Guideline evaluation and implementation mechanisms in school health services (GuideMe): Protocol for a hybrid randomized factorial trial

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Background: Norwegian school health services received a national best-practice guideline in 2017. To promote healthy life skills and identify adolescents needing support, the guideline includes strong recommendations for individual consultations with all 8th graders and increased collaboration with schools. To help implement the recommendations, a blended implementation strategy (SchoolHealth) was co-created with school nurses, students, and stakeholders. SchoolHealth consists of three implementation elements: Digital dialog and administration tool (audit and feedback+), Dialog support (external consultation), and Collaboration materials (targeted dissemination). This hybrid study will test the main and combined effects of the elements on guideline fidelity and effectiveness. Methods The GuideMe study is a factorial cluster randomized controlled trial examining SchoolHealth's effectiveness on guideline fidelity and guideline effectiveness goals. Forty Norwegian secondary schools will be randomized to eight different combinations of the elements in SchoolHealth. Participants will include school nurses and school personnel from these schools, and 8th grade students (n=1200). Primary outcomes are school nurses' fidelity to the guidelines and student's ability to cope with their life (i.e., health literacy, positive health behaviors and self-efficacy). Quantitative methods will be used to test effects and mechanisms, while mixed- and qualitative methods will be used to explore mechanisms, experiences, and other phenomena in depth. Participants will complete digital questionnaires at the start and end of the schoolyear, and after the consultation during the schoolyear. The study will run in two waves, each lasting for one school year. The multifactorial design allows testing of interactions and main effects due to equal distribution of all factors within each main effect. Sustainment and scale-up of optimized SchoolHealth elements using national infrastructure are simultaneously prepared. Discussion The study will investigate possible effects of the implementation elements in isolation and in combination, and hypothesized implementation mechanisms. In-depth study of user experiences will inform improvements to elements in SchoolHealth. The results will yield causal knowledge about implementation strategies and the mechanisms through which they assert effects. Mixed-methods will provide insights into how and when the elements work. Optimizing guideline implementation elements can support adolescents in a crucial life phase. Trail registration ISRCTN reg.nr. 24173836 Registration date 08/08/2022
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Guideline evaluation and implementation mechanisms in school health services (GuideMe): Protocol for a hybrid randomized factorial trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Study protocol Guideline evaluation and implementation mechanisms in school health services (GuideMe): Protocol for a hybrid randomized factorial trial Åse Sagatun, Thomas Engell, Malene Brekke, Hege Sjølie, Stine M. Ekornes, and 8 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-3259621/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 15 Nov, 2023 Read the published version in BMC Health Services Research → Version 1 posted 4 You are reading this latest preprint version Abstract Background Norwegian school health services received a national best-practice guideline in 2017. To promote healthy life skills and identify adolescents needing support, the guideline includes strong recommendations for individual consultations with all 8th graders and increased collaboration with schools. To help implement the recommendations, a blended implementation strategy (SchoolHealth) was co-created with school nurses, students, and stakeholders. SchoolHealth consists of three implementation elements: Digital dialog and administration tool (audit and feedback+), Dialog support (external consultation), and Collaboration materials (targeted dissemination). This hybrid study will test the main and combined effects of the elements on guideline fidelity and effectiveness. Methods The GuideMe study is a factorial cluster randomized controlled trial examining SchoolHealth's