key: cord-1009065-q13m6nk6
authors: Buller, David B.; Buller, Mary Klein; Meenan, Richard; Cutter, Gary R.; Berteletti, Julia; Eye, Rachel; Walkosz, Barbara J.; Pagoto, Sherry
title: Design and baseline data of a randomized trial comparing two methods for scaling-up an occupational sun protection intervention
date: 2020-09-15
journal: Contemp Clin Trials
DOI: 10.1016/j.cct.2020.106147
sha: 2380a3100ea8453dde5b1ca125f8853f089e738a
doc_id: 1009065
cord_uid: q13m6nk6

Background Successful methods for scaling-up evidence-based programs are needed to prevent skin cancer among adults who work outdoors in the sun. Methods A randomized trial is being conducted comparing two methods of scaling-up the Sun Safe Workplaces (SSW) intervention. Departments of transportation (DOTs) from 21 U.S. states are participating and their 138 regional districts were randomized following baseline assessment. In districts assigned to the in-person method (n = 46), project staff meets personally with managers, conducts trainings for employees, and provides printed materials. In districts assigned to the digital method (n = 92), project staff conduct these same activities virtually, using conferencing technology, online training, and electronic materials. Delivery of SSW in both groups was tailored to managers' readiness to adopt occupational sun safety. Posttesting will assess manager's support for and use of SSW and employees' sun safety. An economic evaluation will explore whether the method that uses digital technology results in lower implementation of SSW but is more cost-effective relative to the in-person method. Results The state DOTs range in size from 997 to 18,415 employees. At baseline, 1113 managers (49.0%) completed the pretest (91.5% male, 91.1% white, 19.77 years on the job, 66.5% worked outdoors; and 24.4% had high-risk skin types). They were generally supportive of occupational sun safety. A minority reported that the employer had a written policy, half reported training, and two-thirds, messaging on sun protection. Conclusions Digital methods are available that may make scale-up of SSW cost-effective in a national distribution to nearly half of the state DOTs. Trial registration: The ClinicalTrials.gov registration number is NCT03278340.

In the field of implementation science, scale-up is the effort to increase the impact of successful prevention interventions to benefit more people on a lasting basis. 1 Scale-up methods must be lower cost and increase reach to provide greater access to benefits. [2] [3] [4] Going to scale with a research-tested intervention is more than replication in large populations. Options, knowledge processes, and technologies are expanded to build capacity and influence decision-makers 1 and understand implementation and cost of programs. 5 Costs of national distribution can be daunting, so affordable scale-up methods are needed to maintain sufficient intervention effectiveness, as interventions' effectiveness often declines 6 due to reduced dose and fidelity 7 and adaptions to fit 7 from the baseline survey of managers on occupational and personal sun protection are presented in this paper.

The randomized trial is underway and designed to compare the distribution of SSW using the original in-person method to a digital method for meetings and training.

The protocol originally included 200 fire departments and state departments of transportation (DOTs) enrolled in two waves (to make it more feasible) into a randomized, pretest-posttest two-group experimental design. Employers were to be stratified by size (large v. small; median split on number of employees) and solar intensity (a proxy for climate and UV), which had been significant covariates in our past research. 36 After pretesting, regional districts in the DOTs were randomized to the inperson or digital scale-up method, originally in a planned 1:3 ratio. The intervention period lasts 20-months for each district, after which posttesting will be completed. All procedures were approved by the Western Institutional Review Board.

After the trial commenced, the sample size was reduced to 138 because of budget constraints created by a reduction in the budget from the awarding agency. Also, the sample was altered to include just state DOTs. This also occurred because of budget constraints when a) cost of identifying fire departments was higher than expected, b) the American Association of State Highway and Transportation Officers (AASHTO) was able to attract a large number of state departments of transportation to enroll, and c) state DOTs had similar structures with managers and employees J o u r n a l P r e -p r o o f Journal Pre-proof organized into multiple regional districts. Regional districts became the unit of randomization rather than individual departments. Another change was that the policy measure was changed from an outcome variable to a moderator variable, because in state DOTs, written policies on sun protection are set at the central state office, with employee education delivered at the regional district level. As all 50 state DOTs were invited to participate, stratification by size and solar intensity region was eliminated.

Instead, randomization occurred within state and each state had regional districts assigned to in-person and digital scale-up strategies (except one state that had only a single participating district, which was assigned to in-person strategy). Combined across states, districts were assigned in a 1:2 ratio to in-person to digital strategies. Finally, plans to pretest employees were eliminated due to budget constraints and reluctance by state DOT managers to provide access to employees prior to participating in the study.

