Breathlessness relief at home

ISRCTN	ISRCTN80330546
DOI	https://doi.org/10.1186/ISRCTN80330546
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	V3.0 17.12.2019; CPMS: 43288
Sponsor	University of Hull
Funder	National Institute for Health Research

Submission date: 31/10/2019
Registration date: 11/11/2019
Last edited: 24/11/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Breathlessness is common in people with heart and lung conditions and can get very severe and frightening. When this happens patients or family members often call an ambulance, especially when their own doctor’s surgery is closed. In a recent study, it was found that 1 in 5 of all people taken by ambulance to Accident and Emergency (A&E) called for help because of breathlessness. A third of these did not need to stay in hospital and went home. There are treatments to calm severe breathlessness that could be used in the patient’s home. If paramedics can use this approach, breathlessness may be calmed more quickly and some people may not need to go to A&E. The aim is to see if it is possible to run a research study with people calling ambulances because of breathlessness. The study will test if paramedics trained in breathlessness techniques can ease breathlessness more quickly than usual care, and help more people stay at home. People with severe breathlessness have said this is important and have agreed to help run the study. At the end of this “test” study, it will be known whether i) such care can be used by paramedics, ii) a larger trial can be done and iii) the best way to run it. The researchers will let the participants, local support groups, charities, local clinicians and the funder know their findings and also publish them in a scientific journal. This study is a key first step to help people with severe breathlessness needing emergency help.

Who can participate?
Patients in their normal home environment experiencing a breathlessness crisis and receiving a 999 ambulance response from a participating paramedic

What does the study involve?
Eight paramedics in the Yorkshire area are chosen at random to use the breathing calming techniques in breathless patients or to give usual care. Patients are asked to provide consent for the use of routinely collected information from the call out and about whether there have been any further call-outs in the next 48 hours to be used in the study. They are also asked whether they are willing to be contacted about taking part in the follow-up of the study. Patients agreeing to further contact are contacted by a member of the research team about participating in the follow-up. If the patient agrees, a member of the research team visits them at a place suitable to them to gain written consent before completing an interview and/or three questionnaires. If the patient has a carer, they are invited to join the interview. The patient is contacted again at 1 month and 6 months after the original call-out about repeating the three questionnaires.

What are the possible benefits and risks of participating?
There is no specific benefit to the participants other than the potential to inform future research into the clinical practice of the ambulance service. The intervention is considered to be of low risk as it is based on best practice and optimisation of routine care.

Where is the study run from?
The study is being run by the University of Hull/Hull York Medical School and the Yorkshire Ambulance Service NHS Trust in the Yorkshire and Humber region (UK)

When is the study starting and how long is it expected to run for?
April 2019 to July 2021

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
1. Dr Ann Hutchinson
Ann.Hutchinson@hyms.ac.uk
2. Dr Matthew Northgraves
matthew.northgraves@hyms.ac.uk

Contact information

Dr Matthew Northgraves
Scientific

University of Hull
Cottingham Road
Hull
HU6 7RX
United Kingdom

ORCID ID	0000-0001-9260-8643
Phone	+44 (0)1482463373
Email	matthew.northgraves@hyms.ac.uk

Dr Ann Hutchinson
Scientific

Wolfson Palliative Care Research Centre
University of Hull
Cottingham Road
Hull
HU6 7RX
United Kingdom

ORCID ID	0000-0001-9480-9764
Phone	+44 (0)1482 463604
Email	Ann.Hutchinson@hyms.ac.uk

