远程患者监测与远程会诊以改善儿童哮喘的健康结局并降低医疗保健利用率（ALPACA研究）：一项随机对照有效性试验的方案

Remote Patient Monitoring and Teleconsultation to Improve Health Outcomes and Reduce Health Care Utilization of Pediatric Asthma (ALPACA Study): Protocol for a Randomized Controlled Effectiveness Trial.

作者信息

van der Kamp Mattienne, Hengeveld Vera, Willard Nico, Thio Boony, de Graaf Pascal, Geven Inge, Tabak Monique

机构信息

Pediatric Department, Medisch Spectrum Twente, Enschede, Netherlands.

Biomedical Signals and Systems Department, University of Twente, Enschede, Netherlands.

出版信息

JMIR Res Protoc. 2023 Jul 3;12:e45585. doi: 10.2196/45585.

DOI:10.2196/45585

PMID:37399066

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10365621/

Abstract

BACKGROUND

Childhood asthma is imposing a great financial burden on the pediatric health care system. Asthma costs are directly related to the level of asthma control. A substantial part of these costs may be preventable by the timely and adequate assessment of asthma deterioration in daily life and proper asthma management. The use of eHealth technology may assist such timely and targeted medical anticipation.

OBJECTIVE

This paper describes the Ambulatory Pediatric Asthma Care (ALPACA) study protocol to investigate the effectiveness of an eHealth intervention consisting of remote patient monitoring and teleconsultation integrated into the daily clinical care of pediatric patients with asthma. This intervention aims to reduce health care utilization and costs and improve health outcomes compared to a control group that receives standard care. In addition, this study aims to improve future eHealth pediatric asthma care by gaining insights from home-monitoring data.

METHODS

This study is a prospective randomized controlled effectiveness trial. A total of 40 participants will be randomized to either 3 months of eHealth care (intervention group) or standard care (control group). The eHealth intervention consists of remote patient monitoring (spirometry, pulse oximetry, electronic medication adherence tracking, and asthma control questionnaire) and web-based teleconsultation (video sharing, messages). All participants will have a 3-month follow-up with standard care to evaluate whether the possible effects of eHealth care are longer lasting. During the entire study and follow-up period, all participants will use blinded observational home monitoring (sleep, cough/wheeze sounds, air quality in bedroom) as well.

RESULTS

This study was approved by the Medical Research Ethics Committees United. Enrollment began in February 2023, and the results of this study are expected to be submitted for publication in July 2024.

CONCLUSIONS

This study will contribute to the existing knowledge on the effectiveness of eHealth interventions that combine remote patient monitoring and teleconsultation for health care utilization, costs, and health outcomes. Furthermore, the observational home-monitoring data can contribute to improved identification of early signs of asthma deterioration in pediatric patients. Researchers and technology developers could use this study to guide and improve eHealth development, while health care professionals, health care institutions, and policy makers may employ our results to make informed decisions to steer toward high-quality, efficient pediatric asthma care.

TRIAL REGISTRATION

ClinicalTrials.gov NCT05517096; https://clinicaltrials.gov/ct2/show/NCT05517096.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/45585.

摘要

背景

儿童哮喘给儿科医疗保健系统带来了巨大的经济负担。哮喘治疗费用与哮喘控制水平直接相关。通过在日常生活中及时、充分地评估哮喘恶化情况并进行适当的哮喘管理，这些费用的很大一部分是可以预防的。电子健康技术的使用可能有助于这种及时和有针对性的医疗预判。

目的

本文描述了动态儿科哮喘护理（ALPACA）研究方案，以调查一种电子健康干预措施的有效性，该干预措施包括远程患者监测和远程会诊，并融入哮喘儿科患者的日常临床护理中。与接受标准护理的对照组相比，这种干预旨在降低医疗保健利用率和成本，并改善健康结局。此外，本研究旨在通过从家庭监测数据中获取见解来改善未来的电子健康儿科哮喘护理。

方法

本研究是一项前瞻性随机对照有效性试验。总共40名参与者将被随机分为接受3个月的电子健康护理（干预组）或标准护理（对照组）。电子健康干预包括远程患者监测（肺功能测定、脉搏血氧饱和度测定、电子药物依从性跟踪和哮喘控制问卷）和基于网络的远程会诊（视频共享、消息）。所有参与者将接受3个月的标准护理随访，以评估电子健康护理的可能效果是否更持久。在整个研究和随访期间，所有参与者还将使用盲法观察性家庭监测（睡眠、咳嗽/喘息声音、卧室空气质量）。

结果

本研究已获得联合医学研究伦理委员会的批准。招募工作于2023年2月开始，本研究结果预计将于2024年7月提交发表。

结论

本研究将为现有的关于结合远程患者监测和远程会诊的电子健康干预措施对医疗保健利用率、成本和健康结局有效性的知识做出贡献。此外，观察性家庭监测数据有助于更好地识别儿科患者哮喘恶化的早期迹象。研究人员和技术开发者可以利用本研究来指导和改进电子健康发展，而医疗保健专业人员、医疗机构和政策制定者可以利用我们的结果做出明智的决策，以转向高质量、高效的儿科哮喘护理。