Restarting research at RNOH
The Royal National Orthopaedic Hospital (RNOH) NHS Trust is a designated green site, which means it can continue to provide patient care and deliver clinical research in a COVID-free environment.
The trust, including the Research and Innovation Centre (RIC), has developed protocols and implemented numerous safety measures to obtain and maintain its green site status and to enable the restart of its clinical research activities.
The protocols have enabled them to start bringing patients back for clinical research and currently around 80% of all studies are being reopened. Impressively, they have even opened two new surgical studies.
Iva Hauptmannova, Head of the RNOH RIC, said:
“We have been working with the clinicians who are principal investigators on studies to ensure that we are aware which patients are being brought in for treatment, so we can open studies linked to the hospital priority list. There are patient categories, which are being followed as part of return to normal, so urgent patients are being brought in first.”
Where possible, appointments are now held remotely, either by phone or RNOH’s ‘Attend Anywhere system’, which provides patients with a video clinic.
Those participating in interventional studies who need to come into the hospital, will find many new systems in place for strong infection prevention and controlled practices to ensure both patients and staff are protected.
The new measures have meant that RNOH can safely restart much of their clinical research. The TOPaZ trial, for example, testing treatment for osteogenesis imperfecta (more commonly known as brittle bone disease) provides a great illustration of how the research team have changed protocols to keep the much-needed research running safely.
Patients first go through a detailed assessment to check whether visits can be virtual. Study information is sent to patients in advance, and the patients themselves are now more involved in their own monitoring, by taking on tasks such as weighing themselves and reporting on their medication.
Many of the checks that previously meant a hospital visit can now be conducted at home and patients are able to speak to a clinician if they have any concerns, via a fast track system. Trial medication is also now routinely couriered to patients, which is a bonus for participants as many had previously been required to make a long journey every few months.
Admission and treatment access protocols are being amended all the time based on the latest guidance. This ensures good access, but also safety.
For the appointments where participants do need to attend in person, everything is precision planned.
Hauptmannova explained: “Any patients, both for clinical work and research, are provided with information that stresses that all staff working on site are tested every two weeks in order to keep the site green, and everyone is required to wear a face covering on site.
Anyone entering the site is required to have their temperature measured at all entry points, and no one displaying any symptoms is permitted on site. We had individual discussions with some patients who were a bit more concerned, but most research patients were happy to return.”
Patients are asked to isolate themselves and their household for 14 days before admission for procedures and day-case patients undergoing interventional procedures are tested for COVID-19, two to three days before their procedure. As is now standard NHS procedure, no patient is admitted without a test result.
There is a separate drive-through testing centre and outpatient department used for admission to the general hospital but the RIC have their own clinic room, removing the need for a drive through blood test when attending for research and helping patients to maintain social distancing, because they don’t have to wait in the main outpatients’ department. Precautions on the TOPaZ trial are especially rigorous: the study sponsors, the University of Edinburgh and NHS Lothian, have selected a private hire company to provide secure transport to hospital sites and avoid the risks associated with using public transport.
Whereas some checks used to be ad hoc, attending research patients are now scheduled in fixed slots and are asked to wait outside if arriving early, which reduces the number in waiting areas.
Once inside, there is a temperature check and patients will be asked the COVID-19 screening questions. There are one-way systems in place and social distancing is observed amongst both patients and staff. Social distancing is maintained through a Patient Experience team member at the entrance and exit to the department who allows one person in at a time and directs the patient through the one-way system.
Personal protective equipment (PPE) is worn, with research participants given a fluid resistant surgical face mask on arrival, together with information on hand hygiene.
All the measures taken at RNOH serve as a great model for best practice in implementing the NIHR Restart Framework locally in North Thames. A lot has changed to ensure the patient’s safety and peace of mind and it’s meant a lot of changes for research staff too.
Two members of the research team, whose roles have changed due to their own health status, have commented on their changing responsibilities.
Deirdre Brooking, a senior research practitioner, has taken on more patient facing activities to cover for other members of the team who fall into the high-risk category, and has welcomed the higher profile research has gained during COVID-19. She said:
“Research has suddenly become so much more important in everyone’s life. It was a great experience to be on the front line and see first-hand how we all pulled together, and still do.”
Others, such as Fiona Fitzgerald, a senior research nurse, have had to reduce patient-facing activities to protect themselves or their family. She comments: “From a personal angle, my experience of not being in a patient-facing role has made me realise how crucial that role is.”
Despite the numerous horrors of COVID-19, it’s important to see where there have been benefits. It’s important too, to use these to implement new ways of delivering vital research. Iva Hauptmannova sums up much of her research colleagues’ thinking in saying:
“It has been amazing during COVID as we’ve tried to help out across the trust. We’ve met lots of people that we would have never come across usually and established new contacts, which have helped us in restarting studies. To help us restart we have had to align with the trust far more than ever, for the Urgent Public Health studies like SIREN we’re suddenly collaborating with HR in ways that we never thought possible, and that has been a great benefit for us and the research department.”
Notes: SIREN Study: This important research is focused on healthcare workers and looks at whether prior infection with COVID-19 confers future immunity against reinfection.