https://orcid.org/0000-0003-1133-9723
Figures
Abstract
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.
Citation: Asfar T, Lee DJ, Salloum RG, LeLaurin JH, Kobetz E, Pradhananga N, et al. (2025) Empowering safety managers to champion the implementation of smoking cessation services in the construction industry: Protocol for a sequential multiple assignment randomized trial. PLoS One 20(6): e0324717. https://doi.org/10.1371/journal.pone.0324717
Editor: Zahra Al-Khateeb, PLOS: Public Library of Science, UNITED KINGDOM OF GREAT BRITAIN AND NORTHERN IRELAND
Received: April 18, 2025; Accepted: April 25, 2025; Published: June 9, 2025
This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication.
Data Availability: No datasets were generated or analyzed during the current study. All relevant data from this study will be made available upon study completion.
Funding: This work was supported by the Florida Department of Health, 23K08 James and Esther King Biomedical Research Program.
Competing interests: NO authors have competing interests: The authors declared no potential conflicts of interest regarding this article's research, authorship, and/or publication.
Introduction
Construction workers (CWs) in the United States (U.S.) have the highest smoking prevalence compared to other occupational groups and the general population (27.2% vs. 21.8% and 17%) [1,2]. Almost half of U.S. CWs (43%) are racial/ethnic minorities, with substantially lower hourly wages compared to White CWs ($16 vs. $21) [3]. CWs Cessation efforts are hindered by their mobility and low access to smoking cessation services [4–6]. Workplace smoking cessation programs are consistently recommended by authorities to reduce smoking among U.S. working adults [7]. These programs have been proven to be effective and cost-effective by reducing smoking-related diseases [2,8]. However, CWs have the lowest coverage by such programs among all occupations (14% vs. 29%) [9]. The limited availability of workplace cessation programs in the construction industry, combined with the high rates of cigarette smoking among workers, underscores a significant opportunity to implement workplace smoking cessation programs that could help reduce tobacco use and contain costs within the construction sector.
To date, only a few smoking cessation trials have been conducted among CWs [1,7,9], and all are solely focused on individual workers without considering organizational factors that might affect program implementation, such as leadership engagement, support, and costs [10–12]. To address this gap in research, this project aims to implement and test several adaptive smoking cessation programs with increasing intensity delivered by safety managers in the construction sector. This will be achieved by actively engaging leadership and evaluating costs. Findings will help create a more robust framework for successful smoking cessation initiatives that benefit both workers and the organization in the construction sector.
Expanding the safety manager’s role to implement a sustainable smoking cessation service in the construction industry aligns with the National Institute for Occupational Safety and Health’s Total Worker Health recommendations for integrating disease prevention in work-related safety and health [13]. Safety managers are responsible for the safety and well-being of CWs, are trusted by them, and have daily contact with them, which makes them optimal for delivering a sustainable smoking cessation treatment [14–16]. In addition, one of the best achievements in tobacco control has been the creation of the Tobacco Quitlines (TQLs) [17]. TQLs are free, available in Spanish/English, and allow flexible timing, which makes them suitable for our target population. While their efficacy and potential reach are extensively documented [18], relatively few smokers utilize them [19], and even modest increases in their reach could reduce smoking at the population level [20,21]. TQL usually provides two services: “proactive,” where the TQL counselor initiates the call with the smoker, and “reactive,” where the smoker initiates the call with the TQL. Compared to the reactive service, the proactive service doubles quit rates [18]. An option to improve the reach for proactive service is using the “fax referral service,” where the interventionist completes a form and faxes it to TQL. This allows the TQL counselor to call smokers to provide up to 4 phone counseling sessions, a free 2-week supply of NRT, and an outcome report to be sent back to the referring party within 2 weeks. In addition, proactive counseling in single-session face-to-face programs is effective in improving smoking cessation outcomes in the difficult-to-reach population [22,23]. Thus, given their availability, flexibility, and effectiveness, these two methods have a high potential for implementation in the construction sector.
Multilevel implementation strategies (MLIs) can simultaneously impact multiple contextual levels (e.g., individual, organization) to enhance health outcomes by creating a more efficient and coordinated delivery system [24–26]. Adaptive intervention design optimizes long-term cessation outcomes by personalizing treatment through decision rules that increase program intensity when individuals do not respond to the initial intervention. This method identifies the least resource-intensive program that still achieves acceptable results [27]. The Sequential Multiple Assignment Randomized Trial (SMART) is a multistage experimental design developed to optimize adaptive programs [28]. In Phase 1, patients are randomized to two active treatments. In Phase 2, patients who respond to the initial treatment continue that treatment, while non-responders are re-randomized to additional treatment (more intensive) [29]. Finally, the hybrid type 1 effectiveness-implementation trial design allows researchers to evaluate the implementation and effectiveness of the program simultaneously to reduce the time to uptake evidence-based interventions [30]. In this manuscript, we present the study protocol of a randomized clinical trial designed to expand the role of safety managers to implement a workplace smoking cessation program in the construction industry.
