Case study: Restarting research at East Kent Hospitals University NHS Foundation Trust
As of the end of March 2020, 170 studies were paused at East Kent Hospitals University NHS Foundation Trust. As well as the UPH COVID-19 studies, only 7 studies in oncology remained open the whole time during COVID-19. As of Tuesday 4 August 41 studies are now open and active (including 9 UPH COVID-19 studies).
The Restart process
East Kent Hospitals University NHS Foundation Trust’s Restart process began in the first week in June. The trust R&I team used the NIHR Restart Framework as a guide, focusing first on the prioritisation guidance. Discussions were held between delivery team leaders, the lead nurse, director of research, and the R&I Manager about how they would manage Restart of research, and what needed to be prioritised.
The team prioritised their top three studies at each site using the prioritisation tool from the framework. They looked at which studies came under the heading of ‘urgent treatment - interventional’, ‘urgent treatment - non-interventional’, and ‘observational studies’.
It was decided that a review of capacity and capability would be essential, but without doing the full capacity and capability for each study again. A flowchart was developed to help with the Restart process. The first part of the flowchart was an initial review. They took one study at a time from each site and team leaders had a discussion to see if the study needed to have capacity and capability reviewed.
Many of the studies were ‘urgent treatment’ which did require a review of capacity and capability. Then the PI was contacted to see if they were ready and able to continue with the study.
Some studies were in set-up prior to COVID-19 and they also had to be reviewed and capacity and capability revisited. The R&I team has had to review all the contracts for those that are in set-up and all other studies to relook at recruitment timelines because many sponsors have had to extend their recruitment periods.
The trust put in place Restart documentation to manage the process.
Working with sponsors
If the R&I team thought the study was ready, they then contacted the sponsor and asked them where they were with regard to readiness to start. If the sponsor had already contacted the trust, they went back to them to say in principle, the trust was ready to start. Some sponsors have already said they don't have the funding to carry on, or they do not feel it's appropriate to carry on due to the recruitment timeline running out. Others have said that there are no service support staff available to deliver the service. The sponsors have put in a lot of effort to change protocols, enable phone call follow-ups to try and avoid any face to face appointments.
Urgent Public Health COVID-19 studies
All three sites are still running COVID-19 studies, but one site (The Queen Elizabeth the Queen Mother Hospital) is opening two extra studies (REMAP CAP and TACTIC) so it is slower at reopening studies due to the focus on delivering UPH studies.
Recruitment to the UPH COVID-19 studies has slowed down because the number of patients being admitted to hospital has fallen. The trust is finding a balance between Restart and being ready to recruit to COVID-19 studies if cases increase.
Impact on stroke studies
Services were looked at to see if they were the same as pre-COVID-19. For example, stroke services were moved from two of the trust’s acute hospitals to one of their less acute hospitals which has an impact on stroke studies.
The trust has experienced challenges in reopening their stroke studies. During COVID-19 all stroke patients moved to Kent and Canterbury Hospital and stroke studies were placed on hold when the services were moved. The Queen Elizabeth the Queen Mother Hospital and the William Harvey Hospital previously ran all stroke studies - there were none taking place at Kent and Canterbury Hospital because there were no stroke services there.
R&I have had to negotiate with the sponsor about whether stroke studies can be opened at Kent and Canterbury Hospital as an additional site. They had to ensure approvals were in place for a change of site, and on some occasions change of PI. This is because studies were not open to East Kent Hospitals University NHS Foundation Trust as a whole. Depending on the type of study, R&I would either open a study trust-wide with one PI, or open a single hospital site with a PI at each site.
As the Delivery Team at Kent and Canterbury Hospital had not been involved in stroke research a Research Nurse from another site, experienced in stroke research was redeployed to Kent and Canterbury Hospital for three months to enable training and proper handover of studies to the new delivery team.
Capacity and capability was reviewed at the new site to confirm the resources were in place to reopen studies and to review those studies that were in set-up before COVID-19 (East Kent Hospitals University NHS Foundation Trust has three sites with a delivery team at each site).
There has been a focus on training other staff up to work on stroke studies e.g making sure that pharmacy can work on CTIMPS. There has been a lot of collaboration between the team leaders and the delivery teams to get these studies up and running again at Kent and Canterbury Hospital.
Since the beginning of August, three interventional stroke studies are open at the trust.
As well as changes to the delivery of stroke studies, surgery studies may not be able to open immediately as surgeons are working through the waiting list, focussing on cancer surgeries and other surgeries that were put on hold or delayed during the COVID-19 period. Also some surgeons were classed as being high risk and were shielding so there were fewer surgeons in some surgical departments.
Social distancing: Staff who had been working from home or shielding came back to work in the trust and that had to be done safely ensuring social distancing was in place. This means there is reduced office space and additional workspaces had to be found.