Clinical trial NCT03278340: Using Technology to Scale-Up an Occupational Sun Protection Policy Program
Official title: Using Technology to Scale-Up an Occupational Sun Protection Policy Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Cancer
Keywords: Skin Cancer
Prevention
Policy
Worksite
Scale-up
Cost and Effectiveness
Lead sponsor: Klein Buendel, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Kaiser Permanente
name: National Cancer Institute (NCI)
First posted: 2017-09-11
Enrollment: 2644
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Comprehensive approaches that combine sun protection policy and education for outdoor workers can reduce their risk for skin cancer by reducing their exposure to solar ultraviolet radiation on the job. To effectively disseminate the investigators' evidence-based sun protection policy and education intervention, Sun Safe Workplaces, a balance of effectiveness and cost of scale-up methods is required. The investigators propose to translate the intervention using a technology-based delivery method and compare the cost effectiveness of the original intervention and the intervention delivered by technology in a study that models national distribution strategies to public safety and public works sectors.

Detailed description: A key goal in the Affordable Care Act is building a national culture of prevention through workplace health and safety initiatives. To achieve this goal, methods for scaling up evidence-based programs from research to wide-scale dissemination are needed to help balance effectiveness and cost. In many cases, there are pressures to reduce scale-up costs but at the expense of lower program implementation and effectiveness. A scale-up method that sacrifices effectiveness but reduces costs and reaches a larger number of employers may be acceptable. The investigators will model the effectiveness and cost trade-off, along with the extent and representativeness of reach, when scaling up the evidence-based occupational sun protection intervention, Sun Safe Workplaces (SSW), for national distribution. The intervention, which relies on personal contact with managers and in-person employee training (SSW-IP), created large improvements in comprehensive workplace sun safety (i.e., policy adoption and employee education) in a randomized controlled trial. The investigators will compare the existing in-person program delivery methods (SSW-IP) to a lower-cost dissemination method that utilizes Internet technology (SSW-T), i.e., virtual meetings, social networking, online training, and program materials. The aims of the research are to: 1) estimate the program reach (number and representativeness) and implementation rates (i.e., adoption of policies and delivery of education on occupational sun protection) achieved by the SSW-IP and SSW-T in a model of national distribution to public safety and public works industries; 2) estimate the costs associated with the SSW-IP and SSW-T (i.e., intervention costs and induced employer costs) and compare the estimated program benefits (i.e., policy and education) to cost; and 3) estimate the effect and cost-effectiveness of SSW-IP and SSW-T in secondary outcomes of a) changes in workplace environments and procedures for sun safety and b) workers' sun safety practices. In a 5-year project, SSW-T will be created by redesigning the very effective SSW-IP methods to use the latest web conferencing, social networking, and online training technology for dissemination. The implementation rates (defined as policy adoption and education delivery) and costs associated with SSW-IP (n=50 employers) and SSW-T (n=150 employers) will be modeled in a randomized two-group pretest-posttest design, enrolling a national sample of 200 employers (i.e., firefighting departments and state departments of transportation). Unlike traditional randomized trials, the primary analysis will be of cost effectiveness to test the hypothesis that SSW-T can be delivered cost-effectively to an expanded group of worksites producing a lower implementation rate than SSW-IP but at substantially lower cost. Secondary analyses will compare the two scale-up strategies on implementation rate, differences in rate by employer groups (e.g., size and region), changes to workplace environment/procedures, and employee sun safety practices. The findings will have high impact by helping public health practitioners select the best strategy for scaling up evidence-based workplace health and safety programs to achieve this ACA goal.

Eligibility criteria: Inclusion Criteria:

* Fire Departments and State DOTs in the United States, agreeing to participate, providing written policies at pretest and having at least 6 managers and 50 workers complete the pretest.
* Being a senior manager of a fire department or state DOT located in the United States. Criteria include a) being in a senior management position; b) responsible for work-site safety/health policy and education; c) consenting to participate, and d) completing the pretest. This includes city/county managers, human resources directors, risk managers, and managers of facilities, fire, roads and transportation departments
* Being an employee of a fire department or state DOT located in the United States. Criteria includes a) being employed part/full-time at the employer, b) working at least part of daytime hours outdoors, c) consenting to participate, and d) completing the pretest survey.

Exclusion Criteria:

* Prior participation in the Sun Safe Workplaces program

Primary outcomes:
measure: Implementation of Occupational Sun Protection Policy
timeFrame: Baseline to 2 years followup
measure: Implementation of Sun Safety Education
timeFrame: Baseline to 2 year followup
Secondary outcomes:
measure: Economic Evaluation of the SSW-IP and SSW-T Intervention Programs
timeFrame: Baseline to 2 year followup
measure: Changes in Workplace Environment for Sun Safety
timeFrame: Baseline to 2 year followup
measure: Other Policy-related Measures
timeFrame: Baseline to 2 year followup
measure: Employees Sun Protection Practices
timeFrame: Baseline to 2 year followup
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Foundation Research Institute
state: California
city: Golden
country: United States
facility: Klein Buendel, Inc.
state: Colorado
Study officials:
affiliation: Klein Buendel, Inc.
name: David Buller, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buller DB, Buller MK, Meenan R, Cutter GR, Berteletti J, Eye R, Walkosz BJ, Pagoto S. Design and baseline data of a randomized trial comparing two methods for scaling-up an occupational sun protection intervention. Contemp Clin Trials. 2020 Oct;97:106147. doi: 10.1016/j.cct.2020.106147. Epub 2020 Sep 15.