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Sun Safe Workplaces: Assessment of Benefits and Costs of a Policy Intervention (SSW2)

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ClinicalTrials.gov Identifier: NCT03281161
Recruitment Status : Completed
First Posted : September 13, 2017
Last Update Posted : October 26, 2017
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Kaiser Foundation Research Institute
University of Colorado, Denver
Information provided by (Responsible Party):
Klein Buendel, Inc.

Brief Summary:
Sun Safe Workplaces (SSW), a comprehensive occupational sun safety program, promoted education and policy to 98 cities, counties, and special districts in Colorado. In a two-year follow-up study, Klein Buendel, Inc. (KB) proposes to examine the effectiveness of SSW on employee sun protection practices by employers and return on investment in an economic evaluation of the cost of the SSW intervention. The results of this follow-up study will provide critical information on effective approaches to increasing sun protection across a wide range of employment sectors with outdoor workers.

Condition or disease Intervention/treatment Phase
Skin Cancer Behavioral: Sun Safe Workplaces Program Behavioral: Attention Control Not Applicable

Detailed Description:
Workers in the United States spend large amounts of time on the job, making the workplace a key venue for preventive health programs. A workplace risk that has received limited attention is solar ultraviolet radiation (UVR). Unprotected exposure to solar UVR of outdoor workers can produce both an immediate acute harm (i.e., severe sunburn) and long-term skin damage that can elevate the risk of developing skin cancers. Preventing skin cancer is a priority due to its high prevalence; tendency to recur; association with other cancers; and lost productivity ($66.9 billion in losses were attributed to melanoma-related mortality from 1990-2008). Sun Safe Workplaces (SSW) is a comprehensive occupational sun safety education and policy intervention that was tested by Klein Buendel, Inc.'s (KB) research team in a randomized control trial with 98 cities, counties, and special districts in Colorado. Posttesting was completed in November 2013. The SSW intervention focused on three sectors in the organizations: public works, public safety, and parks and recreation. Half of the employers received the SSW intervention, with the remaining employers in the control condition receiving basic sun safety information. Preliminary analyses indicate that 80% of employers in the SSW intervention condition provided sun safety education to employees and 36% adopted formal sun protection policies. No control organizations reported policy adoption. KB will conduct a two-year follow-up study on the benefits of the SSW intervention (i.e., increasing employees' sun protection) and return on investment (ROI; benefits relative to intervention costs). Employee behavior was not assessed in the current SSW trial because it was uncertain whether the SSW intervention would result in uptake of education and policy and thus have the potential to influence their sun protection practices. The proposed two-year follow-up of the 98 organizations in the SSW trial will include: (1) surveys with employees (n=10,787) and front line supervisors (n=767) to assess employees' sun protection practices and workplace actions to support employee sun safety; (2) on-site observations of sun protection actions by the employers (e.g., posters, sunscreen, shade structures); and (3) tracking of the costs of implementing the SSW intervention and induced employer costs. The proposed analyses will compare the sun protection practices of employees a) between workplaces that received the SSW intervention and controls and b) among workplaces that provided education and adopted policy, provided education only, and control workplaces. Analyses will determine if the extent of sun protection actions by employers influences employees' sun safety practices. The economic evaluation will estimate the ROI (i.e., comparison of the estimated program benefits to combined cost elements). The proposed study is significant and innovative because it provides critical information applicable to a wide range of industrial sectors with outdoor workers on a workplace risk that has received scant attention. Determining the effectiveness and ROI of prevention programs is essential for national and local resource investment.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1990 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Participants were not aware of the condition in which their organization was enrolled.
Primary Purpose: Prevention
Official Title: Sun Safe Workplaces: Assessment of Benefits and Costs of a Policy Intervention
Actual Study Start Date : February 27, 2015
Actual Primary Completion Date : April 30, 2017
Actual Study Completion Date : July 31, 2017

Arm Intervention/treatment
Experimental: Sun Safe Workplaces Program
A follow up to the previous study that promoted the adoption of occupational sun protection policies by the local government organization comprised of personal visits with senior managers to promote policy adoption, promotional materials for sun safety, and in-person training of outdoor workers by research staff over two years. The follow up program consists of an analysis of sun safe practices by employees and an economic evaluation of the SSW intervention completed 2 years after the initial intervention.
Behavioral: Sun Safe Workplaces Program
A follow-up analysis of sun safe practices by employees and an economic evaluation of the SSW intervention was conducted with the work-sites who received occupational sun protection policy promotion materials in the prior trial. The analysis of sun safety practices of employees was done by preparing the protocols and measures for surveying employees and front-line supervisors by online and paper methods. The economic evaluation was a retrospective collection of cost information from the prior project ledgers and an in depth interview with the key contact manager at each work-site. No additional treatment was provided and the groups were evaluated based on their prior condition assignment.

