Clinical research nurses Barbara Campbell and Jill Deane were asked to share some of their experiences, following the outbreak of COVID-19 earlier this year.
Read about how it dramatically changed the way the team worked and about the amazing impact they have had on research into both treatments and vaccines.
“The job of GI Research Nurse here at North Tees and Hartlepool Hospital Foundation Trust in ‘non-COVID’ times involves us working alongside the Principle Investigator to deliver studies within NRHF. Making research studies work involves a mixture of technical and practical nursing skills. It entails some detective work to identify potential study participants, then explaining the study to patients and staff in a way understandable to non-academics and in a non-research/clinical way; letting both groups know that by participating the patients may be playing a vital role in developing new medical treatments and ways of working.
There’s a big chunk of job satisfaction in being part of embedding research into all our clinical pathways and developing the evidence based practice we all rely on to ensure that every patient receives the most appropriate treatment for them.Barbara Campbell and Jill Deane, clinical research nurses
- Research has both it’s up and down sides for nurses. Being allocated protected time with patients to ensure you can give those detailed explanations about studies and discuss the benefits and risks of becoming a research participant still feels like a bit of a luxury after working on the wards; in endoscopy and bowel screening with their high turnover of patients. Using history taking skills to put together a comprehensive picture of patient pathways brings its own satisfaction, when you see how that data contributes to the wider question being investigated.
- But then again, for someone who, both by inclination and training is more of a ‘doer’ than a ‘thinker’- dealing with high volumes of data, developing the IT skills to work across a huge range of web based databases, juggling the exacting demands of academic institutions and drug companies around their very different ways of managing information isn’t always the way you would choose to spend your working days. In a practice, most studies have faded from the research nurses’ consciousness long before the data they have contributed to is aligned with findings from other study sites, the trial goes through the usual course of data analysis, peer review and finally publication. Sometimes, even then, often the study findings won’t proclaim a great change to delivering services or treatments.
Realising that the months or even years of work that you’ve contributed to for a specific research study favours maintaining the status quo, or even have a negative outcome; can feel momentarily dis-spiriting but providing evidence to support long established good practice can be as valuable a part of research as innovation when it comes to improving outcomes for patients.
Then … along comes COVID 19
- In the early months of 2020 health professionals, the media and the public tracked the journey of COVID 19through Wu-Han Province, across the rest of China, Europe and into the UK.
- Regardless of the politics of whether we saw the pandemic coming, whether we should have been better prepared or whether the COVID 19 pandemic was simply the event sent to provide our high profile politicians a reason to use the word ‘unprecedented’ on a scale never previously imagined, COVID 19 was here. By March it was in our communities, on our doorsteps and it was affecting the people we know and love, our family, friends and workmates. Never mind the pontificating, it was time to get on and deal with COVID 19
- We expected that those experienced clinical staff working in research would be redeployed to the front line to work, dealing with the influx of very ill patients and covering for the inevitable gaps in service due to staff sickness. We assumed that all research would be halted and that all the resources of the NHS would be focused into reducing the death toll from the deadly pandemic. We were requested by the Trust to fill in details of our previous experience to facilitate this redeployment. However, that wasn’t how things turned out.
Overnight the field of clinical research changed. The days of hearing about potential research studies, watching the slow and steady progress of expressions of interest and waiting expectantly for studies to start were gone. The new studies were here and the Trust HAD to recruit patients to these were badged as “Urgent Public Health studies” so we are required to support these studies.Barbara Campbell and Jill Deane, clinical research nurses
There had been forward planning with a couple of studies that had already been through all the ethical, costing and capacity reviews that people had ‘been keeping in a drawer, waiting for a pandemic to happen’ (“sleeping studies”). Before we even realized that other research studies (in our case GI work) would have to stop; we had started putting things in place to ensure that the NHS didn’t miss the opportunity to ensure that, as well as dealing with this deadly health pandemic, we started research studies that could lead to identifying improved treatments for patients and ways of dealing with this potentially deadly virus.
That all meant rapid change for us in our research team. Our alignment to clinical specialties was brushed aside. Some of our team members fell into vulnerable groups who were forced to isolate; others working hard to bring things together and, as usually happens in these scenarios, some step up, take responsibility and lead from the front.
