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研究:一项阶梯式楔形整群随机试验的方案,用于比较通过移动应用程序与基于工作站的存储转发远程皮肤病学流程获得医疗服务的情况。

study: protocol for a stepped-wedge cluster randomised trial to compare access to care for a mobile app versus a workstation-based store-and-forward teledermatology process.

作者信息

Done Nicolae, Oh Dennis H, Weinstock Martin A, Whited John D, Jackson George L, King Heather A, Peracca Sara B, Elwy A Rani, Prentice Julia C

机构信息

US Department of Veterans Affairs, Center for Access Policy, Evaluation and Research, Boston, Massachusetts, USA.

Department of Psychiatry, Boston University School of Medicine, Boston, Massachusetts, USA.

出版信息

BMJ Open. 2018 Dec 14;8(12):e022218. doi: 10.1136/bmjopen-2018-022218.

Abstract

INTRODUCTION

Teledermatology has emerged as an important strategy to enhance access to high-quality skin care. is a provider-facing, web-based mobile app designed to integrate into the existing teledermatology workflow in the US Veterans Health Administration (VHA). In this study, we will conduct a systematic evaluation of on access outcomes in VHA facilities using a pragmatic trial guided by clinical and operational leaders.

METHODS AND ANALYSIS

The study is a prospective, stepped-wedge cluster randomised trial with cross-sectional exposure and outcome measurement via retrospective database analysis of administrative records. Each cluster is a VHA facility deemed eligible for the trial. We assign the intervention using a cluster-level balanced randomisation scheme based on facility size, baseline teledermatology uptake and geographic location. The trial will test whether patients receiving dermatological care at participating facilities will have better access compared with patients receiving care through the current standard process. The primary outcomes proxy for patient-level access to dermatology services, including (1) consult completion time for teledermatology consults; (2) appointment completion time for new dermatology consults; and (3) travel distance for dermatology services. As secondary outcomes, we will assess facility-level adoption outcomes, that is, the number of dermatology encounters and the proportion of teledermatology consults out of all dermatology encounters. To account for secular trends in outcomes and for correlation across individuals within clusters, we will assess the impact of the intervention using generalised linear mixed regression models.

DISCUSSION

Streamlining the current practice for store-and-forward teledermatology in the VHA can improve access to expert dermatological care for US veterans. The lessons learnt in this trial could validate the use of mobile technology for consultative store-and-forward dermatology in a large healthcare organisation. The results may also be of interest to other medical specialties assessing the merits of implementing mobile telehealth.

PROTOCOL VERSION

Version 3; 7 November 2018.

TRIAL REGISTRATION NUMBER

NCT03241589; Pre-results.

摘要

引言

远程皮肤病学已成为改善获得高质量皮肤护理服务的一项重要策略。[具体应用名称]是一款面向医疗服务提供者的基于网络的移动应用程序,旨在融入美国退伍军人健康管理局(VHA)现有的远程皮肤病学工作流程。在本研究中,我们将在临床和运营负责人指导的实用试验基础上,对[具体应用名称]在VHA设施中的使用效果进行系统评估。

方法与分析

本研究是一项前瞻性、阶梯式楔形整群随机试验,通过对行政记录的回顾性数据库分析进行横断面暴露和结果测量。每个整群是一个被认为符合试验条件的VHA设施。我们根据设施规模、基线远程皮肤病学使用情况和地理位置,采用整群水平的平衡随机化方案分配干预措施。该试验将测试在参与试验的设施中接受皮肤科护理的患者与通过当前标准流程接受护理的患者相比,是否能获得更好的服务。主要结果代表患者获得皮肤科服务的情况,包括:(1)远程皮肤病学会诊的咨询完成时间;(2)新皮肤科会诊的预约完成时间;(3)皮肤科服务的就诊距离。作为次要结果,我们将评估设施层面的采用效果,即皮肤科诊疗次数以及所有皮肤科诊疗中远程皮肤病学会诊的比例。为了考虑结果的长期趋势以及整群内个体之间的相关性,我们将使用广义线性混合回归模型评估干预措施的影响。

讨论

简化VHA中当前的存储转发式远程皮肤病学实践可以改善美国退伍军人获得专家皮肤科护理的机会。本试验中吸取的经验教训可以验证在大型医疗保健机构中使用移动技术进行咨询性存储转发式皮肤病学的可行性。其他评估实施移动远程医疗优点的医学专科可能也会对这些结果感兴趣。

方案版本

第3版;2018年11月7日。

试验注册号

NCT03241589;预结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a668/6303588/9479782b701a/bmjopen-2018-022218f01.jpg

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