Materials and methods
Study design
Objectives.
This study aims to: 1) develop MLIs to integrate smoking cessation programs in the construction industry, and 2) conduct a hybrid type 1 effectiveness-implementation SMART to test the effectiveness, cost-effectiveness, and implementation feasibility of six adaptive smoking cessation programs with increasing intensity delivered onsite by the safety manager. We hypothesize that B1 + B2 will outperform A1 + A2, and B1 + C will outperform A1 + C. Recruitment in the study started on 4/10/2024 and will continue until 10/01/2027. Participants provided written informed consent that is documented and witnessed.
Design.
The University of Miami Institutional Review Board approved the study on July 13, 2023, under IRB number 20230549, classifying it as “Low Intervention Risk” due to its pragmatic design. The study is currently registered in the ClinicalTrials.gov registry with the identifier NCT06098144.
We will recruit 32 construction sites within 8 construction companies with 608 CWs to conduct 2-arm, cluster, hybrid type 1 effectiveness-implementation, 2-phase SMART to test the 6 adaptive programs with increasing intensity. The 6 programs are: A1) referral to Tobacco Quitline (TQL), B1) referral to TQL + nicotine replacement treatment (NRT) + 1 group behavioral counseling session with the safety manager, A1 + C) A1 + 4 counseling sessions + NRT, B1 + C) B1 + 4 counseling sessions + NRT, A2) A1 + TQL, and B2) B1 + TQL + NRT + 1 group behavioral counseling session. In Phase 1, construction sites will be randomly assigned into two conditions, A1 or B1. All participants in A1 and B1 will receive a 3-month assessment to determine their smoking status. Responders who quit smoking at the 3-month assessment will continue in the same treatment (A1, B1) in Phase 2. Non-responders who did not quit smoking will be re-randomized either to C (conditions A1 + C and B1 + C) or to an extra dose of the same treatment in Phase 1 (conditions A2, B2). In Phase 2, all participants will receive 3 follow-up assessments at 6, 9, and 12 months after enrollment (Fig 1 and Fig 2). 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. Secondary outcomes are the programs’ implementation feasibility (acceptability, barriers/facilitators).
Conceptual framework.
The Consolidated Framework for Implementation Research (CFIR) guides the development of the MLIs [31]. The CFIR highlights five domains that influence the successful implementation of a new program into practice: 1) program characteristics (evidence strength and adaptability), 2) outer setting facilitation (needs and resources), 3) inner setting facilitation (implementation climate, communications), 4) characteristics of involved individuals (e.g., knowledge, beliefs); and 5) process implementation (e.g., planning, executing, evaluating) (Fig 3). The SMART study is guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework, which assesses program outcomes across various settings and behavioral outcomes to enhance real-world integration [32–35].
Setting
The study will be implemented in 36 construction sites within eight companies in South Florida. Three levels will be considered for implementing the program, including organization (e.g., culture, cost/benefits, barriers/facilitators), safety managers delivering the treatment (e.g., training, incentives, self-efficacy), and CWs (e.g., nicotine dependence, job-related stress, social/family norms, peer pressure, age, race). According to the CRRI, the implementation activities will include several steps (Table 1):
- a). Program characteristics: The research team will meet with opinion leaders, safety managers, and representatives of CWs to present the scientific evidence behind the program and its benefits to the organization. The meeting will discuss how implementation can fit the organizational context, along with expected barriers and facilitators.
- b). Outer setting facilitation: The research investigators will provide ongoing consultations regarding program training and delivery during the study. They will assist in problem-solving and offer continuous technical support for developing and implementing tools for data collection, quality monitoring, and tracking activities. This will include using a time-motion tracking log to evaluate the fidelity and intensity (quality and depth) of implementation [36], the timeliness of task completion, and the level of engagement of the involved individuals.
- c). Inner setting facilitation: Each construction company will form an “advisory committee” to guide the program’s implementation. The committee will include a study “champion” who will be a liaison between the company and the research staff and facilitate and oversee all on-site implementation activities, as well as representatives for safety managers who will deliver the program and CWs. Investigators and advisory committees will hold monthly meetings to ensure effective program implementation.
- d). Characteristics of involved individuals. Before implementation, researchers will collect surveys from leaders, safety managers, and workers to identify key factors affecting the program.
