Asfar Taghrid, Lee David J, Salloum Ramzi G, LeLaurin Jennifer H, Kobetz Erin, Pradhananga Nipesh, De Dios Despaux Roxana A, McCollister Kathryn E, Oluwole Olusanya, Corbin Laura, Laine Jennifer, Bursac Zoran
Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, Florida, United States of America.
Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine, Miami, Florida, United States of America.
PLoS One. 2025 Jun 9;20(6):e0324717. doi: 10.1371/journal.pone.0324717. eCollection 2025.
US construction workers (CWs) have the highest cigarette smoking rate among all occupations (27.2% vs. 15%), yet the lowest coverage of workplace smoking cessation services (14% vs. 29%). This study aims to empower safety managers to implement smoking cessation services in the construction industry. Using participatory research methods, this study aims to: 1) Develop multilevel strategies (MLIs) to implement adaptive smoking cessation programs delivered by the safety manager on construction sites, and 2) conduct a cluster-randomized, hybrid type 1 effectiveness-implementation, 2-phase sequential multiple assignment randomized trial (SMART) to test the programs (ClinicalTrials.gov: NCT06098144). The MLIs include: 1) creating the outer setting (research investigators, stakeholders) and inner setting facilitation (companies' advisory committee, study champion), 2) conducting observational field assessments of workflows, 3) training safety managers to deliver the intervention, and 4) conducting implementation process evaluations. In SMART, 32 construction sites within 8 companies with 608 CWs will be enrolled. In Phase 1, sites will be randomized to A1 (referral to Tobacco Quitline -TQL) or B1 (referral to TQL + nicotine replacement treatment (NRT) + 1 group behavioral counseling session). In Phase 2, responders who quit smoking at 3 months continue with the assessment only, while non-responders will be re-randomized to C (4 counseling sessions + NRT; A1 + C, B1 + C) or an extra dose of Phase 1 treatment (A2, B2). Participants will receive 4 follow-up assessments at 3, 6, 9, and 12 months. Primary outcomes are the effectiveness (12-month biomarker-confirmed prolonged abstinence) and cost-effectiveness (cost/quit, cost/quality-adjusted life-year) of A1 + A2 vs. B1 + B2 and A1 + C vs. B1 + C. The secondary outcome is the feasibility of the program's implementation. We hypothesize that B1 + B2 will outperform A1 + A2, and B1 + C will outperform A1 + C. This project will generate novel scientific evidence on the effectiveness, cost-effectiveness, and implementation feasibility of smoking cessation programs in the construction industry.
美国建筑工人的吸烟率在所有职业中最高（27.2% 对比 15%），但其工作场所戒烟服务的覆盖率却最低（14% 对比 29%）。本研究旨在促使安全经理在建筑行业实施戒烟服务。运用参与式研究方法，本研究旨在：1）制定多层次策略（MLIs），以实施由安全经理在建筑工地上提供的适应性戒烟项目；2）开展一项整群随机、混合型 1 有效性 - 实施、两阶段序贯多重分配随机试验（SMART）来测试这些项目（ClinicalTrials.gov：NCT06098144）。多层次策略包括：1）创建外部环境（研究调查人员、利益相关者）和内部环境促进因素（公司咨询委员会、研究倡导者）；2）对工作流程进行现场观察评估；3）培训安全经理以提供干预措施；4）进行实施过程评估。在 SMART 试验中，将招募 8 家公司内的 32 个建筑工地的 608 名建筑工人。在第一阶段，各工地将被随机分配至 A1 组（转介至烟草戒烟热线 -TQL）或 B1 组（转介至 TQL + 尼古丁替代疗法（NRT）+ 1 次团体行为咨询课程）。在第二阶段，在 3 个月时戒烟的响应者仅继续接受评估，而无响应者将被重新随机分配至 C 组（4 次咨询课程 + NRT；A1 + C，B1 + C）或额外一剂第一阶段的治疗（A2，B2）。参与者将在 3、6、9 和 12 个月时接受 4 次随访评估。主要结局是 A1 + A2 对比 B1 + B2 以及 A1 + C 对比 B1 + C 的有效性（12 个月生物标志物确认的长期戒烟）和成本效益（成本/戒烟、成本/质量调整生命年）。次要结局是该项目实施的可行性。我们假设 B1 + B2 将优于 A1 + A2，且 B1 + C 将优于 A1 + C。本项目将为建筑行业戒烟项目的有效性、成本效益和实施可行性提供新的科学证据。
