Condition category
Infections and Infestations
Date applied
05/05/2020
Date assigned
27/07/2020
Last edited
05/08/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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.

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.

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 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 data base 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 April 2021

Who is funding the study?
1. NIHR ARC South London (UK)
2. MRC (UK)
3. Cicely Saunders International (UK)

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

Trial website

https://www.kcl.ac.uk/cicelysaunders/research/evaluating/covpall-study

Contact information

Type

Public

Primary contact

Miss Rachel Cripps

ORCID ID

Contact details

King's College London
Bessemer Road
London
SE5 9PJ
United Kingdom
-
palliativecare@kcl.ac.uk

Type

Scientific

Additional contact

Prof Irene Higginson

ORCID ID

Contact details

King's College London
Bessemer Road
London
SE5 9PJ
United Kingdom
+44 (0)207 848 5516
irene.higginson@kcl.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

LRS-19/20-18541, IRAS 282824

Study information

Scientific title

Rapid evaluation of the COVID-19 pandemic response in PALLiative and end of life care: national delivery, workforce and symptom management (CovPall)

Acronym

CovPall

Study hypothesis

The aim of this study is to evaluate the UK palliative care and end-of-life care response to COVID-19 in terms of services, workforce and symptom management to provide rapid clinical and policy guidance to optimise the response of palliative care clinicians and services to the COVID-19 pandemic.

Ethics approval

1. Approved 21/04/2020, King’s College London Research Ethics committee (Franklin Wilkins Building, 5.9 Waterloo Bridge Wing, Waterloo Road, London, SE1 9NH, UK; +44 (0)20 7848 4020; rec@kcl.ac.uk), ref: LRS-19/20-18541
2. Approved 15/05/2020, Health Research Authority (HRA) and NHS Research Ethics Committee (Barlow House, 3rd Floor, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 (0)207 104 8010; approvals@hra.nhs.uk), ref: 20/NW/0258

Study design

Observational Online survey and qualitative case studies followed by Cohort study

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Other

Trial type

Other

Patient information sheet

https://www.kcl.ac.uk/cicelysaunders/research/images/covpall-survey-wp1-information-sheet-v3.pdf

Condition

COVID-19 (SARS-CoV-2 infection), palliative and end of life care

Intervention

WP1: Online survey of palliative care providers, with in-depth qualitative case study of sampled providers. Data will be collected using REDCap.

WP2: Cohort study of people with COVID-19 receiving palliative care input, with data collected at four timepoints, at first assessment (baseline, T0), 24-hour follow-up, ideally twice, but this will depend on survival (T1, T2), and then at death or discharge (D or Di).

WP1 and WP2 are run quickly, (phase I) and analysed. Then both WP1 and WP2 are repeated 6-8 weeks later (phase II), when case studies are added, to gauge key changes.

Intervention type

Other

Phase

Drug names

Primary outcome measure

WP1. Innovations in services, workforce and volunteer deployment, and their impacts on care and bereavement services; identification of good practice, and sharing of approaches and knowledge. Change in practice, most effective treatments collected at baseline and 6-8 weeks later
WP2. Symptom and problem assessment measured using IPOS score at first assessment (baseline, T0), 24-hour follow-up, ideally twice, but this will depend on survival (T1, T2), and then at death or discharge (D or Di)

Secondary outcome measures

There are no secondary outcome measures

Overall trial start date

01/04/2020

Overall trial end date

24/04/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

WP1: Clinical leads of palliative and hospice care services including: palliative care teams in acute hospitals, in-patient hospices/palliative care wards and palliative care community services providing care in peoples own homes and supporting care homes, usually for adults and children.
WP2: Consecutive patients supported by the participating palliative care services in WP1 (including remote consultation), with clinically diagnosed and/or test confirmed COVID-19 diagnosis. This will include patients with and without pre-existing progressive conditions.

Participant type

Mixed

Age group

Mixed

Gender

Both

Target number of participants

WP1: Targeted invitation to participate directed to providers of specialist palliative and end-of-life care services in the UK; estimated responses from 390 services. WP2: 200 patients receiving palliative care. 9-11 consecutive patients per service from 20 services, would give baseline data on 180-220 patients, follow-up data on 80-100 (allowing for 50-60% attrition from those who die too quickly to give more than baseline or baseline plus T1, estimate based on audit in one service). 80 patients with follow-up data are needed to detect a difference of 5 points on IPOS (SD=6) between two groups (80 percent power, two-sided 0.05 significance level, mean MCID, SD based on previous research). This sample size will also allow the researchers to identify clear subgroups and actual mean and SDs to enable them to develop hypotheses and sample size calculation for the future.

Participant exclusion criteria

WP1: No lead or delegate available
WP2: Patients who are <18 years old

Recruitment start date

24/04/2020

Recruitment end date

31/01/2021

Locations

Countries of recruitment

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

Trial participating centre

Cicely Saunders Institute at King’s College London
Bessemer Road
London
SE5 9PJ
United Kingdom

Trial participating centre

Wolfson Palliative Care Research Centre at University of Hull
Allam Medical Building, University of Hull
Hull
HU6 7RX
United Kingdom

Trial participating centre

Martin House Research Centre at University of York
Area 2 Seebohm Rowntree Building
Heslington
YO10 5DD
United Kingdom

Trial participating centre

International Observatory on End of Life Care at Lancaster University
Furness College, Hazelrigg Lane
Lancaster
LA1 4YG
United Kingdom

Sponsor information

Organisation

King's College London

Sponsor details

Franklin Wilkins Building
5.9 Waterloo Bridge Wing
Waterloo Road
London
SE1 9NH
United Kingdom
+44 (0)20 7848 4020
rec@kcl.ac.uk

Sponsor type

University/education

Website

http://www.kcl.ac.uk/index.aspx

Organisation

King's College Hospital NHS Foundation Trust

Sponsor details

Research and Innovation Office
161 Denmark Hill
London
SE5 8EF
United Kingdom
+44 (0)20 3299 1980
kch-tr.research@nhs.net

Sponsor type

Hospital/treatment centre

Website

https://www.kch.nhs.uk/

Funders

Funder type

Government

Funder name

NIHR ARC South London

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Cicely Saunders International

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Medical Research Council

Alternative name(s)

MRC

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The researchers will release first results (from phase 1) after WP1 is completed at around 2-3 months into the project, for WP2, at 3 months. They will conduct a midpoint analysis during the study to determine whether there are emerging findings, which they should report. These will be reporting to the study steering committee. Phase II will give more reflective and larger analysis where it will be possible to collect additional data and conduct case studies. This will help also if the pandemic/epidemic risks returning.

The final analysis and report (12 months) will also provide a blueprint for the management in future COVID-19 or similar epidemics/pandemics.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.

Intention to publish date

24/04/2021

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/08/2020: The funder "Medical Research Council" has been added. 19/06/2020: Trial’s existence confirmed by King's College London.