Study overview

This paper reports our experiences in the Mumbai Worksite Tobacco Control Study, designed to assess the effectiveness of an integrated worksite tobacco control and OSH intervention called “Healthy, Safe, and Tobacco-free Worksites” [68]. This study was conducted in 22 manufacturing worksites in the Greater Mumbai region as a collaboration among the Harvard T.H. Chan School of Public Health Center for Work, Health and Well-being, the Dana-Farber Cancer Institute, the New England Research Institute in Boston, Massachusetts, and the Healis-Sekhsaria Institute for Public Health in Mumbai. This study was approved by the Healis and Harvard Chan School Institutional Review Boards, as well as by the Indian Council of Medical Research, and has been registered with ClinicalTrials.Gov (ID NCT01841879) and the Clinical Trial Registry of India. Both IRBs approved the informed consent procedure.

This cluster-randomized trial assessed differences in tobacco use quit rates between worksites randomized to receive the intervention compared to those assigned to the delayed-intervention control condition. As we have reported elsewhere, we observed a significant improvement in 30-day tobacco use cessation rates among production workers in the intervention group compared to the control (OR = 2.25, p = 0.03). The magnitude of the effect was similar for six-month sustained quit rates, although the between-group difference was not significant [68].

The Healthy, Safe, and Tobacco-Free Worksites intervention was designed to capitalize on existing OSH infrastructures found in Indian worksites. Here, we report on our efforts to address occupational safety and health as part of our integrated approach to tobacco control. This intervention was adapted from a series of studies testing integrated approaches to worker health in the U.S., and particularly exemplified in our WellWorks-2 Study.

The intervention framework: A model for integrated policies, programs, and practices developed and tested in the U.S.

In studies conducted by researchers at the Center for Work, Health and Wellbeing, we have tested integrated policies, programs and practices across a range of industries, including manufacturing, health care, construction, and transportation. The WellWorks-2 study illustrates this integrated approach and provided a specific framework for adapting this intervention. This study randomly assigned 15 manufacturing worksites to a health promotion (HP) or a health promotion plus occupational safety and health intervention (HP/OSH); both groups targeted smoking and diet; the HP/OSH condition additionally incorporated reduction of adverse occupational exposures. Compared to the HP condition, the HP/OSH condition showed a significant doubling of smoking quit rates among blue-collar workers [29]; a pattern of reductions in hazardous exposures based on modifications at the source of exposure rather than based on workers’ use of personal protective equipment (PPE) [69]; and significantly greater improvements in management commitment and employee participation in OSH programs [45]. The core components of this intervention model included: (1) the use of a participatory framework by engaging workers and managers; (2) interventions to effect change in the work environment and organization, and (3) interventions for individual workers.

Joint worker–management participation: Engaging managers and workers in program planning, priority setting, and implementation is fundamental to program success [49, 70, 71]. In WellWorks-2, program committees were created to provide a channel for worker–manager input to program design and delivery. In some cases, these committees were incorporated into existing health and safety committees.

Interventions targeting the worksite organization and environment: Management was the primary channel for improving the physical work environment because management has both primary control over and responsibility for providing a safe and healthy work environment. The management intervention for OSH encouraged companies to adopt a pro-active, preventive approach, going beyond legally mandated standards for OSH to protect worker health. An industrial hygienist with the study conducted walk-through assessments of exposures and occupational health and safety programs, and provided consultations and technical assistance to management and recommended changes to reduce workers’ exposures to hazardous substances used in work processes. The intervention relied on a hierarchy of controls approach, which prioritizes changes as close to the source of exposure as possible, starting with upstream strategies for materials and process substitution, engineering controls, and as a last option, downstream interventions at the level of the worker, such as reliance on personal protective equipment (PPE) [69]. These consultations also emphasized the importance of the OSH program elements of management commitment and employee participation, hazard analysis, hazard prevention and control, and training and education [45]. We also provided consultations to support implementation of tobacco control policies and ensure the availability of healthy food options in cafeterias and vending machines, which were other core components in the work organization and environment.

Interventions for individual workers: In WellWorks-2, intervention activities were designed to address both exposure to hazardous substances and health behaviors. Using an integrated approach, program content included comprehensive, coordinated messages acknowledging the additive and sometimes synergistic effects of exposures to worksite hazards, individual health and safety behaviors, and other determinants of worker health outcomes [70]. Tobacco control programs incorporated messages concerning OSH, and OSH programs incorporated messages concerning smoking or nutrition.

The adaptation process

To adapt this integrated approach to the Indian context, we employed a step-by-step approach to intervention development and adaptation based on principles used in our prior research in India [72] and as recommended by others. This adaptation and translation process relies on understanding the local context and setting to ensure intervention effectiveness [72, 73], and requires attention to the challenges faced in settings with low resources [74]. We conducted extensive formative research in order to assess the new setting, determine the appropriateness of the evidence-based intervention to be adapted, and examine capacity to implement the intervention based on local resources [75, 76]. We also followed prior recommendations to pilot test the adapted intervention, in order to identify barriers and facilitators to its implementation and determine training likely to be needed. We applied other recommendations to distinguish between core components, which are essential and indispensable to the effectiveness of the intervention, and adaptable elements, allowing for localizing the intervention without undermining the intervention’s integrity [77–79].

Sample

We recruited 22 manufacturing worksites, located in the Mumbai Metropolitan Region including the Mumbai, Thane, and Raigad districts, to participate in the study [80]. Worksite eligibility criteria included: (1) size, with at least 200 production workers or at least 60% of the workforce to be comprised of production workers; (2) location in the Greater Mumbai area (i.e., Mumbai, Thane, or Raigad districts); (3) industry sector (manufacturing); and (4) willingness to provide a current employee roster for the survey. Two worksites participated in our pilot research, which was conducted between September 2011 and February 2012. In addition, we recruited 20 worksites on a rolling basis between July 2012 and July 2013, all of which agreed to random assignment to condition and to complete participation in intervention and data collection activities. Following the baseline assessment, the 20 worksites were randomly assigned to intervention or delayed intervention control conditions. (See Fig 1) This paper describes findings from pilot testing the intervention in the two pilot worksites, and presents the adaptation and implementation of the OSH intervention in the 10 worksites randomly assigned to the intervention condition.

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Fig 1. Study schema: Mumbai Worksite Tobacco Control Study.

https://doi.org/10.1371/journal.pone.0182607.g001

Data collection and analysis

Data collection efforts were designed to ensure confidentiality and informed consent. For surveys, focus groups, and interviews, trained field investigators introduced themselves and the purposes of the research, and read consent information to participating employees, emphasizing that participation was voluntary and that their participation would not affect their work status. All consent was agreed upon verbally prior to completing data collection, and documented by the field investigators. Qualitative data were collected using structured interview guides, including questions and prompts developed by the investigator team; the duration of focus groups and most interviews was approximately 60 minutes. All qualitative data were collected by Dr. Pawar, MPH, BAMS (female research scientist) and other Healis field researchers (with no less than master’s degree, male and female); all were trained in qualitative data collection and in the specific scripts used in this study.

All qualitative interviews and focus groups were audio-recorded and transcribed. Additional field notes were made during the interviews and augmented later. The transcribed data were analyzed by two coders according to a conventional qualitative content analysis method [81–84], which was comprised of a two stage coding process: Level 1 structural coding and Level 2 thematic coding. Structural coding follows the structure of the interview guide, hence every question received a structural code that is applied to the appropriate text. Thematic coding was based on emergent themes that arose from review of the structural coding, and was applied in a second pass analysis. Participant quotes are included as part of the results.

Characteristics of the sample

This paper focuses particularly on the 10 worksites included in the cluster randomized trial that were randomly assigned to the intervention condition. Of these 10 sites, one withdrew from the study before completion of the final survey [68]. The characteristics of the ten worksites randomly assigned to the intervention condition are presented in Table 1. Overall, approximately three-quarters of the workforce were in production, and men comprised 96% of the workers employed in these manufacturing companies.

