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

Matthew Northgraves, Judith Cohen, Victoria Allgar, David Currow, Simon Hart, Kelly Hird, Andrew Hodge, Miriam Johnson, Suzanne Mason, Flavia Swan, Ann Hutchinson
ERJ Open Research 2021; DOI: 10.1183/23120541.00955-2020
Matthew Northgraves
1Hull Health Trials Unit, University of Hull, Hull, UK
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Judith Cohen
1Hull Health Trials Unit, University of Hull, Hull, UK
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Victoria Allgar
2Hull York Medical School / Health Sciences, University of York, York, UK
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David Currow
3Faculty of Health, University of Technology Sydney, Sydney, Australia
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Simon Hart
4Respiratory Research Group, Hull York Medical School, Cottingham, UK
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Kelly Hird
5Yorkshire Ambulance Service NHS Trust, Wakefield, UK
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Andrew Hodge
5Yorkshire Ambulance Service NHS Trust, Wakefield, UK
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Miriam Johnson
6Wolfson Palliative Care Research Group, Hull York Medical School, Hull, UK
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Suzanne Mason
7CURE group, School of Health and Related Research, University of Sheffield, Sheffield, UK
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Flavia Swan
6Wolfson Palliative Care Research Group, Hull York Medical School, Hull, UK
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Ann Hutchinson
6Wolfson Palliative Care Research Group, Hull York Medical School, Hull, UK
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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

This 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.

This is a PDF-only article. Please click on the PDF link above to read it.

  • Received December 18, 2020.
  • Accepted January 7, 2021.
  • ©The authors 2021
http://creativecommons.org/licenses/by-nc/4.0/

This version is distributed under the terms of the Creative Commons Attribution Non-Commercial Licence 4.0. For commercial reproduction rights and permissions contact permissions{at}ersnet.org

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A feasibility cluster randomised controlled trial of a paramedic-administered breathlessness management intervention for acute-on-chronic breathlessness (BREATHE): Study protocol
Matthew Northgraves, Judith Cohen, Victoria Allgar, David Currow, Simon Hart, Kelly Hird, Andrew Hodge, Miriam Johnson, Suzanne Mason, Flavia Swan, Ann Hutchinson
ERJ Open Research Jan 2021, 00955-2020; DOI: 10.1183/23120541.00955-2020

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A feasibility cluster randomised controlled trial of a paramedic-administered breathlessness management intervention for acute-on-chronic breathlessness (BREATHE): Study protocol
Matthew Northgraves, Judith Cohen, Victoria Allgar, David Currow, Simon Hart, Kelly Hird, Andrew Hodge, Miriam Johnson, Suzanne Mason, Flavia Swan, Ann Hutchinson
ERJ Open Research Jan 2021, 00955-2020; DOI: 10.1183/23120541.00955-2020
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