Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06290869
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-02-15
Brief Title:
Tobacco Education and Lung Health Study TEAL
Sponsor:
Georgetown University
Organization:
Georgetown University
Study Overview
Official Title:
Providing Tobacco Treatment to Patients Undergoing Lung Cancer Screening at MedStar Health A Randomized Trial Tobacco Education and Lung Health Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TEAL
Brief Summary:
Primary Objective To compare two smoking cessation interventions among individuals undergoing lung cancer screening Primary outcomes are 3-month self-reported abstinence from cigarettes and 6-month self-reported and bioverified abstinence from cigarettes
Secondary Objectives 1 To evaluate reach and engagement overall and by subgroup eg race and ethnicity underinsured readiness to quit 2 To conduct an economic analysis to evaluate intervention costs from the health system perspective
Secondary Objectives 1 To evaluate reach and engagement overall and by subgroup eg race and ethnicity underinsured readiness to quit 2 To conduct an economic analysis to evaluate intervention costs from the health system perspective
Detailed Description:
Providing smoking cessation treatment in conjunction with the recently expanded lung cancer screening guidelines is estimated to substantially reduce lung cancer deaths and increase life-years gained compared to conducting lung screening alone Although CMS recommends that individuals undergoing lung screening who currently smoke are offered cessation treatment there are multiple barriers to treatment delivery Improving the evidence-base of cessation treatment for patients undergoing lung screening and methods to promote the systematic uptake of cessation treatment into routine practice particularly among diverse populations is essential for realizing the maximum benefit of lung screening Guided by the Practical Robust Implementation Sustainability framework we will extend our prior work CA R01207228 We propose a health system-level pragmatic randomized trial to compare the effectiveness of two evidence-based cessation treatments with implementation strategies designed to address barriers to reach and engagement particularly among underserved groups eg racial and ethnic minority groups underinsured patients and patients not ready to quit who are less likely to receive cessation treatment To maximize generalizability to other health systems and to improve reach among heterogeneous groups all patients scheduled at one of the 10 lung screening sites at MedStar Health the largest and most diverse health system in the Mid-Atlantic will be identified via the EHR contacted for enrollment using an opt-out approach and randomized to 1 Quitline E-referral QL-E N594 via the EHR and quitline integrated system including proactive outreach and standard phone-based counseling nicotine replacement provided by the quitline vs 2 MedStar Health System MHS N594 centralized phone-based NRT intervention adapted and improved from our prior trial with a randomized stepped care intervention for those who are not abstinent at 3 months Specific aims are 1 To compare e-referral to the Quitline vs the centralized Health System intervention Primary outcomes are 3-month self-reported abstinence from cigarettes and 6-month self-reported and bioverified abstinence from cigarettes We will assess intervention mediators eg treatment engagement and moderators eg readiness to quit at 6-months 2 To evaluate reach and engagement overall and by subgroup eg race and ethnicity underinsured readiness to quit and using mixed-methods to understand the contextual factors related to the feasibility and acceptability of the interventions and implementation strategies 3 To conduct an economic analysis to evaluate costs average and incremental cost per quit and budget impact of the intervention at 3- and 6-months from the health system p0erspective Proposal strengths include testing the effectiveness and economic outcomes of two cessation interventions while simultaneously laying the groundwork for future implementation within this and other diverse health systems Our innovative approach capitalizes on the EHR for recruitment provides multilevel training focused on diverse populations and accounts for intervention context to inform future care delivery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None