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Open Access Study protocol

Effectiveness of the Assessment of Burden of Chronic Obstructive Pulmonary Disease (ABC) tool: study protocol of a cluster randomised trial in primary and secondary care

Annerika HM Slok1*, Johannes CCM in ’t Veen2, Niels H Chavannes3, Thys van der Molen45, Maureen PMH Rutten-van Mölken6, Huib AM Kerstjens57, Guus M Asijee18, Philippe L Salomé9, Sebastiaan Holverda10, Richard PN Dekhuijzen11, Denise Schuiten8, Gerard van Breukelen12, Daniel Kotz1 and Onno CP van Schayck1

Author Affiliations

1 Department of Family Medicine, Maastricht University, CAPHRI School for Public Health and Primary Care, PO Box 616, 6200 MD Maastricht, The Netherlands

2 Department of Pulmonology, Sint Franciscus Gasthuis, Rotterdam, The Netherlands

3 Department of Public Health and Primary Care, Leiden University Medical Centre, PO Box 9600, 2300 RC Leiden, The Netherlands

4 Department of Primary Care, University of Groningen, University Medical Centre Groningen, Antonius Deusinglaan 1, 9713 AV Groningen, The Netherlands

5 Groningen Research Institute for Asthma and COPD (GRIAC), University Medical Centre, Groningen, The Netherlands

6 Erasmus University Rotterdam, Institute for Health Policy and Management/Institute for Medical Technology Assessment, PO Box 1738, 3000 DR Rotterdam, The Netherlands

7 Department of Pulmonary Diseases, University of Groningen, University Medical Centre Groningen, Antonius Deusinglaan 1, 9713 AV Groningen, The Netherlands

8 PICASSO foundation for COPD, Alkmaar, The Netherlands

9 Huisartsenzorg IJsselstein, locatie ’t Steyn, IJsselstein, The Netherlands

10 Lung Foundation Netherlands, Amersfoort, The Netherlands

11 Department of Pulmonary Diseases, University Medical Centre Nijmegen, Nijmegen, The Netherlands

12 Department of Methodology & Statistics, Maastricht University, CAPHRI School for Public Health and Primary Care, PO Box 616, 6200 MD Maastricht, The Netherlands

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BMC Pulmonary Medicine 2014, 14:131  doi:10.1186/1471-2466-14-131

Published: 7 August 2014

Abstract

Background

Chronic Obstructive Pulmonary Disease (COPD) is a growing worldwide problem that imposes a great burden on the daily life of patients. Since there is no cure, the goal of treating COPD is to maintain or improve quality of life. We have developed a new tool, the Assessment of Burden of COPD (ABC) tool, to assess and visualize the integrated health status of patients with COPD, and to provide patients and healthcare providers with a treatment algorithm. This tool may be used during consultations to monitor the burden of COPD and to adjust treatment if necessary. The aim of the current study is to analyse the effectiveness of the ABC tool compared with usual care on health related quality of life among COPD patients over a period of 18 months.

Methods/Design

A cluster randomised controlled trial will be conducted in COPD patients in both primary and secondary care throughout the Netherlands. An intervention group, receiving care based on the ABC tool, will be compared with a control group receiving usual care. The primary outcome will be the change in score on a disease-specific-quality-of-life questionnaire, the Saint George Respiratory Questionnaire. Secondary outcomes will be a different questionnaire (the COPD Assessment Test), lung function and number of exacerbations. During the 18 months follow-up, seven measurements will be conducted, including a baseline and final measurement. Patients will receive questionnaires to be completed at home. Additional data, such as number of exacerbations, will be recorded by the patients’ healthcare providers. A total of 360 patients will be recruited by 40 general practitioners and 20 pulmonologists. Additionally, a process evaluation will be performed among patients and healthcare providers.

Discussion

The new ABC tool complies with the 2014 Global Initiative for Chronic Obstructive Lung Disease guidelines, which describe the necessity to classify patients on both their airway obstruction and a comprehensive symptom assessment. It has been developed to classify patients, but also to provide visual insight into the burden of COPD and to provide treatment advice.

Trial registration

Netherlands Trial Register, NTR3788.

Keywords:
Chronic obstructive pulmonary disease; Disease burden; Quality of life; Patient reported outcomes; Shared decision making; GPs; Pulmonologists; Patient empowerment