Predicting risk of hospital admission in patients with suspected COVID-19 in a community setting: protocol for development and validation of a multivariate risk prediction tool (RECAP).

BACKGROUND: During the pandemic, remote consultations have become the norm for assessing patients with signs and symptoms of COVID-19 to decrease the risk of transmission. This has intensified the clinical uncertainty already experienced by primary care clinicians when assessing suspected COVID-19 patients and has prompted the use of risk prediction scores, such as NEWS2, to assess severity and guide treatment. However, the risk prediction tools available have not been validated in a community setting and are not designed to capture the idiosyncrasy of COVID-19 infection.
OBJECTIVE: The objective of this study is to produce a multivariate risk prediction tool (RECAP-V1) to support primary care clinicians in the identification of those COVID-19 patients that are at higher risk of deterioration and facilitate the early escalation of their treatment with the aim of improving patient outcomes.
METHODS: The study follows a prospective cohort observational design, whereby patients presenting in primary care with signs and symptoms suggestive of COVID-19 will be followed and their data linked to hospital outcomes (hospital admission and death). Data collection will be carried out by primary care clinicians in four arms, i.e., North West London Clinical Commissioning Groups (NWL CCGs), Oxford-Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC), Covid Clinical Assessment Service (CCAS) and South East London CCGs (Doctaly platform) and involves the use of an electronic template that incorporates a list of items (known as RECAP-V0) thought to be associated with disease outcome according to previous qualitative work. Data collected will be linked to patient outcomes in highly secure environments (iCARE and ORCHID). We will then use multivariate logistic regression analyses for model development and validation.
RESULTS: Recruitment of participants started in October 2020. Initially, only NWL CCGs and RCGP RSC arms were active. As of 24th of March 2021, we have recruited a combined sample of 3,827 participants in these two arms. CCAS and Doctaly joined the study in February 2021, with CCAS starting recruitment process on the 15th of March 2021. The first part of the analysis (RECAP-V1 model development) is planned to start in April 2021 using the first half of the NWL CCGs and RCGP RSC combined dataset. Posteriorly, the model will be validated with the rest of NWL CCGs and RCGP RSC data as well as CCAS and Doctaly datasets. The study was approved by the Research Ethics Committee on the 27th of May 2020 (IRAS number 283024, REC reference number: 20/NW/0266) and badged as NIHR Urgent Public Health Study on 14th of October 2020.
CONCLUSIONS: We believe the validated RECAP-V1 early warning score will be a valuable tool for the assessment of suspected COVID-19 patients' severity in the community, either in face-to-face or remote consultations, and will facilitate the timely escalation of treatment with the potential to improve patient outcomes. CLINICALTRIAL: ISRCTN registry (ISRCTN13953727). INTERNATIONAL REGISTERED REPORT: DERR1-10.2196/29072.