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Open Access Study protocol

Development, effectiveness and cost-effectiveness of a new out-patient Breathlessness Support Service: study protocol of a phase III fast-track randomised controlled trial

Claudia Bausewein12*, Caroline Jolley3, Charles Reilly1, Paula Lobo4, Jane Kelly4, Helene Bellas5, Preety Madan6, Caty Panell1, Elmien Brink7, Chiara De Biase17, Wei Gao1, Caroline Murphy8, Paul McCrone9, John Moxham3 and Irene J Higginson1

Author Affiliations

1 King’s College London, Cicely Saunders Institute, Department of Palliative Care, Policy and Rehabilitation, London, UK

2 Interdisciplinary Centre for Palliative Medicine, University Hospital Munich, Munich, Germany

3 Respiratory Medicine, King's College Hospital NHS Foundation Trust, London, UK

4 Palliative Care Team, King's College Hospital NHS Foundation Trust, London, UK

5 Physiotherapy, King's College Hospital NHS Foundation Trust, London, UK

6 Occupational Therapy, King's College Hospital NHS Foundation Trust, London, UK

7 Macmillan Information and Support Centre, Cicely Saunders Institute, London, UK

8 King's Clinical Trials Unit, Department of Biostatistics, Institute of Psychiatry, King’s College London, London, UK

9 King's College London, Health Service and Population Research Department, Institute of Psychiatry, London, UK

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BMC Pulmonary Medicine 2012, 12:58  doi:10.1186/1471-2466-12-58

Published: 19 September 2012

Abstract

Background

Breathlessness is a common and distressing symptom affecting many patients with advanced disease both from malignant and non-malignant origin. A combination of pharmacological and non-pharmacological measures is necessary to treat this symptom successfully. Breathlessness services in various compositions aim to provide comprehensive care for patients and their carers by a multiprofessional team but their effectiveness and cost-effectiveness have not yet been proven. The Breathlessness Support Service (BSS) is a newly created multiprofessional and interdisciplinary outpatient service at a large university hospital in South East London. The aim of this study is to develop and evaluate the effectiveness and cost effectiveness of this multidisciplinary out–patient BSS for the palliation of breathlessness, in advanced malignant and non-malignant disease.

Methods

The BSS was modelled based on the results of qualitative and quantitative studies, and systematic literature reviews. A randomised controlled fast track trial (RCT) comprising two groups: 1) intervention (immediate access to BSS in addition to standard care); 2) control group (standard best practice and access to BSS after a waiting time of six weeks). Patients are included if suffering from breathlessness on exertion or at rest due to advanced disease such as cancer, chronic obstructive pulmonary disease (COPD), chronic heart failure (CHF), interstitial lung disease (ILD) or motor neurone disease (MND) that is refractory to maximal optimised medical management. Both quantitative and qualitative outcomes are assessed in face to-face interviews at baseline, after 6 and 12 weeks. The primary outcome is patients' improvement of mastery of breathlessness after six weeks assessed on the Chronic Respiratory Disease Questionnaire (CRQ). Secondary outcomes for patients include breathlessness severity, symptom burden, palliative care needs, service use, and respiratory measures (spirometry). For analyses, the primary outcome, mastery of breathlessness after six weeks, will be analysed using ANCOVA. Selection of covariates will depend on baseline differences between the groups. Analyses of secondary outcomes will include patients’ symptom burden other than breathlessness, physiological measures (lung function, six minute walk distance), and caregiver burden.

Discussion

Breathlessness services aim to meet the needs of patients suffering from this complex and burdensome symptom and their carers. The newly created BSS is different to other current services as it is run in close collaboration of palliative medicine and respiratory medicine to optimise medical care of patients. It also involves professionals from various medical, nursing, physiotherapy, occupational therapy and social work background.

Trial registration

ClinicalTrials.gov (NCT01165034)