Engaging staff in clinical research to tackle the coronavirus pandemic

Introduction

In April 2020, as the coronavirus pandemic hit Calderdale and Huddersfield NHS Foundation Trust, our clinical research delivery team were asked to work in frontline clinical areas, such as intensive care, respiratory and the emergency department.

In total, 70% of our research workforce was redeployed, which resulted in an unexpected challenge in terms of how the remainder managed research workloads to ensure continuity of care and ongoing treatment for patients participating in essential non-Covid-19 trials. These included oncology trials involving the use of hormone or chemotherapy treatments, and gastroenterology trials testing antibody treatments to control inflammatory bowel disease. Failure to continue these trial treatments would have placed patients at risk of disease progression or worsening symptoms.

Innovative approaches were adopted to conduct assessments remotely, organise home delivery of trial medication, liaise with our clinical trials pharmacy team and safely conduct face-to-face assessments of patients having chemotherapy or antibody treatments in line with the Health Research Authority’s (2021) guidance.

In collaboration with our research and development governance team, we quickly devised a policy for the pause of non-essential studies to provide capacity to activate the Urgent Public Health Emergencies (UPHE) trials, including a fast-track governance process, in line with the Department of Health and Social Care’s (2020) coronavirus action plan for the UK and the Medicines and Healthcare products Regulatory Agency’s (2020) advice. This article will focus on our response to the UPHE clinical RECOVERY trial, which was undertaken while the essential non Covid-19 and other UPHE trials were continuing in the background with reduced staff.

Key aims

The key aims were to ensure our clinical research team and research-naïve staff in clinical areas were able to:

• Administer research trials safely;
• Maintain patient focus by offering clinical trial options to as many patients with Covid-19 as possible.

This was particularly important as there were no proven treatment options for Covid-19 and patient participation in clinical trials was vital to build a body of knowledge about what treatment options were most effective.

The research delivery team aimed to support the clinical teams on the wards with all aspects of the trial pathway, including screening for potentially eligible patients, completing randomisation, ensuring patients’ blood samples were obtained where required and that trial treatments had been administered. This ensured the clinical team’s workload was not significantly increased and the conduct of the research complied with research protocol.

“This group made research more accessible by demonstrating flexibility and resource utilisation within challenging and extraordinary times” (Judges’ feedback)

Challenges

Before the coronavirus pandemic, we did not carry out research activity in acute medicine, critical or emergency care due to lack of interest and capacity. The majority of the clinicians working in these fields had little or no research experience. All clinical research requires staff to have completed training to ensure compliance with the MHRA’s (2012) Good Clinical Practice Guide. If clinicians have completed good clinical practice (GCP) training, it is not uncommon to find that they have not consolidated that training or linked it to the actual implementation of the clinical research process.

The prioritised UPHE trials were exempt from GCP, which was a significant challenge as GCP is the ‘rule book’ governing clinical research (MHRA, 2012). We always work within these guidelines and it was more important than ever that the experienced research delivery team were available to ensure our colleagues on the wards who were new to research adopted the correct procedures and had maximum support and guidance. As a team, we made the decision to call the new ways of working challenges rather than barriers.

Personal protective equipment (PPE) was in short supply. Following advice from infection-control colleagues, we were advised not to go into Covid-19 areas, to try to reduce transmission and also to reduce use of much-needed PPE. This, in turn, led to limited access to clinical areas and patients, which was completely alien to us.

It felt wrong not speaking to patients to check their understanding of the research and also not to be able to ensure clinicians were following correct processes. In the first wave, we had to resort to viewing completed consent forms through a glass door. We had to engage and negotiate with busy ward staff, who were research naïve and viewed their involvement as an extra task. We had to show commitment to gain recognition and interest from senior nursing staff. There was varied ward cover; clinicians and nursing staff were being pulled in from many different areas such as gastroenterology, oncology and surgical outpatient clinics, so they were not only working to manage the unknown effects of the novel coronavirus, but also working in a strange environment on a rota system.

Response

Collaboration and engagement were key. We trained more than 100 staff in the clinical trial aims, treatments available, internal process for recruiting patients, how to approach and consent patients with mental capacity, and what to do if the patient was too ill or lacked capacity. This training involved ward nurses, clinicians and the research team via virtual meetings, presentations and updates. Our principal investigator was heavily involved and proactive, often delivering training sessions weekly to ensure all the team were updated.