That’s exactly what happened here at North Tees. In a building far, far away (at least in The Middlefield Centre, across the other side of the car park from the main hospital), we all (nurses; midwives; data assistants; Clinical Trial Practitioners and & our Clinical Research Scientist) became part of the “COVID-19 Research team”.
We went from being a department with long term plans to achieve our strategic goals; to using our newly set up daily huddles to discuss how to manage the landscape of COVID 19 research that was being updated almost hourly.Barbara Campbell and Jill Deane, clinical research nurses
In reality, you can’t just walk away from established research studies. There was plenty of closing down, suspending and putting studies on hold that required making sure all the requisite permissions were recorded, papers filed in the right places and everything made ready to pick up after the pandemic. We weren’t about to let the small matter of a global pandemic jeopardise the hard work everyone had already put in to shape our future clinical practice through research.
COVID-19 at North Tees and Hartlepool
The COVID 19 research studies we’ve worked on here at North Tees and Hartlepool have fallen into two distinct categories. Data gathering exercises set up to capture information about every patient passing through the hospital setting with COVID or being tested in A&E.
A task that has required a small army of people intent on recording the smallest details and populating various study databases with information that will contribute to the understanding of pandemic behavior and the effect of COVID 19 on individual patients.
A number of other of NTHFT personnel who were previously not involve in research were redeployed to support data collection and input in the early days where there were significantly huge amounts of data to process.
- Almost as soon as this work started, we were able to see how it contributed to the national picture of the pandemic. The ISARIC and PRIEST websites were publishing daily reports helping to identify epidemiological patterns and disease processes that influenced how hospitals would organise treatment pathways for COVID 19 patients. Seeing how we were contributing to this national picture and the naturally competitive nature of those working in research spurred us on to make sure we were up there with the big players when it came to producing publicly available results
The main COVID research study that we worked on was the Recovery study. This was a Randomsied Controlled Study designed to investigate if some treatments commonly used in other conditions could reduce the need for mechanical ventilation, improve recovery rates and produce better overall outcomes for patients with COVID 19.
- Initially, the study involved approaching patients with a COVID-19 diagnosis and positive swab and asking them to agree to take part in the research. This would entail them being randomly selected to either receive the usual care that we offer and possibly some additional medication, these included:
- Dexamethasone – a steroid commonly used to relieve symptoms in acute conditions
- Hydroxychloroquine – an anti-malarial that was suspected of providing a level of protection against COVID symptoms and much lauded by President Trump in the US
- Ritonavir-Lopinavir which is an antiviral agent, commonly used for those with HIV and AIDS
- Azithromycin – a commonly used antibiotic
- Tocilizumab and Convalescent Plasma were used later in the study process
As research nurses we were usually viewed as sitting outside the clinical team delivering patient care. Our role usually viewed as one that entailed clinical staff having to undertake additional tasks, asking them to complete extra paperwork and badgering them into completing research related training. Another thing that was about to change due to COVID 19.
Treating patients during COVID-19
All the patients admitted to hospital at the time, as well as suffering distressing symptoms, often viewed themselves as victims of a ‘killer disease’ and were being isolated from family friends and others who make up their usual support networks. Under these circumstances the discussions patients would normally have about taking part in research with those close to them either weren’t able to happen or took the form of telephone or video calls with staff wearing full PPE throughout the process.
Our role as research nurses at this point was to approach patients, make sure that despite how ill and frightened they were, that they had a good understanding of what they were agreeing to do by taking part in research. Because it was important to recruit people as early in the disease process our discussions with patients were often at the point where they were consolidating a range of information given to them by a range of clinicians.Barbara Campbell and Jill Deane, clinical research nurses
They had been given information about test results and been part of discussions about treatment options whilst still absorbing the impact and consequences of being diagnosed with Covid-19. All while suffering distressing symptoms and facing the realization of what being treated in isolation meant; about the lack of contact with their loved ones.
- Some patients were even having to come to terms with other family members also being diagnosed. Feelings of bewilderment, fear and guilt about being a possible source of infection for their loved ones were common factors influencing patient’s reactions to their diagnosis. The discussion initiated by research staff to inform patients about the Recovery study, fairly regularly became the point where these seriously ill people were able to have a conversation to help make sense of what was happening to them and around them.
