A mixed-methods evaluation of remote home monitoring models during the COVID-19 pandemic in England

ISRCTN ISRCTN14962466
DOI https://doi.org/10.1186/ISRCTN14962466
IRAS number 294011
Secondary identifying numbers IRAS 294011, CPMS 48381
Submission date
05/02/2021
Registration date
19/02/2021
Last edited
10/10/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Background and study aims
During the first wave of the COVID-19 pandemic, some patients were not admitted to hospital until they were displaying advanced symptoms of COVID-19. These patients may then have received invasive treatments and/or been admitted to intensive care. Monitoring patients at home may help to reduce these delays and identify patients earlier.
In the UK, a healthcare service called COVID Oximetry @home has been nationally rolled out by NHS England. In COVID Oximetry @home, patients receive COVID care at home. As part of this service, patients are given an oximeter and asked to record their oxygen levels regularly. Patients are monitored and sent for further care if problems arise.
Previous research has looked at home monitoring for other conditions, but no research has looked at whether COVID care at home is effective, how patients experience and engage with COVID care at home and how staff find delivering COVID care at home. This study aims to evaluate patients’ experiences of receiving the COVID care at home service.

Who can participate?
Persons aged 18 years or older who have been offered or care for someone who was offered the COVID Oximetry @home service.

What does the study involve?
To find out about patients’ experiences of receiving and engaging with the COVID care at home service, the researchers will carry out a national survey and conduct some interviews in 14 selected NHS sites. They will conduct a national survey with patients and carers in up to 25 NHS sites across the country. The surveys will explore patient experiences of receiving COVID care at home. They will carry out some case study interviews win 14 selected NHS sites and speak with patients who have received COVID care at home, or who have withdrawn from receiving care or declined care. These interviews will help to find out more about how people experienced receiving COVID care at home and the things that help or get in the way.

What are the possible benefits and risks of participating?
The researchers will be conducting surveys and interviews with patients and family members about their experience of receiving the COVID Oximetry @home service. It is therefore possible that discussing their experience of receiving care whilst experiencing COVID-19 could cause distress. To address these concerns, the researchers will ensure that questions within the survey and interview topic guide are presented sensitively. To do this, they have already sought feedback from their research team's patient and public involvement (PPI) members. They will also state in the information that participation is voluntary and that participants are free to withdraw. Where applicable the researchers will seek to signpost patients to relevant support groups. Secondly, patients may be hesitant to raise criticism of the service that they have received. To address this, the researchers have highlighted on the information sheet that the research team are independent of those delivering care and that there are no right or wrong answers. They will also emphasise that responses will be fully anonymised. They will highlight to participants that they would like to learn about the things that do not work well, in order to improve these for future participants.
The researchers will involve patients, carers and public involvement throughout the project. For example, they have already spoken with some patient representatives to find out their views on the project and the types of questions that they will ask during the surveys and interviews. The researchers will also be piloting the survey and interview questions with patients who have received COVID care at home. Later on in the project, they will also ask for patient and healthcare professionals’ views on their findings.

Where is the study run from?
This is a collaborative project between BRACE and RSET (two NIHR HS&DR programme rapid evaluation teams) with input from colleagues at Public Health England (PHE), NHS England (NHSE), NHS Digital and NHSX, and with other research teams working in this area.

When is the study starting and how long is it expected to run for?
November 2020 to June 2021

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

Who is the main contact?
Pei Li Ng
pei.ng@ucl.ac.uk

Contact information

Prof Naomi Fulop
Scientific

UCL Department of Applied Health Research
1-19 Torrington Place
London
WC1E 7HB
United Kingdom

ORCiD logoORCID ID 0000-0001-5306-6140
Phone +44 (0)203 1083267
Email n.fulop@ucl.ac.uk
Ms Pei Li Ng
Public

UCL Department of Applied Health Research
1-19 Torrington Place
London
WC1E 7HB
United Kingdom

