Background
Chronic obstructive pulmonary disease (COPD) is a leading cause of morbidity and mortality [
1], ranked globally in 2002 as the fifth leading cause of death [
2] and the seventh leading cause of disease burden after ischaemic heart disease and stroke. In Australia, COPD is the fourth leading cause of death for males (4.2% of all deaths) and the sixth leading cause of death for women (3.3% of all deaths); it is also a contributory cause of death in many patients with coronary heart disease or cancer [
3]. In the Burden Of Obstructive Lung Disease survey (BOLD), the prevalence of airflow limitation (GOLD Stage II or higher) in Australians aged ≥40 years was 10.8% [
4], whereas the prevalence of doctor-diagnosed COPD in the same population was 5.9% [
5].
Clinically, COPD is characterised by airflow limitation that is not fully reversible, and is associated with an enhanced chronic inflammatory response to noxious particles or gases [
6]. Patients typically present with breathlessness, cough, and sputum production. The most important cause in developed countries is cigarette smoking, and up to 50% of smokers may eventually develop clinically significant COPD [
7].
Even mild to moderate COPD is associated with impaired health status [
8]. Patients with COPD have increased healthcare utilisation before diagnosis, raising the possibility that earlier diagnosis may allow more rational and directed use of healthcare resources [
9]. The feasibility of a COPD case-finding approach has been established. For example, in an Australian study in 2007, 20% of patients identified as being at risk of COPD responded to invitations to be screened and of these 20% had a new diagnosis of COPD on spirometric criteria [
10]. This is similar to findings from primary care studies in other countries [
11‐
13]. For diagnosis of COPD, spirometry is required [
6], and standards have been developed for the performance of spirometry in primary care [
14]. Practice nurses can feasibly and successfully undertake spirometry [
13,
15]; as for other health professionals, approximately six hours of training are required [
16].
Clinical practice guidelines have been developed and disseminated for the diagnosis and management of COPD [
6], including in Australia (COPD-X guidelines) [
17]. Despite the high level evidence for the efficacy of guidelines-based interventions, the care provided for patients with COPD in community settings indicates low levels of awareness and implementation of these guidelines [
18]. Medication use is often not in accordance with guidelines [
19,
20], and a high proportion of patients prescribed inhalers use them incorrectly [
21,
22].
Effective treatment for COPD improves symptoms, prognosis, and quality of life. Smoking cessation is the most effective measure to reduce progression of the disease [
23]. Because smoking cessation may become less effective at altering the course of disease in patients with severe COPD, interventions that target patients with mild and moderate disease may be more effective [
24]. In the Lung Health Study [
25] smokers with early COPD who were assigned to a smoking cessation intervention had fewer respiratory symptoms after five years follow-up than those who were not. Smokers diagnosed with COPD [
26] or who are told their ‘lung age’ [
27] may be more likely to cease smoking.
General practice is well placed to diagnose COPD and provide early intervention and longer-term management [
28,
29]. Care planning and a team approach are effective in the management of chronic disease. Care planning by general practitioners (GPs) has been shown to improve the clinical outcomes for other chronic diseases such as diabetes [
30] and asthma [
31], but GPs need more support to develop and implement multidisciplinary care plans [
32,
33] Current guidelines recommend the use of multidisciplinary care plans in the management of patients with COPD [
17].
Practice nurses are increasingly contributing to chronic disease management. Specialised nurses have contributed to the care of patients with diabetes and COPD, and there is evidence of improvements in patient self-care, quality of life, and satisfaction [
34]. A Cochrane review [
35] of nursing outreach programs for COPD found significant gains in health-related quality of life for patients with moderate COPD, but the review highlighted the lack of high quality studies and concluded that further study was required.
While the role of specialist nurses in contributing to the care of patients with COPD has been examined [
35‐
37] and some evidence of benefit in disease-specific quality of life has been found, there are few studies examining the potential role of practice nurses working in partnership with GPs in providing more coordinated, integrated, and evidence-based care for patients with newly-diagnosed COPD.