- Not also research staff were able to physically go to the “RED” COVID wards; and a number of staff were (understandably) anxious about going to the wards; despite having a high standard of PPE available to us. None of the research nurses who attended the COVID wards were experienced in respiratory medicine but; we do all have the advantage of previously working in clinical settings, dealing with patients who have what are often termed ‘significant diagnoses’ and are committed to ensuring that patients are active participants; both in their treatment and research studies.
We were all on one of those steep learning curves, common to many in the NHS at this time, which involved drawing on the good old fashioned skills of managing patients in difficult settings, managing expectations and adapting our expertise to making sure what needed to happen for patients, got done.Barbara Campbell and Jill Deane, clinical research nurses
One of the important things to discuss with everyone was the standard care arm of the study, which involved no extra interventions. Most patients and their families were keen to have extra treatments, often expressing their desire to ’try anything that might help’.
We needed to make sure that patients on our standard arm didn’t feel they were missing out on helpful treatments and understood the vital role they played in the study.
- Some of the discussions involved having conversations with loved ones via three-way telephone or video link; again having to answer questions about treatments and research options. Something we didn’t take naturally to, as in research we value body language and non-verbal cues for patients and their families making important clinical decisions.
- The other issue we have is managing the reaction of clinical staff when patients were randomized to standard care. The joint sense of everyone fighting for the best for the patient was palpable and while clinical staff had a clear understanding of research protocols and the need for patient’s to be randomised in a neutral fashion; we had to be careful to ensure that disappointment of staff that they weren’t able to offer any extra treatment to patients wasn’t conveyed.
This was the point when we also became acutely aware of the impact of high profile politicians on public perception of research.
It was heartening to hear the Health Secretary promoting the Recovery study in several daily COVID briefings, raising the profile of the study and encouraging people to take part if they became ill enough to need hospital treatment; this definitely boosted levels of interest in patients and colleagues.Barbara Campbell and Jill Deane, clinical research nurses
However, it was hard for some patients, but especially their relatives who were stuck at home hearing on their TVs, the US President telling the world that Hydroxychloriquine was some sort of wonder drug for curing COVID-19, to accept that using non-biased research techniques was the way to identify the best treatments for the virus and meant that they couldn’t choose an option.
We had quite a few conversations about joining the research that started with patients saying: “I’ll definitely take part if it means I get that Hydoxy-thingie that President Trump is taking”. Ironically Hydroxychloriquine was the first study drug to be identified as being ineffective.
Research nurses working with the wards
During this time our research staff became far more integrated into the ward teams. We were present on a daily basis, providing staff training, support and advice about which patients were suitable for research.
- Providing information for patients and relatives and collecting data meant regular conversations with some patients. For some, who had limited contact with family and friends, we became part of their regular visitors.
- Admiring the latest pictures, they had on their phones of grandchildren, other family members and news about their much loved pets became part of our data gathering routine.
- We weren’t just there to ‘collect the data’. It was fantastic to feel part of the clinical team and we certainly feel that RECOVERY has raised the profile of research among the public; ward staff and wider MDT. We also were pleased to see that we had tremendous support from other departments within the Trust – from pharmacy to the labs and from cleaners to physios who were all keen to find out more about the research and to be involved in the research if possible.
- Working more closely with the ward teams brought other rewards for us. From a research point of view, our team has been far more visible to ward staff. We’ve been able to discuss the benefits of research with a range of staff, who we often don’t have much contact with – including HCAs therapy staff and students. Their curiosity as to why we were there enabled us to generate interest in Recovery and hopefully embed an awareness of how research needs to become part of our everyday clinical practice. We even managed to recruit a new cohort for our Good Clinical Practice (Introduction to Research) course.
Seeing newly qualified Doctors fully involved in research has been immensely gratifying. They are often a bit protected from some things in their early years of practice. Having to share bad news with patients and relatives and dealing with research staff are usually seen as jobs those clinicians who are more senior. During the peak of COVID; it’s been regular practice that Junior Doctors spend their afternoons calling to give reports to relatives of very ill patients. Then, sitting and recording those conversations in patient notes.Barbara Campbell and Jill Deane, clinical research nurses
Taking just a moment to remind themselves of the details of the next patient and their family before starting again. That’s a clinically and emotionally demanding task in normal circumstances, but repeatedly sharing that there’s been limited improvement in someone’s loved one’s condition, fully donned in PPE and wearing a respirator masks adds another level of difficulty and emotional difficulty.