effectiveness on guideline fidelity and guideline effectiveness goals. Forty Norwegian secondary schools will be randomized to eight different combinations of the elements in SchoolHealth. Participants will include school nurses and school personnel from these schools, and 8th grade students (n=1200). Primary outcomes are school nurses' fidelity to the guidelines and student's ability to cope with their life (i.e., health literacy, positive health behaviors and self-efficacy). Quantitative methods will be used to test effects and mechanisms, while mixed- and qualitative methods will be used to explore mechanisms, experiences, and other phenomena in depth. Participants will complete digital questionnaires at the start and end of the schoolyear, and after the consultation during the schoolyear. The study will run in two waves, each lasting for one school year. The multifactorial design allows testing of interactions and main effects due to equal distribution of all factors within each main effect. Sustainment and scale-up of optimized SchoolHealth elements using national infrastructure are simultaneously prepared. Discussion The study will investigate possible effects of the implementation elements in isolation and in combination, and hypothesized implementation mechanisms. In-depth study of user experiences will inform improvements to elements in SchoolHealth. The results will yield causal knowledge about implementation strategies and the mechanisms through which they assert effects. Mixed-methods will provide insights into how and when the elements work. Optimizing guideline implementation elements can support adolescents in a crucial life phase. Trail registration ISRCTN reg.nr. 24173836 Registration date 08/08/2022 Implementation strategies Implementation mechanisms Guideline School health services EPIS Multifactorial design Hybrid study Figures Figure 1 Figure 2 Full Text Additional Declarations No competing interests reported. Supplementary Files Table1GuideMe.docx Table2GuideMe.docx Table3GuideMe.docx Supplementaryfile1OutcomeGuideMe.docx Supplementaryfile2PowercalculationsGuideMe.docx Cite Share Download PDF Status: Published Journal Publication published 15 Nov, 2023 Read the published version in BMC Health Services Research → Version 1 posted Editorial decision: Major revision 27 Sep, 2023 Submission checks completed at journal 06 Sep, 2023 Editor assigned by journal 06 Sep, 2023 First submitted to journal 13 Aug, 2023 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-3259621","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Study protocol","associatedPublications":[],"authors":[{"id":231329129,"identity":"5db8ff79-bb32-485c-a820-bd057c5721b6","order_by":0,"name":"Åse Sagatun","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA5klEQVRIiWNgGAWjYNCDDwwMCSQoZ2NgYJxBshZmHmK08Lcff/iA4Y+dXf/8HrPHtnsY8gxuN7A9+IBHi8SZHGMDxrbk5BnHeMyNc54xFBvcOcBuOAOfNQdy2CQYG5iTGY7xmEnnHPifuOFGAps0Dx4d8uefP//B8Kc+WR6kxeIAA2EtBjcSzIBeP2xnANLCQIwWwxtvjCUS244nGB5LK5PsOcBQLHnnYJskPr/InU9/+OHDn2p7ucOHt0n8OMCQx3e7+ZgEvhADgwQGhsQGOA8YGoQ0gIE9gilBlIZRMApGwSgYQQAA3gdMRCAC4wUAAAAASUVORK5CYII=","orcid":"","institution":"Centre for Child and Adolescent Mental Health, Eastern and Southern (RBUP)","correspondingAuthor":true,"submittingAuthor":false,"prefix":"","firstName":"Åse","middleName":"","lastName":"Sagatun","suffix":""},{"id":231329130,"identity":"cb9b714f-25aa-4346-8227-b129a60fdf22","order_by":1,"name":"Thomas Engell","email":"","orcid":"","institution":"Centre for Child and Adolescent Mental Health, Eastern and Southern (RBUP)","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Thomas","middleName":"","lastName":"Engell","suffix":""},{"id":231329131,"identity":"3926e634-9493-4fcc-a44a-35b819fd58bf","order_by":2,"name":"Malene Brekke","email":"","orcid":"","institution":"Centre for Child and Adolescent Mental Health, Eastern and Southern (RBUP)","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Malene","middleName":"","lastName":"Brekke","suffix":""},{"id":231329132,"identity":"912efc0a-6bea-4c28-869b-287307c0692b","order_by":3,"name":"Hege Sjølie","email":"","orcid":"","institution":"VID Specialized University","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Hege","middleName":"","lastName":"Sjølie","suffix":""},{"id":231329133,"identity":"968c8e5b-d27e-43c7-8e3b-a7491c9439c2","order_by":4,"name":"Stine M. 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