- e). Process evaluation: The research team will conduct an observational field assessment of construction site workflows by shadowing safety managers and conducting informal interviews to identify barriers and facilitators. This will inform the development of a tailored implementation checklist to enhance program delivery. In addition, 3 process evaluations (pre-, mid-, and post-implementation), including interviews and surveys, will be conducted to improve implementation, analyze primary outcomes (e.g., cessation rate), and provide recommendations for future efforts.
- f). Training the safety manager: Each company will be asked to identify the safety manager who will be delivering the intervention. Upon their agreement, safety managers who accept to participate in the study will receive one-day training by study investigators in the following: (a) study protocol, (b) human subjects protection, (c) clinical documentation using Redcap Software (a free cloud-based tool from the University of Michigan), (d) program fidelity, and (e) practical experience in program delivery with standardized encounters using an actor simulating a worker enrolled in the study. They will also complete three hours of online training from the Florida Area Health Education Centers Network to deliver effective tobacco use treatment.
Recruitment and study participants
Our targeted accrual goal is 12–18 company leaders (≈1–2/company), 18–20 safety managers (≈2/company), and 608 workers who currently smoke and are willing to quit smoking. The company leaders and safety managers will participate in the program’s implementation assessment (key informant interviews, surveys), and workers will participate in the SMART study to receive the smoking cessation interventions. Inclusion criteria for company leaders are to be ≥ 18 years old and involved in decision-making in the company. Inclusion criteria for safety managers are to be ≥ 18 years old, non-cigarette smokers, willing to receive tobacco treatment training, willing to deliver the treatment to workers, and not planning to leave the company in the next year to deliver the intervention. Inclusion criteria for CWs are: being a construction worker in the participating company, being an adult aged ≥18 years old, having smoked an average of ≥5 cigarettes/day in the past year, being interested in making a serious quit attempt in the next 30 days, own a telephone with a plan to keep it active for the next 12 months, and not planning to leave the company in the next 6 months. Exclusion criteria for CWs are the inability to provide the consent form and women who are pregnant or nursing (lactating) or of childbearing age planning to become pregnant. CWs who use other tobacco products (e.g., smokeless tobacco, e-cigarettes) will be included in the study to maximize generalizability. Participants with contraindications to NRT can enroll in the study but will not receive NRT [17].
Procedures and data collection
The safety manager will introduce the study and invite CWs to participate during their regular morning safety briefings. Interested participants will meet with one of our research assistants (RAs) during their breakfast/lunch break to be screened and, if eligible, provide written informed consent. The RAs are trained in public health research, study protocol, and human subject protection. Then, participants will complete a 15–20 minute baseline assessment after enrollment, followed by the treatment according to their site randomization the next day to minimize workflow interruption. Given the large population of Hispanic/Latino CWs in Florida [30], all study materials will be available in English and Spanish and administered by bilingual (RAs, safety managers) staff based on participant preference. Participants will receive follow-up phone calls at 3, 6, 9, and 12 months to assess smoking status, use of additional NRT or cessation drugs, other tobacco product use, and contact with the safety manager and TQL. Biochemical validation of smoking status using salivary cotinine analysis will be performed on a random sub-sample of participants reporting prolonged abstinence at the 3 and 12-month assessments within 50 miles of the institution. We will use the disconfirmation rates from this sample to estimate adjusted smoking rates for the entire sample. Saliva samples will be collected using NicoTests®, which detects cotinine in oral fluid/saliva at cut-off concentrations of 30 ng/mL (< 30 indicates abstinence).
Interventions
Rational.
The smoking cessation programs were chosen based on evidence of their feasibility, acceptability, and potential efficacy from our pilot study [12], evidence on their effectiveness and cost-effectiveness in the general population [17,37]), company leaders’ interest [16], their appropriateness to CWs’ work and life circumstances [38], and their potential for scalability and dissemination [12]. TQLs are free to all Floridians, available in Spanish/English, and allow flexible timing, which makes them suitable for our target population [18]. In addition, evidence suggests that single-session face-to-face programs are particularly effective in low-income and minority populations that are difficult to reach [22,23]. Finally, several meta-analyses indicated that increasing the intensity (amount, period) of the behavioral support as an adjunct to NRT is likely to increase the chance of success in quitting by 10% to 25% compared with less or no support [39–41]. These programs are particularly promising for heavily dependent smokers, such as our target population [17]. Based on this evidence, and given their flexibility, effectiveness, and potential for scalability, these three evidence-based interventions have a high potential for implementation and dissemination in the construction sector.
Interventions description.
