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

BackgroundBreathlessness 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.MethodsThe 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.DiscussionBreathlessness 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 registrationClinicalTrials.gov (NCT01165034)

Strategies used in improving and assessing the level of reporting of implementation fidelity in randomised controlled trials of palliative care complex interventions: A systematic review

“…As can be seen from about one-third (62 items) of the strategies were sufficiently reported (rated '++'), while another third (60 items) were either not used or reported (rated 'A'); none of the trials mentioned having set a standard for implementation fidelity that the trial would have to meet. For receipt of treatment, key strategies are having a health literacy component, 55 having patients recall intervention suggestions, considering 'participant responsiveness' and recruitment of willing patients, [34][35][36] assisting with understanding of medical terminology, 55 providing access to information adjusted for health literacy, 28,55,56 answering questions, 28,38,56 verifying understanding, 28,[39][40][41][42][43][44]56 summarising information 29,58,60 and providing an information pack. 29,58 Rehearsal of emergency situations and practising self-monitoring and reporting of patients' results 28,56 would aid in assessment of patients' receipt.…”

How does a new breathlessness support service affect patients?

“…Patients with breathlessness have complex needs, on average experience 13-14 other symptoms (such as pain, fatigue, sleep problems and depression) and frequently attend emergency hospital services [1]. As the best way of organising and delivering a service for the relief of breathlessness is not known, an interdisciplinary service was developed for patients with breathlessness in advanced disease and their carers: the Breathlessness Support Service (BSS) [2]. Here, we report the results of qualitative interviews of patients who received the BSS.…”

“…After the second and final clinic visit, further individualised actions and a discharge plan were agreed. Summaries of both clinic visits were sent to the individual, with a copy to their general practitioner and referring staff [2,5].…”

Kartleggingsverktøy for pustebesvær hos palliative pasienter

“…Dyspnea or breathlessness is a complex symptom in many patients with advanced disease (1,2). Research has shown that 94 per cent of patients with chronic lung disease and 78 per cent of patients with lung cancer suffer from breathlessness during the last year of life (3), and that breathlessness may be associated with poor quality of life, anxiety, reduced functioning, and reduced life expectancy (1,2).…”