This article describes the creation and pilot of a national career development opportunity for research nurses and midwives wishing to develop as leads for delivering research studies at site
Abstract
The chief nursing officer for England’s strategic plan for research identified the important contribution that nurses and midwives make to research, and how this group can be developed in the future. The value of the contribution of clinical research and the specialist staff that deliver research studies was also further demonstrated throughout the Covid-19 pandemic. This article describes the creation and pilot of a new national career development opportunity for research nurses and midwives who wish to develop as leads for delivering research studies at site.
Citation: Ward K, Dorgan S (2024) National scheme to support careers of research nurses and midwives. Nursing Times (online); 120: 11.
Authors: Karl Ward is lead nurse for research and innovation education, St James’ University Hospital, Leeds Teaching Hospitals NHS Trust, and nursing and midwifery senior research leader, National Institute for Health and Care Excellence; Sharon Dorgan is associate director of nursing and midwifery, National Institute for Health and Care Research, and health and care director, Regional Research Delivery Network, North East and North Cumbria.
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Introduction
Clinical and healthcare research provides critical evidence to improve the future care and treatment of patients (Downing et al, 2017). Clinical research nurses (CRNs) and midwives (CRMs) make significant contributions to the care of patients, as well as the delivery and integrity of clinical research (Jones et al, 2022). This was amplified and further demonstrated throughout the global Covid-19 pandemic, in which CRNs and CRMs supported the delivery of urgent public health studies that led to the assessment and implementation of life-saving treatments.
One example of this was the landmark Randomised Evaluation of Covid-19 Therapy trial (recoverytrial.net), which aimed to identify effective treatments for Covid-19 among a range of existing therapies, and became one of the largest randomised controlled trials for treatments in the world. Furthermore, the safety and efficacy of Covid-19 vaccines were tested in large-scale clinical trials and supported by CRN/CRMs, which led to the national Covid-19 vaccination programme (Burden et al, 2021; Iles-Smith et al, on behalf of the Association of UK Lead Research Nurses, 2020). As a result, this critical workforce group is no longer seen as a luxury, but an essential part of the healthcare multi-disciplinary team (Maxton et al 2021). Therefore, the development of CRN/CRMs is crucial to retaining expertise and acknowledging this emerging area of practice, while also providing meaningful research career pathways for clinical professionals. One area for consideration is for nurses and midwives to lead the delivery of clinical research and undertake the role of the local principal investigator (PI) to safely lead appropriate studies in their institution.
The Department of Health and Social Care has prioritised supporting clinical research and enhancing the clinical research environment by encouraging participation from health professionals from all backgrounds, as outlined in its (2021) document Saving and Improving Lives: The Future of UK Clinical Research Delivery. Furthermore, the chief nursing officer for England’s strategy for research, which was published in 2021, identified the important contribution that nurses and midwives make to research, as well as how this group can – and should – be developed in the future. One of the key themes of this strategy is “developing the future leaders of research” (NHS England and NHS Improvement, 2021).
As outlined by the Medicines and Healthcare products Regulatory Agency (MHRA) (2012), the PI has been defined in UK law as an “authorised health professional responsible for the conduct of a research trial at a site and, if the trial is conducted by a team of authorised health professionals at a trial site, the investigator is the leader responsible for that team”.
Historically, the role of the PI has predominantly been medically led, particularly in drug and medical device clinical trials that have been supported by CRN/CRMs (Smythe et al, 2022; Braidford and Terry, 2015). However, this is changing, and it is becoming more commonplace to see CRN/CRMs in the PI role (Smythe et al, 2022), as not all research conducted in healthcare is interventional. Moreover, nurses and midwives can act as a PI in a complex interventional study – such as one for devices and drugs – as long as there is appropriate medical cover to assess key areas. Examples of these areas include eligibility and drug safety, as this is mandated in the MHRA’s (2012) good clinical practice guidance and in law – namely, the Medicines for Human Use (Clinical Trials) Regulations 2004.