This study will test 6 adaptive interventions: A1 and B1 in Phase 1, and A2, B2, A1 + C, and B1 + C in Phase 2. Below, we describe the intervention in each group.
Group A1 This group includes referrals to the TQL using the “fax referral form.” Participants will be informed that the TQL is free, and the TQL counselor will provide up to 4 phone counseling sessions to devise a specific plan to quit smoking and arrange the delivery of up to 12 weeks of free NRT. Participants will be advised to request nicotine gums instead of patches to accommodate their job circumstances (excessive heat).
Group B1 In addition to A1, CWs in B1 will receive 6 weeks of NRT, a brief (15–20 min) in-person behavioral group counseling session, and two follow-ups (in-person or by phone) (Table 2) [17]). The behavioral counseling session has been developed based on the social cognitive theory [42,43]), previous formative work [44], and cessation literature [17,45–48]). The session will discuss preparing to quit, coping with stress, getting social support, the “5 A’s” for preventing relapse (Avoid, Alter, Alternatives, Anticipate, and Active), and proper use of NRT [17]. The first follow-up occurs 1 day before the quit date to remind participants about their quit date and provide extra support. The second follow-up occurs 2 weeks after the quit date to discuss progress and skills to prevent relapse and help reengage the participant in another quit attempt if they have lapsed [17].
Group A1 ± C and B1 ± C: Participants who do not quit in Phase 1 and are re-randomized to C in Phase 2 will receive 6 weeks free supply of NRT from the research team, 4 (20-min) group behavioral
counseling sessions, and two follow-ups (in-person or by phone) (Table 3). Session 1 (2 weeks before the quit date) discusses reasons to quit, preparing to quit, coping with negative affect and job stress, and the “5 A’s.” Session 2 (on the quit date) focuses on short-term relapse prevention training, surviving the first few days as a nonsmoker, challenges in previous quit attempts, and managing nicotine withdrawal. Session 3 (2 weeks after the quit date) determines if participants quit; if not, we will record reasons, reset the quit date, and review motivating images. Session 4 (4 weeks after the quit date) focuses on long-term relapse (4 rules for limiting access to cigarettes, personalized relapse
plan) and negative thoughts. NRT use and adherence, or side effect issues, will be discussed in every session. In the first (6 weeks after the quit date) and second follow-ups (8 weeks after the quit date), we will discuss progress and skills to prevent relapse and help reengage another quit attempt if they have lapsed.
Group A2 and B2 Participants who do not quit in Phase 1 and are re-randomized to their original treatment in Phase 2 will receive the same treatment in A1 and B1. The focus will be on utilizing the insights gained from Phase 1 and implementing effective problem-solving strategies to address the high-risk situations contributing to relapse.
All participants will receive information about the incremental risks of smoking on CWs, given their exposure to occupational hazards, advice to quitting all tobacco products, and self-help materials summarizing their program in their preferred language. The initial dose of Nicoderm™ gums (2 mg, 4 mg) will be established based on cigarette consumption [17]. Participants will receive instructions on proper gum use and potential side effects. NRT will be kept in a temperature-controlled field office and monitored by the site safety manager.
Strategies to improve adherence to interventions.
The study team has an excellent history of retaining clinical trial participants among the target population [12]. Active communication and consideration of safety managers and CWs’ time when scheduling research activities will be maintained during the study. Compliance and retention will be maximized by: (a) holding two annual meetings with the companies’ advisory committee to review progress, (b) coordinating with safety managers to schedule site visits for enrolling participants and completing the required assessments during workers’ breaks, (c) documenting all safety managers’ activities in RedCap, (d) conducting a monthly meeting with safety managers to address problems and discuss individual cases, and (e) establishing rapport and maintain active communication with participating CWs throughout the study.
Measures
Baseline assessment.
The baseline assessment includes sociodemographic (age, sex, race/ethnicity, income, education), job characteristics, smoking history, nicotine dependence [49], stages of change [50], quit ladder [51], self-efficacy [52], depression (CES-D-10) [53], job stress [54], ASSIST for alcohol and substance use assessment [55], social support [56], exposure to secondhand smoke, and exhaled carbon monoxide (Table 4) [57].
Follow-up assessment at 3, 6, 9, and 12 months.
These assessments will evaluate smoking status [58], concomitant smoking and NRT use, use of other cessation drugs and tobacco products, number/time of total contact with the safety manager and TQL, the Minnesota the Minnesota Withdrawal Scale [59], and the Questionnaire of Smoking Urges-Brief Scale [60].
Outcomes.
Primary outcomes.
