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      Reducing asthma attacks in disadvantaged school children with asthma: study protocol for a type 2 hybrid implementation-effectiveness trial (Better Asthma Control for Kids, BACK)

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          Abstract

          Background

          Asthma is a leading cause of children’s hospitalizations, emergency department visits, and missed school days. Our school-based asthma intervention has reduced asthma exacerbations for children experiencing health disparities in the Denver Metropolitan Area, due partly to addressing care coordination for asthma and social determinants of health (SDOH), such as access to healthcare and medications. Limited dissemination of school-based asthma programs has occurred in other metropolitan and rural areas of Colorado. We formed and engaged community advisory boards in socioeconomically diverse regions of Colorado to develop two implementation strategy packages for delivering our school-based asthma intervention — now termed “Better Asthma Control for Kids (BACK)" — with tailoring to regional priorities, needs and resources.

          Methods

          In this proposed type 2 hybrid implementation-effectiveness trial, where the primary goal is equitable reach to families to reduce asthma disparities, we will compare two different packages of implementation strategies to deliver BACK across four Colorado regions. The two implementation packages to be compared are: 1) standard set of implementation strategies including Tailor and Adapt to context, Facilitation and Training termed, BACK-Standard (BACK-S); 2) BACK-S plus an enhanced implementation strategy, that incorporates network weaving with community partners and consumer engagement with school families, termed BACK-Enhanced (BACK-E). Our evaluation will be guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, including its Pragmatic Robust Implementation Sustainability Model (PRISM) determinants of implementation outcomes. Our central hypothesis is that our BACK-E implementation strategy will have significantly greater reach to eligible children/families than BACK-S (primary outcome) and that both BACK-E and BACK-S groups will have significantly reduced asthma exacerbation rates (“attacks”) and improved asthma control as compared to usual care.

          Discussion

          We expect both the BACK-S and BACK-E strategy packages will accelerate dissemination of our BACK program across the state – the comparative impact of BACK-S vs. BACK-E on reach and other RE-AIM outcomes may inform strategy selection for scaling BACK and other effective school-based programs to address chronic illness disparities.

          Trial registration

          Clinicaltrials.gov identifier: NCT06003569, registered on August 22, 2023, https://classic.clinicaltrials.gov/ct2/show/NCT06003569.

          Supplementary Information

          The online version contains supplementary material available at 10.1186/s13012-024-01387-3.

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          Most cited references75

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          Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact.

          This study proposes methods for blending design components of clinical effectiveness and implementation research. Such blending can provide benefits over pursuing these lines of research independently; for example, more rapid translational gains, more effective implementation strategies, and more useful information for decision makers. This study proposes a "hybrid effectiveness-implementation" typology, describes a rationale for their use, outlines the design decisions that must be faced, and provides several real-world examples. An effectiveness-implementation hybrid design is one that takes a dual focus a priori in assessing clinical effectiveness and implementation. We propose 3 hybrid types: (1) testing effects of a clinical intervention on relevant outcomes while observing and gathering information on implementation; (2) dual testing of clinical and implementation interventions/strategies; and (3) testing of an implementation strategy while observing and gathering information on the clinical intervention's impact on relevant outcomes. The hybrid typology proposed herein must be considered a construct still in evolution. Although traditional clinical effectiveness and implementation trials are likely to remain the most common approach to moving a clinical intervention through from efficacy research to public health impact, judicious use of the proposed hybrid designs could speed the translation of research findings into routine practice.
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            Longitudinal data analysis using generalized linear models

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              RE-AIM Planning and Evaluation Framework: Adapting to New Science and Practice With a 20-Year Review

              The RE-AIM planning and evaluation framework was conceptualized two decades ago. As one of the most frequently applied implementation frameworks, RE-AIM has now been cited in over 2,800 publications. This paper describes the application and evolution of RE-AIM as well as lessons learned from its use. RE-AIM has been applied most often in public health and health behavior change research, but increasingly in more diverse content areas and within clinical, community, and corporate settings. We discuss challenges of using RE-AIM while encouraging a more pragmatic use of key dimensions rather than comprehensive applications of all elements. Current foci of RE-AIM include increasing the emphasis on cost and adaptations to programs and expanding the use of qualitative methods to understand “how” and “why” results came about. The framework will continue to evolve to focus on contextual and explanatory factors related to RE-AIM outcomes, package RE-AIM for use by non-researchers, and integrate RE-AIM with other pragmatic and reporting frameworks.
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                Author and article information

                Contributors
                amy.huebschmann@ucdenver.edu
                Journal
                Implement Sci
                Implement Sci
                Implementation Science : IS
                BioMed Central (London )
                1748-5908
                15 August 2024
                15 August 2024
                2024
                : 19
                : 60
                Affiliations
                [1 ]GRID grid.430503.1, ISNI 0000 0001 0703 675X, Anschutz Medical Campus Department of Medicine, Division of General Internal Medicine, , University of Colorado, ; 12631 E. 17th Ave., Mailstop B180, Aurora, CO USA
                [2 ]Adult and Child Center for Outcomes Research and Delivery Science (ACCORDS), 1890 Revere Ct, Suite P32-3200, Mailstop F443, Aurora, CO 80045 USA
                [3 ]Ludeman Family Center for Women’s Health Research, Aurora, CO USA
                [4 ]Department of Pediatrics, University of Colorado School of Medicine, ( https://ror.org/04cqn7d42) Aurora, USA CO
                [5 ]Department of Family Medicine, University of Colorado School of Medicine, ( https://ror.org/04cqn7d42) Aurora, CO USA
                [6 ]GRID grid.240341.0, ISNI 0000 0004 0396 0728, National Jewish Health and University of Colorado College of Nursing and Clinical Sciences, ; Aurora, CO USA
                [7 ]Breathing Institute, Children’s Hospital Colorado, ( https://ror.org/00mj9k629) 13123 East 16Th Avenue, Mailstop B395, Aurora, CO 80045 USA
                [8 ]Trailhead Institute, 1999 Broadway Suite 200, Denver, CO 80202 USA
                Author information
                http://orcid.org/0000-0002-9329-3142
                Article
                1387
                10.1186/s13012-024-01387-3
                11325631
                39148094
                6d615fa7-b0eb-4b83-997c-bc1e82e7f92f
                © The Author(s) 2024

                Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.

                History
                : 21 June 2024
                : 16 July 2024
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100000026, National Institute on Drug Abuse;
                Award ID: K01DA056698
                Award Recipient :
                Funded by: FundRef http://dx.doi.org/10.13039/100000050, National Heart, Lung, and Blood Institute;
                Award ID: UG3HL151297
                Award ID: UH3HL151297
                Award ID: K23HL146791
                Award Recipient :
                Funded by: FundRef http://dx.doi.org/10.13039/100007590, Colorado Department of Public Health and Environment;
                Award ID: Expansion 2024*0346
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © BioMed Central Ltd., part of Springer Nature 2024

                Medicine
                asthma,social determinants of health,implementation science,school health services,health equity,child health

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