Facilitation to Increase Tobacco Treatment
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorVA Office of Research and Development
About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Active prescription for bupropion, varenicline, or any nicotine replacement therapy
Trial design
Design model
Single group
Treatments tested in this trial
Multi-component facilitation
Other interventionFacilitation 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.
Treatment groups
65 Participants
are divided into 1 treatment groupGroup A: Multi-component external facilitationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
12 months after start of implementation at each site2
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.
Time frame
Weekly for the duration of the implementation at each site (12 months)Other outcomes
1
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.
Time frame
Before implementation, at end of implementation (12 months), and 12 months after end of implementation (24 months)2
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.
Time frame
Monthly 12 months before through 12 months after the end of implementation (36 months)3
Changes in tobacco use
Effectiveness: Changes in the proportion of Veterans quitting tobacco from the VHA corporate data warehouse.
Time frame
Monthly 12 months before through 12 months after the end of implementation (36 months)Sponsors and contacts
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Source ClinicalTrials.gov
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