Condition category
Infections and Infestations
Date applied
19/10/2020
Date assigned
02/11/2020
Last edited
02/11/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
New methods to assess and improve the management of Covid-19 patients are essential to maximise safety for patients and health care providers.
The RECAP (Remote COVID-19 Assessment in Primary Care) project emerged as a collaboration between the University of Oxford and Imperial College London with the aim of developing a tool to assist primary care providers in the identification of those COVID-19 patients at risk of becoming severe, in order to enable the rapid escalation of their treatment and increase the chances of better outcomes.

Who can participate?
We are recruiting primary care centres across England to collaborate with us in the identification and assessment of patients with signs and symptoms of Covid-19 and recording patient's characteristics at the time of appointment (either face-to-face or video/telephone consultation). Any practice is welcome to collaborate as long as it uses an electronic medical record system that supports the Covid-19 assessment template developed for the study. Practices may be asked to join the RCGP Research and Surveillance Centre in order to participate since this will ensure data collected can be linked to hospital outcomes. Patients recruited must have signs and symptoms of Covid-19 infection, be 18 years old or older, and be able to provide inform consent.

What does the study involve?
Interested practices will be accepted into the study by a member of the study team, who will provide more information on the study. The participation involves the deployment of the Covid-19 electronic template in EMIS or SystmOne each time the general practitioner identifies a patient that fulfils the inclusion criteria. Patients' consent will be recorded by clicking a box in the template. Once the completed template is saved, the data will be automatically extracted for the study.

What are the possible benefits and risks of participating?
General practitioners and patients will benefit from a more systematic assessment of the patient's condition thanks to the use of the Covid-19 assessment template in their electronic medical records. Moreover, when the risk prediction score is developed, general practitioners will be able to identify patients at risk of severe disease and escalate their treatment as appropriate, which will hopefully improve patient safety and disease outcomes. We do not anticipate any risks for patients or general practitioners taking part in the study.

Where is the study run from?
Imperial College London and University of Oxford (UK)

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

Who is funding the study?
1. NIHR Oxford Biomedical Research Centre (UK)
2. NIHR Imperial Biomedical Research Centre (UK)
3. NIHR Imperial Patient Safety Translational Research Centre (UK)
4. Economic and Social Research Council (UK)
5. Community Jameel Imperial College Covid-19 Excellence Fund (UK)

Who is the main contact?
Dr Ana Belen Espinosa-Gonzalez
a.espinosa-gonzalez15@imperial.ac.uk

Trial website

https://imperialbrc.nihr.ac.uk/research/covid-19/covid-19-ongoing-studies/recap/

Contact information

Type

Scientific

Primary contact

Dr Ana Belen Espinosa Gonzalez

ORCID ID

http://orcid.org/0000-0002-8226-416X

Contact details

10th Floor Queen Elizabeth Queen Mother Wing
St Mary's Hospital South Wharf Road
London
W2 1NY
United Kingdom
+44 (0)7472035868
a.espinosa-gonzalez15@imperial.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 283024, CPMS 45890

Study information

Scientific title

Remote COVID-19 Assessment in Primary Care: a learning system approach to develop an early warning score for use by primary care practitioners

Acronym

RECAP

Study hypothesis

Early warning scores (EWSs) are often used in medicine these days. For example, the National Early Warning Score (NEWS2) is used in hospitals to alert nurses and doctors to someone who is deteriorating and may need urgent assessment and treatment. This validity of this score to identify Covid-19 patients at risk of severity has been a subject of intense debate among clinicians and academic community during the height of the first Covid-19 wave. It considers features such as pulse, blood pressure, respiratory rate, oxygen saturation level and conscious level. The more abnormal these features are, the sicker the patient is likely to be. However, the use of NEWS2 outside the hospital setting has not been validated, and, more importantly, it is not COVID-19-specific. We would like to develop an EWS that is both COVID-19-specific and that can be used by general practitioner's (GPs) when dealing with patients with signs and symptoms of Covid-19 infection.

Ethics approval

Approved 27/05/2020, North West-Greater Manchester East Research Ethics Committee (3rd Floor, Barlow House, 4 Minshull Street, Manchester, M1 3DZ, UK; +44 (0)207 104 8199; gmeast.rec@hra.nhs.uk), ref: 20/NW/0266

Study design

Multi-centre observational prospective cohort study.

