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在初级保健中使用医疗信息亭管理慢性病患者的健康结局:一项试点随机对照试验方案

Health outcomes of patients with chronic disease managed with a healthcare kiosk in primary care: protocol for a pilot randomised controlled trial.

作者信息

Ng Grace, Tan Sze Wee, Tan Ngiap Chuan

机构信息

Singapore Health Services (SingHealth) Polyclinics, Singapore.

Biomedical Research Council, Agency for Science, Technology and Research (A*STAR), Singapore.

出版信息

BMJ Open. 2018 Mar 23;8(3):e020265. doi: 10.1136/bmjopen-2017-020265.

Abstract

INTRODUCTION

The rising prevalence of chronic disease is leading to an increase in the demand for primary care services and a shortage of primary care physicians globally. Addressing these challenges calls for innovations in the healthcare delivery model with greater use of healthcare technology tools. We previously examined the feasibility of using an automated healthcare kiosk for the management of patients with stable chronic disease in the primary care setting. The aim of this follow-up study is to evaluate the health outcomes of patients with chronic disease who are on kiosk management compared with patients who are on routine management by nurse clinicians.

METHODS AND ANALYSIS

The pilot study will be a two-armed randomised controlled trial of 120 patients with well-controlled chronic disease on 4-monthly follow-up visits over a 12-month period. Patients with prior diagnoses of hypertension, hyperlipidaemia and/or diabetes will be included in the study and will be randomly assigned to intervention or control groups to receive kiosk or nurse management, respectively. The main primary outcome measure is the overall chronic disease control of the patients. Other primary outcome measures are the blood pressure and low-density lipoprotein cholesterol levels for patients without diabetes, and blood pressure, low-density lipoprotein cholesterol and haemoglobin A1c levels for patients with diabetes. Secondary outcome measures are visit duration, patient satisfaction with the management process, health-related quality of life and the occurrence of any adverse event. Data will be captured longitudinally at baseline, 4 months, 8 months and 12 months, and will be analysed using multiple regression models.

ETHICS AND DISSEMINATION

The study has been approved by the Singapore Health Services (SingHealth) Centralised Institutional Review Board (2017/2715). Findings of the study will be submitted for publication in peer-reviewed journals and presented at national and international conferences.

TRIAL REGISTRATION NUMBER

NCT03274089; Pre-results.

摘要

引言

慢性病患病率的不断上升导致全球对初级保健服务的需求增加,同时初级保健医生短缺。应对这些挑战需要创新医疗服务提供模式,更多地使用医疗技术工具。我们之前研究了在初级保健环境中使用自动化医疗亭管理稳定慢性病患者的可行性。这项后续研究的目的是评估通过医疗亭管理的慢性病患者与由护士临床医生进行常规管理的患者的健康结局。

方法与分析

该试点研究将是一项双臂随机对照试验,对120例慢性病控制良好的患者进行为期12个月的随访,每4个月进行一次复诊。既往诊断为高血压、高脂血症和/或糖尿病的患者将被纳入研究,并随机分为干预组或对照组,分别接受医疗亭管理或护士管理。主要的主要结局指标是患者的总体慢性病控制情况。其他主要结局指标是无糖尿病患者的血压和低密度脂蛋白胆固醇水平,以及糖尿病患者的血压、低密度脂蛋白胆固醇和糖化血红蛋白水平。次要结局指标是就诊时长、患者对管理过程的满意度、健康相关生活质量以及任何不良事件的发生情况。数据将在基线、4个月、8个月和第12个月纵向收集,并使用多元回归模型进行分析。

伦理与传播

该研究已获得新加坡健康服务局(SingHealth)中央机构审查委员会的批准(2017/2715)。研究结果将提交至同行评审期刊发表,并在国内和国际会议上展示。

试验注册号

NCT03274089;预结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0aea/5875634/676d61a35bf2/bmjopen-2017-020265f01.jpg

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