State DOTs in all 50 states were invited to participate in the trial by a letter sent to the state DOT directors from the AASHTO Chief Executive Officer along with a description of the study. Project investigators followed up by telephone and email to secure agreement to participate. A key contact at the state office provided information on the state DOT districts, including district locations and characteristics, and manager outdoor workers; c) consenting to participate, and d) completing the pretest. The manager cohort included Safety Officers/Leads, Safety Coordinators, Maintenance Administrators/Supervisors, Resident/Construction Engineers, Maintenance/District Superintendents, Operations/Infrastructure Managers, and Project/Section Supervisors.

Managers were sampled by position at pretest and persons holding those same positions will be posttested. Survey invitations were sent by email followed by weekly reminders for up to 5 weeks. After that, persistent non-responders received a printed survey by U.S. mail, with a return-addressed stamped envelope. If the position holder changes, we will attempt to posttest both the new and original position holders. At posttest, eligibility criteria for employees to be assessed are a) being employed part/fulltime in a participating regional district, b) working at least part of daytime hours outdoors, and c) consenting to participate. Employees will be sampled at posttest from employee rolls. Districts were the unit of randomization within each state. After each state completed the pretest protocol, the project statistician randomized districts into scale-up strategy (in-person or digital).

The SSW program was designed by our team and demonstrated effectiveness in a randomized trial. [9] [10] [11] It promoted comprehensive occupational sun protection (i.e., adoption of sun safe policies and provision of sun safety education) to ensure employee sun safety was promoted and supported long term. The intervention was based on principles of Diffusion of Innovations Theory (DIT) and two theories of relationship developmentsocial penetration theory 37,38 and stages of relational development. [39] [40] [41] In DIT, organizational diffusion is achieved through changes in management, policies, J o u r n a l P r e -p r o o f Journal Pre-proof and procedures 42-45 facilitated by increasing perceived need for workplace sun safety, demonstrating that policy/education fit the organizational mission/practices, and helping plan for policy/education, realizing that policies/education and/or the organization may need to change to improve fit and changes need to be clarified to managers/ employees. [46] [47] [48] In meetings and follow-up communication with managers, program staff aimed to a) reduce managers' uncertainty 49,50 about sun safety; b) highlight advice from national health authorities to build credibility/trust 51, 52 ; and c) obtain commitment to adopt and implement the policies/education. [53] [54] [55] Operationally, SSW consisted of personal visits with managers and materials promoting sun protection policies and education. 56 It started with a program announcement packet and in-person meetings between senior managers and program staff that covered: 1) Introduction to SSW; 2) Sun Safety Practices in the Workplace; 3) Sun Safety Policy for Outdoor Workers; 4) Sun Safety Policy Adoption; 5) Sun Safety Policy Reinforcement and Maintenance. The SSW website was provided to workplaces with promotional materials on: skin cancer and UV, risk factors, personal risk assessment, workplace prevention strategies (i.e., sunscreen, sunglasses, long-sleeved shirts, hats, shade, scheduling), prevention at home, and online workplace audit and policy writing tool. Program staff conducted in-person Sun Safety Training to staff during worksite visits that presented: 1) The U.S. Skin Cancer Problem; 2) The Sun, UV Rays and Skin Cancer; 3) Assessing Your Personal Risk; and 4) Practicing Sun Safety. A Sun Safety Tool Box provided support materials for policy and education (i.e., worksite audit and facts sheets on sun safety and barriers to policy implementation and theorybased printed posters, risk assessment brochures, and tip cards for employees). In J o u r n a l P r e -p r o o f Journal Pre-proof However, all of the state DOTs had highly restrictive cybersecurity policies that prohibited the use of social media in the workplaces. Thus, this component of the digital method was eliminated.

To improve communication with managers in both scale-up methods, procedures were developed to tailor the communication with managers to their readiness to adopt occupational sun safety, based on DIT and a protocol developed in another project:

Agenda Setting (i.e., need for sun safety), Matching (i.e., fit of sun safety with existing policy/procedures), Structuring (i.e., initial implementation of policies/actions), and Clarifying (i.e., communicating with employees, other managers, and clients to garner support and counter opposition). By tailoring on readiness, program staff connects with districts where they are in the innovation process so they provide the most relevant coaching and resources. A tailored report on the DOT's current support and actions for occupational sun safety is prepared for state-level key contacts based on the existing sun safety content in their written policies and managers' responses to a pretest survey and a checklist of workplace sun safety actions they complete during the first meeting.

