Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201, United States
Location contact
Corinne N Kacmarek, PhD
CONTACT
Corinne N Kacmarek, PhD
PRINCIPAL_INVESTIGATOR
Cynthia Y Giron-Hernandez
CONTACT
NCT Number: NCT07455526
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.
Trial opening soon.
Get NotifiedAll sexes
Interventional
Not applicable
Baltimore, Maryland, 21201, United States
Corinne N Kacmarek, PhD
CONTACT
Corinne N Kacmarek, PhD
PRINCIPAL_INVESTIGATOR
Cynthia Y Giron-Hernandez
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Providers:
Veterans receiving direct letters:
Veteran chart review:
Exclusion criteria
Providers:
Veterans receiving direct letters:
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Corinne N Kacmarek, PhD
CONTACT
Cynthia Y Giron-Hernandez
CONTACT
VA Office of Research and Development
Fed
External Facilitation to Expand Reach of Tobacco Treatment to SMI Veterans
Acronym: FITT
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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