Study information

Primary study design	Interventional
Study design	6-month mixed-methods feasibility cluster randomised controlled trial (cRCT)
Secondary study design	Cluster randomised trial
Study type	Participant information sheet
Scientific title	Breathlessness RElief AT HomE (BREATHE): a feasibility cluster randomised controlled trial (cRCT) to test if a definitive cRCT is possible to evaluate the effectiveness and cost-effectiveness of a paramedic-administered breathlessness crisis intervention for people with acute-on-chronic breathlessness compared with usual care
Study acronym	BREATHE
Study objectives	To determine whether an adequately powered cluster randomised controlled trial (cRCT) of a breathlessness crisis intervention delivered by first responders (paramedics) is possible.
Ethics approval(s)	Current ethics approval as of 13/04/2021 Approved 22/11/2019, Substantial amendment 1 was approved 26/02/2020; Substantial Amendment 2 was approved 15/06/2020; Substantial Amendment 3 was approved 27/07/2020; Substantial Amendment 4 was approved 22/02/2021. NHS HRA Yorkshire & The Humber - Sheffield REC (NHS Blood and Transplant Blood Donor Centre, Holland Drive, Newcastle upon Tyne, Tyne and Wear, NE2 4NQ; +44 (0)207 104 8086; nrescommittee.yorkandhumber-sheffield@nhs.net), ref: 19/YH/0314 Previous ethics approval as of 24/08/2020: Approved 22/11/2019, Substantial amendment 1 was approved 26/02/2020; Substantial Amendment 2 was approved 15/06/2020; Substantial Amendment 3 was approved 27/07/2020. NHS HRA Yorkshire & The Humber - Sheffield REC (NHS Blood and Transplant Blood Donor Centre, Holland Drive, Newcastle upon Tyne, Tyne and Wear, NE2 4NQ; +44 (0)207 104 8086; nrescommittee.yorkandhumber-sheffield@nhs.net), ref: 19/YH/0314 Previous ethics approval as of 19/06/2020: Approved 22/11/2019, Substantial amendment 1 was approved 26/02/2020, NHS HRA Yorkshire & The Humber - Sheffield REC (NHS Blood and Transplant Blood Donor Centre, Holland Drive, Newcastle upon Tyne, Tyne and Wear, NE2 4NQ; +44 (0)207 104 8086; nrescommittee.yorkandhumber-sheffield@nhs.net), ref: 19/YH/0314 Previous ethics approval: Approved 22/11/2019, NHS HRA Yorkshire & The Humber - Sheffield REC (NHS Blood and Transplant Blood Donor Centre, Holland Drive, Newcastle upon Tyne, Tyne and Wear, NE2 4NQ; Tel: +44 (0)207 104 8086; Email: nrescommittee.yorkandhumber-sheffield@nhs.net), ref: 19/YH/0314
Health condition(s) or problem(s) studied	Breathlessness as a result of either COPD, bronchitis, asthma, bronchiectasis, emphysema, heart disease or cancer in the lungs
Intervention	A group of paramedics (paramedic-participants) will be randomised to either deliver usual care or adopt the BREATHE intervention into routine practice for breathlessness patients. These paramedics will act as the cluster factor in a feasibility cluster randomised controlled trial: Usual care: The paramedic-participants in the control group will deliver usual care according to national guidelines including; initial history, baseline vital signs and tailored examination (chest auscultation, peak flow readings, 12-lead ECG). BREATHE intervention: In additional to usual care, patient-participants managed by paramedics-participants allocated to the intervention will receive a paramedic-administered short non-pharmacological complex intervention. This includes i) face-to-face advice (positioning, breathing techniques, panic management, fan) ii) a laminated leaflet and iii) a breathlessness management booklet to keep and refer to later. This booklet will have information to help the patient and carer self-manage breathlessness and information on local services they can turn to for support.
Intervention type	Mixed
Primary outcome measure(s)	Feasibility outcomes related to paramedics: 1. Paramedic recruitment rate recorded as the number of eligible paramedics who consent to participate in the study 2. Paramedic attrition rate recorded as the number of paramedics who consent to participate that remain in the study until the end of recruitment 3. Willingness of paramedics to be randomised recorded as number of paramedic declining participation for this reason 4. Patient recruitment per paramedic recorded as number of patients recruited by each paramedic Feasibility outcomes related to patients: 1. Patient recruitment rate recorded as the number of eligible patients who consent to participate to Day 0 data use 2. Patient consent rate for follow-up data provision recorded as the number of patients who consent to Day 0 data use who also consent to follow-up 3. Patient attrition rate recorded as the number of patients who consent to participate in follow-up that remain in the study until the end of follow-up
Key secondary outcome measure(s)	Other feasibility outcomes: 1. Data quality of routinely collected and patient/proxy reported data recorded as completeness of data at Day 0 and 48-hour post-call-out data 2. Data quality of patient-reported outcomes recorded as completeness of questionnaire completion at 14 days, 1 month and 6 months 3. Intervention fidelity recorded as elements of BREATHE intervention used by the paramedic during Day 0 call-out 4. Patient adherence to the BREATHE intervention recorded as how they take part in the intervention in the call-out on Day 0 5. Acceptability of the BREATHE intervention to the patients is reported from qualitative analysis of interviews at 14 days post call out 6. Acceptability of the BREATHE intervention to the paramedics is recorded by Process evaluation and qualitative interviews at end of recruitment 7. Use of BREATHE intervention by patient since initial visit on Day 0 is reported from qualitative analysis of interviews at 14 days post call out and Health service utilisation questionnaires at 1 month and 6 months 8. Intracluster coefficient and sample size calculation for candidate primary outcomes Potential definitive trial primary outcomes: 1. Improvement in breathlessness intensity at end of paramedic visit is measured by patient-participant report or paramedic-participant proxy report NRS intensity “now” every 2 minutes till decision to transfer to ED or decision to keep at home on Day 0 2. Conveyance to Accident & Emergency is being collected from routinely collected data at Day 0 Clinical measures: 1. Paramedic routinely collected clinical and service delivery data (pulse, respiratory rate, blood pressure (systolic and diastolic), capillary blood oxygen saturation level (SPO2) with air, SPO2 with oxygen) recorded at first and last assessments of call-out on Day 0 2. Working impression is recorded as paramedic impression on Day 0 Health service utilisation: 1. Duration of index call (Day 0) is collected from routine data 2. Future call-outs in 48 hrs (routinely collected) at 14 days 3. Health service utilisation relating to the 6 months prior to Day 0 is collected by Health service utilisation questionnaire at 14 days 4. Utilisation of primary and emergency services is collected by Health service utilisation questionnaire at 14 days, 1 month and 6 months Health status: This will be measured by the SF-6D which is derived from the SF-36. The SF-6D is a validated health status measurement tool widely used in health economic evaluations. For the purposes of this feasibility study data completion will be assessed and quality-adjusted life years will not be calculated Chronic Respiratory Questionnaire dyspnoea domain: This includes measurement of mastery of breathlessness and is recommended in addition to a unidimensional tool such as the NRS. This will be measured at 14 days, 1 month and 6 months
Completion date	31/07/2021