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Table 1. Characteristics of the worksites assigned to the intervention condition: Mumbai Worksite Tobacco Control Study.

https://doi.org/10.1371/journal.pone.0182607.t001

Formative research results

Formative research included key informant interviews and focus groups; central themes emerging from this research are summarized in Table 2. Through key informant interviews, we found that OSH efforts relied primarily on secondary prevention through medical screening as well as treatment of injury, rather than on primary prevention involving monitoring, evaluation, and control of hazardous exposures. Managers and workers alike reported that on-site medical care was a major component of OSH efforts; having an ambulance onsite for transporting an injured worker to the hospital, for example, was seen as an important resource. Safety officers provided further support, as mandated by the Factories Act, although in many cases, safety officers had additional responsibilities that made use of their engineering training, limiting the time available for safety issues. Key informants reported that OSH efforts relied heavily on the use of PPE. A few sites reported using engineering controls such as protective hoods for ventilation or safety switches on machines; or using administrative controls, for example, in the case of the fumes and related bad odors, job rotation was employed to limit exposure duration. Although by law, companies are to be inspected by the Directorate of Industrial Safety and Hygiene at least once a year through safety audits by factory inspectors, we saw little evidence that these inspections were conducted with regularity.

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Table 2. Adaptation process: Core steps for translation.

https://doi.org/10.1371/journal.pone.0182607.t002

We identified additional themes in our focus groups with workers (see Table 2). Workers reported stressors on the job, including potential hazardous exposures, needing to be alert when handling dangerous chemicals or dealing safely with mechanical equipment, and the pace of work, as described by one worker:

“I am in production, which is very much about how to have alertness, so that creates mental stress because everything should be proper, everything should be in set position, because any minor mistake or unalertness can create a bigger problem with respect to safety, because this is a chemical plant—so much more is about mental stress.”

Many workers reported that they used tobacco in response to stressors on the job. Working rotating and night shifts and long hours were common. To cope with the challenge of staying awake, workers reported using tobacco, as illustrated in the following quote:

“Some people who have night shift cannot stay awake. They have got the habit…they can stay awake only after consuming tobacco.”

Pilot intervention results

The pilot intervention conducted in two worksites included one event for management and one for workers. Consultation for management included presentation of reports on OSH, based on the industrial hygienist walkthrough and report, and on tobacco policy, based on management interviews to assess current policies and practices. The event for workers included education around the harms associated with tobacco and occupational hazards. Company management noted the benefits of the integrated approach, as illustrated in the quote below from one of the pilot sites:

“Connecting health and safety themes together in the program ensured greater participation as it engaged users as well as non-users [of tobacco]. If the safety component had not been there, many people, especially the non-users, would have missed the event thinking that since they don’t use tobacco the event was not meant for them.”

Despite attempts to provide a balanced intervention focus, however, workers and managers alike reported in focus groups and interviews that the program emphasized tobacco control. Nonetheless, managers reported that the OSH walkthroughs were useful and provided guidance on recommended changes. Workers reported that the attention to safety demonstrated management concerns for their workers, as illustrated by the following quote:

“…Workers think that management is telling us only to complete the work…So, all this, they start thinking that, no, management is thinking all this also about us—health and safety—so some positive effect happens in their mind.”

Time and competing work demands, particularly concerns about loss of production time, were critical obstacles to participation among both workers and managers.

Adaptation process

Following the adaptation process described above, we integrated findings from the formative research and pilot intervention to define the core components of the intervention plan. This process is summarized in Table 2. We identified and built on opportunities to utilize existing resources and standard procedures, for example, the presence of a safety officer and, depending on company size and presence of hazards, a medical officer, and existing worker training, including during safety week.