Phone +44 (0)2031083236
Email pei.ng@ucl.ac.uk

Study information

Study designMulticenter observational mixed quantitative/qualitative study
Primary study designObservational
Secondary study designCohort study
Study setting(s)Home
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleCOVID Oximetry @home (CO@h): a rapid patient experience study
Study acronymCO@h
Study hypothesis1. What are the experiences and behaviours (i.e. engagement with COVID Oximetry @home (CO@h), use of other services) of patients in CO@h?
2. Do these experiences and behaviours vary by type of model, patient characteristics, and mode of remote monitoring?
Ethics approval(s)Approved 12/02/2021, London - Bloomsbury Research Ethics Committee (HRA RES Centre Manchester, 3rd Floor Barlow House, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 (0)2071048285; bloomsbury.rec@hra.nhs.uk), REC ref: 21/HRA/0155
ConditionCOVID-19 (SARS-CoV-2 infection)
InterventionThe study will carry out a national survey and conduct some interviews with patients and carers who have received COVID care at home, or who have withdrawn from receiving care or declined care.

The national survey of patients and carers will aim to capture the experiences of patients who have received COVID oximetry @ home, and their engagement with the service. The researchers will recruit patients and carers from as many NHS sites as possible (as COVID oximetry@ home has now been rolled out nationally). Staff from NHS sites will send the survey to their patients who have received COVID oximetry @ home, via text or post. The researchers will ask patients to complete the survey. If patients do not want to complete the survey or are unable to complete the survey, they will be able to allow their carer to complete the survey on their behalf. The patients and carers will complete the survey and return them directly to the research team (electronically on the survey platform, or via post for paper copies). The survey will take between 15 and 30 minutes to complete.

The researchers will aim to carry out one-to-one interviews with patients and carers in a sample of 14 NHS sites. These interviews will explore patient experience and engagement in more depth. The researchers will also aim to explore the views of those who have withdrawn from the service or declined participation. They aim to speak to six patients from each site (four who have received the COVID Oximetry @ home service and two who refused to receive the service or have withdrawn from the service). If patients do not want to take part in the interview or are unable to take part in the interview, the researchers will ask patients if they can approach their carer (if they have one) to capture their experiences. The interviews will take between 30 minutes and 60 minutes, depending on how much patients have to say.
Intervention typeOther
Primary outcome measureBehaviours and experiences of patients and carers who have received the COVID Oximetry@home service, assessed using a national survey and interviews once the patients have been discharged from the service
Secondary outcome measuresThere are no secondary outcome measures
Overall study start date02/11/2020
Overall study end date30/06/2021

Eligibility

Participant type(s)Mixed
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants1,072
Participant inclusion criteria1. 18 years or over
2. Proficient in English
3. Eligible to receive COVID Oximetry @ home
4. Must have been offered and either received or refused the COVID oximetry @ home service
5. Care for someone who was eligible to receive COVID oximetry @home, and who received or refused COVID oximetry @home
Participant exclusion criteriaParticipants will be excluded from the study if they do not meet the criteria for the COVID Oximetry @ home service
Recruitment start date23/02/2021
Recruitment end date01/06/2021

