Tobacco Treatment
A study testing Multi-component facilitation in people with Serious Mental Illness and Tobacco Use Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Serious Mental Illness, Tobacco Use Disorder
- What is being tested?
- Multi-component facilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2026to 1 May 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- Providers:
- None
- Veterans receiving direct letters:
- Active prescription for bupropion, varenicline, or any nicotine replacement therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
Corinne N Kacmarek, PhD, (410) 340-0727, corinne.kacmarek2@va.gov
Frederick M Ivey, PhD, (410) 605-7000 ext. 56510, Frederick.Ivey@va.gov
About this study
Official title: 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.
Read the 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.
- Conditions
- Serious Mental Illness, Tobacco Use Disorder
- Being tested
- Multi-component facilitation
- 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
- Medical subject headings
- Tobacco Use Disorder, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-component facilitationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Multi-component external facilitation | Experimental | 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. Receives: Other: Multi-component facilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Weekly for the duration of the implementation at each site (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start3 Aug 2026
- Primary completion31 Jan 2030 (estimated)
- Study completion1 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serious Mental IllnessStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multi-component external facilitation strategy
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Corinne N Kacmarek, PhD, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07455526
- Sponsor's protocol ID
- HSR4-014-25M-T
- Other IDs
- 1IK2RD000661-01A2
- Acronym
- FITT
- Status last verified
- Oct 2026
- First submitted
- 24 Feb 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Facilitation to Expand Reach of Tobacco Treatment to SMI Veterans
- ClinicalTrials.gov ID
- NCT07455526
- Acronym / sponsor ID
- FITT / HSR4-014-25M-T
- Conditions
- Serious Mental Illness, Tobacco Use Disorder
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 3 Aug 2026 (actual)
- Primary completion
- 31 Jan 2030 (estimated)
- Study completion
- 1 May 2031 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multi-component external facilitation strategy
| Arm | Type | Receives |
|---|---|---|
| Multi-component external facilitation | Experimental | Other: Multi-component facilitationThe 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 may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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
- 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
Key exclusion criteria (4 listed)
- None
- Active prescription for bupropion, varenicline, or any nicotine replacement therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-component facilitationFacilitation 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. | Other | Multi-component external facilitation |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Corinne N Kacmarek, PhD principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-component facilitation in people with Serious Mental Illness and Tobacco Use Disorder, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Corinne N Kacmarek, PhD ((410) 340-0727, corinne.kacmarek2@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semi-structured, one-on-one interviews (time frame: 12 months after start of implementation at each site). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.