Clinical trials – improving patient experience
Clinical nurse specialists and clinical research nurses can work collaboratively to promote opportunities for research and improve patients’ experiences before, during and after trials
Increasing participation in clinical trials is a priority for the NHS. Cancer Research UK supports this aim and knows that it is vital that all eligible patients are given the opportunity to participate in research. Studies have found that patient outcomes are better at more ‘research-active’ hospitals. However, not enough cancer patients are being made aware of the opportunities to participate, according to the latest Cancer Patient Experience Surveys in England and Scotland.
The 2015 surveys highlighted that there is national variation – in the top fifth of trusts, the average percentage of patients who had a discussion about research was 39%, compared with the bottom fifth of trusts, where the figure was half that at 18%.
Improved collaboration between clinical nurse specialists (CNSs) and clinical research nurses (CRNs) is one way that opportunities for participation could be identified and increased and patient experience improved, for the benefit of current and future patients.
While there are barriers to collaboration acknowledged by both groups, such as heavy workloads, the lack of integration across the care pathway and different ways of working in different organisations, there are models of good practice that are transforming the way CNSs and CRNs are working together.
A roundtable meeting was organised by RCNi and Cancer Research UK to explore and share this best practice and find other solutions to improve patients’ experiences before, during and after trials.
Key themes from the discussion
Caroline Shuldham, chairing the discussion, began by sharing how some patients want to participate in research and how nurses have a responsibility to enable it.
‘Patients have a sense of social responsibility and often want to help other people; clinical research is one of the ways they can do that,’ Dr Shuldham said.
‘As professionals, we have a responsibility to ensure that research is being done, and to a good standard. Recruitment of patients is important at all sorts of levels, patient benefit being the key one.’
The roundtable, made up of five CNSs, four CRNs and one joint CNS/advanced clinical trials practitioner, along with academic Verna Lavender, Cancer Research UK’s lead research nurse Anne Croudass and senior cancer information nurse Deborah Stalkartt, identified solutions to improve collaboration for the benefit of patient care.
The CNS role in research is important: they have close and trusting relationships with patients and can help to identify those who may be eligible and support communication of complex information. One challenge for CNSs is the lack of information about clinical trials: which are happening for which types of cancer and where; when they are opened and closed; and eligibility criteria. Even when CNSs do have access to such information, it is often complex and uses jargon. The roundtable agreed that information on trials must be ‘demystified’. CNS Julia McVeigh summed up many of her colleagues’ attitudes when she said: ‘Research is another world.’
The roundtable heard that knowledge sharing is crucial. Monthly information bulletins and simple trial summaries free of jargon and acronyms would be helpful to CNSs – making them more confident to engage with trials. At Oxford University Hospitals, an electronic shared drive provides open access to documents about ongoing clinical trials for all hospital staff. A short ‘clinical study guide’ is included. Written in plain English, it provides trial synopses that can be explained to patients.
CRN Michael Mawhinney said: ‘This is regularly used by the oncology/haematology wards when they have our patients admitted so they can see quickly what is involved in the trial and what type of drugs/safety information each patient has.’
The shared drive has been successful, even though it does take time to maintain and update.
In Manchester, the Christie Hospital produces a newsletter for doctors – but it is not sent to CNSs. The group agreed that sometimes it is easier to pick up the phone or email the relevant CRN about whether a particular patient can benefit from a trial. CRN Sharon Woolley said: ‘Sometimes it’s better just to pick up the phone because trials now open and close so quickly.’
Julia McVeigh agreed about making that phone call: ‘Making the effort to get in touch with the research team – it’s worth it.’
CRNs could help by directing CNSs to internet sites such as Cancer Research UK’s clinical trials database (see tools and resources panel), which lists most trials recruiting in the UK and can be filtered by cancer type, drug name and location. Julia McVeigh said: ‘My takeaway is getting in touch with my CRN, drawing up a list of all the places my patients can go for information.’
Clinical research training and revalidation
One way that CNSs can learn more about clinical research is through Good Clinical Practice (GCP) e-learning and face-to-face training, which is provided by the National Institute for Health Research, standardised and free to the NHS, UK universities and other publicly funded organisations conducting clinical research.
GCP training can be used by CNSs as a revalidation opportunity, as can peer-to-peer learning, where a CNS spends time with a CRN and research team. Peer-to-peer learning is also an opportunity to improve collaboration.
At the Royal Shrewsbury Hospital for example, which runs phase II and III trials, all CNSs are encouraged to learn more about research by spending time with the research team. Many of them have completed GCP training.
Research sister Helen Moore said the research team had very good relationships with CNSs, who are invited to site initiation visits for trials and are sent study summaries; CRNs attend multidisciplinary team (MDT) meetings and the lead CRN attends CNS meetings.
More formal, organised communication between CNSs and CRNs at the beginning, during and at the end of trials was seen as another way of improving collaboration and patient experience.
At the beginning of a trial, it is helpful for CRNs to talk to the relevant CNS to help identify eligible patients, or attend MDT meetings with CNSs and the medical team.
Once a patient has been selected for a trial, a good handover of the patient from CNSs to CRNs is vital. Too commonly, it is seen as a ‘passing of the baton’, which is confusing for patients. Having some face-to-face contact between CNSs and CRNs at that point, and during and after trials can be helpful.
Patients generally want one point of contact – which is likely to be the CRN during the trial, but academic and researcher Verna Lavender told the roundtable about her clinical research involving young people, which found they appreciated access to a CNS as an impartial, trustworthy, ‘neutral friend’.
End of trial plan
Handover at the end of the trial is particularly sensitive, with some patients feeling bereft and abandoned once it has been completed. Patients need to know their main contact at all time points. The opportunity to improve patient experience at the end of the trial could come at the entry point: CRNs can prepare patients for what will happen as part of the consent process, thereby better managing patient expectations.
At the trial end, a scheduled joint meeting where the CRN reintroduces the patient to their CNS would foster a sense of continuity in their care. This would also avoid patients having to repeat their history to multiple healthcare professionals.
The roundtable noted that there is no standardised ‘end of trial process’, with no national guidance or uniformity. Typically, a letter is sent to the patient’s GP. Members thought this should also be sent to the relevant CNS.
Even better, formal written narrative documents – end of trial plans – could be produced, possibly by the CRN. This initiative could be formalised by amending the CRN’s job description.
Holistic needs assessments
The roundtable acknowledged that there can be tension over who carries out holistic needs assessments (HNAs) during and at the end of trials. The current process for HNAs was considered too prescriptive and lacking an important narrative aspect. Working out jointly between CNSs and CRNs who is best placed to undertake HNAs would aid collaboration and engagement, as would the development of a tool for best practice in use of HNAs. CRN Laura Favero said: ‘It’s been really useful for me to see the HNA is an issue for both sides, that’s refreshing.’
Tips for talking to patients about opportunities for trial participation
- Manage patients’ expectations by being honest and clear about the benefits and drawbacks of joining a trial.
- Ensure patients have a named contact for any questions.
- You do not have to have all the answers, but you should know how, and where, to refer patients to trusted sources of further information (see tools and resources).
- Try to ensure that trials information is available in languages other than English and that it is culturally appropriate.
- Stop conversations at appropriate moments to check patients’ understanding and to give them, or their families/carers if present, the opportunity to ask questions.
- Consider how you might support patients who lack good social networks or who are socially isolated.
Sharing trial results
When patients have taken part in clinical trials, the roundtable thought it was important that the results were fed back to them, however many years later results were published. The nursing staff at all locations who had played a part in the care of that patient should also be informed.
Research sister Helen Moore said: ‘My takeaway is the need for more organised formal communication with CNSs and feeding back with our results.’
CRN Sharon Woolley’s team is kept informed of trial results and research updates during a monthly breakfast meeting with staff members.
Roundtable members supported a number of innovative best practice initiatives (listed below), which, in time, could be rolled out nationally. Verna Lavender said: ‘As an academic and researcher I can see there are some models here that we can take forward and test.’
Joint CNS and research posts
Tara Nicholson has recently been appointed Macmillan myeloma CNS/advanced clinical trials practitioner, a new joint role, at Southampton General Hospital.
The role aims to overcome the danger of key worker involvement becoming disjointed as a patient transits from standard practice to trial and back again, potentially on several occasions. Ms Nicholson said: ‘It enables me to oversee the entirety of a patient pathway and to retain active involvement and key worker status irrespective of whether an individual patient is on a clinical trial or not.
‘I am experienced not just in the technical aspects of an individual trial but in the symptoms and natural history of specific diseases such as myeloma, thereby being in a stronger position to provide comprehensive support and guidance to patients with those conditions.
‘One clear consequence of this role will be that all patients with a given diagnosis will be able to experience the same high quality of medical and nursing care and engagement irrespective of trial participation. No patient group should therefore be disadvantaged. By being more disease-specific, the joint role will be able to provide a more comprehensive package of care to a patient, irrespective of background and disease stage.’