Active Comparator: Attention Control
A follow up to the previous study that promoted occupational sun protection practices by employees in local government organizations through two mailings containing educational materials and presentations at state professional meetings by project staff. The follow up program consists of an analysis of sun safe practices by employees and an economic evaluation of SSW completed 2 years after the initial program contact.
Behavioral: Attention Control
A follow-up analysis of sun safe practices by employees and an economic evaluation of the SSW intervention was conducted with the work-sites who received occupational sun protection practice promotion materials in the prior trial. The analysis of sun safety practices of employees was done by preparing the protocols and measures for surveying employees and front-line supervisors by online and paper methods. The economic evaluation was a retrospective collection of cost information from the prior project ledgers and an in depth interview with the key contact manager at each work-site. No additional treatment was provided and the groups were evaluated based on their prior condition assignment.




Primary Outcome Measures :
  1. Survey of sun protection practices by employees. [ Time Frame: 9 Months ]
    Quantitative research in the form of a posttest survey was conducted to examine the sun safety practices by employees among workplaces that received education but did not adopt written policies, those workplaces that received education and adopted written policies and those that were in the control group.safety practices by employees among workplaces that received education but did not adopt written policies.


Secondary Outcome Measures :
  1. Observational checklist to review sun protections items within the workplace. [ Time Frame: 9 months ]
    An observational visit checklist was used to review sun protection items within the environment to assess employer actions to improve worker sun safety in the SSW parent study project. This checklist accounted for program materials (posters, tip cards, brochures, policy tool box items) and other sun safety protective items such as sunscreen and portable and permanent shade provided by the workplace for employees.

  2. In-depth manager interview to assess relationship of employer sun safety actions to employee sun safety. [ Time Frame: 9 Months ]
    Analysis of the association of employer actions (education only vs. education plus policy) on sun safety with employee's sun protection practices.

  3. In-depth manager survey to assess relationship of employer sun safety actions to employee sun safety. [ Time Frame: 9 Months ]
    Analysis of the association of employer actions (education only vs. education plus policy) on sun safety with employee's sun protection practices.

  4. Extraction of costs from parent study ledgers to conduct economic analysis of the SSW intervention. [ Time Frame: 9 Months ]
    Cost information from the SSW parent study project ledgers was extracted for the economic evaluation of the benefits and costs of the intervention.

  5. In-depth manager interview to conduct economic analysis of the SSW intervention. [ Time Frame: 9 Months ]
    An In-depth manger interview was conducted with managers to determine what sun safety items and practices the worksite was doing before and after the program and the costs associated with those practices.

  6. Analysis of employee surveys to compare the impact of workplaces implementing education-only versus education plus policy adoption on employee sun safety practices. [ Time Frame: 9 Months ]
    To compare the actions of intervention employers implementing education, intervention employers implementing education and adopting policy on employee sun safety.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Participation in the prior Sun Safe Workplaces: A Campaign on Sun Protection Policies for Outdoor Workers.
  • A local government organization with employees who worked outdoors in at least one of the following service areas: public works, public safety, and parks and recreation,
  • Having a full time executive
  • Having a population of at least 3000 residents
  • Being employed at a participating local government organization as a manager or employee?
  • Being employed at a participating local government organization in a job requiring outdoor work at least part of the time.

Exclusion Criteria:

  • Organization had participated in the authors' previous occupational sun protection project.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281161


Locations
United States, California
Kaiser Foundation Research Institute
Oakland, California, United States, 94612-3466
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045-0508
Sponsors and Collaborators
Klein Buendel, Inc.
National Cancer Institute (NCI)
Kaiser Foundation Research Institute
University of Colorado, Denver
Investigators
Principal Investigator: David Buller, PhD Klein Buendel, Inc.

Responsible Party: Klein Buendel, Inc.
ClinicalTrials.gov Identifier: NCT03281161     History of Changes
Other Study ID Numbers: 5R01CA187191-02 ( U.S. NIH Grant/Contract )
5R01CA187191-02 ( U.S. NIH Grant/Contract )
0284 ( Other Identifier: Klein Buendel, Inc. )
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Klein Buendel, Inc.:
skin cancer
prevention
worksite
policy
cost and effectiveness
implementation

Additional relevant MeSH terms:
Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases