RESEARCH

Embedding the 6 Cs into clinical research practice and management Jayne Hardicre

C

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ompassion in Practice was launched by the Chief Nursing Officer (CNO), Jane Cummings, at the CNO’s Conference in December 2012 (Cummings and Bennett, 2012). The values and behaviours of this 3-year plan have been embraced. It has driven the NHS action and change agenda with calls for every nurse, midwife and member of the care team to implement the 6 Cs into practice (NHS Commissioning Board, 2013) and, furthermore, into all areas of health, public health and social care services. This was almost palpable around NHS Change Day in March 2014 and the rapid recruitment of caremakers acting as ambassadors for change and the implantation of the 6 Cs into practice. The values and behaviours of the 6 Cs are: ■■ Care ■■ Compassion ■■ Competence ■■ Communication ■■ Courage ■■ Commitment. There is no doubt that the nursing profession has previously and still today suffers negative media attention with reference to the recent failings of Mid Staffordshire NHS Foundation Trust and the well-publicised findings of the Francis (2013) Inquiry and Keogh (2013) Review. Foster (2013) highlighted that this has led to people losing trust in the care we deliver. Foster goes on further to suggest that to regain that trust, we must be clear about the values and behaviours required if we are to provide the skills and compassion needed to develop a culture of compassionate care. This article explores how the Compassion in Practice vision and actions can be embedded into the world of clinical research. While it is accepted that not all clinical research is undertaken within the NHS, this article focuses on those research patients within the Jayne Hardicre is Lecturer in Nursing Adult Specialty at University of Salford Accepted for publication: March 2014

British Journal of Nursing, 2014, Vol 23, No 7

National Institute for Health Research Research & development

Patient and public involvement Care

Research fellow Commitment Clinical research nurses Research registrar

Compassion

Research patient Courage

NHS trusts

Clinical trials units (NHS)

Research practitioner Competence

Communication Academic institutions AHP researcher

Clinical research facilities (industryfunded)

Consultant researcher

Figure 1. Some influences on the research patient experience

public service, but with recognition that the principles discussed have the potential to be translated with ease into other areas.

Research in the NHS Research is essential to the provision and development of effective, efficient and safe health and social care. New treatments, medicines, regimens, practices and services are developed through research. Put simply, we are where we are today because of research that has been undertaken and the research of today will influence and impact on what we do tomorrow (Hardicre, 2013). The National Institute for Health Research (NIHR) network is the clinical research delivery arm of the NHS. A report released in 2013 by the NIHR showed that more

than 630 000 NHS  patients in England took part in clinical research in 2012. This was the highest level since the network’s research began (NIHR, 2013a). It also reported that 99% of NHS trusts in England now carry out some clinical research studies. According to a consumer poll commissioned by the NIHR in 2013, 79% of those polled believed it was important for the NHS to carry out research. Of these people who felt research in the NHS was important, 87% indicated that they would prefer to be treated in a hospital (or surgery) that had an active research culture (NIHR, 2013b). While the development of the research infrastructure and recruitment into clinical research studies (or trials) has risen year upon year, so too has the clinical research nurse

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Care

■■ High-quality person-centered care ■■ Standard operating procedures to underpin and guide best practice ■■ Spending time with the research patient ■■ Respond to concerns immediately ■■ Family care ■■ Ensure all research equipment is calibrated, functioning and adheres to trust infection control policies at all times

Compassion

■■ High-quality compassionate care ■■ Treat every research patient with compassion, dignity and respect ■■ Respect decisions whatever they are ■■ Develop an understanding of the potential fears or barriers to research participation ■■ Show understanding if a patient wants to withdraw from the research and maintain the research patient relationship following this decision is possible

Competence

■■ Continuous support and development in addition to basic Good Clinical Practice training ■■ Adhere to ALL training required in line with trust policies ■■ Protocol specific training with patient journey simulation prior to recruitment. Also consider regular simulation if low recruiting study to maintain competence readiness ■■ Training in standard operating procedures ■■ Further opportunities at regional and national level ■■ Encourage use of social media for networking and updates and support

Communication

■■ Clear accurate communication with patient and family prior to, during and after consent ■■ Maintain continuous communication and confirm understanding of participation at EVERY time point ■■ Clear accurate communication with clinical team ■■ Clear and accurate documentation in medical records, case report forms (CRF) and e-CRF

Exploring the 6 Cs Clinical research nurses and allied health professionals (AHPs) strive to undertake high-quality research while maximising the enjoyability of research patients’ experience. They must ensure that high-quality data is captured while protecting the patients from harm. That being said, many would argue that all research could be potentially harmful to patients (Long and Johnson, 2007), either through clinical trials testing new drugs or devices or research seeking evidence about sensitive topics. Either of these things could cause inadvertent emotional distress and potential damage (Royal College of Nursing, 2009). This subject will be discussed in more depth in a separate article later in this series. The Department of Health’s (DH) (2005) Research Governance Framework outlines the need for quality research cultures within the NHS and lists the key elements as follows: ■■ Respect for participants’ dignity, rights, safety and wellbeing ■■ Valuing the diversity within society ■■ Personal and scientific integrity ■■ Leadership ■■ Honesty ■■ Accountability ■■ Openness ■■ Clear and supportive management. It is essential that each and every patient taking part in research is treated and managed in such a way as to maximise the quality and enjoyment of that experience. Whatever the motivator behind patients’ decision to participate in research, each person should be managed with dignity, respect, and with the highest level of care delivered by a highly qualified workforce with effective and supportive leadership. Patients and families participating in research give up their time and bodies to developing the treatments and services of tomorrow. This can involve completing a simple questionnaire or taking part in

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Courage

Commitment

■■ Research nurses and practitioners to act as the patient’s advocate at all times ■■ Bring to the attention of senior any concerns regarding research protocols or patients ■■ Have the courage not to approach a patient even if deemed eligible if you feel not suitable at the time ■■ Bring to the attention of senior any concerns with patient care or researcher conduct

■■ Commitment to high-quality care ■■ Commitment to professionalism and integrity as a researcher ■■ Commitment to leadership development and succession planning ■■ Clear links with clinical leads aiming for joint appraisal between research and clinical leads within directorate/specialty ■■ Commitment to further integrate with clinical teams with high visibility ■■ Commitment to maximising the patient experience

Figure 2. Some areas of consideration when embedding the 6 Cs into research practice

complex trials involving early developmental phase medication—sometimes over a period of months (or even years). Researchers have performance matrices, benchmarks and targets, yet their main focus is (or should always be) on delivering the highest quality care. There are many people who may be involved in a patient’s research journey and many who, while not directly involved, influence and drive the quality of that journey (Figure 1). It is suggested that embedding the vision and actions of the 6 Cs into research care and management would further enhance the quality of care. This could also further enhance research patients’ experience while facilitating closer working relationships with

the existing clinical teams within the different specialties. Partnership working varies greatly from specialty to specialty and from trust to trust. If we are ever to get to the point where research truly becomes a part of the NHS patient pathway, we need to continue to work closely with our clinical colleagues and there are a number of ways in which this can be done. Agreeing to present regularly at clinical governance or ward meetings is a great way of updating staff and involving them more closely in your work. Securing a research-dedicated board is an excellent communication method for both staff and patients. The production of a regular newsletter is also an effective communication

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workforce. A conservative estimate by Pidd (2011) was that by the end of 2013, the NIHR clinical research nurse workforce would have risen to 10 000 strong. It must also be pointed out that not all clinical research nurses are those supported by the NIHR and that, in reality, the research community is diverse in its structure. In addition to NIHR clinical research nurses, there are NHS trust-employed research nurses, as well as a whole variety of academic research nurses, practitioners, fellows, associates, registrars and doctors who may have direct contact with research patients within the NHS.

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RESEARCH Box 1. Standards of care for research participants Every research participant* is entitled to and can expect the following standards: ■■ Research

participants can expect their care and treatment to be consistent with the research protocol guiding their participation and consent, that valid data is collected and recorded by the research team, and that the team undergoes continuous structured education and development ■■ Research participants can expect that the treatment and monitoring received will be invidualised, within the confines of the protocol, and that in all cases their safety, comfort and wellbeing will take priority over research requirements ■■ Research participants can expect prompt assessment and appropriate responses to changes in their condition or any untoward responses to any research procedures, whether expected or unexpected ■■ Research participants can expect the researchers to communicate and collaborate effectively with other members of the clinical research team and clinical team to ensure coordinated continuity and high-quality informed care ■■ Research participants can expect that information about their care and condition is discussed and communicated within the boundaries of confidentiality and the Data Protection Act and that all care is documented accurately ■■ Research participants can expect to develop an understanding of their own condition, research participation and treatment and be able to undertake and manage self-care following expert instruction and assessment ■■ Research participants (and families) can expect to be the focal point of discussions and decisions regarding their plan of care and research participation ■■ Research participants should expect to know who is responsible for their care and research participation and how to contact that person (or team) if required ■■ While participating in research, participants should expect to receive evidence-based care, consistent and compliant with trust policy and the standards(s) relating to their particular condition or therapy ■■ Research participants can expect that they will be treated with dignity and respect and receive prompt, courteous and individualised care from researchers and clinical teams and that this will continue after study participation has ended either by study end, closure or consent retraction *the term participants can be substituted with patient

