TY - JOUR T1 - A feasibility cluster randomised controlled trial of a paramedic-administered breathlessness management intervention for acute-on-chronic breathlessness (BREATHE): Study protocol JF - ERJ Open Research JO - erjor DO - 10.1183/23120541.00955-2020 SP - 00955-2020 AU - Matthew Northgraves AU - Judith Cohen AU - Victoria Allgar AU - David Currow AU - Simon Hart AU - Kelly Hird AU - Andrew Hodge AU - Miriam Johnson AU - Suzanne Mason AU - Flavia Swan AU - Ann Hutchinson Y1 - 2021/01/01 UR - http://openres.ersjournals.com/content/early/2021/01/14/23120541.00955-2020.abstract N2 - Introduction Chronic breathlessness, persistent and disabling despite optimal treatment of underlying causes, is a prevalent and frightening symptom and is associated with many emergency presentations and admission to hospital. Breathlessness management techniques used by paramedics may reduce the need for conveyance to hospital. The Breathlessness RElief AT HomE study (BREATHE) aims to explore the feasibility of conducting a definitive cluster randomised controlled trial (cRCT) for people with acute-on-chronic breathlessness who have called an ambulance, to evaluate the effectiveness and cost-effectiveness of a paramedic-administered non-pharmacological breathlessness intervention.Methods and analysis The trial is a mixed-methods feasibility cluster randomised controlled trial. Eight paramedics will be randomised 1:1 to deliver either the BREATHE intervention in addition to usual care or usual care alone at call-outs for acute-on-chronic breathlessness. Sixty participants will be recruited to provide access to routine data relating to the index call-out with optional follow-up questionnaires at 14 days, 1 month and 6 months. An in-depth interview will be conducted with a subgroup. Feasibility outcomes relating to recruitment, data quality (especially candidate primary outcomes), and intervention acceptability and fidelity will be collected as well as providing data to estimate a sample size for a definitive trial.Ethics and dissemination Yorkshire and The Humber – Sheffield Research Ethics Committee approved the trial protocol (19/YH/0314). The study results will inform progression to, or not, and design of a main trial according to pre-determined stop-go criteria. Findings will be disseminated to relevant stakeholders and submitted for publication in a peer-reviewed journal.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. Northgraves has nothing to disclose.Conflict of interest: Dr. Cohen reports grants from NIHR, during the conduct of the study;.Conflict of interest: Dr. Allgar has nothing to disclose.Conflict of interest: D. Currow reports he is an unpaid advisory board member for Helsinn Pharmaceuticals. He is a paid consultant and receives payment for intellectual property with Mayne Pharma and is a consultant with Specialised Therapeutics Australia Pty. Ltd.Conflict of interest: Dr. Hart reports personal fees and non-financial support from Chiesi UK, grants, personal fees and non-financial support from Boehringer Ingelheim, outside the submitted work;.Conflict of interest: Dr. Hird has nothing to disclose.Conflict of interest: Mr. Hodge has nothing to disclose.Conflict of interest: Dr. Johnson has nothing to disclose.Conflict of interest: Dr. MASON has nothing to disclose.Conflict of interest: Dr. Swan has nothing to disclose.Conflict of interest: Dr. Hutchinson has nothing to disclose. ER -