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临床试验/NCT03355677
NCT03355677已完成不适用

A Clinical Interventional Study Into Airways Disease Case Finding and Complex Case Management

University of Southampton1 个研究点 分布在 1 个国家目标入组 327 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
327
试验地点
1
主要终点
Case finding

研究概览

简要总结

Chronic Obstructive Pulmonary Disease (COPD) is a disease of the lungs which is generally caused by smoking tobacco. It is a largely preventable disease that causes severe and irreversible damage to the lungs. If not detected early, this damage will progress causing significant breathing difficulties, disability and poor survival rates. Patients with COPD can experience exacerbations of their disease which can also lead to can be described as a worsening of the patients symptoms COPD is a global health concern and it is estimated to become the third leading cause of death by 2020. In the United Kingdom, around 900,000 people have a formal diagnosis of COPD. However, it is believed that over 2 million more people may be living with the disease and are unaware that they have it. The cost of treating lung disease in the National Health Service (NHS) is estimated to be approximately £4.7billion per year . The majority of these costs are caused by a small group of COPD patients with severe disease and complex problems , . Late diagnosis has been proven as a contributing factor to the worsening of COPD, disease progression and increased healthcare costs. Indeed, recent research has shown that patients may attend their general practitioner (GP) practice with signs of the disease up to five years before they have the condition diagnosed. A delay in diagnosis is known to hasten the decline in lung function and worsen disease severity making treatment options less useful in the long term. This has led to national guidelines recognising that patients with COPD need to be diagnosed and treated effectively at the earliest opportunity.

The aim of this study is to find the best way to identify or 'case find' patients who have not yet been diagnosed with COPD, and also identify patients with more complex disease using a computerised search programme. The study will examine whether this intervention has saved the NHS money by reducing GP and hospital visits and by decreasing rescue medicine usage for respiratory problems, by comparing this data to similar GP practices where the intervention had not been implemented. Once patients have been identified, they will be invited to attend a clinic appointment at their GP practice to participate in a tailored intervention programme for patients at risk of having COPD and those with existing complex COPD. GP practices will also be offered a training package in order to continue the intervention programme in the future.

详细描述

Background Chronic Obstructive Pulmonary Disease (COPD) COPD is a disease of the lungs characterised by airway inflammation leading to airflow obstruction. It is a progressive and largely preventable disease caused by the inhalation of noxious gases generally through cigarette smoking. Patients experience persistent symptoms including breathlessness, reduced exercise tolerance and an increase in the production of mucus in the airways. The impact of the disease to the individual is substantial in terms of physical disability and psycho-social issues.

Patients with COPD can experience an exacerbation of their disease, defined as a sudden worsening of symptoms above and beyond the individual's normal daily variation. COPD exacerbations are the second most common cause of emergency hospital admissions in the UK, with an estimated 94,000 admissions per annum. Indeed, COPD is one of the most expensive inpatient conditions in the UK, costing the National Health Service (NHS) over £800 million in direct healthcare costs. COPD is also set to become the third leading cause of death worldwide by the year 2030, surpassed only by heart disease and stroke. Despite this high level of mortality, public awareness of COPD is low in the United Kingdom (UK): around 89% of the general public have never heard of COPD.

Under-diagnosis of COPD Evidence suggests that 13% of people over 35 have COPD but many are diagnosed late and most are currently undiagnosed. Almost a third of patients admitted to hospital with a COPD exacerbation had not been diagnosed. Opportunities for early diagnosis of COPD are missed in primary care: a recent study demonstrated that 85% of patients had consulted primary care with lower respiratory symptoms in the five years immediately before their diagnosis of COPD. The insidious onset of COPD means undiagnosed patients may unconsciously modify their way of life, and only present to primary care in the later stages of disease. Furthermore, smokers, who constitute a substantial portion of the target population for case finding, have been shown to hold self-exempting beliefs and thus may be less likely to present to primary care. In addition, many patients visit their GP for problems related to COPD, such as chest infections and breathlessness, but the correct diagnosis is not made.

