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
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