The report presents a plan for implementing sun safety for employees with resources matched to state contact's readiness.

Outcome Measures SSW Implementation. SSW implementation is the primary outcome in the cost analysis. A primary measure will be managers' reports of any training or other sun safety actions, using measures modified from the trial testing the effectiveness of SSW and implementation of school sun safety policy. 62, 63 Managers will report if training was J o u r n a l P r e -p r o o f provided to employees, and to supervisors and managers:

1. Training on the health risks of sun exposure is provided to employees 2. Training regarding sun safety is delivered to managers and supervisors They also report on nine sun protection actions in the workplace:

1. Employer monitors UV Index and work scheduled is adjusted for harm associated with UV level.

2. Employees wear UV-protective clothing or uniforms (shirts with sleeves; long pants), hats, and/or eyewear when outdoors. At posttest, employees will report whether they received the sun safety training and whether employers communicated about sun safety on the job through oral, written, or electronic messages. This will be a secondary measure, validating managers' reports.

In our prior research, managers' and employees' reports of sun safety education were highly correlated. 36

Employees' Sun Protection. The secondary outcome is employees' sun protection at work assessed at posttest. Employees will report frequency of sun protection practices on 5-point frequency scales, including sunscreen with SPF 15 or greater and with SPF 30 or greater, sun-protective clothing such as long-sleeved shirts and long pants, hat with any type of brim and with a wide-brim all the way around (including hat with flap on the back the protects ears and neck), sunglasses, shade use, limit exposure to midday sun, and have sunscreen, hat and eye protection at work at all times (1=never, 5=always). They will also report on prevalence of sunburn in the past 12 months anywhere and on the job (yes/no; number of times). These are standard, validated, and reliable measures from past studies. [64] [65] [66] [67] [68] [69] [70] [71] [72] [73] [74] Managers will complete these measures, too.

Given that policy is set by the central state DOT office, written sun protection policy was changed to be a potential effect moderator. Human resources and safety documents were excerpted and coded by research assistants blind to condition at pretest. Composite scores will assess presence, strength, intent, and responsibility from a coding protocol developed previously. 9 Specifically, it assesses 15 policy categories: engineering controls (physical environment of the workplace), administrative controls J o u r n a l P r e -p r o o f (workplace procedures), and employee education (workers' sun safety). Each category receives a point (0, 1) for presence (total score=15) and a 3-level strength score (-1=not allowed, 0=not mentioned, 1=allow/ recommend, 2=require; total score=30). Policies on engineering controls (scheduling/shade) and sun safety practices (hats/protective clothing/protective eyewear) could exist for reasons other than sun safety (e.g., to prevent injury), so those categories receive a point (0,1) when sun protection is explicitly cited (total intent score=5). A 3-level responsibility score is assigned, noting who provides protection equipment (0=not specified, 1=employee, 2=employer; total score=10). These ordinal composite scores are continuous and summed across categories. Training ensured inter-coder reliability exceeds 0.70. There is no basis for the minimum number of components that must be changed to improve workplace sun safety, so we will assess both presence and extent of change. The ordinal measures can detect expansion of existing policies. The proportion of employers who have any policy will be estimated. We will also assess extent (number of elements) and strength (-1=not allow, 0=not mentioned, 1=allow/ recommend, 2=require summed across policy components) of policy.

Costs associated with the in-person and digital scale-up methods will be recorded. Using a micro-costing approach, resource allocations for each component of the scale-up methods will be identified (e.g., in-person and virtual visits; follow-up communications; staff-delivered and virtual training, web resources, and mailed materials). Both labor and non-labor elements associated with in-person and virtual meetings, staff-delivered and virtual trainings, printed materials, follow-up J o u r n a l P r e -p r o o f Journal Pre-proof communications, and website resources, and induced employer costs of policy and education implementation, will be recorded. For project personnel, the proportion of FTE across activities will be estimated by contemporaneous staff self-report into categories (e.g., recruitment, intervention development, intervention delivery). In posttest surveys, senior managers will identify organizational sun safety actions induced by SSW and attach cost estimates to each (i.e., hours spent by manager and employees implementing action; items purchased to implement actions). 75 Costs will be summed to produce overall cost estimates.

