- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03281161
Sun Safe Workplaces: Assessment of Benefits and Costs of a Policy Intervention (SSW2)
24 octobre 2017 mis à jour par: Klein Buendel, Inc.
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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
1990
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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California
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Oakland, California, États-Unis, 94612-3466
- Kaiser Foundation Research Institute
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Colorado
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Aurora, Colorado, États-Unis, 80045-0508
- University of Colorado Denver
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Oui
Sexes éligibles pour l'étude
Tout
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
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.
|
|
Comparateur actif: 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.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Survey of sun protection practices by employees.
Délai: 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.
|
9 Months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Observational checklist to review sun protections items within the workplace.
Délai: 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.
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9 months
|
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In-depth manager interview to assess relationship of employer sun safety actions to employee sun safety.
Délai: 9 Months
|
Analysis of the association of employer actions (education only vs. education plus policy) on sun safety with employee's sun protection practices.
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9 Months
|
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In-depth manager survey to assess relationship of employer sun safety actions to employee sun safety.
Délai: 9 Months
|
Analysis of the association of employer actions (education only vs. education plus policy) on sun safety with employee's sun protection practices.
|
9 Months
|
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Extraction of costs from parent study ledgers to conduct economic analysis of the SSW intervention.
Délai: 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.
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9 Months
|
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In-depth manager interview to conduct economic analysis of the SSW intervention.
Délai: 9 Months
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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.
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9 Months
|
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Analysis of employee surveys to compare the impact of workplaces implementing education-only versus education plus policy adoption on employee sun safety practices.
Délai: 9 Months
|
To compare the actions of intervention employers implementing education, intervention employers implementing education and adopting policy on employee sun safety.
|
9 Months
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: David Buller, PhD, Klein Buendel, Inc.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
27 février 2015
Achèvement primaire (Réel)
30 avril 2017
Achèvement de l'étude (Réel)
31 juillet 2017
Dates d'inscription aux études
Première soumission
6 septembre 2017
Première soumission répondant aux critères de contrôle qualité
8 septembre 2017
Première publication (Réel)
13 septembre 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
26 octobre 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
24 octobre 2017
Dernière vérification
1 octobre 2017
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 5R01CA187191-02 (Subvention/contrat des NIH des États-Unis)
- 0284 (Autre identifiant: Klein Buendel, Inc.)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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