Primary outcomes are the programs’ effectiveness (12-month validated prolonged abstinence) and cost-effectiveness (cost/quit, cost/quality-adjusted life-year) for A1 + A2 vs. B1 + B2 and A1 + C vs. B1 + C (Table 5). Prolonged abstinence is defined as self-reported no smoking, not even a puff, after a grace period of two weeks after the quit date confirmed by a saliva cotinine level of < 30 ng/mL [61]. Participants who quit cigarettes but switch to alternative nicotine products (e.g., NRT, smokeless tobacco) will be considered not abstinent according to guidelines [62]. A secondary outcome of “harm reduction” for those who exclusively switch to e-cigarettes will also be collected. For cost-effectiveness, we will utilize a standardized cost data collection survey based on the Drug Abuse Treatment Cost Analysis Program (DATCAP) [63]. Program costs include standard resource categories (e.g., personnel, advertisement, NRT, educational materials). Personnel costs are based on detailed time logs from study personnel that track time spent on research and program activities. Advertisement, NRT, and educational material costs are based on invoices and allocated according to the number of participants in each program. Research costs will be excluded from cost calculations to inform real-world program applications.
Secondary outcomes.
Secondary outcomes are the programs’ implementation feasibility, acceptability, barriers and facilitators, and sustainability potential. Three evaluations (pre-, mid-, and post-implementation) among company leaders, safety managers, and CWs will be conducted (Table 5). Each evaluation involves: (a) Surveys conducted among participating leaders, safety managers, and CWs (n ≈ 36; randomly selected from SMART) will include the Organizational Readiness to Change Assessment (ORCA) [64], TQL enrollment rates [65], implementation acceptability, CWs
satisfaction using the Client Satisfaction Questionnaire [66], safety managers’ training, incentives,
and treatment delivery, self-efficacy, and behavior capabilities [65]), and implementation barriers; and (b) In-depth key-informant interviews conducted with leaders and safety managers. The interview guide includes a short series of closed-ended questions (e.g., demographics) and open-ended questions that focus on perceptions regarding evidence, inner/outer context, barriers and facilitators of implementation, program sustainability [67], and suggestions for implementation improvement.
Randomization
In Phase 1, site-level randomization in a 1:1 ratio to A1 and B1 is conducted using stratified random sampling based on company and site size. Smaller companies will be grouped into the same stratum to ensure sufficient sites for stratification by size. In Phase 2, individual-level stratified randomization by site and by the treatment in Phase 1 will be conducted in a 1:1 ratio. Randomization will be done using computer-generated random permuted blocks with random block sizes to ensure balanced allocation over time. All randomization sequences will be generated by a study statistician, who will not interact with companies or CWs, using computer-generated random permuted blocks with random block sizes to eliminate bias and ensure balanced allocation over time.
In Phase 1, the research team will create the allocation sequence and communicate the allocation results to the safety managers. The safety managers will then inform the workers about the study. Following this, the research staff will enroll participants and assign them to the respective interventions. A similar procedure will be followed in Phase 2.
Blinding
This study is a single-blind trial. Since the intervention is behavioral, the researchers and safety managers administering it will clearly know which treatment each participant receives. However, participants will be blinded to their allocation and not informed of their study conditions. They will be informed that they will receive a tobacco cessation intervention and NRT delivered by their safety manager. Outcome assessors and data analysts are not blinded but are not involved in the treatment.
Data collection, management, and monitoring
Two authorized research assistants will enter data into RedCap, an online data collection platform. Our data analyst will periodically manage and check the data for accuracy. All data (questionnaires and biomarkers) will be checked for out-of-range values and normality. If any spurious data (outliers) were identified, we will fit nonparametric statistical models to assess the robustness of our primary parametric data analysis. All analyses will be performed with SAS/STATv15.2 and R, and significance will be set at the two-tailed alpha level of 0.05 within the scope of all available statistical and clinical evidence.
To ensure standardization of program content and delivery, we will use standardized training, treatment manuals, and procedures [45, 68–70]. Safety managers will use a checklist to document treatment delivery in each session. Participants will complete a brief questionnaire at the end of treatment to assess learning. Standard procedures will be used for the study protocol and data management. The research team will provide ongoing training and supervision for safety managers and RAs through biweekly meetings and process reviews. Additionally, 10% of counseling sessions will be audiotaped for review and feedback.
We will collect personal information about potential and enrolled participants through informed consent forms and questionnaires. We will ensure that all personal information is securely stored and accessed only by authorized personnel. We will share personal information only with the research team and regulatory agencies, and we will do so through password-protected access or encryption to ensure confidentiality.