Managers' attitudes toward skin cancer prevention and occupational sun protection and awareness of sun protection policies and procedures are assessed in the managers' pretest and posttest survey. Perceived susceptibility to skin cancer is assessed by two Likert-type items for self and employees within the organization (1=strongly disagree; 5=strongly agree). Support for occupational sun protection is measured by two Likert-type questions: I personally support adopting policies to protect employees from the sun at my organization and Employees should take action on their own to protect themselves from the sun while at work, without my organization telling them to do so (reverse coded). Managers rate occupational sun protection (i.e., changing formal written policies, procedures, and training in my organization to protect employees' skin and eyes from the sun) on six innovation characteristics suggested by DIT: 42-45 necessary, too expensive, compatible with work procedures, too complicated, acceptable to employees, and would improve organization's existing risk management or employee wellness programs (1=strongly disagree; 5=strongly agree). Managers and J o u r n a l P r e -p r o o f employees report if the organization has a formal written policy, administrative procedure, or training standard on sun protection of employees and unwritten informal standard operating procedures on sun safety (i.e., presence and content of procedures).

Those aware of a policy also indicate degree of acceptance (How much do employees that report to you agree with the formal written policy; Do I agree with the formal written policy [1=not at all; 3=very much]) and compliance (How much are the employees that report to me follow the policy; Do I follow the policy [1=not at all; 5=completely]) with the policy on sun protection.

Community and organizational characteristics are being collected and tested as moderators of the scale-up methods. At the community level, population size, education, and socioeconomic status are being obtained from the U.S. Census. Mean annual hours of sunshine will be recorded from the National Weather Service. For each state DOT and regional district, number of employees and job type (e.g., public works, public safety, etc.) are collected.

Also, potential moderators were collected in manager pretest survey. Job winter (November to March). Their tanning desires are measured by an item asking if they thought they looked better with a tan (1=strongly disagree; 5=strongly agree 78 ).

Managers were also asked whether the organization has any policy that makes it more difficult for employees to use sun protection. Finally, skin type (always burn and unable to tan; usually burns but can tan if work at it; sometimes mildly burns and then tans easily; rarely burns and tans easily), 79 skin cancer history and demographic characteristics of managers and employees were collected: age, education, Hispanic ethnicity, race, and gender. We plan to assess job characteristics, outdoor work and skin type, skin cancer history, and demographic characteristics in posttest surveys of employees, too.

Cost Analysis. The primary analysis will model the cost-effectiveness of digital relative to in-person scale-up strategy, based on the estimated rate of employers (i.e., regional districts) who implement policies and education and the cost of delivering each intervention. Secondary analyses will explore the representativeness of districts who implement the interventions. The proportion of regional districts adopting sun safety education in the trial establishing the effectiveness of SSW was used to estimate the J o u r n a l P r e -p r o o f sample size of districts. To be conservative, we expected implementation to be slightly lower in the in-person scale-up group than in the original trial and designed the sample size of the digital scale-up group to be larger, on the possibility it produces a lower implementation rate than in-person method. In the SSW trial, the proportion of districts implementing education was 0.80 (40 of 50), but we assumed that in-person scale-up method will have a lower rate of implementing education of 0.600. We further expected up to 10% of the organizations to be unavailable/refuse to provide follow-up data. A sample of 40 regional districts assigned to the in-person group, with 36 providing full data, allows for 95% confidence intervals ( Comparisons of education have >80% power to test implementation rate differences between interventions. The smallest sample size would be 42 and 84 respectively, but 84 does not provide for an estimated nonzero lower limit of the 95% CI for implementation, a key figure for calculating cost-effectiveness. Thus, the sample size was increased to provide a nonzero lower limit of the 95% CI. We invited all eligible managers in the DOT regional districts, with the aim of pretesting 840 (6 per district) so we could reasonably expect to posttest 672 (5 per district; 80% follow-up).

Hypothesis Test. We estimated the power for the hypothesis test for comparison Research Question. Finally, for employees' reported sun protection practices, sample size is adjusted for the design effect due to clustering within DOT regional districts (i.e., intra-class correlation [ICC]), which inflates variance and Type I error, making significance testing too liberal. We assumed 50 employees per regional district on average and a total of n=2300 in the in-person scale-up method (n=46 regional districts) and n=4,550 in the digital scale-up method at posttest. Adjusting for an ICC of up to 0.02, which usually is much lower for individual behaviors, reduces effective sample size to n=1079 in the in-person method and n=2,614 in the digital method, but a small difference in proportions of 0.60 to 0.65 is detectable with 80% power.