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

GP practices

Trial type

Other

Patient information sheet

https://imperialbrc.nihr.ac.uk/wp-content/uploads/2020/10/RECAP_Patient_information_Sheet.pdf

Condition

Prognosis of patients with a clinical diagnosis of Covid-19 infection

Intervention

Based on an initial model previously defined with qualitative data, the study team will firstly design a template to be completed by GPs when assessing patients with signs and symptoms of Covid-19 infection. The template will be activated in either EMIS or SystmOne software, which are widely used in GP practices across England. Once the template is completed, the anonymised patient information will be linked to hospital outcomes. In North West London, primary care data is already linked to hospital data. In other sites, patients' consent for data linkage will be requested at the time of filling the template (by clicking a box on the template).

Once we have collected primary care data on patients with possible Covid-19 infection and linked their data to hospital outcomes, we will run logistic regressions analysis to identify those patients' characteristics (symptoms, signs, age, ethnicity) that seem to predict patients' outcomes (i.e., hospital admission, ICU admission and death). Models obtained through classical statistical methods will be compared with predictive models obtained with machine learning techniques.

Finally, the patients' characteristics that seem to have higher predictive power will be included in the final risk prediction score that will be built into the electronic Covid-19 templates in EMIS and SystmOne. This will guide GPs on the management of Covid-19 patients and allow early escalation of patients' treatment in cases of high likelihood of severity.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Hospital admission defined as hospital stay of 24 hours or longer during the period of study measured using patient records

Secondary outcome measures

1. Intensive Care Unit admission defined as admission in an intensive care unit of any length during the period of study measured using patient records
2. Death during the period of study measured using patient records

Overall trial start date

15/05/2020

Overall trial end date

01/04/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Patients:
1. At least 18 years old
2. Seek care at their primary care centre for signs and symptoms compatible with Covid-19 infection
3. Consent for their data to be linked to hospital data (only for practices outside North West London).

Primary care practices:
1. Based in NWL CCG or belong to the RCGP Research and Surveillance Centre
2. Use SystmsOne or EMIS software

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2,870

Participant exclusion criteria

Primary care practice sites:
Not using a compatible electronic record system or using a remote monitoring system that cannot provide an output that is at least mapped to the appropriate SNOMED concepts

Recruitment start date

01/10/2020

Recruitment end date

28/02/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Imperial College London
North West London CRN 10th Floor Queen Elizabeth Queen Mother Wing St Mary's Hospital South Wharf Road
London
W2 JNY
United Kingdom

Trial participating centre

University of Oxford
RCGP Research and Surveillance Centre Radcliffe Primary Care Building Radcliffe Observatory Quarter Woodstock Road
Oxford
OX2 6GG
United Kingdom

Sponsor information

Organisation

Imperial College London

Sponsor details

Imperial College Healthcare NHS Trust
Room 215
Medical School Building
St Mary's Hospital
Praed Street
London
W21NY
United Kingdom
+44 (0)20 759 49459
Becky.ward@imperial.ac.uk

Sponsor type

University/education

Website

https://www.ic.ac.uk/clinicalresearchgovernanceoffice

Funders

Funder type

University/education

Funder name

Community Jameel Imperial College COVID-19 Excellence Fund

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NIHR Oxford Biomedical Research Centre

Alternative name(s)

NIHR Biomedical Research Centre, Oxford, OxBRC

Funding Body Type

private sector organisation

Funding Body Subtype

Research institutes and centers

Location

United Kingdom

Funder name

Patient Safety Translational Research Centre

Alternative name(s)

NIHR Imperial Patient Safety Translational Research Centre, PSTRC, NIHR Imperial PSTRC

Funding Body Type

government organisation

Funding Body Subtype

Research institutes and centers

Location

United Kingdom

Funder name

Economic and Social Research Council

Alternative name(s)

ESRC

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Funder name

NIHR Imperial Biomedical Research Centre

Alternative name(s)

Imperial Biomedical Research Centre, NIHR Imperial BRC, BRC

Funding Body Type

private sector organisation

Funding Body Subtype

Research institutes and centers

Location

United Kingdom

Results and Publications

Publication and dissemination plan

We are currently disseminating the study via Twitter and the Institute of Global Health Innovation blog, where we have scheduled an entry for November 2020.
We are preparing a manuscript to be submitted to a high-impact peer-reviewed journal at the end of the year or as soon as we have some preliminary results.
The protocol is available at https://imperialbrc.nihr.ac.uk/wp-content/uploads/2020/10/RECAP-06-STUDY-PROTOCOL.pdf

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication

Intention to publish date

02/02/2020

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

NHW 20/10/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR)