TY - JOUR T1 - Mixed-methods feasibility cluster randomised controlled trial of a paramedic-administered breathlessness management intervention for acute-on-chronic breathlessness (BREATHE): Study findings JF - ERJ Open Research JO - erjor DO - 10.1183/23120541.00257-2022 SP - 00257-2022 AU - Ann Hutchinson AU - Victoria Allgar AU - Judith Cohen AU - David C. Currow AU - Susan Griffin AU - Simon Hart AU - Kelly Hird AU - Andrew Hodge AU - Suzanne Mason AU - Matthew Northgraves AU - Joanne Reeve AU - Flavia Swan AU - Miriam J. Johnson Y1 - 2022/01/01 UR - http://openres.ersjournals.com/content/early/2022/08/11/23120541.00257-2022.abstract N2 - Introduction One-fifth of emergency department presentations by ambulance are due to acute-on-chronic breathlessness. We explored the feasibility of an evaluation-phase, cluster randomised controlled trial (cRCT) of the effectiveness and cost-effectiveness of a paramedic-administered, non-pharmacological breathlessness intervention for people with acute-on-chronic breathlessness at ambulance call-out (BREATHE) regarding breathlessness intensity and conveyance to hospital.Methods This mixed-methods, feasibility cRCT (ISRCTN80330546), randomised paramedics to usual care or intervention plus usual care. Retrospective patient consent to use call-out data (primary endpoint) and prospective patient/carer consent for follow-up was sought. Potential primary outcomes included breathlessness intensity (numerical rating scale) and conveyance. Follow-up included: interviews with patients/carers and questionnaires at 14 days, 1 and 6 months; paramedic focus groups and surveys.Results Recruitment was during COVID-19, with high demands on paramedics and fewer call-outs by eligible patients. We enrolled 29 paramedics; nine withdrew. Randomisation/trial procedures were acceptable.Paramedics recruited thirteen patients, not meeting recruitment target (n=36); eight patients and three carers were followed up. Data quality was good but insufficient for future sample size estimation.The intervention did not extend call-out time, was delivered with fidelity and was acceptable to patients, carers and paramedics. There were no repeat call-outs within 48 h. All trained paramedics strongly recommended BREATHE as a highly relevant, simple intervention.Conclusion Patient recruitment to target was not feasible during the pandemic. Training and intervention were acceptable and delivered with fidelity. Results include valuable information on recruitment, consent, attrition, and data collection that will inform the design and delivery of a definitive trial.FootnotesThis manuscript has recently been accepted for publication in the ERJ Open Research. It is published here in its accepted form prior to copyediting and typesetting by our production team. After these production processes are complete and the authors have approved the resulting proofs, the article will move to the latest issue of the ERJOR online. Please open or download the PDF to view this article.Conflict of interest: Dr. Hutchinson reports grants from NIHR, during the conduct of the study.Conflict of interest: Dr. Allgar reports grants from NIHR, during the conduct of the study.Conflict of interest: Dr. Cohen reports grants from NIHR, during the conduct of the study.Conflict of interest: Dr. Currow reports the following Helsinn Pharmaceuticals - Advisory Board member Mayne Pharma -paid consultant and received payment for intellectual property.Conflict of interest: Dr. Griffin reports grants from NIHR, during the conduct of the study.Conflict of interest: Dr. Hart reports grants from NIHR, during the conduct of the study; personal fees from Trevi therapeutics, personal fees and non-financial support from Chiesi, personal fees and non-financial support from Boehringer Ingelheim, outside the submitted work.Conflict of interest: Dr. Hird reports grants from NIHR, during the conduct of the study.Conflict of interest: Dr. Mason reports grants from NIHR, during the conduct of the study.Conflict of interest: Dr. Northgraves reports grants from NIHR, during the conduct of the study.Conflict of interest: Dr. Reeve reports grants from NIHR, outside the submitted work.Conflict of interest: Dr. Swan reports grants from NIHR, during the conduct of the study.Conflict of interest: Dr. Johnson reports grants from NIHR, during the conduct of the study. ER -