BreathEase: rationale, design and recruitment of a randomised trial and embedded mixed methods study of a multi-professional breathlessness service in early palliative care

Background The Munich Breathlessness Service (MBS) has adapted novel support services to the German context, to reduce burden in patients and carers from breathlessness in advanced disease. It has been evaluated in a pragmatic fast track randomised controlled trial (RCT) (BreathEase, NCT02622412) with embedded qualitative interviews and postal survey. The aim of this paper is to describe the intervention model and study design, analyse recruitment to the trial and compare sample characteristics with other studies in the field. Methods Analysis of recruitment pathways and enrolment, sociodemographic and clinical characteristics of participants and carers. Results Of 439 people screened, 253 (58%) were offered enrolment and 183 (42%) participated. n=97 (70%) carers participated. 186 people (42%) did not qualify for inclusion, mostly because breathlessness could not be attributed to an underlying disease. All participants were self-referring, 60% through media sources. Eligibility and willingness to participate were associated to social networks and illness-related activities as recruitment routes. Mean age of participants was 71 years (51% women), with COPD (63%), chronic heart failure (8%), interstitial lung disease (9%), pulmonary hypertension (6%) and cancer (7%) as underlying conditions. Postal survey response rate was 89%. Qualitative interviews were conducted with 16 patients and 9 carers. Conclusion The BreathEase study has a larger and more heterogeneous sample compared to other trials. The self-referral-based and prolonged recruitment drawing on media sources approximates real-world conditions of early palliative care. Integrating qualitative and quantitative components will allow a better understanding and interpretation of the results of the main effectiveness study.