title: Development, effectiveness and cost-effectiveness of a new out-patient Breathlessness Support Service: study protocol of a phase III fast-track randomised controlled trial.
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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov (NCT01165034).
authors.affiliation: King's College London, Cicely Saunders Institute, Department of Palliative Care, Policy and Rehabilitation, London, UK. Claudia.bausewein@kcl.ac.uk
authors.forename: Claudia
authors.initials: C
authors.lastname: Bausewein
authors.forename: Caroline
authors.initials: C
authors.lastname: Jolley
authors.forename: Charles
authors.initials: C
authors.lastname: Reilly
authors.forename: Paula
authors.initials: P
authors.lastname: Lobo
authors.forename: Jane
authors.initials: J
authors.lastname: Kelly
authors.forename: Helene
authors.initials: H
authors.lastname: Bellas
authors.forename: Preety
authors.initials: P
authors.lastname: Madan
authors.forename: Caty
authors.initials: C
authors.lastname: Panell
authors.forename: Elmien
authors.initials: E
authors.lastname: Brink
authors.forename: Chiara
authors.initials: C
authors.lastname: De Biase
authors.forename: Wei
authors.initials: W
authors.lastname: Gao
authors.forename: Caroline
authors.initials: C
authors.lastname: Murphy
authors.forename: Paul
authors.initials: P
authors.lastname: McCrone
authors.forename: John
authors.initials: J
authors.lastname: Moxham
authors.forename: Irene J
authors.initials: IJ
authors.lastname: Higginson
mesh_terms: D000368:Aged; D000553:Ambulatory Care / Q000379:methods*; D003362:Cost-Benefit Analysis; D004417:Dyspnea / Q000191:economics / Q000209:etiology / Q000628:therapy*; D005260:Female; D006333:Heart Failure / Q000150:complications; D018575:Home Care Services, Hospital-Based / Q000191:economics*; D006801:Humans; D008131:London; D008175:Lung Neoplasms / Q000150:complications; D008297:Male; D008875:Middle Aged; D010348:Patient Care Team / Q000191:economics*; D016730:Program Development / Q000191:economics*; D029424:Pulmonary Disease, Chronic Obstructive / Q000150:complications; D016896:Treatment Outcome