The importance of early diagnosis of COPD National health policy initiatives in the UK underscore improved diagnosis as a priority Early diagnosis of COPD followed by optimisation of treatment has potential cost savings for the NHS of more than £1 billion over 10 years . Prevention strategies (smoking cessation, dietary, exercise promotion, self-management and vaccination) can be targeted on this group of patients to maintain and improve health, and appropriate pharmacologic therapies (that can improve symptoms, exercise tolerance and quality of life and reduce the risk of exacerbations) commenced in newly identified people if appropriate. A recent systematic review of the literature concluded that a combination of a screening questionnaire and micro-spirometry seems to demonstrate the best overall screening test accuracy, but there has been little uptake of this strategy in UK primary care and doubts remain as to its feasibility and cost-effectiveness. However, whilst a variety of approaches to case finding have been trialled world-wide published studies have been variable in quality and the most effective, economical method of screening has yet to be identified. The National Institute for Health and Clinical Excellence (NICE) and the Department of Health (DoH) in the UK have recommended both systematic and opportunistic case finding to diagnose symptomatic patients . The UK National Screening Committee concurs, explicitly recommending case finding (defined as targeting patients with symptoms suggestive of COPD) rather than screening (defined as identifying apparently healthy people who may be at increased risk of COPD). A recent All Party Parliamentary Group report on Respiratory Deaths (APPG RD) concluded that tools to aid health care professionals to case find for COPD need to be developed in order to prioritise for use at national level.

Case-finding: identifying symptomatic but not yet diagnosed patients 'TargetCOPD' is an ongoing NIHR funded randomised controlled trial comparing the cost-effectiveness of two alternative case-finding approaches for identifying undiagnosed COPD. Both approaches rely on patient self-reported questionnaires to identify symptoms; one opportunistically administered, the other systematically administered. 'TargetCOPD' should provide some useful information on case-finding using questionnaires. However, evidence suggests that alternative approaches to case finding such as electronic searches based on routine primary care data may be a valuable tool for identifying symptomatic patients with as yet undiagnosed COPD. However, further validation of electronic case-finding strategies is required.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Case Finding
  • • Registered with one of the participating GP practices as at 1st January 2015
  • ≥40 years old
  • Ex or current smoker
  • No COPD diagnosis
  • Willing and able to give written informed consent.

排除标准

  • • Unable to give informed consent
  • Suffering from a terminal illness
  • Patients whom the GP or clinical investigator deem inappropriate to participate
  • Existing COPD diagnosis
  • Obvious contraindications to spirometry (e.g. unstable abdominal aortic aneurysm)
  • Under secondary care for investigation of breathlessness
  • Housebound
  • Inclusion Criteria - Complex Case Management
  • Registered with one of the participating GP practices as at 1st January 2015
  • On the practice COPD or asthma registers
  • Identified by the electronic search Exclusion Criteria
  • Unable to give informed consent
  • Suffering from a terminal illness
  • Patients whom the GP or clinical investigator deem inappropriate to participate
  • No existing respiratory diagnosis
  • Under secondary care for respiratory issues
  • Housebound

结局指标

主要结局

Case finding

时间窗: 12 months

The proportion of those patients identified by the case-finding algorithm at the chosen threshold who are diagnosed with COPD within 12 months following assessment at a case-finding clinic (for the intervention group practices) or following the practice-matched index date (for the control group practices). For the intervention group this will be the proportion of those invited to attend. For the control group this will be the proportion of those patients who would have been invited to attend, based on identical case-finding algorithm criteria.

次要结局

  • Co Morbidities - case finding(12 months)
  • smoking -(12 months)
  • Broncholdilator Usage(12 months)
  • Breathlessness(6 and 12 mths)
  • Treatments - case finding(12 months)
  • secondary care referrals - case finding(12 months)
  • Corticosteroids(12 months)
  • Healthcare Usage(12 months)
  • Primary care attendance(12 months)
  • Number of respiratory consultations(12 months)
  • Attendance - Case finding(12 months)
  • Newly Diagnosed - Case finding(12 months)
  • Healthcare status(6,12 months)
  • Admission(12 months)
  • Smoking cessation - case finding(12 months)
  • Airway disease control(6,12 months)
  • Depression(6,12 months)
  • Asthma disease control(6,12 months)
  • Anxiety(6,12 months)
  • Exacerbations(12 months)
  • COPD Severity(6,12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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