Case study: Hospital in Medway giving patients an opportunity to be involved in the COVID-19 RECOVERY trial
CRN Kent, Surrey and Sussex spoke to Iram Ahmed, a Senior Clinical Research Practitioner at the trust about RECOVERY.
Iram Ahmed said: “We realised that RECOVERY was an important trial from the beginning and wanted to be involved. We were also very keen to find a trial which would offer Tocilizumab (an anti-inflammatory treatment given by injection) to patients. We were really pleased when this was made available through RECOVERY and when we were selected as a site to deliver this via a second arm of the trial. Not every site was selected for this arm initially and the fact we were one of them was very exciting.
“My role in the RECOVERY trial was, and still is, primarily to coordinate and facilitate the delivery of the trial and to include as many patients as possible. This at the outset involved: recruiting team members to the study; collaborating with the clinicians and getting as many junior doctors on board as possible throughout the trust to increase recruitment; liaising with pharmacy to facilitate controlled drug stocks to wards; ensuring correct consent procedures were in place; and chasing data collection for follow up. This continues, although now at a slower pace. We have approximately 65 people on a WhatsApp group dedicated to the trial where all information is disseminated, for example, any updates to the trial, any changes or amendments, where to find the trial folders, or alert people to potential patients.
“Trial folders which include patient packs were made for several of the ‘hot’ and ‘warm’ COVID-19 wards. The packs include consent forms, patient information sheets, and labels for patient’s notes and drug charts so staff on the wards know that the patient has been randomised. We also created post-randomisation labels which we developed internally with the pharmacy team. These labels indicate potential drug interactions for the drug that the patient has been randomised to. The relevant labels are placed in the patient notes to help the clinicians monitor adverse events.
"Our trust communications team have played a key role and have been very supportive by helping us communicate important information about the trial trust-wide via a COVID-19 bulletin. We recognised and acknowledged the doctor who had significantly contributed to trial recruitment for that particular week via this bulletin to show our gratitude to them. The ‘top recruiter’ for the week was also given a box of chocolates and a certificate from the R&I team. Additionally, as several colleagues had questions and queries about the trial, we arranged an internal Q&A webinar which was very well received and helped iron out any issues.
“Even though the trial is very pragmatic and has been designed to run very simply, it kept us really busy initially as we had implemented additional requirements for our clinician’s reassurance. For example, we performed electrocardiograms (ECGs) on all patients randomised to two specific arms of the study, as locally we felt that two of the drugs could potentially cause arrhythmia. It was fortunate for us that I was contacted by the cardiorespiratory team at the trust who very kindly offered to help with the trial due to their decreased workload - so I happily delegated this task to them.
“The trial has encouraged several doctors, mostly junior doctors, who were naive to research to become more interested and engaged in research. It has been quite exciting for them as they have seen how treatment offered in research trials can potentially benefit patients.
“It has been challenging trying to find the best strategy to include as many patients as possible as clinicians were too busy to inform us, and could not use their phones on the wards for infection control purposes. So we also relied on looking at the medical take list from the hospital. Some patients were not just coming into the hospital with COVID-19, and were admitted with a different illness and were found to be swab positive for the virus incidentally. We were therefore missing some patients and it was hard to keep track. For this reason, the Principle Investigator assigned one of the registrars the task of screening these patients for potential recruits. I feel we have managed really well as a team and succeeded in recruiting well to the study, and as a result we have been contacted by other sites for advice.”
“It is important to recruit as many patients as possible into these trials even though hospital admissions have slowed down and things are slowly resuming back to some form of normality. We must now concentrate on ensuring that we don’t miss patients as the sooner we achieve larger numbers, the sooner we can see interim analysis of the data from the trial team to determine whether any of the trial drugs are effective.
“Delivering COVID-19 studies has been a highly challenging but rewarding experience. I feel proud that we have been able to play a fundamental role in determining whether potential treatments will be beneficial for patients in future. It has been great to see how various people within different parts of the trust have all come together to deliver this important research in our trust.”