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采用整群随机化阶梯式楔形试验设计将麦克伦教练引入初级保健。

Implementation of Coach McLungs into primary care using a cluster randomized stepped wedge trial design.

机构信息

Department of Family Medicine, Atrium Health, Charlotte, NC, USA.

School of Health and Rehabilitation Sciences, University of Pittsburgh, Pittsburgh, PA, USA.

出版信息

BMC Med Inform Decis Mak. 2022 Nov 4;22(1):285. doi: 10.1186/s12911-022-02030-1.

DOI:10.1186/s12911-022-02030-1
PMID:36333727
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9636750/
Abstract

BACKGROUND

Asthma is a prevalent chronic disease that is difficult to manage and associated with marked disparities in outcomes. One promising approach to addressing disparities is shared decision making (SDM), a method by which the patient and provider cooperatively make a decision about asthma care. SDM is associated with improved outcomes for patients; however, time constraints and staff availability are noted implementation barriers. Use of health information technology (IT) solutions may facilitate the utilization of SDM. Coach McLungs is a collaborative web-based application that involves pediatric patients, their caregivers, and providers in a personalized experience while gathering patient-reported data. Background logic provides decision support so both audiences can develop a well-informed treatment plan together. The goal of this study is to evaluate the implementation of the Coach McLungs intervention into primary care.

METHODS

Implementation will be evaluated using a stepped wedge randomized control study design at 21 pediatric and family medicine practices within a large, integrated, nonprofit healthcare system. We will measure changes in emergency department visits, hospitalizations, and oral steroid use, which serve as surrogate measures for patient-centered asthma outcomes. We will use a generalized linear mixed models with logit link to test the hypothesis for the reduction in exacerbation rates specifying the fixed effects of intervention and time and random effects for practice and practice*time. This design achieves 84% power to detect the hypothesized effect size difference of 10% in overall exacerbation between control (40%) and intervention (30%) periods (two-sided, p = 0.05). Implementation will be guided using the Expert Recommendations for Implementing Change (ERIC), a compilation of implementation strategies, and evaluated using the CFIR (Consolidated Framework for Implementation Research) and RE-AIM (Reach Effectiveness, Adoption, Implementation, Maintenance).

DISCUSSION

We anticipate that a tailored implementation of Coach McLungs across diverse primary care practices will lead to a decrease in emergency department visits, hospitalizations, and oral steroid use for patients in the intervention group as compared to the control condition.

TRIAL REGISTRATION

Clincaltrials.gov, NCT05059210. Registered 28 September 2021, https://www.

CLINICALTRIALS

gov/ct2/show/NCT05059210.

摘要

背景

哮喘是一种常见的慢性疾病,难以控制,且其结局存在显著差异。解决这些差异的一种有前景的方法是共同决策(SDM),这是一种患者和提供者共同决定哮喘护理的方法。SDM 与患者结局的改善相关;然而,时间限制和人员可用性是实施障碍。使用健康信息技术(IT)解决方案可能有助于促进 SDM 的利用。Coach McLungs 是一种协作式基于网络的应用程序,它使儿科患者、他们的护理人员和提供者参与到个性化体验中,同时收集患者报告的数据。背景逻辑提供决策支持,以便两个受众都可以共同制定一个明智的治疗计划。本研究的目的是评估 Coach McLungs 干预措施在初级保健中的实施情况。

方法

在一个大型综合非营利性医疗保健系统内的 21 家儿科和家庭医学诊所,将采用逐步楔形随机对照研究设计来评估实施情况。我们将测量急诊就诊、住院和口服类固醇使用的变化,这些变化是患者为中心的哮喘结局的替代指标。我们将使用具有对数链接的广义线性混合模型来检验假设的缓解率降低,指定干预和时间的固定效应以及实践和实践*时间的随机效应。该设计实现了 84%的功效,以检测控制(40%)和干预(30%)期间总体恶化率的假设效应大小差异为 10%(双侧,p=0.05)。实施将使用 Expert Recommendations for Implementing Change(ERIC)进行指导,这是一组实施策略的汇编,并使用 Consolidated Framework for Implementation Research(CFIR)和 Reach Effectiveness, Adoption, Implementation, Maintenance(RE-AIM)进行评估。

讨论

我们预计,在不同的初级保健实践中,对 Coach McLungs 进行有针对性的实施,将导致干预组患者的急诊就诊、住院和口服类固醇使用减少,而与对照组相比。

试验注册

Clincaltrials.gov,NCT05059210。注册于 2021 年 9 月 28 日,https://www.clincaltrials.gov/ct2/show/NCT05059210。

临床试验

NCT05059210。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9916/9636750/200eb49da982/12911_2022_2030_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9916/9636750/95cafae86f4c/12911_2022_2030_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9916/9636750/2e32551254ee/12911_2022_2030_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9916/9636750/200eb49da982/12911_2022_2030_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9916/9636750/95cafae86f4c/12911_2022_2030_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9916/9636750/2e32551254ee/12911_2022_2030_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9916/9636750/200eb49da982/12911_2022_2030_Fig3_HTML.jpg

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