Sample size calculation and justification
Our power estimates are based on detecting a difference between A1 + A2 and B1 + B2, and between A1 + C and B1 + C on biomarker-confirmed prolonged abstinence at 12-month assessment using unadjusted proportions. We assume nominal values for the Type I and II error rates (i.e., 5% and 20%, respectively; two-tailed) and based power on 12-month biomarker-confirmed cessation rates. Our pilot study yielded quit rates of 20.3% in A1 and 27.7% in B1 at 6-month [12]. Relevant to C, a meta-analysis of 47 trials has shown that increasing the amount of behavioral support as an adjunct to pharmacotherapy for smoking cessation increased the chance of success in quitting by 10% to 25% [41]. For the first phase of the SMART, we assume a 40% TQL enrollment rate in A1 and a 60% TQL enrollment rate in B1 [12]. For the second phase, we assume a 12-month biochemical-verified abstinence rate of 15% in A1 + A2, 28% in B1 + B2, 30% in A1 + C, and 45% in B1 + C [12,39–41]. Within 8 companies, construction sites (n = 32; 4 sites/company) will be randomized to A1 or B1 initially (16 sites/group), each containing 15 participants for a total of 480. This design and sample size achieve a power of 80% to detect an increase in abstinence of 13% between A1 + A2 and B1 + B2 and 15% between A1 + C and B1 + C. These estimations assume that a chi-square test from a generalized estimating equations (GEE) analysis or a logistic regression model is used at an alpha level 0.05. Missing values are assumed to occur at random. The autocorrelation matrix of the outcome responses within a cluster is assumed to match compound symmetry structure with an intraclass correlation coefficient of 0.01. To account for a 20% loss for attrition, as observed in our pilot study, we will enroll 608 participants.
Statistical analysis plan
The SMART provides the opportunity to test multiple hypotheses [71,72]. Our primary hypotheses address the capability of the specific programs in each phase to extend effectiveness beyond the preceding phase: 1) for static regimens, is B1 + B2 better than A1 + A2 at 12 months? and 2) for dynamic regimens, is B1 + C better than A1 + C at 12-month? Secondary analyses will compare embedded dynamic treatment regimens.
Program effectiveness.
Our primary effectiveness analyses will be performed using GEE to account for clustering sites within construction companies and participants within the site [73,74]. We will use robust standard errors for statistical inference, incorporating appropriate upward covariance adjustment to correct these estimates’ downward bias when the number of clusters is limited [75]. We will compare 12-month abstinence among participants assigned to the respective treatments by the designated follow-up times by fitting the weighted GEE model with repeated measures to estimate the group, time, and group-by-time interaction contrasts. Observations will be weighted based on their inverse probability of receiving the program due to imbalance by design since only ½ of the initial non-responders remain on the initial program. Separate analyses will be applied to compare dynamic treatment in Phase 2. We will use an inverse probability of program-weighted, piecewise generalized linear estimating equations and robust standard errors to estimate the immediate and sustained effects of treatment “C” for non-responders (condition A1 + C compared to B1 + C) on 12-month abstinence. To compare dynamic strategies appropriately, we will include both participants who responded at the initial follow-up and remained in the original treatment (conditions A1 + A2 or B1 + B2) and those who did not respond and were randomized to step up “C.” Each group will be weighted by the inverse probability of receiving the program path followed. Covariates include two time variables denoting the number of months spent in each phase: a first-phase program indicator and a second-phase program indicator. Interactions between time in the first phase and first phase program and time in the second phase and first phase program, second phase treatment, and the interaction between the first and second phase program are also included [76]. The marginal longitudinal piecewise model allows for trajectories to change at each decision point/phase, with all individuals in the population offered each embedded treatment regimen. An exchangeable working correlation matrix will be used, and bootstrapped standard errors will be calculated. A sensitivity analysis will be conducted by stratifying participants who miss more than two scheduled sessions and do not re-schedule. At each phase, GEE will be applied to a binary outcome model. It will include the company as a site-level factor and participants’ (CWs) level covariates as predictor variables to control for baseline imbalances when site-level randomization is used [77]. Other potential covariates (all fixed effects) that may be included in a model include nicotine dependence, job stress, self-efficacy, demographics (e.g., age, race), NRT side effects, use of other tobacco products or programs that may have influenced their abstinence rates, and program adherence.
Evaluating multiple hypotheses under the SMART design has the potential to inflate the study-wise Type 1 error [78]. To address this issue, we will designate effectiveness and cost-effectiveness as co-primary outcomes and consider all other analyses as secondary. Because our hypothesis tests for the six programs address distinct questions, we will apply a Bonferroni-Holm multiple comparison adjustment to account for the 2 co-primary outcomes when evaluating each program, but will not perform additional multiple-comparison adjustments for the six programs [78]. Secondary GEE analyses with a binary outcome model will also be used for exclusively switching to e-cigarettes after quitting cigarettes [62].
