Case study: Critical care research at Maidstone and Tunbridge Wells NHS Trust transformed into COVID-19 trials
CRN Kent, Surrey and Sussex spoke to Ciaran Hart, Critical Care Research Nurse and Claire Pegg, Lead Research Nurse at Maidstone Hospital and Tunbridge Wells Hospital about their experience of working on REMAP-CAP and The GenOMICC Study, and other COVID-19 studies.
Ciaran Hart said: Other sites across the country opened REMAP-CAP and The GenOMICC Study because of the pandemic but were able to implement the COVID arm of REMAP-CAP pretty swiftly because it was already running which made it easier for us as it is difficult study to get your head around but we were already used to how it worked.”
“REMAP-CAP is a platform trial looking at how we treat community-acquired pneumonia. It looks at multiple different interventions under the umbrella of one trial. A patient can be randomised to multiple platforms so it might mean that if they are not eligible for one aspect of the trial they could be eligible for another arm, or all domains of the trial. Before COVID-19 we were looking at which antibiotics made a difference and were going to open the steroid arm”
The study uses a study design known as a REMAP - a Randomised, Embedded, Multifactorial, Adaptive Platform trial. Patients who are eligible to participate are randomised to receive one intervention in each of one or more categories of treatment (domains). These interventions can be tested simultaneously. The study was designed for the event of an epidemic of a novel or re-emerging respiratory pathogen and in the case of COVID-19 the platform responded rapidly.
Ciaran Hart added: “Because REMAP-CAP is a critical care study, patients in ICU don't generally have the capacity to consent to take part in the trial. When patients are admitted to the intensive care unit (ICU) they are ventilated and sedated so consultants will decide whether it will be in the patient's best interest or not to participate. Normally we would approach the relatives but as we haven't been able to have any visiting we have not been able to do this. The patients that I have spoken to are very keen to take part in any research that will help the pandemic, and this applies to all the studies we are involved in.”
Another urgent public health study already open at the trust was The GenOMICC Study (Genetics Of Mortality In Critical Care). Before COVID-19 the GenOMICC study was looking at emerging infections (SARS/MERS/Flu), sepsis, and other forms of critical illness.
Ciaran Hart said: “We opened The GenOMICC Study last autumn. It is interesting looking at the unknowns and why some people fall particularly ill with an infection when other people don't and the answer may be in DNA. We aim to recruit anyone who has tested COVID-19 positive, whereas before we were only recruiting people aged over 70 with particular illnesses. People have been keen to participate in this study and donate blood.”
Maidstone and Tunbridge Wells NHS Trust has also been running the COVID-19 related RECOVERY trial and been involved with CCP-UK.
Claire Pegg said: “We have been fortunate to have support from our executive leaders from the start for these trials. Emails have gone out to all members of staff across the trust from our lead clinician and medical director talking about the importance of all of the COVID-19 trials and studies and how colleagues can help deliver these studies to benefit our patients.”
“We have a research pathway for every patient coming into our hospitals with COVID-19. We are Tier 0 for CCP-UK so patients do not need to consent, but we do collect data on every single patient that comes through who is COVID-19 positive. If a patient deteriorates and needs active treatment, they can be offered the RECOVERY trial. If they deteriorate even further, then we can offer them the REMAP-CAP trial within ICU. We also have the GENOMICS study. I think it is great that as a distinct general hospital we’ve been able to offer patients from every clinical pathway an opportunity to take part in research.”