Collaborative working between research nurses and clinical nurse specialists allows researchers to increase patients’ participation in clinical trials
Many clinical trials face challenges in recruiting enough participants and research teams often lack capacity to expand the scope of their activities. This is partly because research is still seen by some as an add-on to care, rather than core business. At an acute trust, research nurses established a partnership with clinical nurse specialists to assist on research projects. This collaborative working has led to increases in the number of trials, the number of participating patients and the number of specialties involved.
Citation: Lancaster N, Dumville J (2019) Benefits of involving clinical nurse specialists in research. Nursing Times [online]; 115: 4, 34-36.
Authors: Nicola Lancaster is lead research nurse at Barnsley Hospital Foundation Trust; Jane Dumville is senior research nurse, Doncaster and Bassetlaw Teaching Hospitals Foundation Trust.
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Clinical research is often seen as separate from routine care, even though it leads to better care and patient outcomes (Majumdar et al, 2008). This means that research nurses and clinical nurse specialists (CNSs) often work in isolation from each other. At Doncaster and Bassetlaw Hospital Foundation Trust, we introduced collaborative working between research nurses and CNSs, which has dramatically increased patient participation in trials.
Recruiting for research
In 2014, the results of a survey carried out by the National Institute for Health Research revealed that 89% of people would be willing to take part in a clinical trial (NIHR, 2014). Despite this, many trials face challenges in recruiting enough participants (Caldwell et al, 2010). Boaz et al (2015) identified evidence that suggests research can improve healthcare performance. However, engaging clinicians in research is still in its infancy.
The Care Quality Commission, updated its inspection framework in October 2018 to include research, mainly focusing on:
- Awareness – how does the trust publicise research opportunities to patient and staff?
- Facilitation – how does the trust support this from a board level down to bedside?
- Equity – how does the trust support research across services to support equity of opportunities across specialties? (CQC, 2018).
CQC assessor teams will include research experts, who will look for visible research information for patients and the public. They will be asking all levels of staff about research and the opportunities for patients to get involved. They want to see evidence that research forms a key part of clinical care at the point of care, to ensure that healthcare organisations see research as a core business. The 2014 NIHR ‘OK to Ask’ campaign reminded health professionals to be research-aware and encouraged patients to ask about research opportunities.
NHS England (2017) has a legal duty to promote research and the use of research evidence in the NHS. This ensures the NHS supports and harnesses the best research and innovations to improve patient outcomes, transform services and ensure value for money. The NHS Long Term Plan (NHS England, 2019) commits to increasing the number of people registering to participate in health research to one million by 2023/24.
At Doncaster and Bassetlaw Hospital Foundation Trust, research nurses are assigned to teams who work in collaboration with clinical specialties to raise awareness of research – ensuring a balanced portfolio across all specialties. CNSs are informed of studies in their disciplines and support available to patients, but do not usually actively recruit for or help conduct trials.
Teams of research nurses are often limited in size and struggle to engage with all specialties. The first time patients hear about research is often when they are approached by a research nurse, which is also likely to be their first contact with research. We decided to explore how research can be embedded into routine care and review the way patients are introduced to trials.
Introducing patients to research
The trust provides acute care across three main hospital sites serving a population of more than 420,000. It has a team of nine research nurses and employs more than 100 CNSs in a wide range of specialties. In 2015, we conducted a trust-wide review of how research is introduced to patients.
Initially, the research nurse discussed research with patients during their outpatient appointment, but they struggled to recruit and received feedback from patients saying this had caught them off guard. Changes were therefore required in the way patients are informed of existing studies, invited to participate, and eased into the research process.
In April 2015, a partnership was formed with CNSs, who now introduce clinical trials to patients during consultations and refer interested patients to the research team. This has enabled us to increase:
- The number and range of clinical trials that we can offer patients;
- The number of patients participating in research (Fig 1);
- The number of clinical specialties involved in research;
- Job satisfaction among CNSs;
- The number of commercial trials.
Access to research
Thornton (2017) acknowledges that CNSs play an important part in research, as they often establish close relationships with patients and are well-placed to identify those suitable for research. They identify patients who may be interested in taking part in a trial, explain the trial to them and, if patients are still interested, inform the research team. This enables a smooth, ‘natural’ introduction to research, as patients have an existing rapport with their CNS. Box 1 describes how this new process was used in a colorectal clinic.
The involvement of CNSs also means potential recruits are identified seven days a week instead of five. The new process has given patients access to research that would not have been previously accessible. The research department is able to offer more studies to patients in a wider range of specialties, as the workload is shared between research nurses and CNSs. Table 1 lists examples of the trials our trust has been involved in since the new process was introduced.
Box 1. Case study: recruiting for research in a colorectal clinic
The lead research nurse attended a colorectal clinic team meeting and provided information about a study underway on two-week referral of bowel symptoms to review the symptoms patients are referred with and the outcome of the consultation including any diagnostic tests. That information was incorporated into the clinics. Healthcare assistants distributed information sheets about the study to patients in the waiting room before their consultation, during which CNSs gave them further information.
At the end of the consultation, CNSs explained the study in greater detail and, if patients decided to participate, elicited their consent. From then on research procedures were conducted as per the protocol.
Feedback from patients showed that they felt at ease with this approach. Over a 12-month period from April 2015 to April 2016, 189 patients were recruited in this way and the new process had no detrimental effects on the running of the clinic or the patient pathway.