Cost-Effectiveness Analysis. The economic evaluation will explore whether SSW-T can be delivered cost-effectively to worksites producing a lower implementation rate J o u r n a l P r e -p r o o f Journal Pre-proof than SSW-IP but at substantially lower cost. To begin the cost analysis, we will estimate implementation of education in two ways, i.e., if at least 1 manager reports training for districts and the average number of managers who report it. We will create similar measures of implementation of other sun safety actions, including if at least 1 manager reports implementing the action and the average number of managers who report it.

Implementation will be defined conservatively, i.e., district both delivers training and other sun safety actions, and liberally, i.e., either training or other sun safety actions.

Next, we will use an incremental cost-effectiveness ratio (ICER) to summarize the up cost savings from a worksite not implementing at or below its cost savings (see Figure 1 ). We will not have access to WTP/WTA data from participating agencies or worksites, so we cannot state definitively that either digital or in-person scale-up methods will be cost-effective relative to the other. However, we will strive to validate our ICER results using external comparators (e.g., budgets for known implemented health-related policies and programs). Note that this is not an analysis of SSW simply delivered "as is" to more worksites. Content remains the same, but the delivery mechanism and associated resources differ between the two scale-up methods.

For policy purposes, development costs will be considered "sunk" and excluded, so the economic evaluation will be that of an existing program. However, to the extent possible, SSW-T development costs will be tracked and reported as appropriate.

Research and evaluation costs will be removed. Univariate and multivariate sensitivity analyses will model representativeness. Regional district size will be examined to evaluate the digital scale-up method's ability to (cost-effectively) contact individual workers. It may be cost-effective but if mostly small districts implement, digital scaleup's representativeness (i.e., "reach") is limited among individual workers. Further, we will calculate ICERs within each of the five U.S. Census regions, with similar ratios indicating representativeness across regions. Our cost analysis will not include or account for potential feedback effects, such as business interactions that expose other worksites to the digital method or long-term health outcomes, such as reduced skin cancer incidence.

We will extend the economic analysis by recalculating ICERs based on number of employees that report pre-post improvement in sun protection (see below). This Representativeness of implementation achieved by the digital method will be explored by adding to the regression models variables such as size and U.S. Census region and other moderators potentially affecting implementation. These variables will be added as fixed factors and their interactions with condition examined at p=.05 (2-tailed), unadjusted for multiple comparisons. Using the correlation structure from the primary outcome variables, we will assess order effects to determine which components may drive the implementation of policy and education.

Ancillary Analyses of Engagement with Scale-up Methods. Districts' engagement with the two scale-up methods may differ and affect implementation rates achieved by them. We will explore mediation of education and other sun safety actions implementation rates by program exposure assessed by process measures, using mediational analyses from Judd and Kenny 80 and elaborated by MacKinnon. 81 To satisfy the conclusion of mediation, significance will be determined via interval estimation using a bootstrap estimate. 82 Ratio of indirect to total effect will estimate proportion of effect mediated by engagement.

Departments of transportation in 21 states agreed to participate (see map in Figure   2 ). The DOTs ranged in size from 997 to 18,415 employees and were located in four Census regions (7 South, 6 Midwest, 4 Northeast, 4 West). There were 138 regional districts from the state DOTs enrolled, pretested, and randomized (range=1 to 27 per state). Randomization resulted in 46 districts being assigned to the in-person scale-up method and 92 to the digital scale-up method. One state had a single district and was assigned to the in-person scale-up strategy.

A total of 1,113 managers (49.2%) in 138 regional DOT districts completed the baseline survey out of 2,262 managers invited. The managers' characteristics are displayed in Table 1 . As would be expected for senior staff, they are generally long-term employees (nearly 20 years on average), almost all make decisions about workplace safety and health policy, procedures, and training, and serve as opinion leaders on those topics. Many regularly read professional publications and attend conferences, which can expose them to innovative ideas such as occupational sun safety. Nearly all managers are male. Education is widely distributed, with one-fifth having a high school education, one-third some education beyond high school, and 43.4% having a college degree. Many of these managers work outdoors at least part time on the job (66.5%).

