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一项关于在慢性心力衰竭和慢性阻塞性肺疾病患者中使用远程监测的综合护理路径的质量评估:一项准实验研究方案。

Quality Assessment of an Integrated Care Pathway Using Telemonitoring in Patients with Chronic Heart Failure and Chronic Obstructive Pulmonary Disease: Protocol for a Quasi-Experimental Study.

作者信息

Herkert Cyrille, Kraal Jos Johannes, Spee Rudolph Ferdinand, Serier Anouk, Graat-Verboom Lidwien, Kemps Hareld Marijn Clemens

机构信息

Flow, Center for Prevention, Telemedicine and Rehabilitation in Chronic Disease, Máxima Medical Center, Eindhoven, Netherlands.

Faculty of Industrial Design Engineering, Delft University of Technology, Delft, Netherlands.

出版信息

JMIR Res Protoc. 2020 Nov 19;9(11):e20571. doi: 10.2196/20571.

Abstract

BACKGROUND

Chronic heart failure (CHF) and chronic obstructive pulmonary disease (COPD) often coexist and are associated with a high morbidity and reduced quality of life (QoL). Although these diseases share similarities in symptoms and clinical course, and exacerbations of both diseases often overlap, care pathways for both conditions are usually not integrated. This results in frequent outpatient consultations and suboptimal treatment during exacerbations, leading to frequent hospital admissions. Therefore, we propose an integrated care pathway for both diseases, using telemonitoring to detect deterioration at an early stage and a single case manager for both diseases.

OBJECTIVE

This study aims to investigate whether an integrated care pathway using telemonitoring in patients with combined CHF and COPD results in a higher general health-related QoL (HRQoL) as compared with the traditional care pathways. Secondary end points include disease-specific HRQoL, level of self-management, patient satisfaction, compliance to the program, and cost-effectiveness.

METHODS

This is a monocenter, prospective study using a quasi-experimental interrupted time series design. Thirty patients with combined CHF and COPD are included. The study period of 2.5 years per patient is divided into a preintervention phase (6 months) and a postintervention phase (2 years) in which end points are assessed. The intervention consists of an on-demand treatment strategy based on monitoring symptoms related to CHF/COPD and vital parameters (weight, blood pressure, heart rate, oxygen saturation, temperature), which are uploaded on a digital platform. The monitoring frequency and the limit values of the measurements to detect abnormalities are determined individually. Monitoring is performed by a case manager, who has the opportunity for a daily multidisciplinary meeting with both the cardiologist and the pulmonologist. Routine appointments at the outpatient clinic are cancelled and replaced by telemonitoring-guided treatment.

RESULTS

Following ethical approval of the study protocol, the first patient was included in May 2018. Inclusion is expected to be complete in May 2021.

CONCLUSIONS

This study is the first to evaluate the effects of a novel integrated care pathway using telemonitoring for patients with combined CHF and COPD. Unique to this study is the concept of remote on-demand disease management by a single case manager for both diseases, combined with multidisciplinary meetings. Moreover, modern telemonitoring technology is used instead of, rather than as an addition to, regular care.

TRIAL REGISTRATION

Netherlands Trial Register NL6741; https://www.trialregister.nl/trial/6741.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/20571.

摘要

背景

慢性心力衰竭(CHF)和慢性阻塞性肺疾病(COPD)常并存,且发病率高、生活质量(QoL)下降。尽管这两种疾病在症状和临床病程上有相似之处,且两种疾病的急性加重常相互重叠,但针对这两种疾病的护理路径通常未整合。这导致门诊频繁就诊以及急性加重期治疗欠佳,进而导致频繁住院。因此,我们提出一种针对这两种疾病的综合护理路径,利用远程监测在早期发现病情恶化,并为两种疾病配备一名个案管理员。

目的

本研究旨在调查与传统护理路径相比,针对合并CHF和COPD的患者采用远程监测的综合护理路径是否能带来更高的总体健康相关生活质量(HRQoL)。次要终点包括疾病特异性HRQoL、自我管理水平、患者满意度、对方案的依从性以及成本效益。

方法

这是一项采用准实验性中断时间序列设计的单中心前瞻性研究。纳入30例合并CHF和COPD的患者。每位患者2.5年的研究期分为干预前阶段(6个月)和干预后阶段(2年),在这两个阶段评估终点。干预措施包括基于监测与CHF/COPD相关症状及生命体征参数(体重、血压、心率、血氧饱和度、体温)的按需治疗策略,这些数据上传至数字平台。监测频率以及用于检测异常的测量限值因人而异。监测由一名个案管理员执行,该管理员有机会每天与心脏病专家和肺病专家进行多学科会诊。取消门诊常规预约,代之以远程监测指导下的治疗。

结果

在研究方案获得伦理批准后,首例患者于2018年5月入组。预计2021年5月完成入组。

结论

本研究首次评估了针对合并CHF和COPD的患者采用远程监测的新型综合护理路径的效果。本研究的独特之处在于由一名个案管理员对两种疾病进行远程按需疾病管理,并结合多学科会诊的理念。此外,使用现代远程监测技术替代常规护理,而非作为常规护理的补充。

试验注册

荷兰试验注册中心NL6741;https://www.trialregister.nl/trial/6741。

国际注册报告识别码(IRRID):DERR1-10.2196/20571。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ad26/7714643/942551f10c00/resprot_v9i11e20571_fig1.jpg

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