Program cost-effectiveness.
The cost-effectiveness analysis will follow recognized standards and will track start-up and program implementation resources for each program [79]. The primary cost-effectiveness analysis will be performed from the construction sector perspective. Secondary analyses will include both program and participant costs. In the secondary analysis, participant costs will include time missed from work to participate in the program. For greater generalizability of results, we will use a national hourly wage rate to determine the economic value of time for all participants. The cost-effectiveness analysis will include incremental cost/quit, and per QALYs [80,81]. Using either program start-up plus implementation costs (primary analysis) or program + participant costs (secondary analysis), we will determine the incremental cost-effectiveness of program B1 + B2 relative to A1 + A2 and B1 + C relative to A1 + C. The generic formula for the incremental cost-effectiveness ratio is: CE–CC/ EE–EC =IC EC/ IEEC = ICERE vs. C; where CE = average costs for an experimental group; CC = average costs for a control condition; EE and EC are the measured effectiveness of the experimental and control conditions (abstinence, QALYs), IC and IE are incremental cost and incremental effectiveness for the experimental condition relative to control, and ICER is the incremental cost-effectiveness ratio for the experimental condition relative to control. For this study, the ICER will express the incremental cost per quit (12-month prolonged abstinence) and incremental cost per QALYs gained in program B1 + B2 vs A1 + A2, and B1 + C vs A1 + C. Sensitivity analyses will be conducted to explore potential sources of uncertainty in the resource units or unit costs and will develop confidence intervals around the cost-effectiveness ratios using Monte-Carlo simulation techniques [82,83]. We also will examine cost-effectiveness in terms of health-related quality of life (HRQoL) by calculating QALYs gained in each study condition over the course of the program [84].
Program implementation feasibility.
The program’s implementation feasibility is a secondary outcome that includes the program’s acceptability, barriers and facilitators, and potential for sustainability. We will conduct three evaluations (pre-, mid-, and post-implementation) among company leaders, safety managers, and CWs will be conducted (Table 5). Each evaluation involves:
- a). Surveys conducted among participating leaders, safety managers, and CWs (n ≈ 36; randomly selected from SMART) will include the Organizational Readiness to Change Assessment (ORCA) [64], TQL enrollment rates [65], implementation acceptability, CWs satisfaction using the Client Satisfaction Questionnaire [66], safety managers’ training, incentives, and treatment delivery, self-efficacy, and behavior capabilities [65], and implementation barriers.
- b). In-depth key-informant interviews conducted with leaders and safety managers. The interview guide includes a short series of closed-ended questions (e.g., demographics) and open-ended questions that focus on perceptions regarding evidence, inner/outer context, barriers and facilitators of implementation, program sustainability [67], and suggestions for implementation improvement.
Safety and adverse event reporting
Severe adverse events (SAEs) will be reported to the IRB at the University of Miami within 24 hours after their detection. Relationships with the study medications will be evaluated, considering the opinion of the personnel notifying them of the adverse event and the safety information available for each active antibiotic permitted. A periodic reconciliation of safety data will be performed to ensure all the eCRF-gathered information is appropriately communicated to the competent authorities.
Ethical and regulatory considerations
The University of Miami Institutional Review Board (IRB) approved the study on July 13, 2023, under IRB number 20230549, classifying it as “Low Intervention Risk” due to its pragmatic design. The last IRB modification was approved on March 3, 2025 (MOD00019563). The study is currently registered in the ClinicalTrials.gov registry with the identifier NCT06098144.
Principles of the Declaration of Helsinki are considered, and all participants must sign an informed consent form before any procedure is done. Accordingly, written informed consent will be obtained from all participants before randomization and intervention. Participants will receive $100 in incentives ($20x5 assessments). Safety managers will receive a $500 gift card for participating in the study. In the implementation process evaluation, CWs (n ≈ 36; randomly selected from SMART) and safety managers (n ≈ 20) will receive an additional $60 for completing 3 surveys ($20 each). Participating leaders (n ≈ 12) in the key informant interviews will receive university-themed memorabilia (t-shirt, cup, bag).
Follow-up reports on recruitment and data safety updates will be sent to the UM IRB. Data protection legislation is considered for any data treatment in the study. Access to study data will be restricted to investigators until the database is completely locked, analyzed, and published. Results will be published according to CONSORT standards [85].