Initially the CNSs were dubious about linking research to routine care, which was surprising considering that research and continuing education form part of their roles. However, this reluctance is not a new phenomenon. Skea et al (2017) experienced similar difficulties and resolved them by ensuring that research nurses engaged and motivated CNSs.
The research nurses spent time explaining the partnership and ensuring CNSs had control over the depth of their involvement. This was tailored to the amount of time CNSs were able to give, ranging from minimum input (identifying eligible patients) to maximum input (becoming study lead). CNSs became more amenable to involvement in the research process.
The research role of CNSs has expanded. Some CNSs have made the leap from identifying patients in clinic to eliciting their consent and carrying out research-specific assessments independently. This has significantly improved the whole process, as research nurses do not have the in-depth knowledge of a clinical specialty that CNSs have. This has proven particularly successful in dermatology, where research nurses conduct procedures specific to research and CNSs deliver specialist care according to the research protocol. Without this collaboration, research nurses would not be able to conduct clinical trials that require specialist skills. Collaborative working allows them to take more patients through research protocols.
CNSs verbally reported that they found the research process interesting; that being involved added new depth to their role, furthered their education and increased their motivation; that the research protocols provided immediate benefit to patients in terms of symptom relief; and that involvement in research was rewarding, as they felt they were helping to shape future practice and treatments.
This had a positive effect on job satisfaction, which is considered important within the nursing profession, as job dissatisfaction may reduce the quality of care (Wu et al, 2016) and ultimately lead to high staff turnover (O’Brien-Pallas et al, 2010).
Thanks to the involvement of CNSs, research nurses were able to move from recruiting participants to engaging research-naive clinical areas and working on more complex, commercial and experimental drug trials.
The number of commercial trials has significantly increased, allowing more patients access to new, unlicensed drugs. This is of great benefit to those who have tried every available licensed treatment without success and therefore feel there is no hope left for them. Offering another treatment avenue via experimental research studies can give them renewed hope (Box 2). A further benefit to the trust is that the income generated through engaging in research with pharmaceutical companies can be used to purchase equipment to further benefit patient care.
Box 2. Case study: benefits of research participation
A patient who had suffered with rheumatoid arthritis for more than 10 years and tried every available treatment was invited to participate in a trial of sarilumab. After three months, the patient reported-life changing effects of having movements in his hands and being able to grip – something he had not managed in at least five years. He was so overwhelmed at being given this research opportunity that he contacted the local news team and used his story to encourage others to take part in research. Sarilumab is now a licensed drug recommended by NICE for rheumatoid arthritis.
With CNSs supporting research in established areas, the research team was able to involve research-naive areas and further increase the number of patients offered participation in research – one of the strategic aims of the NIHR (Hamer, 2017).
In research-naive areas, we met the CNSs to discuss patients’ clinical needs and identify suitable studies. This fostered their engagement, as the studies were of clinical relevance and they could see the potential benefits for patients. This fulfils another NIHR goal of working with clinical teams to ensure clear understanding and awareness of the research nurse role.
When the changes were first discussed, CNSs were apprehensive and expressed concerns regarding the time needed to explain studies to patients. Clinics were full and CNSs were under pressure to stick to schedules. They thought the new processes might have detrimental effects on time management. These apprehensions were quickly dispelled once CNSs started to talk the first patients through studies, as they saw first-hand the dramatic increase in participation.
Our collaborative model has also led to research being conducted in previously research-naive specialties. It has scope to grow as the number of studies increases. We are receiving more enquiries from health professionals within the trust from a variety of specialties and roles who are keen to offer patients the opportunity to participate in research. This is now increasingly feasible thanks to the involvement of CNSs.
- Clinical research is often seen as an add-on to patient care rather than core business
- Research teams lack time to engage with all clinical specialties
- Clinical nurse specialists have expert skills and a good rapport with patients
- Involving clinical nurse specialists in patient recruitment frees up time for research nurses to increase the scope of their activities
- Patients participating in clinical trials may gain access to new, unlicensed drugs
Boaz A et al (2015) Does the engagement of clinicians and organisations in research improve healthcare performance: a three-stage review. BMJ Open; 5: 12, e009415.
Caldwell PH et al (2010) Strategies for increasing recruitments to randomised controlled trials: systematic review. PLos Med; 7: 11, e1000368
Care Quality Commission (2018) Inspection Framework – NHS Hospitals: Outpatients.
Majumdar SR et al (2008) Better outcomes for patients treated at hospitals that participate in clinical trials. Archives of Internal Medicine; 168: 6, 657-662.
National Institute for Health Research (2014) Nine Out of Ten People Would Take Part in Clinical Research.
NHS England (2019) NHS Long Term Plan.
NHS England (2017) NHS England Research Plan.
O’Brien-Pallas L et al (2010) Impact and determinants of nurse turnover: a pan-Canadian study. Journal of Nursing Management; 18: 8, 1073-1086.
Skea ZC et al (2017) ‘It’s trying to manage the work’: a qualitative evaluation of recruitment processes within a UK multicentre trial. BMJ Open; 7: 8, e016475.
Thornton J (2017) Clinical trials – improving patient experience. Cancer Nursing Practice; 16: 2, 16-22
Wu S et al (2016) Compassion fatigue, burnout, and compassion satisfaction among oncology nurses in the United States and Canada. Oncology Nursing Forum; 43: 4, E161-E169