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Open Access Study protocol

A pragmatic cluster randomized controlled trial of early intervention for chronic obstructive pulmonary disease by practice nurse-general practitioner teams: Study Protocol

Jeremy M Bunker1, Helen K Reddel2, Sarah M Dennis3, Sandy Middleton4*, CP Van Schayck5, Alan J Crockett6, Iqbal Hasan3, Oshana Hermiz3, Sanjyot Vagholkar7, Guy B Marks8 and Nicholas A Zwar1

Author Affiliations

1 School of Public Health and Community Medicine, University of New South Wales, Sydney, NSW, 2052, Australia

2 Woolcock Institute of Medical Institute, University of Sydney, Sydney, NSW, Australia

3 Centre for Primary Health Care and Equity, University of New South Wales, Sydney, NSW, 2052, Australia

4 National Centre for Clinical Outcomes Research, Australia, Australian Catholic University, Sydney, NSW, Australia

5 Research School Caphri, Maastricht University, Maastricht, The Netherlands

6 Discipline of General Practice, School of Population Health And Clinical Practice, The University of Adelaide, Adelaide, 5005, South Australia

7 General Practice Unit, Fairfield Hospital, South Western Sydney Local Health District/School of Public Health & Community Medicine, University of New South Wales, Sydney, NSW, 2052, Australia

8 Woolcock Institute of Medical Research, University of Sydney and Department of Respiratory Medicine, Liverpool Hospital, Liverpool, NSW, 2170, Australia

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Implementation Science 2012, 7:83  doi:10.1186/1748-5908-7-83

Published: 7 September 2012

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\