PrimaryBreathe: programme to develop and test a brief remote primary care intervention for chronic breathlessness

Background Breathlessness affects the daily lives of one in ten people, and a quarter of adults aged over 70. Many people with long-term conditions suffer from this trans-diagnostic symptom, particularly those with chronic lung or heart disease. With an aging, increasingly multimorbid population, the global burden of breathlessness is rising inexorably, compounded by COVID-19. This debilitating and distressing symptom often leads to crisis calls for help; breathlessness contributes to one in five emergency department attendances by ambulance. Clinicians manage breathlessness by focusing on treatment of underlying disease. Although a necessary first step, this approach alone is often insufficient, due to the weak relationship between disease and symptom severity. Rehabilitation programmes help, but are not always accessible or acceptable for patients. Specialist breathlessness services have emerged within palliative care over the last decade, using approaches like breathing techniques, relaxation and incremental activity. These evidence-based services mostly support people with advanced disease, particularly cancer, and capacity is highly limited. We hypothesise that breathless patients will benefit from symptom-directed self-management support, irrespective of diagnosis, disease stage or postcode. To enable widespread access to this, we propose a five-year programme to develop and test a primary care intervention for chronic breathlessness. Objectives Co-design a brief intervention that translates specialist breathlessness management into a deliverable form for primary care. Determine clinical and cost-effectiveness of the intervention. Develop an implementation strategy to facilitate roll-out across UK primary care using existing resources. Methods Workstream 1 contains three developmental studies. Checklists will be developed to optimise medical management of the main diseases causing breathlessness (study 1A). In a multiphase qualitative study, the two-step PrimaryBreathe intervention, involving primary care staff receiving online training and then delivering a 4-week intervention, will be co-designed with stakeholders (study 1B). Single-arm trial feasibility testing will occur in two diverse regions (study 1C). Workstream 2 comprises a cluster randomised trial to test intervention clinical and cost-effectiveness (study 2A), incorporating a parallel process evaluation (study 2B). Forty general practices across five UK regions will be cluster randomised, with 640 patients receiving either the breathlessness intervention with concurrent optimal medical management, or optimal medical management alone. The primary endpoint will be the change in the Chronic Respiratory Questionnaire Mastery Scale at 6 weeks. Secondary measures include emergency hospital and primary care attendances. Workstream 3 aims to facilitate future roll-out of the intervention, if effective, as well as stand-alone outputs such as the optimal medical management checklists and subsidiary patient-information app. Evidence from patients, carers and primary care staff will be integrated with the strategic perspectives of managers, commissioners and relevant national organisations to co-produce an implementation strategy (study 3). Information from two cross-cutting themes, on implementation enablers and on ethnic minority inclusivity, will be incorporated into the strategy. This work will enable a step-change in access to support for people suffering from chronic breathlessness. It has been endorsed by national and international stakeholders including the Asthma UK / British Lung Foundation, Primary Care Respiratory Society, British Thoracic Society and International Primary Care Respiratory Group.