Outcomes of Patients Who Survived Treatment on an Intensive Care Unit for COVID-19 in England and Wales

Study Overview
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Brief Summary
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This retrospective cohort study aims to characterise outcomes for patients treated on an intensive care unit (ICU) with COVID-19 in England and Wales, one year after discharge from hospital. Outcomes will be compared with patients admitted as an emergency to an ICU for other conditions. The study will use existing national audit data linked to routine healthcare datasets.

Detailed Description
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Across England and Wales, over 10,000 patients have been treated for severe coronavirus disease 2019 (COVID-19) on an intensive care unit. Around 60% survived to leave hospital. It is unknown how survivors' severe COVID-19 infection, or the treatment they received on the intensive care unit, will affect their long-term health. Understanding what happens to these patients can help ensure they receive suitable care from their General Practitioner (GP) and other National Health Service (NHS) services after they leave hospital. This study will follow up survivors for 1 year after discharge from hospital. The investigators will use data collected by the Intensive Care National Audit and Research Centre (ICNARC) to identify patients who were treated on an ICU for COVID-19. The investigators will then use NHS data to see whether these patients were readmitted to hospital and why. Information from the Office of National Statistics will identify whether patients died. By linking different sources of patient data, the investigators will estimate the health risks faced by survivors of severe COVID-19. These risks will be compared to those in patients treated on an ICU for other conditions.

Official Title
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Outcomes of Patients Who Survived Treatment on an Intensive Care Unit for COVID-19 in England and Wales: a Comparative Retrospective Cohort Study (OPTIC-19)

Conditions
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Covid19, Myocardial Infarction, Stroke, Critical Illness, Heart Failure, Deep Vein Thrombosis, Pulmonary Embolism, Renal Failure

Intervention / Treatment
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* Other: Not applicable as observational study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 16 years or over Admitted to an adult, general ICU in England or Wales as an emergency (unplanned) Admitted to ICU for either: a) confirmed COVID-19 between 1st January to 1st July 2020 or b) without confirmed COVID-19 between 1st July 2016 and 1st July 2020- Exclusion Criteria: Patients who died in hospital after treatment on an ICU

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Covid19<br>Patients admitted to an adult (16 years or over), general ICU in England or Wales as an emergency with confirmed COVID-19 between 1st January to 1st July 2020. | Other: Not applicable as observational study<br>* Not applicable as observational study.<br>|
| Non Covid19<br>Patients admitted to an adult (16 years or over), general ICU in England or Wales as an emergency without confirmed COVID-19 between 1st July 2016 and 1st July 2020. | Other: Not applicable as observational study<br>* Not applicable as observational study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality Rate | Mortality after discharge from hospital | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of emergency hospital admission | Emergency hospital admission | one year | 
| Rate of emergency hospital admission for respiratory infection | Emergency hospital admission for respiratory infection | one year | 
| Rate of emergency hospital admission for a major adverse cardiac event | Emergency hospital admission for a major adverse cardiac event (myocardial infarction, stroke, heart failure) | one year | 
| Rate of emergency hospital admission for a venous thrombotic event | Emergency hospital admission for a venous thrombotic event (deep vein thrombosis or pulmonary embolism) | one year | 
| Rate of development of end stage renal failure | Development of end stage renal failure treated by renal replacement therapy | one year |