Intervention implementation: Process evaluation and post-intervention qualitative results

Using a standard protocol, the study team delivered the intervention on a rolling basis in the ten intervention worksites over 7 to 12 months in each worksite. As noted, one of the 10 worksites randomly assigned to the intervention condition withdrew from the study and did not participate in the intervention due to a change in management in the company. We used a set of process objectives to guide the intervention and evaluate its delivery through a process evaluation system. At the completion of the intervention in each worksite, we conducted a close-out interview with the member of management or an administration staff who was appointed as the program liaison; eight of the ten worksites participated. We additionally conducted post-intervention focus groups in two randomly selected intervention worksites. We analyzed these qualitative data to identify the challenges encountered and successes achieved in our efforts to integrate OSH and tobacco control as part of the Healthy, Safe, and Tobacco Free Worksites program. As observed in the pilot, the interviews and focus groups confirmed that respondents perceived that the predominant focus of the intervention was on tobacco control, which was the primary motivator for management engagement in the program. In applying this model to India, we followed the WellWorks-2 structure that included three primary components; below we summarize information from both the qualitative research and process evaluation.

Joint worker–management participation: The intervention efforts in each worksite were coordinated by a member of management/administration staff who assisted with scheduling and promoting events, coordinating consultations with management, and functioning as a liaison with study staff. Following the WellWorks-2 model, we aimed to engage a program committee in program planning and implementation. Only two of the eight sites completing the close-out interview reported actively engaging a program committee, and reported that major barriers included competing responsibilities and production demands. For example, in one post-intervention interview, a manager reported that:

“The program team was not helpful. It could not be effectively formed or function because of the program team members’ own workload… Since most were production supervisors, they are too overburdened with work-related deadlines; they could not be involved in the program very much.”

Management participation in the overall intervention was inconsistent; for example, while several worksites reported no management involvement, others noted that management saw the benefits to encouraging worker engagement and facilitating tobacco policy changes.

Interventions targeting the work organization and environment: As noted in our description of the WellWorks-2 intervention, protecting worker health and safety through changes in the work organization and environment is the centerpiece of OSH interventions because primary control over occupational hazards rests with management. To adapt this approach to the Indian context, the intervention included an industrial hygiene walk-through using a standardized assessment based on an adoption of a Bureau of Indian Standards checklist [85, 86]. In our recruitment of worksites to the study, we observed that this walkthrough posed a barrier to participation for many employers who were reluctant to permit this external review of their work processes and OSH infrastructure [80]. Similarly, a manager at a participating multi-national company reported that the OSH component of the intervention was not a high priority for them, and might be a barrier for participation for similar companies more interested in the tobacco control component. We also observed that although all participating worksites employed a safety officer, the person often had additional roles and responsibilities related to the production process, posing potential competing demands.

Two industrial hygienists were trained to provide the OSH consultation, including for conducting the OSH walkthrough, preparing and presenting the report with findings, and placing the OSH component into the goals of the overall intervention. Based on the walkthrough, the industrial hygienist presented a brief written report to management, summarizing findings from the walkthrough and recommending changes to reduce potential for exposures to hazards in the work environment. Nine of the ten intervention sites participated in the walkthrough assessment. Recommendations made based on the walkthrough were related to housekeeping, ventilation, making simple and doable changes in the physical infrastructure (e.g. marking of areas, cementing floors), use of PPE, improvements in engineering controls and shielding open machinery parts. Among the Indian-owned companies, five of the six reported making some changes in response to the report; although changes made generally required few resources (e.g., additional signage around hazardous areas, housekeeping), one company reported exploring designating a dedicated safety officer as a resulted of the intervention. Three of the eight companies participating in the close-out interviews reported having “strong” OSH programs already in place, either in response to requirements associated with the nature of their industry (e.g., oil and natural gas) or because they were part of a multinational corporation that required compliance with stringent corporate-wide OSH standards and found further input unnecessary. In follow up focus group discussions in two worksites, workers consistently reported that they were not aware of any changes to improve the work environment.

We also provided consultation related to the company’s tobacco control policy, including consultation and technical assistance on the adoption, implementation, and enforcement of worksite tobacco control policies. Six of the ten worksites already had tobacco control policies in place to restrict or ban smoking or tobacco use on site due to fire hazards or quality control concerns; by the end of the intervention, all nine sites participating in the intervention had a policy, including six of the nine that had written policies in place. For example, one manager reported that:

“The management easily accepted the idea of adopting a tobacco policy mainly especially because it did not involve any costs to the company.”