Eligibility

Participant type(s)	Mixed
Age group	Adult
Sex	All
Target sample size at registration	68
Total final enrolment	42
Key inclusion criteria	Paramedic-participants: 1. From a participating ambulance stations 2. Able to provide informed consent 3. Willing to undergo training and to deliver intervention if so randomised 4. Willing to undergo training to participate in study measures and processes Patient-participants: 1. In their normal home environment experiencing a breathlessness crisis and receiving a 999 ambulance response from participating paramedics 2. Who do not require immediate life-saving intervention/transfer to ED in the opinion of the attending paramedic 3. Call-out due to breathlessness 4. Who experience chronic breathlessness (defined as short of breath most days in the last 3 months or longer) 5. With a self-reported diagnosis of a cardiorespiratory disease (including lung cancer [primary or secondary], COPD, bronchitis, asthma, bronchiectasis, emphysema, heart disease 6. Able to give retrospective consent at the end of the paramedic call-out to use collected data for researcher use Carer-participants: If any of the patient-participants who consent to the interview have a carer, the carer will be invited to be part of the interview
Key exclusion criteria	Paramedic-participants: 1. Failure of inclusion criteria Patient-participants: 1. Patients requiring urgent disease-directed intervention and transfer to the ED for acute pathology in the opinion of the attending paramedic 2. Patient does not have capacity to provide retrospective consent 3. Patient is currently enrolled on the trial or has previously participated
Date of first enrolment	02/12/2019
Date of final enrolment	30/06/2021

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Yorkshire Ambulance Service NHS Trust

Brindley Way
Wakefield 41 Business Park
Wakefield
WF2 0XQ
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Data sharing statement to be made available at a later date
IPD sharing plan	The data sharing plans for the current study are unknown and will be made available at a later date

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		21/11/2022	24/11/2022	Yes	No
Protocol article		29/03/2021	14/04/2021	Yes	No
HRA research summary			28/06/2023	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

24/11/2022: Publication reference and total final enrolment added.
17/08/2021: Internal review.
14/04/2021: The following changes were made to the trial record:
1. Ethics approval details and publication reference added.
2. The overall trial end date was changed from 30/03/2022 to 31/07/2021.
24/08/2020: The following changes have been made:
1. Recruitment has resumed.
2. The recruitment end date has been changed from 31/12/2020 to 30/06/2021.
3. The overall trial end date has been changed from 30/09/2021 to 30/03/2022.
4. The ethics approval has been updated.
19/06/2020: The following changes have been made:
1. The recruitment end date has been changed from 31/05/2020 to 31/12/2020.
2. The overall trial end date has been changed from 30/03/2021 to 30/09/2021.
3. The intention to publish date has been changed from 30/03/2022 to 30/09/2022.
4. The ethics approval has been updated.
5. The plain English summary has been updated to reflect the changes above.
16/04/2020: Due to current public health guidance, recruitment for this study has been paused.
16/04/2020: The protocol number has been changed from "Protocol 2 (23.09.19)" to "V3.0 17.12.2019".
28/11/2019: The ethics approval date was added.