CRN Michael Mawhinney discussed his experience of ‘shared care’ during an early phase trial at University College London Hospitals (UCLH), which involved patients with glioblastoma. ‘The neurological CNS would come along once every three weeks to the patient’s day 1 of the cycle, we would meet the patient together, so the CNS would be up to date with the patient’s status. The CNS would guide me as well, behind the scenes.’
This collaborative working had a positive effect on patient experience, not least because the CNS was involved throughout. ‘When the patients came off the trial… it was quite a traumatic time, but the CNS was able to take over that role without any sense of loss,’ Mr Mawhinney said.
CRNs and CNSs in pre-clinic meetings
At UCLH, the haematological cancer trial team have a unique model where the MDT, comprising CNSs, CRNs and consultants, meets for 30 minutes before every acute leukaemia clinic to discuss all patients to be seen that day. These meetings are nurse-led so CRNs discuss their trial patients and CNSs discuss theirs. They also run joint ward rounds.
There is the opportunity to discuss patient care, flag any issues and identify patients who may be eligible for trials.
CRN Laura Favero, who manages the leukaemia and bone marrow transplant team at UCLH, said: ‘Pre-clinic meetings are such good things – they have made a huge difference. They can flag up patients for trials, everyone gains.
‘Generally, the CNSs are very involved; they understand the trial protocols, they benefit from teaching. We don’t have huge barriers in collaboration.’
Factors contributing to this success include geography – the nurses are in the same building – and they are caring for patients with one cancer type. CNS Michelle Greenwood pointed out that this is more difficult for CNSs working across multiple tumour groups.
Demystification of clinical trials
Michael Mawhinney said that when an experienced nurse starts to work on a trial it can be ‘overwhelming’: they are doing blood tests they have never done before as standard care and other new types of work.
But demystification of clinical research can occur early in a nurse’s career. In Oxford, when band 5 nurses are doing a rotation in haematology oncology they spend time in the clinical trials unit. They have always fed back that it is rewarding because they learn why certain clinical activities, such as cDNA tests, are done. Mr Mawhinney said: ‘It takes the fear away.’
Longer term initiatives
There were other longer term initiatives that, while challenging, could ultimately lead to improved practice and patient experience and, therefore, increased uptake of clinical trials.
Clinical trials should always be designed in the best interests of patients. Therefore, both patients and nurses should be involved in the protocol writing stage. Having CNSs and all stakeholders involved could enable better understanding of the patient journey and more patient-centric trials to improve patient experience.
At the end of a trial, there is no standardised approach on how to manage patients, whether they are receiving further treatment or not, or being referred to palliative care services. Developing a national guideline advocating an integrated approach to end of trial care plans would be useful and could significantly improve patients’ experiences.
Some roundtable members thought it unfair that trial participants had to travel long distances for treatment and that it could potentially prohibit participation, especially if they were aware they were on the standard treatment arm. Having CRNs who travel to trial patients for treatment, rather than the other way round, could be one solution although this might not be feasible.
The roundtable highlighted a need for guidance on ‘shared care’ models as they can vary in different teams even in the same trust.
The roundtable enabled the two nursing roles to step into each other’s shoes and understand each other’s priorities – and appreciate that they both want what is best for patients.
There was consensus that communication is key. They should never assume that the other was too busy to talk to them about, for example, patient eligibility, or whether they had potential patients for a trial.
Instead, they should be ‘proactive and take a forward stance’. As CNS Vivienne Tickle said: ‘Stop thinking: that is for CRNs and that is for CNSs.’
The initiatives that were shared and explored showed how more collaborative working could improve patient experience before, during and after trials. They also reminded roundtable members of their primary aim: ‘We are all nurses wanting the best for patients,’ said CNS Charlotte Bloodworth. Cancer Research UK lead research nurse Anne Croudass summed up: ‘Put the patient in the middle of what we do – not what we think our role is.’
Tools and resources
• Cancer Research UK clinical trials database
Reliable, easy-to-understand information on cancer clinical trials for you and your patients
• Cancer Research UK free patient resources, including Understanding Clinical Trials for Cancer leaflet
Clear information on what a trial is, the different types of trials and how they work
• Cancer Research UK about cancer
Written specifically for patients and their loved ones, covering all aspects of cancer
• Future Learn: Demystifying Targeted Cancer Treatments
Free online course. Learn from experts and gain a deeper understanding of how targeted treatments work to support your patients
• NIHR Good Clinical Practice (GCP) training
GCP is the international ethical, scientific and practical standard for clinical research
Jacqui Thornton is a freelance journalist
This article was initiated, funded and developed by Cancer Research UK