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

Hammersmith Hospital
NIHR CRN: North West London
Imperial College Healthcare NHS Trust
3rd Floor Administrative Block South
Du Cane Road
London
W12 0HT
United Kingdom
NHS Gloucestershire CCG
Sanger House
Valiant Ct
Gloucester Business Park
Gloucester
GL3 4FE
United Kingdom
NHS West Leicestershire CCG
55 Woodgate
Loughborough
LE11 2TZ
United Kingdom
NHS East Lancashire CCG
Walshaw House
Regent Street
Nelson
BB9 8AS
United Kingdom
Royal Free Hospital
Royal Free London NHS Foundation Trust
Pond Street
London
NW3 2QG
United Kingdom
NHS Dorset CCG
Vespasian House
Bridport Road
Dorchester
DT1 1TG
United Kingdom
Salford Royal Hospital
Salford Royal NHS Foundation Trust
Stott Lane
Salford
Manchester
M6 8HD
United Kingdom
West Hertfordshire Hospitals NHS Trust
Watford General Hospital
Vicarage Road
Watford
WD18 0HB
United Kingdom
NHS Bristol, North Somerset and South Gloucestershire CCG
South Plaza
Marlborough Street
Bristol
BS1 3NX
United Kingdom
NHS Derby and Derbyshire CCG
Cardinal Square
10 Nottingham Road
Derby
DE1 3QT
United Kingdom
North Bristol NHS Trust
Southmead Hospital
Southmead Road
Westbury-On-Trym
Bristol
BS10 5NB
United Kingdom
Whittington Health NHS Trust
The Whittington Hospital
Magdala Avenue
LONDON
N19 5NF
United Kingdom
NHS West Hampshire CCG
Omega House
112 Southampton Road
Eastleigh
SO50 5PB
United Kingdom
NHS North Hampshire CCG
Central 40 Lime Tree Way
Crockford Lane
Chineham Business Park
Chineham
Basingstoke
RG24 8GU
United Kingdom
NHS Tees Valley CCG
North Ormesby Health Village
First Floor, 14 Trinity Mews
North Ormesby
Middlesbrough
TS3 6AL
United Kingdom
NHS Shropshire CCG
William Farr House
Mytton Oak Road
Shrewsbury
SY3 8XL
United Kingdom
NHS Telford and Wrekin CCG
Halesfield 6
Epic Park
Telford
TF7 4BF
United Kingdom
Cornwall Partnership NHS Foundation Trust
Carew House
Beacon Technology Park
Dunmere Road
Bodmin
PL31 2QN
United Kingdom
NHS Isle of Wight CCG
Unit a
The Apex
St Cross Business Park
Newport
PO30 5XW
United Kingdom
NHS Portsmouth CCG
4th Floor
1 Guildhall Square
Portsmouth
PO1 2GJ
United Kingdom
Wrightington, Wigan and Leigh NHS Foundation Trust
Royal Albert Edward
Infirmary
Wigan Lane
Wigan
WN1 2NN
United Kingdom
Royal Cornwall Hospitals NHS Trust
Royal Cornwall Hospital
Treliske
Truro
TR1 3LJ
United Kingdom
NHS Devon CCG
County Hall
Topsham Road
Exeter
EX2 4QL
United Kingdom
King Edward VII Hospital
NHS East Berkshire CCG
St Leonards Road
Windsor
SL4 3DP
United Kingdom
NHS Wakefield CCG
White Rose House
West Parade
Wakefield
WF1 1LT
United Kingdom
St. Martin's Hospital
NHS Bath and North East Somerset, Swindon and Wiltshire CCG
Clara Cross Lane
Bath
BA2 5RP
United Kingdom

Sponsor information

University College London
University/education

1st floor, Maple House (Suite B)
149 Tottenham Court Road
London
W1T 7DN
England
United Kingdom

Phone +44 (0)2034475696
Email pushpsen.joshi1@nhs.net
Website http://www.ucl.ac.uk/
ROR logo "ROR" https://ror.org/02jx3x895

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location
United Kingdom

Results and Publications

Intention to publish date30/06/2022
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planThroughout the project, the researchers will regularly share feedback on their findings. They will share this information through their networks and findings will be available on their website. The researchers aim to publish their findings in academic journals and submit a final report to their funder, the National Institute for Health Research.
IPD sharing planThe datasets generated during and/or analysed during the current study are not expected to be made available as some of the data collected are identifiable personal data.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file version V1.2 10/02/2021 19/02/2021 No No
Results article Observational results on impact of post-hospital remote monitoring 01/06/2022 05/12/2022 Yes No
Results article Observational results on impact of remote home monitoring 01/03/2022 05/12/2022 Yes No
Results article Patients' experiences and engagement 07/07/2022 05/12/2022 Yes No
Other publications Learning networks in the pandemic: mobilising evidence for improvement 07/10/2022 13/02/2023 Yes No
HRA research summary 28/06/2023 No No
Results article effectiveness, costs, implementation, and staff and patient experiences 31/07/2023 10/10/2023 Yes No

Additional files

ISRCTN14962466_PROTOCOL_V1.2_10Feb21.pdf
Uploaded 19/02/2021

Editorial Notes

10/10/2023: Publication reference added.
13/02/2023: Publication reference added.
05/12/2022: Publication references added.
19/02/2021: Uploaded protocol Version 1.2, 10 February 2021.
10/02/2021: Trial’s existence confirmed by National Institute for Health Research (NIHR).