Nearly a quarter (24.4%) have skin types at high-risk for skin cancer and several have been diagnosed with skin cancer. This is not too surprising given that nearly all ---Insert Table 1 about here---

Managers were supportive of occupational sun safety ( Table 2) . Managers felt personally vulnerable to skin cancer (51.6% strongly agree or agree) and that employees were at risk for getting skin cancer (65.3% strongly agree or agree). They strongly supported adopting policies on occupational sun protection at their organization (85.5% strongly agree or agree). However, most managers also felt that employees should take responsibility for sun safety at work without the organization telling them to do so (83.1% strongly agree or agree). Manager considering the innovation characteristics of occupational sun safety suggested by DIT to be favorable, including being necessary (64.7% strongly agree or agree), compatible with work procedures (71.9% strongly agree or agree), not too expensive (93.2 strongly disagree, disagree, or neutral), not too complicated (92.2% strongly disagree, disagree, or neutral), acceptable to employees (64.5% strongly agree or agree), and improve on the organization's existing risk management or employee wellness programs (72.3% strongly agree or J o u r n a l P r e -p r o o f Journal Pre-proof agree).

Only a minority of managers reported that there was a written sun protection policy or unwritten standard operating, administrative, or training procedures at their workplace (Table 2) . Also, they felt that employees generally agreed with and followed the sun protection policy or procedures, when it was present. Further, training and other actions to support occupational sun protection were occurring in some workplaces (Table 2 ). About half of managers reported that training on sun protection on the job occurred with employees and/or managers. Two-thirds of managers said that messages on sun protection were conveyed to employees and three-fifths said that their employer provided personal protection resources such as sunscreen, protective clothing, hats, or eyewear to employees (i.e., employers gives these resources to employees or provides money for employees to purchase them). However, managers felt that only a minority of employees were using sunscreen or sun-protective protective clothing. Very few managers reported other occupational sun protection actions such as providing shade in the work environment, monitored the UV Index and modified work activities for UV levels, asking contractors/subcontractors to comply with sun safety policy in the organization's work environment, conducting risk assessments of sun exposure and sun protection, or encouraging employees to get regular skin checks with self-or clinical exams. Overall frequency of these other sun protection actions averaged 2.54 out of 9.

Randomization balanced the treatment groups on baseline occupational sun protection training and actions. The only apparent difference was that more managers Table 2 about here---

Managers were inconsistent in their sun protection practices (Table 3) , with only a mid-range value on the composite sun protection score. The most frequent personal protection for sun exposure was wearing sunglasses (80.6% always or often) and a hat with any type of brim (65.0% always or often). However, wide-brim hats were not commonly worn by managers (23.3% always or often) and only a minority wore sunscreen routinely (28.4% always or often on the face and 34.1% on exposed body parts). Still, many reported that they had sunscreen, a hat and eye protection with them at work when outdoors (65.7% always or often). Sun-protective clothing (35.5% always or often) and shade (42.0% always or often) also were used less frequently by managers. Few managers limited their time outdoors during midday (24.4% always or often), the daily period of highest UV.

Further, over half of managers had been sunburned in the past year. Many reported that this over-exposure occurred at work, with two-fifths reporting that they were sunburned at least once in the past 12 months while working (Table 3) .

---Insert Table 3 about here---

Occupational sun exposure receives limited attention, 83, 84 despite its link to skin cancer. [14] [15] [16] Health promotion approaches that incorporate policy with education such as J o u r n a l P r e -p r o o f Journal Pre-proof in our Sun Safe Workplaces intervention can impact safety, disease management, 85 and disease prevention [86] [87] [88] [89] [90] [91] [92] [93] [94] [95] [96] [97] [98] [99] by working synergistically to integrate health promotion and safety procedures, 85 clarify personal/organizational responsibilities (e.g., who provides sunscreen and protective clothing), and formally direct employees to take precautions to overcome low perceived risk, personal preferences (say for tanning), and other barriers, as well as equalize gender and age differences in health practices. 12, 100, 101 Our team has successfully recruited two-fifths of the state departments of transportation in the United States to participate in the randomized trial on the cost effectiveness of two scale-up methods. These departments employ over 100,000 workers, many of whom work outdoors. As the managers reported, employees work for many years at the state DOTs (managers average nearly 20 years) and spend substantial time outdoors both in the summer and winter, making them vulnerable to solar UV skin damage including skin cancer. The reliance on a single industry provides some measure of control against confounding of organizational characteristics but the 21 states are diverse in terms of climate and ambient UV levels, and racial composition of the workforce, that alter their approach to on-the-job sun protection. The sample of managers in this trial is similar to the one we recruited from cities, counties, and special taxing districts in Colorado, with the exception that they were longer-term employees, more variable on education, and more predominately male.