Other companies reported that the tobacco policy and accompanying signage provided an “important display for visitors,” and key information for new recruits “to know that these habits are not permitted at the workplace.”

Interventions for individual workers: Most participating worksites reported having annual safety training as part of compliance with the Factories Act, and reported that the content of these training sessions included, for example, mock fire drills and use of PPE. All of the companies also reported that they observed the required annual safety week. None of the participating companies had prior tobacco control programs to promote or support tobacco use cessation.

We were able to implement the worker-level program fully in seven and partially in two of the 10 intervention worksites. The program included six health education events at the worksite for workers, regardless of whether they used tobacco or not. Conducted by trained health educators from the study, each of the six events was offered for one day in each company, allowing maximum participation by workers, including workers on evening and night shifts. Each event was delivered on a single day during multiple 15 to 20 minute sessions at each intervention company, and was open to all workers. The purpose of these visits was to enhance workers’ understanding of the risks associated with tobacco use, increase their motivation to quit or help someone quit, and build the skills and social support needed for cessation. The messages and materials additionally linked tobacco control with the work environment. By including those who did not use tobacco, we aimed to expand messages around a safe and healthy work environment, and to provide supports for quitting and build social norms around tobacco control. To accommodate management concerns about timing and production impacts, the programming was generally scheduled during work breaks or at the end of shifts to prevent disruptions to production. Some workers reported that time pressures, workload and the need to meet production targets constrained their participation in the program; directives from supervisors to attend the program contributed to increased participation.

We aimed to use “success stories” to build a supportive work culture around tobacco control and OSH. Although we were able to highlight successes around quitting tobacco and supporting others in their quit attempts, managers were generally not willing to highlight OSH efforts in a similar way; we were only able to incorporate an OSH success story in one of the 10 intervention worksites. Employers were generally unwilling to open discussions of OSH-related issues either with workers or study staff. Not surprisingly, in focus group discussions with workers, we learned that most workers thought the program was about quitting tobacco, which was the main study outcome, and most had little awareness of the minimal OSH efforts.

We also developed messages around tobacco control that took into account the conditions of work. For example, we learned from our formative research that rotating shifts were common, and workers reported challenges trying to stay awake with the frequent schedule changes, as noted above. Workers reported using tobacco during night shifts to stay awake, or to work faster to increase production. We incorporated messages about alternative strategies to address these potential functions of tobacco use. Workers also noted that stressors on the job included dealing with potential hazards, such as needing to be alert when handling dangerous chemicals or dealing safely with mechanical equipment. Many workers reported that they used tobacco in response to stressors on the job. Although we were able to incorporate stress reduction into the intervention messages, we were not able to effect changes in work practices to address organizational sources of stress.

Additionally, themes identified from the key informant interviews with management and company liaisons also highlighted several adaptations made in response to the local setting:

• Building on existing practices: Although in many companies there was little tradition of health promotion programming, we were able to build on other common practices. For example, in one company, management representatives noted that:

“Since the company already has a concept of daily ‘Tool Box Talks’ with employees every morning, this platform was effectively used for conducting the health education sessions.”

Similarly, another company reported that “the company has a protocol of conducting morning assembly before the workers begin the day’s work; the sessions were conducted during that time.”

• Consideration of the cultural context. For example, in one company, the educational program was conducted in the canteen because the health educators were not allowed in the plant. However, this posed a barrier for some workers. As a manager in this company reported:

“Women workers don’t often go to the canteen, hence they missed out. But the message did reach them through posters and banners. Separate events could have been conducted for the ladies. Pamphlets could have been circulated to each worker even if the event could not reach all.”

• Variations in program delivery. Flexibility in the delivery of the program was cited repeatedly as important to managers, including flexibility in scheduling, number of sessions, and ability to locate the program in multiple locations due to the large size of the plants. For example, one manager reported:

“It was difficult for your staff to cover the area of the company; we could not always provide vehicles due to their unavailability. And it was difficult to gather employees at one place due to time constraints, so sessions had to be conducted in individual locations many times. So, one program event should have been conducted at least thrice to cover the maximum employees.”