Study aims
The primary aim is to assess the effectiveness of early intervention by a GP-nurse team applying evidence-based guidelines, compared with usual care, in the assessment and management of patients newly diagnosed with COPD. Secondary aims are to assess the acceptability of the two management approaches to GPs, nurses and patients, and to assess the utility of the COPD Diagnostic Questionnaire (CDQ) and COPD Assessment Test (CAT) in an Australian population.
Study hypothesis
The study hypothesizes that intervention by a GP-practice nurse team leads to improved health-related quality of life and greater adherence with clinical practice guidelines for patients with newly-diagnosed COPD, compared with usual care.
Discussion
There is substantial evidence that COPD is under-diagnosed in the community, and that even once a diagnosis of COPD is made, many patients are not managed according to evidence-based guidelines. By the time the diagnosis is made, COPD is often far-advanced, limiting the benefit that could potentially be achieved through early intervention with strategies such as smoking cessation, dietary advice, and increased exercise. This study will use proven case-finding methods in an at-risk population to identify new patients with COPD, followed by a pragmatic cluster randomised study design to test a novel intervention designed to improve the implementation of evidence-based guidelines for newly-diagnosed COPD. Practice nurses and GPs will be trained in practical strategies for assessing and managing COPD, and in working as a team in managing patients with chronic diseases. Elements of the intervention have been piloted and found to be feasible. The impact of this team-based approach to COPD management on quality of life will be compared with usual care using a widely used and validated tool (SGRQ). Other outcome measures will evaluate the concordance of patient management with evidence-based guidelines for management of COPD, using instruments with demonstrated validity and reliability, which are congruent with the recommendations of the ERS/ATS Task Force on COPD trials [
56]. In addition, the acceptability of the team management approach to GPs and practice nurses, and barriers and facilitators to its implementation, will be evaluated with structured interviews at study end.
This study targets COPD patients in general practice where the contact with potential patients with mild and moderate COPD is greatest, and where improved care has the potential for substantial health benefit. Because COPD is a major contributor to the burden of disease in countries such as Australia, improved care is of great public health significance. If successful, the trial will provide a model for care of COPD patients in the community that is feasible and sustainable. Publication of the results of the trial will influence policy and practice on how care for COPD is provided at a national and international level.
Sustainability of the intervention
In this pragmatic study, the intervention deliberately makes use of and augments existing practice structures, staffing, and approaches to chronic disease management. While there is potential for nurses to undertake advanced practice in primary care, this study will not require practice nurses to work at an advanced practice level. For this study, the role of the practice nurse is focussed on patient assessment; counselling; education; and liaison with medical and allied health colleagues, using expertise that forms part of the skills base of registered nurses. The intervention is thus potentially generalizable and easily transferable.
Competing interests
HR has participated on COPD advisory committees for Novartis, has spoken about COPD guidelines at symposia funded by AstraZeneca and Boehringer Ingelheim, has received travel support from AstraZeneca, GlaxoSmithKline and Novartis, and has received independent research funding from GlaxoSmithKline for an investigator-initiated COPD study. GBM is on an advisory board for Novartis and his institution has received funds from AstraZeneca for consultancies. He has spoken at education symposia sponsored by AstraZeneca and GlaxoSmithKline. NZ has provided expert advice on smoking cessation education programs to Pfizer Pty Ltd and GlaxoSmithKline Australia Pty Ltd and has received support to attend smoking cessation conferences. Other authors have no competing interests.
Authors’ contributions
The study was conceived by JB, NZ and GM, and all authors contributed to the study design. CPvS advised on the design of the CDQ utility study. AC designed the spirometry toolkit for diagnosis of COPD. HR wrote the initial draft of the manuscript. All authors contributed to and approved the final version of the manuscript.