Using Technology to Scale-Up an Occupational Sun Protection Policy Program (SSW-T)

November 12, 2024 updated by: Klein Buendel, Inc.
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2644

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Oakland, California, United States, 94612-3466
        • Kaiser Foundation Research Institute
    • Colorado
      • Golden, Colorado, United States, 80403
        • Klein Buendel, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Sun Safe Workplaces - Technology (SSW-T)
Program promoting the adoption of sun protection policies by fire departments and state Departments of Transportation that is delivered via a range of technology systems including web-enabled visits with senior managers, online training of outdoor workers, and online access to collateral materials (e.g., brochures, posters, tip cards).
Behavioral: Sun Safe Workplaces - Technology
After randomization, program staff will contact managers at the recruited employer and schedule the initial web-enabled visit in the first 6 months. Follow-up meetings will be scheduled as needed to discuss policy adoption, and managers will schedule employee education using the SSW-T online training. Staff will follow-up with managers through Month 34 (Wave 1) or Month 46 (Wave 2). Electronic materials will be published on KB's state-of-the-art web server for employers to access and use.
Other Names:
  • SSW-T
Active Comparator: Sun Safe Workplaces - In Person (SSW-IP)
Program promoting the adoption of sun protection policies by fire departments and state Departments of Transportation that is delivered via personal visits with senior managers and in person training of outdoor workers by research staff over two years. Collateral materials (e.g., brochures, posters, tip cards) will be provided to worksites.
Behavioral: Sun Safe Workplaces -In Person
After randomization, program staff will contact managers the recruited employer and schedule the initial in-person visit in the first 6 months. Follow-up meetings will be scheduled as needed to discuss policy adoption; managers will schedule employee education with SSW-IP project staff. Printed materials will be sent to SSW-IP employers 3 times during the intervention. Staff will follow-up with managers through Month 34 (Wave 1) or Month 46 (Wave 2).
Other Names:
  • SSW-IP

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Implementation of Occupational Sun Protection Policy
Time Frame: Baseline to 2 years followup
Policies will be collected from work sites and coded at both before and after the intervention period. Project staff will code written workplace policy documents on the presence of 15 "content categories" in three domains: 1) environmental controls; 2) administrative procedures; and 3) personal protection practices. Presence of policy is defined as having one or more policy components present in the written workplace policy documents (value = 1) versus no content components present (value = 0).
Baseline to 2 years followup
Implementation of Sun Safety Education
Time Frame: Baseline to 2 year followup
Senior managers and employees will report on sun safety education provided to employees. The primary measure will be managers' reports of any training or any sun safety messages/materials distributed (e.g., newsletter articles, SSW website, or emails). Employees' reports of sun safety education will be secondary, validating managers' reports. These measures will be obtained in senior manager and employee pretest and posttest surveys, conducted online and by mail
Baseline to 2 year followup

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Economic Evaluation of the SSW-IP and SSW-T Intervention Programs
Time Frame: Baseline to 2 year followup
Project staff will record costs associated with the SSW-IP and SSW-T, following protocols from prior projects. Project staff will identify resource allocations and both labor and non labor elements for each component of the SSW-IP and SSW-T (in-person and virtual visits; follow-up communications; staff-delivered and virtual training, web resources, and mailed materials). For personnel, the proportion of FTE across activities will be estimated by contemporaneous staff self-report. Senior manager and employee survey data will identify organizational changes induced by SSW-IP and SSW-T and attach cost estimates to each. The investigators will use the accounting systems of the trial itself, supplemented with survey responses and additional primary data collection or external sources. Costs will be recorded in custom-made spreadsheets and summed to produce overall cost estimates.
Baseline to 2 year followup
Changes in Workplace Environment for Sun Safety
Time Frame: Baseline to 2 year followup
Managers will report changes in the work environments (providing shade and adjusting outdoor work schedules) or procedures (risk assessment, posting UV Index, and providing sunscreen, hats, protective clothing, and sunglasses) for sun safety. To validate, trained staff (blind to condition) will visit 18 randomly-selected employers at post-test and record shade, posting of UV Index, sunscreen availability, employee clothing, hats, and sunglasses, and educational materials, using a protocol from our Go Sun Smart trial.
Baseline to 2 year followup
Other Policy-related Measures
Time Frame: Baseline to 2 year followup
The investigators will measure two ancillary policy outcomes in the senior manager surveys, the content of informal procedures (not written) and enforcement of any sun protection policies (i.e., how well is policy being implemented and how well are staff complying with policy [very well, well, about average, poorly, or very poorly]).
Baseline to 2 year followup
Employees Sun Protection Practices
Time Frame: Baseline to 2 year followup
Employees will report a) frequency of sun protection at work, i.e., sunscreen with SPF 15+, long-sleeved shirts, long pants, hat with brim, sunglasses, shade use, limit exposure to midday sun, and have sunscreen, hat and eye protection at all times (1=never, 5=always) and b) prevalence of sunburn in the past three months on the job (yes/no; number of times) from SSW and GSS trials. These are standard, validated, and reliable measures from past studies.
Baseline to 2 year followup

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Klein Buendel, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)
Kaiser Permanente

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Buller, PhD, Klein Buendel, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 14, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 11, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0316 (Other Identifier: Klein Buendel, Inc.)
  • R01CA210259 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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