One of the biggest challenges was communicating quickly and effectively with all members of the research team and the many clinicians working on Covid-19 trials, split across two sites. To address this, we used WhatsApp while ensuring close adherence to the trust’s information governance guidance. The rules and benefits of using WhatsApp are outlined in Box 1.

During the pandemic, clinical rotas were challenging and often the turnover of clinical staff on duty was erratic. The research delivery team had oversight of the whole trial pathway, including identification of suitable patients, screening, approaching patients, informed consent, randomisation and follow-up. This provided continuity, ensured patient safety and also led to every patient who was Covid-19 positive or clinically suspected to have Covid-19 being considered.

With reduced staff, the research team provided cover for two hospital sites seven days per week, including evenings and bank holidays, to support the clinicians and randomise remotely so patients could have access to trial treatments.

Due to the speed with which the RECOVERY trial was able to gather significant results for many treatment options, there were frequent changes to processes. This meant the research team had to implement change quickly and ensure training and updates were in place.

There was strong collaboration with support departments such as pharmacy, pathology and the blood transfusion team, which was vital for success. In addition to their responsibilities in non Covid-19 clinical trials, our dedicated pharmacy team implemented guidelines for ward staff and clinicians, highlighting prohibited medications and instructions for reconstituting tocilizumab.

Clinical trial prescriptions for all RECOVERY trial medications were incorporated in our electronic patient record system, enabling clinicians to quickly locate the correct prescription and prescribe using ‘search, select and click’. To ensure patient safety, reminders for nursing staff to check vital signs or undertake patient monitoring during infusions were included in the prescription.

The Covid-19 pandemic was an anxious time for all and our approach following guidance from the Covid trauma response group (The King’s Fund, 2020) ensured success. This included open and honest briefings, encouraged staff to use support mechanisms and monitored support needs as the pandemic changed.

The research team were required to work very differently and in new clinical areas. To ensure maximum wellbeing of the team, we adopted a ‘buddy system’, in which we paired the novice or anxious staff member with expert staff, and held daily ‘huddles’, whether virtual or socially distanced. This was a mechanism to raise concerns, deal with panic and provide mental and emotional support. We used these huddles to discuss RECOVERY recruitment strategies, action plans, to coach or train and share practice (Driscoll, 2006).

Results

Due to our recruitment success (Fig 1), our site was one of three in the Yorkshire and Humber Clinical Research Network to be selected to receive funding to pilot seven-day RECOVERY cover for November 2020. We recruited 33 patients to the RECOVERY trial over four weekends, which was a significant contribution to research.

Delivering these ground-breaking clinical trials at our trust has allowed us to contribute to identifying treatments that could save millions of lives. In comparison with other regional NHS trusts, our research team is small and, compared with neighbouring trusts, we redeployed the largest number to staff to frontline services. Our recruitment success is testament to teamwork, determination and the resilience of our staff and frontline clinicians supporting the trial and our ability to change. We brought together over 40 ‘research-naïve’ clinicians and mentored them using a hands-on approach, delivering vital research in a pressurised environment with minimum capacity to do anything other than care for our patients who were acutely ill with Covid-19.

Our increased presence in clinical areas raised awareness of the significant impact made by research and its benefits for patient treatment and care, particularly in ward areas where clinical research was new; this increased involvement of clinical teams has heightened interest in this work. It has led to greater exposure for our team through organisation-wide communication routes and we have received invitations to forums such as the trust board, finance department and executive board meetings, as well as nursing forums such as the matron and lead nurse briefings, to raise awareness of clinical research.

Following analysis of the steroid versus standard practice option, dexamethasone became standard practice. It was added to our e-prescribing system and was ready to administer to patients within two hours of the RECOVERY press release being issued.

Our new way of working during the initial Covid-19 pandemic continued following our entry for the Nursing Times clinical research award. We addressed the learning from our experiences and improved processes to ensure continuity under changing circumstances. We have embedded this way of working as we restart non-Covid-19 clinical trials. This will provide new investigators with excellent support and guidance to develop knowledge and skills in clinical research.