CLINICAL DELIVERY TEAM

And Their Current Key Studies

INTERVIEWEES:

Kirsty Gladas, Senior Research Nurse Manager, CRN Wessex

Michelle Just, Senior Clinical Trials Assistant, CRN Wessex

Kerry Gunner, Ruth Jackson and Kate Battley, Research Nurses at CRN Wessex

Alice Jenden, Research Midwife at CRN Wessex

Tell us about the CDT

The CDT consists of our original CRN Wessex core nursing team who originally had a focus on primary care, and the new Direct Delivery Team (DDT) which has now been established for 18 months.

The DDT was set up when funding came through from the NIHR Transformation of Delivery Initiative to enable an agile workforce to better support and deliver research in public health, social care and under-served communities.

My role is to manage and support the team to deliver research day to day across the Wessex region.

What contribution has the CDT team made to research delivery in Wessex?

We've helped support a lot of the COVID-19 vaccine research locally. I don't think that that would have been possible on the scale we have seen without the support from the CDT and the wider CRN Wessex team.

We have also been able to support partner organisations to either sustain their research portfolio or increase recruitment.

I think our contribution is to highlight and actively promote research opportunities to future participants within the region and engage them in some small way. This will ultimately help the Wessex wide community and contribute evidence towards clinical practice that can be shared with colleagues, the UK and further afield.

What is their skill set?

The CDT team has a wide variety of backgrounds and skills that contribute to the new areas that we will be supporting and delivering research within. These include a midwife, a paramedic and people who have worked in pharmacies, laboratories, the blood service, patient transport services and care homes to name a few.

How will the CDT benefit patients and the public?

We are expecting two new research buses to be in use by late 2023.

I think this will pave the way for how we look at bringing research to patients and the public in non-NHS settings.

We currently have research hubs in Bournemouth, Portsmouth and Southampton, with a new hub in Weymouth due to open later this year. Our hubs allow us to bring studies to the community and will help improve access to research for people living in Wessex.

What’s next for the CDT?

Consolidating the knowledge and experience that we've gained so far will be important. I think it would be particularly useful to grow our understanding of how research can be delivered in public health and social care.

Things like being aware of the different terminology will be useful as we go forward, for example, most clinical staff who have been working in a hospital setting use the word ‘patient’, whereas in a social care setting you should use the term ‘service user’ or ‘client’. We have much to learn from the new settings and look forward to working side by side delivering research for community benefit.

I've really enjoyed leading the team and I'm looking forward to seeing where we can take research in the community next and the relationships we can build with organisations in the region. I hope our research passion rubs off onto others and they too see the benefit research can bring to individuals and their communities.

ATTACK study

The CDT is currently supporting the Wessex-led ATTACK study, which is investigating whether people living with Chronic Kidney Disease (CKD) should take a low-dose of aspirin daily to help reduce their risk of a first heart attack or stroke.

CKD is a common long term condition where the kidneys do not work as well as they should. People living with CKD are often at greater risk of other health conditions, such as Cardiovascular Disease (CVD).

Previous studies have shown that aspirin can reduce the risk of further heart attacks or strokes in people living with CVD, and that these benefits are greater than the increased risk of bleeding caused by taking aspirin.

However, before aspirin can be recommended as a preventative measure for people with CKD who have not yet developed CVD, there is a need to find out whether the benefits of daily aspirin outweigh any long-term risks.

The ATTACK study, which is sponsored by the University of Southampton and funded by the NIHR and the British Heart Foundation, aims to answer this important research question and will inform National Institute for Health and Care Excellence (NICE) guidelines on the management of CKD going forward.

KERRY GUNNER, CRN Wessex Research Nurse, who has been working in research for a decade, explains her role in delivering the study:

“As a research nurse within the CDT, I support research across a range of different settings, although my main remit has always been the set up and delivery of research in primary care.

“When we first started recruiting to ATTACK in 2019, the study was being delivered in a face-to-face format. As a team, we were going into general practices to run the study, carrying out activities such as receiving consent, confirming study eligibility and collecting blood and urine samples from our participants. Recruitment was going very well, but the study had to pause following the outbreak of coronavirus.

“As soon as it was safe to do so, everyone was keen to get the study up and running again as it’s such an important research question. Patients living with CKD have always been very interested in the study and eager to help, even though it may not benefit them directly.

“The study team were very pragmatic and managed to adapt the study and train nurses to deliver it remotely, which was safe for us and our patients.

“It’s been fantastic to see the study recruiting participants again, despite all of the clinical pressures in general practice post pandemic. This is something we are very aware of as a team, and we will continue to be versatile and flexible to support practices.

“Our primary aim is to ensure that patients and the public have access to research opportunities. Within primary care, I find it particularly interesting that we are often trialling existing therapies and treatments but in a new way for different conditions or for a different cohort of patients.

“Whether they’re positive or negative, the results of the ATTACK study will guide future practice by supporting GPs and patients with the management of CKD.”

Treat to Target (T2T)

Gout is a type of arthritis that causes sudden and severe joint pain. An attack of gout will usually last up to a week, and additional attacks are common, particularly if not treated.

Current treatment for gout aims to reduce pain and swelling. It can include anti-inflammatory medication such as ibuprofen or steroids and it is also possible to make lifestyle changes which can stop or reduce further flare ups.

The CRN Wessex Clinical Delivery Team (CDT) is supporting an NIHRfunded study which aims to improve the future treatment of gout.

The Treat to Target (T2T) gout study, sponsored by the University of Nottingham, will test whether a new gout medication strategy can help to reduce both the number and severity of gout attacks compared to usual care.