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method, particularly if circulated in paper and electronic formats. Regular visibility and inclusion in ward rounds is an effective way of embedding research into the ward culture and gives the opportunity to talk to clinical colleagues about your role, individual studies and potential patients requiring review. It is also recommended that research teams have a direct link with senior clinical leaders. Research team leaders should enjoy the benefits of a research manager and clinical lead joint appraisal/review. In addition to keeping everyone informed of any updates, either within research or trust practices, formalised direct links facilitate further validated acceptance and attachment to the clinical team or directorate if this had previously been lacking. Figure 2 highlights some areas of consideration when embedding the 6 Cs into research practice. There are a variety of

thoughts, which can easily be added to and adapted to your particular area. Box 1 outlines standards of care for research patient participants with the essence of the 6 Cs in mind. This has been produced as a guide to demonstrate how the 6 Cs can be made explicit within your teams’ codes of practice but could also be shared with patients.

Summary The White Paper, Equity and Excellence: liberating the NHS (DH, 2010) emphasises the promotion and conduct of research as a core NHS role. The updated NHS Constitution (DH, 2013) outlines its commitment to innovation and also to the promotion and conduct of research to improve the current and future health and social care of the population. Furthermore, NHS England (2013) in its guidance, Everyone Counts: planning for patients

2014/15 to 2018/19, identified research as one of the essential elements for a successful and sustainable health economy recommending research and evaluation be embedded across the whole patient pathway. The 6 Cs were launched in 2012 to drive the Compassion in Practice vision with calls for every nurse, midwife and member of the care team to implement them into practice (NHS Commissioning Board, 2013). The 6 Cs can be embedded into the world of clinical research so that research patients are afforded the same levels of compassionate care by all members of the research workforce and, indeed, to drive compassion in practice for the researchers themselves. It is suggested that this will result in high quality, compassionate personalised care for all and that the biggest voices will be BJN those of the patients themselves.  Conflict of interest: none. Cummings J, Bennett V (2012) Compassion in Practice: Nursing, Midwifery and Care Staff – Our Vision and Strategy. NHS Commissioning Board, Leeds. http:// tinyurl.com/c5lc4n2 (accessed 26 March 2014) Department of Health (2005) Research Governance Framework for Health and Social Care, 2nd edn. DH, London. http://bit.ly/OOR4vK (accessed 26 March 2014) Department of Health (2013) The NHS Constitution: the NHS belongs to us all. http://tinyurl.com/c9qmsac (accessed 26 March 2014) Foster D (2013) How the 6Cs relate to clinical leaders. Nurs Times 109(1-2): 12-3 Francis, R (2013) Mid Staffordshire NHS Foundation Trust Public Inquiry: final report. http://www. midstaffspublicinquiry.com/report (accessed 26 March 2014) Hardicre J (2013) An exploration of the role of the research nurse and its impact. Br J Nurs 22(3): 168-9 Keogh B (2013) Review into the quality of care and treatment provided by 14 hospital trusts in England: overview report. http://tinyurl.com/ph9e267 (accessed 26 March 2014) Long T, Johnson M, eds (2007) Research Ethics in the Real World: Issues and Solutions for Health and Social Care. Churchill Livingstone, London National Institute for Health Research (2013a) Figures show “new high” in NHS patients participating in clinical research. http://bit.ly/OOKxRP (accessed 26 March 2014) National Institute for Health Research (2013b) How is your Trust performing on research? 2012/13. http:// tinyurl.com/nae7olp (accessed 26 March 2014) NHS Commissioning Board (2013) Compassion In Practice: A Summary of the Implementation Plans. http://tinyurl.com/ol784l7 (accessed 26 March 2014) NHS England (2013) Everyone Counts: Planning for Patients 2014/15 to 2018/19. http://tinyurl.com/nl9uhcs (accessed 26 March 2014) Pidd H (2011) Maximising the Nursing Contribution to the UK Clinical Research Agenda. http://bit. ly/1iRG4sL (accessed 26 March 2014) Royal College of Nursing (2009) Research ethics: RCN guidance for nurses, 3rd edn. http://bit.ly/1eCnbZy (accessed 26 March 2014)

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Embedding the 6 Cs into clinical research practice and management.

The White Paper, Equity and Excellence:liberating the NHS (DH, 2010) emphasises the promotion and conduct of research as a core NHS role. The updated ...
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