A feasibility cluster randomised controlled trial of a paramedic-administered breathlessness management intervention for acute-on-chronic breathlessness (BREATHE)

Northgraves, M; Cohen, J; Allgar, V; Currow, D; Hart, S; Hird, K; Hodge, A; Johnson, M; Mason, S; Swan, F; Hutchinson, A

A feasibility cluster randomised controlled trial of a paramedic-administered breathlessness management intervention for acute-on-chronic breathlessness (BREATHE)

Northgraves, M Cohen, J Allgar, V Currow, D

Hart, S Hird, K Hodge, A Johnson, M Mason, S Swan, F Hutchinson, A

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Publisher:: European Respiratory Society (ERS)
Publication Type:: Journal Article
Citation:: ERJ Open Research, 2021, 7, (1), pp. 00955-2020
Issue Date:: 2021-01-21

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Field	Value	Language
dc.contributor.author	Northgraves, M
dc.contributor.author	Cohen, J
dc.contributor.author	Allgar, V
dc.contributor.author	Currow, D https://orcid.org/0000-0003-1988-1250
dc.contributor.author	Hart, S
dc.contributor.author	Hird, K
dc.contributor.author	Hodge, A
dc.contributor.author	Johnson, M
dc.contributor.author	Mason, S
dc.contributor.author	Swan, F
dc.contributor.author	Hutchinson, A
dc.date.accessioned	2021-09-05T23:16:55Z
dc.date.available	2021-01-07
dc.date.available	2021-09-05T23:16:55Z
dc.date.issued	2021-01-21
dc.identifier.citation	ERJ Open Research, 2021, 7, (1), pp. 00955-2020
dc.identifier.issn	2312-0541
dc.identifier.issn	2312-0541
dc.identifier.uri	http://hdl.handle.net/10453/150331
dc.description.abstract	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. The trial is a mixed-methods feasibility cRCT. 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. 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 predetermined stop-go criteria. Findings will be disseminated to relevant stakeholders and submitted for publication in a peer-reviewed journal.
dc.format	Electronic-eCollection
dc.language	eng
dc.publisher	European Respiratory Society (ERS)
dc.relation.ispartof	ERJ Open Research
dc.relation.isbasedon	10.1183/23120541.00955-2020
dc.rights	info:eu-repo/semantics/openAccess
dc.title	A feasibility cluster randomised controlled trial of a paramedic-administered breathlessness management intervention for acute-on-chronic breathlessness (BREATHE)
dc.type	Journal Article
utslib.citation.volume	7
utslib.location.activity	England
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/IMPACCT
utslib.copyright.status	open_access	*
pubs.consider-herdc	false
dc.date.updated	2021-09-05T23:16:52Z
pubs.issue	1
pubs.publication-status	Published
pubs.volume	7
utslib.citation.issue	1

Abstract:

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. The trial is a mixed-methods feasibility cRCT. 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. 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 predetermined stop-go criteria. Findings will be disseminated to relevant stakeholders and submitted for publication in a peer-reviewed journal.

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http://hdl.handle.net/10453/150331