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Type: Journal article
Title: A pragmatic cluster randomized controlled trial of early intervention for chronic obstructive pulmonary disease by practice nurse-general practitioner teams: Study Protocol
Author: Bunker, J.
Reddel, H.
Dennis, S.
Middleton, S.
Van Schayck, C.
Crockett, A.
Hasan, I.
Hermiz, O.
Vagholkar, S.
Marks, G.
Zwar, N.
Citation: Implementation Science, 2012; 7(1):1-10
Publisher: BioMed Central Ltd
Issue Date: 2012
ISSN: 1748-5908
Statement of
Jeremy M Bunker, Helen K Reddel, Sarah M Dennis, Sandy Middleton, CP Van Schayck, Alan J Crockett, Iqbal Hasan, Oshana Hermiz, Sanjyot Vagholkar, Guy B Marks and Nicholas A Zwar
Abstract: BACKGROUND Chronic Obstructive Pulmonary Disease (COPD) is a leading cause of disability, hospitalization, and premature mortality. General practice is well placed to diagnose and manage COPD, but there is a significant gap between evidence and current practice, with a low level of awareness and implementation of clinical practice guidelines. Under-diagnosis of COPD is a world-wide problem, limiting the benefit that could potentially be achieved through early intervention strategies such as smoking cessation, dietary advice, and exercise. General practice is moving towards more structured chronic disease management, and the increasing involvement of practice nurses in delivering chronic care. DESIGN A pragmatic cluster randomised trial will test the hypothesis that intervention by a practice nurse-general practitioner (GP) 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. Forty general practices in greater metropolitan Sydney Australia will be recruited to identify patients at risk of COPD and invite them to attend a case finding appointment. Practices will be randomised to deliver either practice nurse-GP partnership care, or usual care, to patients newly-diagnosed with COPD. The active intervention will involve the practice nurse and GP working in partnership with the patient in developing and implementing a care plan involving (as appropriate), smoking cessation, immunisation, pulmonary rehabilitation, medication review, assessment and correction of inhaler technique, nutritional advice, management of psycho-social issues, patient education, and management of co-morbidities. The primary outcome measure is health-related quality of life, assessed with the St George’s Respiratory Questionnaire 12 months after diagnosis. Secondary outcome measures include validated disease-specific and general health related quality of life measures, smoking and immunisation status, medications, inhaler technique, and lung function. Outcomes will be assessed by project officers blinded to patients’ randomization groups. DISCUSSION This study will use proven case-finding methods to identify patients with undiagnosed COPD in general practice, where improved care has the potential for substantial benefit in health and healthcare utilization. The study provides the capacity to trial a new model of team-based assessment and management of newly diagnosed COPD in Australian primary care. TRIAL REGISTRATION ACTRN12610000592044\
Keywords: Humans; Pulmonary Disease, Chronic Obstructive; Early Diagnosis; Research Design; Quality of Life; Education, Continuing; Nurse Practitioners; Case Management; Patient Care Team; Guideline Adherence; Australia; Randomized Controlled Trials as Topic; General Practitioners; General Practice; Translational Medical Research; Early Medical Intervention
Description: Extent: 10p.
Rights: © 2012 Bunker et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the CreativeCommons Attribution License (, which permits unrestricted use, distribution, andreproduction in any medium, provided the original work is properly cited.
RMID: 0020122366
DOI: 10.1186/1748-5908-7-83
Grant ID:
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