Although the UM Data Safety Monitoring Committee (DSMC) does provide oversight to social-behavioral studies, this trial does not require or benefit from the UM DSMC for two reasons: 1) the risk level is low (there is no risk to subjects in terms of the therapeutic interventional treatment), and 2) endpoints are not considered to be highly favorable or unfavorable result, or even a finding of futility, at an interim analysis might ethically require termination of the study before its planned completion.
Discussion
This project is committed to eliminating tobacco-related health disparities among CWs by developing rigorous multi-level implementation strategies and testing adaptive smoking cessation programs delivered by the safety managers within the construction sector. This program will be constructed through a strong collaboration with construction company leadership, safety managers, and construction workers, ensuring its effectiveness and relevance. Expanding the safety manager role in delivering the program is an innovative approach to engage and build trust with a highly mobile and understudied workforce. Furthermore, utilizing the SMART design to test several adaptive smoking cessation programs with increasing intensity to generate needed data on the optimal treatment algorithm for implementation in the construction sector in terms of effectiveness and cost-effectiveness is highly innovative. This will also determine whether progressively adding more cessation resources increases effectiveness over and above implementing less resource-intensive approaches. The use of a hybrid type 1 effectiveness-implementation design promises to speed up the process of evidence generation and translation. Finally, the study employs many core elements of pragmatic trials to maximize generalizability [86], including using minimal exclusion criteria, enrolling a diverse set of CWs, and using intent-to-treat analyses [87–89]. Overall, this design promises to speed up program uptake in real-world settings, improve understanding of key organizational factors for long-term use, and reduce costs by streamlining and combining elements of the traditional step-wise progression of research [30].
There are several challenges with this study. We may encounter challenges in recruiting construction companies and workers. To mitigate this risk, commitments from eight construction companies were secured before receiving the funding. If needed, more companies will be recruited. The study team has a strong history of successful collaboration with the construction industry, ensuring successful project outcomes and innovative solutions. Busy work schedules may affect safety managers’ commitment to the study, but the research team will provide ongoing communication and support. Low fidelity poses another potential challenge. Therefore, additional training sessions for safety managers will be provided as needed.
In conclusion, this project will generate real-world evidence on the most effective and economically viable adaptive smoking cessation program for implementation in the construction sector. It will inform stakeholders, policymakers, and public health advocates about its potential and lay the groundwork for future studies aimed at reducing smoking and improving the health of construction workers [2].
Dissemination plans
The University of Miami is committed to enhancing the value of research and advancing public knowledge. We recognize that the public dissemination of our scientific results can facilitate the creation of collaborative efforts. Furthermore, we realize that the proposed project may result in novel data that could benefit the entire research and tobacco control community, which is the target audience for this study. Final research data will be shared openly and in a timely manner while being mindful that the confidentiality and privacy of participants in the proposed research must be protected at all times.
Our research team has devised a two-pronged approach to disseminate and share the research findings and products generated from this research study. Prong #1 includes drafting abstracts, scientific manuscripts, and reports of study findings and lessons learned for broad dissemination in peer-reviewed scientific journals (e.g., Journal of Environmental and Occupational Medicine, American Journal of Public Health, Tobacco Control, Journal of Immigrant and Minority Health). We will also disseminate our research findings at national, state, and local scientific and labor/union conferences. Prong #2 includes the development of fact sheets and policy briefs based on the research findings and lessons learned in developing and evaluating tobacco cessation programs for this high-risk population.
To maximize the impact of the dissemination plan, we have partnered with key stakeholders in industry, union, and government to assist our research team in sharing the study findings with other groups and networks engaged in protecting the health of minority male workers (e.g., Florida Department of Health, Occupational Health and Safety Program, The Center for Construction Research and Training, Occupational Health and Safety Administration Regional Office).
Quality-controlled raw data and processed data used in publications will be made available to allow interested groups to reproduce results from the raw data. All final peer-reviewed manuscripts arising from this proposal will be submitted to the digital archive PubMed Central and made publicly available.
Supporting information
S1 Protocol.
The last IRB-approved version of the study protocol.
https://doi.org/10.1371/journal.pone.0324717.s002
(PDF)
Acknowledgments
We wish to thank the participating companies (Robins & Morton, Pro-Max, Kibler, DPR, Whiting-Turner, Skanska, Camcon, Grycon) for facilitating the study implementation, safety managers who agreed to receive the tobacco treatment training and delivering the intervention (Carlos Pauletti, Shannon Minor, Gabriel Galiano, Rolando Serrano, Miguel Perullas, Henry Torres, Jonathan Medrano, Shakir Elvin), and Maxine F. Daggett from Tobacco Free Florida for providing the monthly report about participants’ enrollment and smoking status.
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