Assessing patients’ risk of COVID-19 severe infection: developing a risk prediction score
| ISRCTN | ISRCTN13953727 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13953727 |
| IRAS number | 283024 |
| Secondary identifying numbers | IRAS 283024, CPMS 45890 |
- Submission date
- 19/10/2020
- Registration date
- 02/11/2020
- Last edited
- 29/08/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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 February 2022
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
Contact information
Scientific
10th Floor Queen Elizabeth Queen Mother Wing
St Mary's Hospital South Wharf Road
London
W2 1NY
United Kingdom
 ORCID ID |
0000-0002-8226-416X |
|---|---|
| Phone | +44 (0)7472035868 |
| a.espinosa-gonzalez15@imperial.ac.uk |
Study information
| Study design | Multi-centre observational prospective cohort study. |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | GP practice |
| Study type | Other |
| Participant information sheet | https://imperialbrc.nihr.ac.uk/wp-content/uploads/2020/10/RECAP_Patient_information_Sheet.pdf |
| 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 |
| Study acronym | RECAP |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 15/05/2020 |
| Completion date | 02/02/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 2,870 |
| Total final enrolment | 8311 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2020 |
| Date of final enrolment | 28/02/2021 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
10th Floor Queen Elizabeth Queen Mother Wing
St Mary's Hospital South Wharf Road
London
W2 JNY
United Kingdom
Radcliffe Primary Care Building
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
Sponsor information
University/education
Imperial College Healthcare NHS Trust
Room 215, Medical School Building
St Mary's Hospital
Praed Street
London
W21NY
England
United Kingdom
| Phone | +44 (0)20 759 49459 |
|---|---|
| Becky.ward@imperial.ac.uk | |
| Website | https://www.ic.ac.uk/clinicalresearchgovernanceoffice |
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
University/education
No information available
Private sector organisation / Research institutes and centers
- Alternative name(s)
- NIHR Biomedical Research Centre, Oxford, OxBRC
- Location
- United Kingdom
Government organisation / Research institutes and centers
- Alternative name(s)
- NIHR Imperial Patient Safety Translational Research Centre, PSTRC, NIHR Imperial PSTRC
- Location
- United Kingdom
Government organisation / National government
- Alternative name(s)
- ESRC
- Location
- United Kingdom
Private sector organisation / Research institutes and centers
- Alternative name(s)
- NIHR Imperial BRC, Imperial Biomedical Research Centre, BRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/04/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| 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 plan | All data generated or analysed during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 25/05/2021 | 05/05/2021 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | Development and validation of RECAP prediction tools | 01/09/2022 | 29/08/2023 | Yes | No |
Editorial Notes
29/08/2023: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The overall study end date has been changed from 30/05/2021 to 02/02/2022 and the plain English summary updated accordingly.
05/05/2021: Publication reference added.
15/04/2021: The following changes were made to the trial record:
1. The overall trial end date was changed from 01/04/2021 to 30/05/2021.
2. The intention to publish date was changed from 02/02/2020 to 30/04/2021.
NHW 20/10/2020: Trial’s existence confirmed by National Institute for Health Research (NIHR)
