CovPall: Improving palliative care for people affected by the COVID-19 pandemic by sharing learning – the national and international response

Plain English Summary

Background and study aims
The COVID-19 pandemic is placing an unprecedented strain on health services, with an estimated 1-4% of people dying from this new disease. Some of the symptoms, such as breathlessness, fever, agitation and pain, are very distressing. But in this new disease these symptoms are not well understood. Palliative care services are adapting rapidly to this situation, but in different ways, not knowing what is best.
This research aims to rapidly evaluate the palliative care response in COVID-19 to improve care in the future. There are two main components, called work packages, to the research.

Added 11/05/2021:
In December 2020 the researchers received additional funding following a rapid call for COVID-19 data research initiatives by Health Data Research UK, Office for National Statistics and UK Research and Innovation (UKRI) to ‘build on existing UKRI and NIHR work to use national data to answer key COVID-19 research questions’ (https://www.hdruk.ac.uk/news/projects-to-accelerate-use-of-data-for-vital-covid-19-research/). This project is an extension of CovPall and is called CovPall-Connect.

Who can participate?
WP1. Voluntary hospices, hospital based palliative care teams, home care/community teams and other services that offer palliative and/or end of life care.
WP2. Services participating in WP1 from the UK, able to collect information on ≥10 patients in their care. We aim to recruit ~20 services across settings (hospital, community, voluntary hospice), and areas with different cultural/ethnic and socioeconomic diversities.

What does the study involve?
There are two main components, called work packages, to the research.
WP1 will survey, UK wide, palliative care clinical leads in different services, about their changes in practice, how they use the workforce and volunteers and what symptom management they are using. Later, we will collect some more detailed information from a small number of services through interviewing them.
WP2 collects data about patients’ symptoms, how they change over time, and the effects of treatments.

Added 11/05/2021:
CovPall-Connect will use national data to boost findings from CovPall. The researchers hope to allow the use of CovPall data for other research. They will assess how the response to COVID-19 affects a number of factors, looking at the following:
- Whether the number of people dying during COVID-19 was reported correctly, or if some deaths were missed
- The number of cases of COVID-19 in the UK population
- The number of people admitted to hospital with COVID-19 and the number of people discharged
- Business, financial and social impacts of COVID-19
- How charities have supported health services and how this information can be captured
- How palliative care information should be collected in the future, focusing on patients with more than one illness

What are the possible benefits and risks of participating?
The research team will draw on their considerable experience in conducting research in this area to ensure a design sensitive to this professional and patient group. We have worked with service teams to discuss the acceptability of the research aims, design and local implementation.
WP1: Qualitative case studies: Interviews will be organised at a time and place to suit the participants, and conducted by researchers with experience of discussing sensitive topics. Written consent will be obtained from all participants in the qualitative case studies, and regular checks made that participants are happy to continue. Arrangements will be made to inform participants of support agencies if required. The main anticipated risk is that of becoming unduly distressed whilst discussing issues associated with the extreme challenges of the COVID-19 pandemic. We will work to minimise this risk by conducting the interviews in a sensitive and responsive manner, drawing on our research and clinical experience in this field. We have a clear distress protocol to be followed during the research should any distress be apparent or detected during data collection.
There is also the possibility that participants may disclose information about care which reveals risk or poor practice. If they do, this situation will be discussed with the participant and their views on sharing this information with a senior member of staff sought. Where possible their views will be respected, but if a situation is revealed which severely compromises their own or others health or wellbeing, the researcher will inform the participant that they have a duty to disclose this information to the most relevant person.
WP2: We have designed this data collection to be feasible in the current circumstances by minimising the burden on the direct clinical care team whilst maintaining patient confidentiality. There is no burden
We are collecting individual-level pseudonymised patient data that will be securely transferred to the research team at Kings College London via REDcap. This is done by sending via secure email (e.g. NHS mail) each participating service a unique set of 11 randomly generated codes. They use one code per patient about which they enter information. They keep a local record of the details of which patient has been assigned to which code, but this information is not transferred to the research team. The REDcap database does not include any identifying features, including the name of the service, its region, nor any patient identifiable details. ). Obtaining patient consent in the current situation is not feasible therefore we have minimised the dataset to remove any confidential patient information e.g. changed date of birth to age, postcode to LSOA.
These will still be individual-level data, albeit pseudonymised, so we will ensure that these data are transferred securely between research sites and Kings College London. Once on the Kings College London server they will be held securely on password-protected encrypted files.
Current infection control policies restrict our ability to display posters at the study sites, but transparency statements will be made available on the Kings College website and all participating study sites so that patients are informed of this study.

Where is the study run from?
1. Cicely Saunders Institute, King’s College London (UK) in collaboration with:
2. Wolfson Palliative Care Research Centre at the University of Hull (UK)
3. Martin House Research Centre at the University of York (UK)
4. International Observatory on End of Life Care at Lancaster University (UK)

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

Who is funding the study?
1. Jointly funded by UK Research and Innovation (Medical Research Council) and NIHR (COV0011; MR/V012908/1) (UK)
2. Cicely Saunders International (UK)
3. HDRUK (UK) (HDRUK2020.145)

Who is the main contact?
Mev Hocaoglu or Rachel Cripps (palliativecare@kcl.ac.uk)

Study website

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• Argentina
• Australia
• Brazil
• Canada
• England
• India
• Ireland
• Netherlands
• Portugal
• South Africa
• Switzerland
• United Kingdom

Study participating centres

Sponsor information

King's College London
University/education

Franklin Wilkins Building
5.9 Waterloo Bridge Wing
Waterloo Road
London
SE1 9NH
England
United Kingdom

Phone	+44 (0)20 7848 4020
Email	rec@kcl.ac.uk
Website	http://www.kcl.ac.uk/index.aspx
"ROR"	https://ror.org/0220mzb33

King's College Hospital NHS Foundation Trust
Hospital/treatment centre

Research and Innovation Office
161 Denmark Hill
London
SE5 8EF
England
United Kingdom

Phone	+44 (0)20 3299 1980
Email	kch-tr.research@nhs.net
Website	https://www.kch.nhs.uk/
"ROR"	https://ror.org/01n0k5m85

Funders

Funder type

Government

Results and Publications

Study outputs

Additional files

ISRCTN16561225_PROTOCOL_V4.0_28Oct20.pdf

Editorial Notes

06/08/2024: Publication references added.
19/10/2022: Protocol uploaded (not peer reviewed).
24/11/2021: Trial websites, WP2 total final enrolment number and individual participant data (IPD) sharing statement added.
20/10/2021: The overall trial end date has been changed from 30/09/2021 to 30/11/2021 and the plain English summary has been updated accordingly.
11/05/2021: The following changes were made to the trial record:
1. The scientific title was updated to add "CovPall-Connect: Evaluation of the COVID-19 pandemic response in palliative and end of life care: connecting to boost impact and data assets."
2. The study hypothesis, plain English summary and publication and dissemination plan were updated.
3. The acronym was updated to add 'CovPall-Connect'.
4. The study design was updated to add 'CovPall-Connect: Data linkage'.
5. The recruitment end date was changed from 31/01/2021 to 21/02/2021.
6. The overall trial end date was changed from 24/04/2021 to 30/09/2021.
7. Health Data Research UK was added as a funder, Medical Research Council was changed to UK Research and Innovation.
24/03/2021: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
19/03/2021: Publication and preprint reference added.
16/03/2021: Internal review.
05/08/2020: The funder "Medical Research Council" has been added.
19/06/2020: Trial’s existence confirmed by King's College London.