A very pronounced knowledge-practice gap appears to exist in occupational sun safety in these organizations, according to reports from managers. Many of the managers recognized that they and their employees are at risk for skin cancer and are supportive of occupational sun safety, but only some managers said their organizations J o u r n a l P r e -p r o o f Journal Pre-proof were taking steps to address it. Only half of managers said training was occurring, but two-thirds said the organization was communicating about sun safety with employees.

Employees were more likely to receive training than managers. This may be an oversight given that managers are spending time outdoors on-the-job and training may motivate them to be opinion leaders for occupational sun safety. Two-thirds of managers said that organizations were providing personal protection resources, but most employees were not using them according to managers. Training and communication to employees may need to be expanded to get more use of personal protection. Further, the organizations were not taking advantage of the UV Index to alert employees or adjust work schedules for the risks posed by high UV, although we have found in the past that adjusting work schedules is one of the least likely actions by employers. In this case, concerns over safety of employees (i.e., motorist can see them better during daylight) may favor daytime work schedules. The organizations also are not providing shade, although this too may be challenging for employees who are traveling long distances to monitor and work on roadways. Still, shade canopies can be mounted on some equipment (e.g., tractors) and vehicles and other environmental objects such as trees, underpasses, and buildings cast shade and can be used during breaks to reduce UV exposure (although auto glass blocks UVB better than UVA).

Still, the initial support for occupational sun protection and the fact that state DOTs were taking some actions on sun safety bodes well for the successful scale-up and implementation of our evidence-based sun safety intervention. There does not appear to be strong resistance from the management of DOT regional districts to occupational sun safety. Rather, it may be that sun safety is a lower priority than other J o u r n a l P r e -p r o o f Journal Pre-proof safety issues such as safe driving practices, fall prevention, hazardous materials, and construction site safety. Also, well-designed training and resources for sun safety at a reasonable cost may not be widely available to risk management and training staff.

Information on costs (and intervention delivery resources) is essential for moving research into practice 8, 28 and under-reported in dissemination and implementation. 8

Cost will undoubtedly be relevant when attempting to reach and serve these very large organizations in the trial that maintain transportation infrastructure of over 1.9 million square miles. The size of the regional districts makes them more manageable organizational units for testing the scale-up methods. However, the regional districts do pose many challenges to implementation of occupational sun safety, with most districts having employees based in multiple locations, from central offices and yards to remote The trial design has a number of strengths and weaknesses. The participation of a large proportion of a major U.S. public sector industry adds to the realistic nature of the test and generalizability. The prospective, randomized trial design is rigorous and will control several confounders among the regional districts. The multiple levels of analysis, from policy coding to surveys of managers and employees will provide a more comprehensive assessment of the scale-up processes and impact. The scale-up methods are based on a theoretical framework used extensively in the implementation sciences and the assessment of cost, as well as impact on implementation activities and employee behavior will provide key information for decision makers charged with distributing evidence-based programs and adopting them with at-risk groups.

However, the study is limited by a single industry, although it does have a variety of outdoor occupations, and the fact that it is a public rather than private employer.

Public employers may have longer term employees, have less concerns over profits that limit resources for health programs, and provide other types of occupations. Public employers supported by taxes also can experience budget constraints. The implementation and some of the cost measures will be reported by managers, rather than obtained from observations, which are impractical in this geographically large study area but which are subject to social desirability biases, demand effects, and memory errors. We will conduct a small-scale validation study on these reports. State DOTs centralize some of the risk management functions, so the regional districts will vary in their abilities to make independent decisions on all sun safety actions. This paper was written during the first months of the COVID-19 pandemic in the United States. While DOTs were classified as essential employers in all states, all DOTs J o u r n a l P r e -p r o o f suspended in-person training and out-of-town travel was inadvisable during stay-athome orders in many states. Thus, the in-person scale up method has been suspended during the spring and summer 2020. The digital scale-up procedures have continued in a very limited number of districts where managers were still willing to engage with our intervention staff. As states transition to safer-at-home and other forms of opening, the scale-up methods will be re-started. We should be able to intervene and posttest in 10 states with little interruption to the study timeline but posttesting will be delayed in 11 states to provide sufficient time to implement scale up procedures through the spring and summer 2021. We will handle this deviation in intervention duration by including a covariate for the time between baseline and posttest period and use least squares means for the adjusted post analysis that accounts for possible attenuation of effects due to the longer interval of time.

