Abstract
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.
Footnotes
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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.
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- Received December 18, 2020.
- Accepted January 7, 2021.
- ©The authors 2021
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