The hepatology department at Hull and East Yorkshire Hospitals NHS Trust participates in a range of both portfolio (National Institute for Health Research-funded) and commercial clinical trials. As a newly appointed research nurse, it quickly became apparent to the first author that improving standards of patient care, clinical management and experience through research is essential. Academic research is embedded in university nurse education and clinical research should also be a central feature of professional development in nursing (Tingen et al, 2009; Carrick-Sen et al, 2016).
It has been widely documented that there is often confusion surrounding the role of specialist nurses, which could lead to disharmony between general nurses and their specialist colleagues (Callara et al, 2008). This reflects the first author's experience, as she was initially unsure of what to expect of the role.
This article will discuss the role of research in nursing from the authors' experience, examining patient satisfaction and how the Hull and East Yorkshire Hospital Trust's research team is working to raise the profile of research as an essential component of patient care.
A varied role
The hepatology research nurse role is demanding, but varied and interesting. The principal investigator (PI), usually a clinician, is ultimately responsible for patient clinical care and trial management at each site in the Trust. The research nurses manage day-to-day patient care according to specific trial protocols, monitor and report patient safety issues and coordinate trial logistics.
Research nurses are essential to clinical trials; their role is primarily one of coordination. Each trial has its own study protocol that outlines what needs to be done at each patient visit. Any one patient visit can take up to 5 hours, occasionally more. A standard visit in a hepatology trial usually comprises a variety of tasks such as patient recruitment, obtaining informed consent, performing an echocardiogram and imaging scans, administering questionnaires, performing venepuncture, tissue sample collection, sample processing, safety reporting and data collection.
Trials involve both complex patient care and the opportunity to be actively involved in advancing treatments and patient care through clinical research. Research nursing requires a lot of autonomous work and decision making and at times it can be isolating. However, hepatology patients can present in a variety of settings, such as medical day units, outpatient clinics, wards, the emergency department and endoscopy services. Consequently, it is the role of the research nurse to develop and promote productive working relationships with staff in a range of hospital settings to ensure the smooth conduct of trial activities, optimising both the patient and staff's experience of trial-related work.
An essential part of the role of a hepatology research nurse is to ensure an appropriate informed consent process is undertaken. A medical PI will usually take informed consent for drug trials and nurses usually take informed consent for non-drug trials. This involves providing the patient with a patient-information sheet about the trial, answering any questions or concerns they may have, and allowing them enough time to make an informed choice. This requires the research nurse to be an expert in the trial protocol to ensure the patient is appropriately informed at the time of consent. In this way, research nurses can act as patient advocates to ensure informed consent represents the patients' best interests.
Recruiting to some hepatology trials can be particularly difficult because some patients are from marginalised vulnerable groups such as alcohol misusers or intravenous drug users. These patients may experience substance withdrawal or hepatic encephalopathy at the time of consent. Trials where this may be the case will require additional informed consent processes involving independent legal representatives.
The Trust's hepatology research department is currently participating in pioneering trials for the treatment of non-alcoholic fatty liver disease, primary biliary cholangitis, alcoholic hepatitis, decompensated liver cirrhosis, and hepatitis C, among other conditions. An in-depth knowledge and understanding of hepatology, alongside a broad understanding of research processes and legislation surrounding clinical trials, is mandatory to the role. It is ideal for self-confessed academics who do not want to lose contact with patients and more hands-on nursing practice. Being able to sit with patients and families to have an in-depth conversation about the trial and their condition, and to offer emotional support, is a luxury few general nurses experience regularly.
Best practice
General nursing skills acquired from years of experience provide the foundation for research nursing, but the transition from a hands-on ward-based role to predominantly administration-based research nursing has been a steep learning curve for the first author. The role is specialised, therefore new skills must be acquired and some skills are not regularly practised, such as general ward-based care.
The research nurse should be utilised as a resource for current best practice, assisting in enhancing evidence-based practice and raising awareness of the importance of research in the NHS.
In 2018, the authors' department conducted a nurse-led education session to raise the profile of research nursing, to support Trust strategy to embed research into everyday nursing activity. In this initiative, general nurses were invited to attend a gastroenterology and hepatology nurse education day. Positive feedback showed that health professionals both need and want access to research-focused training to ensure best practice. The initiative encouraged a collaborative way of working and created an opportunity to disseminate hepatology research information.
Patient benefits
Participating in a clinical trial has many potential benefits to patients, such as having access to medications not yet available to the wider public, a sense of altruism and closer links to the hepatology department. Often marginalised groups such as alcohol-dependent patients or intravenous drug users face stigma. From the authors' experiences, the general consensus is some do not have the same access to treatments that other patients with less chaotic lifestyles may have (Room, 2005). This could be due to socioeconomic reasons, such as difficulty in accessing primary/secondary care services, having no fixed abode or low levels of education (Marmott et al, 2010). For that reason, offering these patients the opportunity to participate in research could make them feel valued.
The National Institute for Health Research (NIHR) started an annual campaign ‘OK to ask’ in 2013 to raise the profile of research and accessibility to patients as research overall has a low visibility in the NHS. The campaign focuses on encouraging patients to approach health professionals about clinical trials and to enquire whether they might be suitable participants (NIHR, 2013). Lack of health professional knowledge about clinical trials has the potential to inhibit patient participation in trials.
Currently clinical research is thriving in the NHS with more than 725 333 patients taking part in studies in 2017/2018 (NIHR 2018). Although some patients feel they could potentially gain from clinical trial participation, altruism is one of the biggest drivers for patients participating in trials (Jansen, 2009). As some hepatology conditions are rare, patients find a sense of comfort in potentially helping to improve treatments for people like themselves by participating in research.
As most randomised controlled trials (RCT) have a placebo arm, there is not always a direct therapeutic benefit to the patient, yet it is generally known patients who participate in clinical trials commonly perform better and experience better health outcomes. This could be because individuals may modify their behaviour as a result of observation or the care provided under the guidance of a clear research protocol may be of a higher standard (West et al, 2005; Krzyzanowska et al, 2011).
Financial compensation is a frequent ethical question raised by ethics committees, public and patient involvement groups and patients. Some countries with private healthcare systems, such as the USA, may offer free treatment to those who take part in clinical trials. However, in the NHS, where treatment is free at the point of care, financial reward is not an incentive when considering participation.
Research nurses need to create rapport with patients in order to ensure positive retention and medication compliance on long-term clinical trials. Research nurses are often more accessible and can offer greater flexibility when scheduling clinic visits than doctors. Patients describe a sense of trust and build lasting relationships with the research nurses.
Health professionals have a responsibility to provide patients with the most up-to-date evidence-based information; this includes ensuring patients are aware of all treatments that are available to them, and empowering patients to take ownership of their condition.
Conclusion
Research is the foundation of all treatments, procedures and medication, and it is essential that it is embedded into everyday practice for nurses and all health professionals. Clinical trials contribute positively both to the patients and the wider research and scientific community.
It is the role of all health professionals to inform patients of the benefits of clinical trials. The hepatology research department in the authors' Trust works to increase the visibility of hepatology research in order to raise awareness and integrate it into general nursing.
The transition from ward-based nursing to the niche sector of hepatology research nursing has had its challenges. However, the new set of skills acquired, the in-depth knowledge of clinical trials developed, along with an understanding of research legislation, and the regular contact with patients, has made the role rewarding.