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Mixed-methods feasibility cluster randomised controlled trial of a paramedic-administered breathlessness management intervention for acute-on-chronic breathlessness (BREATHE): study findings

Hutchinson, Ann; Allgar, Victoria; Cohen, Judith; Currow, David C.; Griffin, Susan; Hart, Simon; Hird, Kelly; Hodge, Andrew; Mason, Suzanne; Northgraves, Matthew; Reeve, Joanne; Swan, Flavia; Johnson, Miriam J.


Victoria Allgar

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Dr Judith Cohen;
Director, Hull Health Trials Unit

David C. Currow

Susan Griffin

Kelly Hird

Andrew Hodge

Suzanne Mason

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Dr Flavia Swan
Research fellow in cancer rehabilitation


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 hours. 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.


Hutchinson, A., Allgar, V., Cohen, J., Currow, D. C., Griffin, S., Hart, S., …Johnson, M. J. (2022). Mixed-methods feasibility cluster randomised controlled trial of a paramedic-administered breathlessness management intervention for acute-on-chronic breathlessness (BREATHE): study findings. ERJ Open Research, 8(4), Article 00257-2022.

Journal Article Type Article
Acceptance Date Aug 11, 2022
Online Publication Date Aug 24, 2022
Publication Date Oct 1, 2022
Deposit Date Aug 25, 2022
Publicly Available Date Aug 25, 2022
Journal ERJ Open Research
Electronic ISSN 2312-0541
Publisher European Respiratory Society
Peer Reviewed Peer Reviewed
Volume 8
Issue 4
Article Number 00257-2022
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Copyright Statement
Copyright ©The authors 2022<br /> This version is distributed under the terms of the Creative Commons Attribution Non-Commercial Licence 4.0. For commercial reproduction rights and permissions contact

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