CRN/CRMs are ideally placed to be the local PI in their organisation due to their clinical expertise, deep understanding of research governance, the delivery of complex research trials and care of patients on these pathways. The Whitehouse Report – namely, Whitehouse and Smith (2018) – highlighted this by showing that there was a significant interest across the UK clinical research workforce in formally developing the nursing and midwifery PI role in practice to:
Provide this group with increased confidence in their roles;Build the portfolio of studies on offer to participants.
Although the National Institute for Health and Care Research (NIHR) has established research training and award programmes to support academic career pathways for investigators (such as the Health Education England/NIHR Integrated Clinical and Practitioner Academic Programme), there has been limited focus on developing career structures for nurses and midwives wishing to develop as clinical research delivery leaders, with training opportunities being limited or not that clearly defined (Kunhunny and Salmon, 2017).
Since 2018, the NIHR Associate Principal Investigator (API) Scheme has given health professionals an opportunity to become more involved in clinical research as part of their professional role. This programme provides a six-month, in-work training opportunity for health professionals from all clinical disciplines who are starting their research career. It allows those who may not typically have the chance to participate in clinical research in their day-to-day role to gain practical experience of working on, and delivering, an NIHR portfolio trial under the mentorship of a local research leader and PI. The API scheme is not suitable for, or open to, those who have research experience or are working in a funded research role, as many of its elements are already part of their daily research responsibilities.
The Association of Royal Medical Colleges and the NIHR have also developed the national Clinician Researcher Credentials Framework, which offers a master’s level course and practical ‘hands-on’ experience in research delivery and leadership for all registered medical and healthcare professions. However, not all staff may aspire to this level of study.
Some Local Clinical Research Networks (LCRNs) have also developed programmes, often referred to as ‘greenshoots’, for those already working in a research delivery capacity and seeking to enhance their skills, knowledge and expertise to the level of a PI. These programmes usually span a two-year period and come with attached funding – however, they are limited geographically and are not a national offering.
Given the limitations and variations of the above schemes, there was a national need to develop, pilot and evaluate a new scheme aimed at research nurses and midwives that built on the successful elements of existing programmes.
Method
The concept of an NIHR PI programme specifically for CRN/CRMs was created. A national steering group was convened to oversee and guide the development of such a programme. Drawing on members’ expertise, the steering group:
Provided advice;Encouraged further collaboration;Identified ongoing areas for programme development.
It was created to represent a range of stakeholders, with membership including individuals and representatives from:
NIHR Nursing and Midwifery Office;NIHR API Scheme;Leeds Teaching Hospitals NHS Trust (LTHT) research and innovation education team;Nursing and midwifery research delivery teams from across England.
The steering group met monthly. Through extensive stakeholder engagement, consultation and discussion forums, a new scheme – the Principal Investigator Pipeline Programme (PIPP) – was created and four main elements of it were identified (Box 1, Fig 1). These elements, which are to be done in sequential order, aim to offer a range of theoretical and practical components.
Box 1. The four elements of the PIPP
Element 1 – understanding the role and the responsibilities of the PI on an NIHR portfolio study and why the role is important in the delivery of high-quality researchElement 2 – providing supervised experience in the PI role, enabling the development of practical knowledge and skills in a safe environmentElement 3 – continuing to build on the practical experience gained in Element 2 by undertaking the PI role on an NIHR portfolio studyElement 4 – consolidating all of the programme learning by asking participants to mentor other learners in Element 3 of the programme
NIHR = National Institute for Health and Care Research; PI = principal investigator; PIPP = Principal Investigator Pipeline Programme.
The scheme has two key aims:
Increase the number of PIs to support the delivery of NIHR portfolio studies;Expand career opportunities for research nurses and midwives to reach the level of PI and beyond.
The anticipated timeframe for programme completion is 12-18 months.
When describing the overarching programme, learning to drive has been used as an analogy to show how the learner progresses through the various individual elements. This analogy highlights how theoretical learning serves as the starting point (similar to learning the Highway Code), followed by practical application with an experienced colleague (such as applying L plates and learning alongside an instructor), then applying the learning to independent practice (such as driving with P plates) and, finally, building knowledge, experience and skills to an advanced level.
The anticipated benefits of the PIPP are:
Successful applicants who join the programme will gain valuable skills, understanding and experience in the role and responsibilities of being a PI delivering NIHR portfolio research;The organisation will benefit from building the capacity and capability of its research workforce, which may improve recruitment and retention of staff by providing opportunities to participate in the programme;PIs will benefit from sharing their knowledge and skills with others, contributing to the development of a knowledgeable workforce;Potential research participants will benefit from increased access to a wider range of studies, as the organisation may be able to run more of these due to the increased number of trained PIs.
To consider the composition of the taught theory content for Element 1, the NIHR PIPP project lead liaised with the senior research and innovation educator in the LTHT Research and Innovation Academy (LTHTRA). Discussion took place about the possibility of building on the nursing, midwifery and allied healthcare professional PI course that had been previously developed and successfully evaluated by the LTHTRA in the Yorkshire and Humber region. This course was subsequently adapted for a national CRN/CRM audience and an accompanying evaluation plan was developed.
To pilot the proposed PIPP Element 1 programme, 30 CRN/CRMs were sought to receive the taught programme, which was to be delivered by the lead educator. The NIHR PIPP project lead liaised with the 15 national LCRN workforce development leads to facilitate the selection process.
Participants were sought from a variety of clinical specialities and disciplines; 15 of these were experienced (defined as having more than five years’ experience working in a research delivery role) and 15 were less experienced in the speciality of clinical research. This was to make sure the pilot project would be able to help ascertain whether the course content was pitched and delivered at the optimum level for future groups of PIPP participants.
“Historically, the role of the principal investigator has predominantly been medically led”
Duration and delivery of the pilot
Four half-day sessions (each lasting for four hours) were delivered virtually over January and February 2023. The sessions used a number of modularised ‘learning bursts’, defined by Vaughn et al (2001) as short targeted educational sessions. This model accommodates adult learning theory, attention, motivation and the variety of learning styles that are found in learners (Vaughn et al, 2001).
The PIPP pilot was delivered as an interactive programme that included group work, discussion and sharing of best practice between the facilitator and the learners. This was enhanced due to the mixture of participants, as the research nurses/midwives who were more experienced were able to share insights from practice when they had been study PIs. ‘Word clouds’ were also used via the online platform Slido to increase group interaction and participation, and to gauge learning throughout the programme.
In total, 29 learners attended, completed and evaluated the full pilot programme; of those, 25 were CRNs and four were CRMs.
Results and evaluation
The evaluation strategy for the pilot was in line with Kirkpatrick and Kirkpatrick’s (2006) model of evaluation for training programmes. This is a commonly used model to assess the impact of healthcare education and training. It assesses learners against four levels of criteria:
Reaction;Learning;Behaviour;Results.
Evaluation of the PIPP mainly focused on the first two levels of the Kirkpatrick model for evaluating training programmes:
Reaction to learning – how did the learners feel about the training programme?Learning – to what extent did the learners’ knowledge improve as a result of the training programme?
All of the learners highlighted (either “well” or “very well”) that the course effectively enabled them to further understand the process of research in the NHS. Additional real-time feedback was also collected at the end of the final session using an interactive ‘word cloud’ posing the question: “After Element 1 of PIPP, how do you now feel about becoming or developing as a PI?” Pre- and post-programme knowledge (self-reported by the participants) was used to determine whether there was a difference between pre-course and post-course responses and increase in knowledge.
