Case study: Pandemic brings new ways of delivering research

We’ve all made changes in response to the coronavirus pandemic. This happened very quickly on the frontline of research delivery, as staff found new ways of working safely and effectively.

"Our studies were quickly suspended."

Sindu Srikaran, Research Coordinator based at Northwick Park Hospital (NPH), part of London North West University NHS Trust, supports genetic studies in the North West Thames Regional Genetics Service at NPH and at Imperial College Healthcare NHS Trust, supervised by the R&D department at NPH and the NIHR Clinical Research Network (CRN) North West London genetics lead Dr. Fleur van Dijk. During the pandemic she was asked to help the research team at NPH to deliver priority COVID-19 research.

“Our studies were quickly suspended”, recalls Sindu. “We took on COVID-19 studies but I couldn’t go onto the ICU because I had a household member who was shielding.”

The GenOMICC study — supported by the NIHR CRN North West London — was already up-and-running before the pandemic hit, aiming to identify genetic changes that cause some people to be vulnerable to certain infectious diseases. The study was quickly adapted to explore COVID-19. Dr. Alastair McGregor, Infectious Disease consultant, was asked to be Principal Investigator at NPH.

“I looked over the protocol and made a plan on how to recruit together with the research team”, Sindu said. “However, I needed someone to help with sample collection. I could run the study, I just had to make sure I didn’t need to go to the ICU.”

This particular problem was solved as Dr Catherine Dennise, Clinical Genetics Specialist Registrar had been redeployed to NPH ICU. Sindu and Catherine collaborated intensely over the following weeks and months.

Successful delivery of this study has been down to flexible working, technology and responding effectively to fast changing guidance. Recruiting ICU patients has been a particular challenge.

Assigning research team members tasks they could safely deliver was the first challenge. The issue of gaining consent from ICU patients was the next: “All of our patients were sedated and ventilated so we couldn’t get consent from them”, Sindu said. “We had to contact the next-of-kin and also have witnesses to make sure no one was being coerced.”

Taking part in research feels like a big ask at this time, particularly when the study has no direct benefit to the patient. It involves giving a small blood sample and the goal is that the findings go on to help other critically ill patients in future. Having these conversations over the telephone was difficult but necessary.

The relative who had to decide did not have the luxury of time. Patients and families would normally have a week-or-so to consider signing up to a study. But the urgency of the pandemic meant things had to move at a much faster pace. The team were very aware of the impact this would have.

“I would call them back later on in the day or sometimes the next day”, Sindu said. “They’re stressed because of a loved one being in the hospital and every time they get a call from the hospital they’re thinking ‘this is bad news’, so I always tried to put them at ease.”

"The patients were really tired and in a fragile state."

As time went on, fewer patients were admitted to ICU. The team were thankful for this, but still needed to meet their recruitment target of 20 individuals. This meant approaching patients who had just left ICU and had been stepped down to medical wards. This presented new issues.

“The patients were really tired and in a fragile state. So we would talk to them over a couple of days to give them time to process the information”, Sindu said.

Catherine would go to the ward — wearing the necessary personal protective equipment — after having had a video call with Sindu to discuss the consenting process “to talk to the patients to make sure they were happy to take part”.

The team also provided input with regards to data capturing which was important as the study was initially designed for other infectious diseases and not specifically for COVID-19. By trying to capture as much clinical detail of patients with COVID-19 as possible, the team made sure that important details of patients with COVID-19 were registered.

Technology has been key to the successful delivery of research during this pandemic. Using video calls has meant that teams could still work effectively together, even when working remotely. Sindu has been able to play a big part in the delivery of the research, while also protecting a household member who was shielding.

It was also an important opportunity for the Clinical Genetics Registrar to be involved in recruiting to a research study, as this fits with an important aim of CRN to try to involve more medical professionals in the delivery of clinical research during their training.

Going forward, Sindu and the team are looking forward to restarting the studies that were paused as the pandemic took hold. “All the genetic studies are starting to reopen. It isn’t happening yet but we are starting to prepare.”

And those preparations will include discussions on what new ways of working will be implemented permanently. The pandemic has led most people — patients and staff — to engage with technology like never before. It has shown how certain processes can be streamlined, leading to better ways of working and fewer site visits for patients. The future is likely to see better use of technology “if the patients are happy”, Sindu said.

The team at Northwick Park are in the top 20 national recruiting sites for the GenOMICC study, hitting their target of 20 recruits. They are now helping Ealing Hospital with their target of recruiting 10 individuals with COVID-19.

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