In these situations, reminding these young men and women that taking part in research is one of the small positives to share with patient’s families and supporting them in simple ways has been important.
Simply saying ‘Well done, you did well there. That patient’s family will have no doubt that they are getting good treatment and how much you obviously care about them’ is enough to make a noticeable difference.Barbara Campbell and Jill Deane, clinical research nurses
- Don’t get me wrong, the juniors have had excellent support from more senior staff, but sometimes, a kind word from someone not viewed as judging their performance could help to lift a bit of the burden off their shoulders.
- They are a cohort of staff who have already taken on that demon of sharing difficult news, but have hopefully been buoyed by the public outpouring of support and warm wishes for NHS staff.
- Having played some small part in positively shaping their futures is one of the things I’ll take as a positive from these COVID times. Hopefully, as well as retaining an interest in research, some of them will remember us research nurses with a touch of fondness
The research process
As mentioned earlier, research is usually a pretty long, drawn out process with very separate phases. As well as the usually long, drawn out approval processes, data is usually collected during clearly defined points in time. This data is then collated and analysed, usually remotely from the collection point, papers are written, re-written and then peer reviewed prior to publication. The Recovery study operated very differently.
The aim was to recruit 2000 participants to each arm of the study (including the standard treatment arm); evaluate these results and make recommendations as to their suitability of treating COVID.Barbara Campbell and Jill Deane, clinical research nurses
The first arm that gave us results was the finding that Hydroxycholroquine did not make any significant difference to patient recovery or prevent them deteriorating and needing more intensive treatment.
- As well as letting everyone know about the results; for us as research nurses any change to a research study means lots of paperwork.
- This meant a sweep around the wards; making sure all old paperwork was collected and destroyed and printing organizing and delivering the replacements; updating notice boards; changing information packs and data collection sheets to ensure that patients and clinical staff had the most up to date information.
- All done in the blink of an eye’ to make sure that we didn’t miss the opportunity for any patients to take part in this important research … this was repeated a number of time for Recovery – every time the health secretary stood up for the 5pm daily briefings!
Researchers are absolute sticklers to make sure that all study materials are standardized; whichever university; hospital or department that you work in. Everything in the study needs to follow the same stick protocol.
We need to be able to withstand academic scrutiny and research nurses are the ones delegated with making sure that we are always using the latest versions of the paperwork or implementing new processes.
Be warned; if a research nurse ever removes paperwork from your hands when you are keenly trying to recruit someone to a study; and hastily replaces them with others, don’t argue with them. It will be in the name of rigourous scientific methodology.
It’s been a time where we have learnt new skills and dredged up old ones from the past and put them to a new use; worked with lots of new faces and people with different skills.
- We have worked hard to develop our sense of team and learnt to recognize each other’s strengths and weaknesses. Despite difficult circumstances and seeing the NHS under significant pressure, bringing them into the world of research and make it accessible and relevant. A lesson we hope that they will all take forward into their future careers.
- Five months into the pandemic, we are currently seeing less patients admitted to NTHFT; so this has given us time to reflect on the last few months and also to catch our breaths and support the wider research team who are in the middle of collating and recording the deluge of data that will contribute to the world wide understanding of the virus.
- We feel that our job satisfaction sky rocketed and we all feel very proud to have worked on these important studies and we have contributed to something that really makes a difference.
- We are also aware that our lives have completed been taken over by COVID – both at work and at home. It was easy spending each day going to the COVID wards; and living life in lockdown outside of work with all the limitations that entailed and worries about our own families.
- The workload changed as a number of the research team succumbed to COVID19 symptoms. Whilst we have all been in the thick of the COVID activity none of who tested positive, feel that we caught the virus from patients due to the use of adequate PPE and are much more likely to have contracted it from outside of the hospital; but Track and Trace was not in place at this time.
We look forward to a time when we can restart our other important research studies, looking to improve outcomes for patients in a variety of specialties. And to ensure that clinical practice is based on the wealth and breadth of evidence based findings from research. It has been difficult to see patients and staff suffer during the last few months but is has been a privilege to be alongside them for this journey.”Barbara Campbell and Jill Deane, clinical research nurses
If you’re interested in joining the research team, check out our vacancies below.Full list of Trust vacancies