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改善贫困家庭哮喘儿童哮喘发作情况:2 型混合实施有效性试验(更好地控制儿童哮喘,BACK)的研究方案。

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).

机构信息

Anschutz Medical Campus Department of Medicine, Division of General Internal Medicine, University of Colorado, 12631 E. 17th Ave., Mailstop B180, Aurora, CO, USA.

Adult and Child Center for Outcomes Research and Delivery Science (ACCORDS), 1890 Revere Ct, Suite P32-3200, Mailstop F443, Aurora, CO, 80045, USA.

出版信息

Implement Sci. 2024 Aug 15;19(1):60. doi: 10.1186/s13012-024-01387-3.

DOI:10.1186/s13012-024-01387-3
PMID:39148094
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11325631/
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 .

摘要

背景

哮喘是导致儿童住院、急诊就诊和缺课的主要原因。我们的基于学校的哮喘干预措施已经减少了丹佛大都市区中经历健康差距的儿童的哮喘恶化,部分原因是解决了哮喘和健康的社会决定因素(SDOH)的护理协调,例如获得医疗保健和药物。在科罗拉多州的其他大都市区和农村地区,基于学校的哮喘项目的传播有限。我们在科罗拉多州社会经济多样化地区组建并参与了社区咨询委员会,制定了两种实施策略包,以提供我们的基于学校的哮喘干预措施 - 现在称为“改善儿童哮喘控制(BACK)”- 根据区域优先事项、需求和资源进行调整。

方法

在这个拟议的 2 型混合实施效果试验中,主要目标是公平地为家庭提供服务,以减少哮喘差距,我们将比较两种不同的实施策略包,在科罗拉多州的四个地区提供 BACK。将比较的两种实施包是:1)包括定制和适应背景、促进和培训的一套标准实施策略,称为 BACK-标准(BACK-S);2)BACK-S 加上一个增强的实施策略,该策略包括与社区合作伙伴建立网络和与学校家庭进行消费者参与,称为 BACK-增强(BACK-E)。我们的评估将由可达性、有效性、采用率、实施率和维持率(RE-AIM)框架指导,包括其务实的强大实施可持续性模型(PRISM)的实施结果决定因素。我们的中心假设是,我们的 BACK-E 实施策略将比 BACK-S 更广泛地覆盖符合条件的儿童/家庭(主要结果),并且 BACK-E 和 BACK-S 组的哮喘恶化率(“发作”)和哮喘控制都将显著降低与常规护理相比。

讨论

我们预计 BACK-S 和 BACK-E 策略包都将加速我们的 BACK 计划在全州的传播 - BACK-S 与 BACK-E 对可达性和其他 RE-AIM 结果的影响比较可能为扩大 BACK 和其他有效的基于学校的项目以解决慢性疾病差距的策略选择提供信息。

试验注册

Clinicaltrials.gov 标识符:NCT06003569,于 2023 年 8 月 22 日注册,https://classic.clinicaltrials.gov/ct2/show/NCT06003569。

临床试验

ClinicalTrials.gov/NCT06003569。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/db83/11325631/856ac02a3eee/13012_2024_1387_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/db83/11325631/21718ebd2615/13012_2024_1387_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/db83/11325631/e54551500169/13012_2024_1387_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/db83/11325631/086139d75bdc/13012_2024_1387_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/db83/11325631/856ac02a3eee/13012_2024_1387_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/db83/11325631/21718ebd2615/13012_2024_1387_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/db83/11325631/e54551500169/13012_2024_1387_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/db83/11325631/086139d75bdc/13012_2024_1387_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/db83/11325631/856ac02a3eee/13012_2024_1387_Fig4_HTML.jpg

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本文引用的文献

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Developing a Social Determinants of Health Needs Assessment for Colorado Kids (SNACK) Tool for a School-Based Asthma Program: Findings from a Pilot Study.为基于学校的哮喘项目开发科罗拉多儿童健康社会决定因素需求评估(SNACK)工具:一项试点研究的结果。
Ethn Dis. 2024 Apr 24;DECIPHeR(Spec Issue):126-131. doi: 10.18865/ed.DECIPHeR.126. eCollection 2023 Dec.
2
Notes From the Field: Diverse Partner Perspectives Improve the Usability and Equity Focus of Implementation Guides.现场笔记:多样化的合作伙伴视角可提高实施指南的可用性和公平性重点。
Ethn Dis. 2024 Apr 24;DECIPHeR(Spec Issue):132-134. doi: 10.18865/ed.DECIPHeR.132. eCollection 2023 Dec.
3
Understanding Core Community Needs for School-Based Asthma Programming: A Qualitative Assessment in Colorado Communities.
了解基于学校的哮喘项目的核心社区需求:科罗拉多社区的定性评估。
Ethn Dis. 2024 Apr 24;DECIPHeR(Spec Issue):35-43. doi: 10.18865/ed.DECIPHeR.35. eCollection 2023 Dec.
4
The Longitudinal Implementation Strategy Tracking System (LISTS): feasibility, usability, and pilot testing of a novel method.纵向实施策略跟踪系统(LISTS):一种新方法的可行性、可用性及试点测试
Implement Sci Commun. 2023 Nov 28;4(1):153. doi: 10.1186/s43058-023-00529-w.
5
Advancing research on teams and team effectiveness in implementation science: An application of the Exploration, Preparation, Implementation, Sustainment (EPIS) framework.推进实施科学中团队及团队效能的研究:探索、准备、实施、维持(EPIS)框架的应用
Implement Res Pract. 2023 Jul 27;4:26334895231190855. doi: 10.1177/26334895231190855. eCollection 2023 Jan-Dec.
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How does facilitation in healthcare work? Using mechanism mapping to illuminate the black box of a meta-implementation strategy.医疗保健中的促进作用是如何发挥的?利用机制映射来揭示一种元实施策略的黑匣子。
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Reflections on 10 years of effectiveness-implementation hybrid studies.对十年有效性-实施混合研究的思考
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The ultimate question? Evaluating the use of Net Promoter Score in healthcare: A systematic review.终极问题?评估净推荐值在医疗保健中的应用:系统评价。
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