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预防远程医疗支持服务对早期慢性阻塞性肺疾病的影响:一项实用随机对照试验的研究方案。

Preventative tele-health supported services for early stage chronic obstructive pulmonary disease: a protocol for a pragmatic randomized controlled trial pilot.

机构信息

University of Sheffield, South Yorkshire, UK.

出版信息

Trials. 2011 Jan 7;12:6. doi: 10.1186/1745-6215-12-6.

Abstract

BACKGROUND

Chronic Obstructive Pulmonary Disease (COPD) is a prevalent debilitating long term condition. It is the second most common cause of emergency admission to hospital in the UK and remains one of the most costly conditions to treat through acute care.Tele-health monitoring offers potential to reduce the rates of re-hospitalisation and emergency department visits and improve quality of life for people with COPD. However, the current evidence base to support technology adoption and implementation is limited and the resource implications for implementing tele-health in practice can be very high. This trial will employ tele-health monitoring in a preventative capacity for patients diagnosed with early stage COPD following discharge from hospital to determine whether it reduces their need for additional health service support or hospital admission and improves their quality of life.

METHODS/DESIGN: We describe a pilot study for a two arm, one site randomized controlled trial (RCT) to determine the effect of tele-health monitoring on self-management, quality of life and patient satisfaction. Sixty patients who have been discharged from one acute trust with a primary diagnosis of COPD and who have agreed to receive community clinical support following discharge from acute care will be randomly assigned to one of two groups: (a) Tele-health supported Community COPD Service; or (b) Usual Care. The tele-health supported service involves the patient receiving two home visits with a specialist COPD clinician (nurse or physiotherapist) then participating in daily tele-monitoring over an eight week period. Usual care consists of six home visits to the patient by specialist COPD clinicians again over eight successive weeks. Health status and quality of life data for all participants will be measured at baseline, on discharge from the service and at six months post discharge from the service.

DISCUSSION

The tele-health service under study is a complex service delivered through a collaboration between local authority and health care partners. The implementation of this service demanded significant changes to established working patterns and has been a challenging process requiring considerable planning - a challenge that many providers are likely to face in the future.

TRIAL REGISTRATION

Current Controlled Trials ISRCTN68856013.

摘要

背景

慢性阻塞性肺疾病(COPD)是一种普遍存在的使人虚弱的长期疾病。它是英国因急症入院的第二大常见原因,也是通过急性治疗最昂贵的治疗条件之一。远程健康监测有潜力降低再住院率和急诊就诊率,提高 COPD 患者的生活质量。然而,目前支持技术采用和实施的证据基础有限,在实践中实施远程健康监测的资源影响可能非常高。本试验将在出院后诊断为早期 COPD 的患者中采用远程健康监测进行预防,以确定其是否减少了对额外医疗服务支持或住院的需求,并提高了他们的生活质量。

方法/设计:我们描述了一项两臂、单站点随机对照试验(RCT)的试点研究,以确定远程健康监测对自我管理、生活质量和患者满意度的影响。将 60 名从一家急性信托医院出院的患者随机分配到两组之一:(a)远程健康支持社区 COPD 服务;或(b)常规护理。远程健康支持服务包括患者接受两次由专科 COPD 临床医生(护士或物理治疗师)进行的家访,然后在八周期间每天进行远程监测。常规护理包括在连续八周内由专科 COPD 临床医生对患者进行六次家访。所有参与者的健康状况和生活质量数据将在基线、服务结束时和服务结束后六个月进行测量。

讨论

正在研究的远程健康服务是一项通过地方当局和医疗保健合作伙伴之间的合作提供的复杂服务。该服务的实施需要对既定工作模式进行重大改变,这是一个具有挑战性的过程,需要大量的规划-许多提供者在未来可能会面临这一挑战。

试验注册

当前对照试验 ISRCTN68856013。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2505/3024953/933425e29c83/1745-6215-12-6-1.jpg

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