Evidence-based programs have been successfully scaled-up for HIV treatment/prevention, 102,103 obesity prevention, 3,104 and health service delivery, 103 ,105 yet a research-to-practice gap remains between effective programs and real world application. 26 It is hoped that this trial identifies cost-effective methods for disseminating program widescale and help to realizing their promised benefits of the Sun Safe Workplaces intervention to fulfill one of the priorities of the Surgeon General in his recent call to action for skin cancer prevention. 106 J o u r n a l P r e -p r o o f J o u r n a l P r e -p r o o f 

World Health Organization, Department of Reproductive Health and Research. Scaling up health service delivery: from pilot innovations to policies and programmes. World Health Organization

Why don't we see more translation of health promotion research to practice? Rethinking the efficacy-to-effectiveness transition

Process evaluation of an up-scaled community based child obesity treatment program: NSW Go4Funr

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National Institues of Health approaches to dissemination and implementation science: current and future directions

The concept of scalability: increasing the scale and potential adoption of health promotion interventions into policy and practice

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Results of a randomized trial on an intervention promoting adoption of occupational sun protection policies

Implementation of occupational sun safety at a two-year follow-up in a randomized trial: comparison of sun safe workplaces policy intervention to attention control

Sun safe workplaces: Effect of an occupational skin cancer prevention program on employee sun safety practices

The health beliefs and skin cancer prevention practices of Wisconsin dairy farmers

Description of the use of a risk estimation model to assess the increased risk of non-melanoma skin cancer among outdoor workers in Central Queensland

UV-induced skin cancer at workplace and evidence-based carcinoma: a systematic review and meta-analysis

Is occupational solar ultraviolet irradiation a relevant risk factor for basal cell carcinoma? A systematic review and metaanalysis of the epidemiological literature

Exposure to solar uv during outdoor construction work in Britain

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Different outdoor professions have different risks -a cross-sectional study comparing nonmelanoma skin cancer risk among farmers, gardeners and mountain guides

Severe sunburn and subsequent risk of primary

Malignant melanoma in southern Germany: different predictive value of risk factors for melanoma subtypes

The relationship of malignant melanoma, basal and squamous skin cancers to indoor and outdoor work

Three collaborative models for scaling up evidence-based practices

Supporting replication and scale-up of evidence-based home visiting programs: assessing the implementation knowledge base

Interagency Collaborative Team model for capacity building to scale-up evidence-based practice

Evaluating the public health impact of health promotion interventions: the RE-AIM framework

Moves that matter: issue selling and organizational change

Uncertainty Reduction: Managing Uncertainty in Organizational Communication

Uncertainty reduction, self-enhancement, and ingroup identification

Credibility assessments of online health information: The effects of source expertise and knowledge of content

Contributing factors to the use of health-related websites

Influence: science and practice

Giving commitment: employee support programs and the prosocial sensemaking process

Interpersonal communication: Theoretical perspectives, future perspectives

Workplace health policy 2.0: online tools to promote sun safety policy for outdoor workers

Social comparison, self evaluation, and conformity to the group

The in-between world of knowledge brokering

Developing a Web-Based Tool Using Information and Communication Technologies to Expand the Reach and Impact of Photovoice

Investigating Multimodal Communication in Virtual Meetings: The Sharing of Dynamic Representations

Performing knowledge requirements analysis for public organisations in a Virtual Learning Environment: a social network analysis approach

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Randomized controlled trial evaluating an intervention supporting implementation of sun safety policies in California public elementary schools

Measuring self-reported sunburn: challenges and recommendations

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Sunscreen use related to UV exposure, age, sex, and occupation based on personal dosimeter readings and sun-exposure behavior diaries

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Stability of questionnaire items measuring behaviours, attitudes and stages of change related to sun exposure

Sunscreen use and malignant melanoma

Measures of sun exposure and sun protection practices for behavioral and epidemiologic research

Validity of beachgoers' selfreport of their sun habits

A controlled trial of objective measures of sunscreen and moisturizing lotion

Validity of self-reported sunscreen use by parents, children, and lifeguards

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Workplace health protection and promotion: a new pathway for a healthier-and safer-workforce

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Combined scale: Compared to people working in other organizations or companies in the United States, I am more likely to get skin cancer in my lifetime and the employees in my organization are more likely to get skin cancer in their lifetime compared to people working in other organizations and companies in the United States

The authors express their appreciation to the American Association of State Highway Transportation Officials and the managers of the 21 state departments of transportation