A Feasibility Cluster Randomised Controlled Trial of Paramedic- Administered Breathlessness Management Intervention for Acute- On-Chronic Breathlessness (BREATHE): Study Findings

ABSTRACT

Background/aims: One-fifth of conveyances to the emergency department (ED) are due to acute-on-chronic breathlessness. Paramedic breathlessness management may ease distress quicker and/or reduce ED conveyances. We evaluated the feasibility of a full trial of a paramedic delivered intervention to reduce avoidable conveyances (recruitment, randomisation, consent, training and intervention acceptability, adherence, data quality, best primary outcome, sample size estimation). The intervention comprised evidence-based non-drug techniques and a self-management booklet. Methods: This mixed-methods feasibility cluster randomised controlled trial (ISRCTN80330546) with embedded qualitative study about trial processes, training and intervention delivery, randomised paramedics to usual care or to intervention + usual care. Retrospective patient consent to use call-out data and prospective patient/carer consent for follow-up was sought. Potential primary outcomes were breathlessness intensity (numerical rating scale) and ED conveyance. Follow-up included an interview for patients/carers and questionnaires at 14 days, 1 and 6 months and paramedic focus groups and survey. Results: Recruitment was during the COVID-19 pandemic, leading to high demands on paramedics and fewer call-outs by eligible patients. We enrolled 29 paramedics;9 withdrew. Randomisation and trial procedures were acceptable. Paramedics recruited 13 patients;8 were followed up. Data quality was good. The intervention did not extend call-out time, was delivered with fidelity and no contamination and was acceptable to patients, carers and paramedics. There were no repeat call-outs < 48 hours. Recruitment stop-go criteria were not met. We had insufficient data for sample size estimation. Conclusions: A full trial in the same circumstances is not feasible. However, valuable information was gained on recruitment, attrition, consent, training and intervention acceptability and adherence, and patient-reported data collection.