RUTH JACKSON, CRN Wessex

Research Nurse, is part of the team supporting T2T. Here, she explains its importance and why she enjoys working in research.

“The study is really important for helping people living with gout. Often, patients have been struggling with gout for a long time and haven’t really been able to find the ideal treatment that works for them”.

“This study is trying to identify a better way of treating and managing gout for people experiencing recurrent flare ups, and will explore the clinical and cost effectiveness of Allopurinolbased T2T urate lowering therapy.

“Although Allopurinol is well known and has been used to treat gout for many years, we need to improve our understanding around the effectiveness of different doses, so the T2T study will compare whether tailoring the dose to each patient is more effective than standard GP care for gout.

Allopurinol works best for them.

“We then follow up with participants after one and then two years. It’s been a valuable experience going back and seeing how they’re getting on. Lots of patients have fed back that they’ve enjoyed being part of the study and have found it straightforward and not a burden which is positive.

“Most of the study appointments are face to face and could not be carried out remotely. Whilst this did mean we had to pause recruitment to the study during the pandemic, it’s great to be open again now and we’re halfway to our recruitment target.

“Since the study opened in 2019, I have been supporting general practices across Wessex with setting it up. Once a practice is on board, we have been getting in touch with patients who might be eligible to see if they’d like to take part.

“Once participants have joined the study, they are randomised to the treatment arm or standard care. Those in the treatment arm of the study will then have regular blood tests to help decide what dose of

"I enjoy working clinically and seeing the participants, and that's the rewarding and enjoyable element of my role. I also love knowing that research is there to improve healthcare and future treatments; it can be exciting working on studies knowing they will make a difference.

“As a team, the CDT is here to give patients the opportunity to take part in research and ensure that studies are carried out efficiently across all settings.

“We work in so many different environments, on various studies for a vast range of conditions, which is fantastic. We’re very supportive of research and evolving our healthcare knowledge base to improve the treatments and care we offer patients.

iDx study

This iDx Lung trial is funded by UK Research and Innovation, with funding support from Cancer Research UK. It is taking place in collaboration with the Southampton Clinical Trials Unit at the University of Southampton, the University of Leeds and healthcare and diagnostic companies. The study is piloting new diagnostic tests that aim to find ways to detect lung cancer at an early stage when it is more treatable.

We speak to members of the CDT team, Alice Jenden, Michelle Just and Kate Battley, who have been working on the study at sites across Hampshire.

Please tell us what’s involved in the study

Alice: Any patients aged 55 to 74 who have ever smoked are invited to a Lung Health Check, providing their smoking status is correctly recorded in their GP record. The lung health check is a two staged process, firstly involving a telephone call with a specialist nurse, then if they are deemed high risk they are given an appointment for a CT scan. Any people attending their CT scan as part of their lung health check are eligible for the research study. If they are happy to take part, we take them from the CT scanner to our dedicated research van. Here we take blood samples and tissue from inside of the nose.

All samples are taken to the Southampton Tissue Bank for processing and then sent to partner laboratories for biomarker analysis. The participants will be followed up remotely for at least three years using their health records. This clinical data will then be reviewed in line with the samples taken by the study doctors.

The data will help to assess whether adding biomarker samples to CT scanning for at risk populations can improve early diagnosis for lung cancer.

Can you tell us more about the iDx van?

Michelle: The research van enables the CDT to follow the scanner locations. Excitingly, it means we can take research out into the community to make it more accessible.

Kate: It poses different challenges to working in a hospital or clinic setting but I think that's what makes it really interesting.

What are your roles in the delivery of this study?

Michelle: We're really flexible as a team. There are specific guidelines around who can consent but otherwise we rotate all the jobs. We all do everything from setting up the bus to nasal brushing and taking bloods.

Kate: From a practical level, it's very much about teamwork. No one person carries out the same job each time. We take it in turns to do things like driving the bus, filling up the petrol, setting up the steps, all those jobs that as a research nurse you may never have come across.

How long has the study run for and what were your target recruitment figures?

Alice: The study started in May 2021 in Southampton and it's due to finish by the end of March 2023. We have a national target of 7,000 participants.

How have you found recruiting to the study?

Alice: The radiographers who work with the CT scanner have been a big part of us recruiting because they are the first people that participants see. Early into the study, an idea was suggested about using a walkie talkie to communicate. We have one on the research bus and they have one on the CT scanner, they let us know that there's an eligible participant and we can meet them or know to expect them. That has really helped with recruitment, it's just sometimes thinking outside the box. in all kinds of roles, from facilities managers to site contractors.

What have been your highs and lows of the study?

Michelle: Our participants have been a high for me. They’re from all walks of life and are often happy to share personal stories about family members and their experiences with cancer. They are more than willing to help if it means that they are helping future generations.

Alice: I think from a staff perspective, a real high is how the study has pulled us all together. Teams from Southampton, Portsmouth and Bournemouth, pharmacy teams, radiographers and of course research teams.

Michelle: Where the study has meant so much to us all, we are elated when we get good figures and things are going well but can also feel really disappointed when we have a bad day.

Has this study involved much cross-team collaboration?

Michelle: Absolutely it has! We have been working with staff from different trusts and in a variety of roles. And not only people in the NHS – because of the van, we’ve got to know people

Alice: I agree with that. We have a WhatsApp Group for those of us working on the study, where we communicate any updates. Quite a lot of the time, people share how their day has been as well. You can definitely feel that team happiness when things are going well and there’s a lot of support when you’re struggling which has been amazing.

Kate: This was our first study as the CDT too, which was quite an achievement. It was probably the first research study that some of our team had worked on, they've been able to get involved from the get go and use some practical skills as well.