Before and after participating in the PIPP Element 1 taught programme, 27 participants responded to 10 questions that aimed to evaluate their confidence, understanding and grasp of the programme’s learning objectives. The learning objectives centred around having a greater understanding of the requirements, responsibilities and practical implications of being a PI and managing the delivery of a clinical study within the participants’ area of practice. This centred on feasibility, study set-up, governance, informed consent and safety reporting. The 10 questions related to their understanding and confidence of key concepts. Participants responded to the questions using a five-point Likert scale ranging from “not very well” (1) to “very well” (5).
Of those undertaking this PI training, 15 had more than five years experience in a research delivery role. All participants who completed the pre- and post-knowledge check (n=28) reported that they had a greater understanding of all the key learning objectives at the end of the programme. This self-reported improvement was defined as being statistically significant for all learning objectives, with the exception of informed consent. However, it is important to note that learners’ understanding of informed consent was already very high at the start of the course, due to the nature of the role of CRNs and CRMs.
“The chief nursing officer’s strategy for research identified the important contribution that nurses and midwives make to research”
Qualitative evaluative data
Qualitative data was also collected at the end of the programme. All participants who completed the programme were asked “What was the most useful part of the course and why?” and “What was the least useful part of the course and why?”. Specific feedback to help develop the PIPP Element 1 training was also sought by asking: “Do you have any other comments relating to the format, pace, facilitation or organisation of the course?”
Qualitative feedback from participants was positive and included:
“I thoroughly enjoyed all of the course, the interactive sessions on the last session were really useful, I enjoyed how the sessions were broken down and the content. Having Padlet to access resources was also a valuable tool.”
“I found the whole course useful especially being fairly new to research.”
Pilot recommendations
Several suggestions from the pilot feedback have since been incorporated into the finalised programme:
Development of a blended learning element of the course to reduce the number of taught sessions needed and enhance the learning experience overall. This has been actioned through the creation of a short interactive video on informed consent;Increased use of breakout rooms and group work during Element 1 teaching sessions;Cofacilitator(s) for PIPP Element 1 to reduce teaching “burden” and ensure cover for planned and unplanned leave;Professional endorsement was sought, and received, from the Royal College of Nursing and Royal College of Midwives;Development of a standardised and centralised application process.
Next steps
The NIHR PIPP for CRNs and CRMs was launched and opened to applications in July 2023. The programme will have twice-yearly intakes. An oversight group will monitor the impact of the programme from a variety of angles – namely, organisational benefit and patient benefit, as well as examining whether the PIPP improves career opportunities for research nurses and midwives over time. Reflections from each cohort will also be utilised to make any necessary adaptations to the programme.
“Historically, the role of the principal investigator has predominantly been medically led”
Conclusion
Element 1 of the PIPP programme was very well received by the pilot participants. Evaluative data clearly indicates that the proposed content for this first part of the programme has been pitched at the correct level and provides the necessary level of theoretical insight from which participants will be able to proceed to the next stage of the programme.
PIPP, as a whole, aims to provide a structured leadership development opportunity for those CRNs and CRMs who wish to develop in the role of PI by filling a gap that has been identified in career pathways for this professional group.
● Special thanks are given to the Principal Investigator Pipeline Programme (PIPP) Steering Group members, who oversaw the creation and development of the programme, and all those stakeholders who took part in group and individual discussions throughout the project, thereby providing invaluable input, guidance and consultation. For more information on PIPP, visit.
Key points
Strategic plans for research, such as that by the chief nursing officer for England, highlight the importance of research and nurses’ pivotal roleThe National Institute for Health and Care Research offers a range of career development opportunities for nurses and midwivesClinical and healthcare research does not always need to be led by medical staffResearch nurses and midwives are ideally placed to be local principal investigatorsThe National Institute for Health and Care Research Principal Investigator Pipeline Programme helps research nurses and midwives develop the skills, knowledge and experience they need to lead researchAcknowledgments – Special thanks are given to the PIPP Steering Group who oversaw the creation and development of the programme and all those stakeholders who took part in group and individual discussions throughout the project, providing invaluable input, guidance and consultation.References
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