RESEARCH REPORT to AUTHOR: Theresa Foster, Research Manager REPORT PERIOD: April 2015 to March 2017
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1 RESEARCH REPORT 2015 to 2017 AUTHOR: Theresa Foster, Research Manager REPORT PERIOD: April 2015 to March 2017
2 1.0 Introduction Research is core business for the NHS, bringing benefits to patients, clinicians and the NHS Organisation (Box 1). Principle 3 of the NHS Constitution is that, The NHS aspires to the highest standards of excellence and professionalism, and states, The importance of innovation and medical research is underscored by this Principle as integral to driving improvements in healthcare services for patients (Handbook to the NHS Constitution, July 2015). Box 1 Why we do research Benefits of research For our patients: Patients in clinical trials do better regardless of which treatment they are on Most patients want to take part in clinical research Taking part in clinical trials results in improved clinical care. For the NHS: Research findings result in better treatment for patients Improves use of scarce NHS resources Enables fair use of resources. For healthcare clinicians: Involvement in research increases clinical skills Helps clinicians to understand evidence and use this in their clinical practice Improves job satisfaction Encourages team working. For healthcare organisations: Involvement in research helps attract more forward looking staff Increases the number of clinicians with expertise in research Drives the development of research relevant to the population served. The report presents an overview of research activity within the East of England Ambulance Service NHS Trust (EEAST) during the timeframe April 2015 to March This has been the busiest period, in terms of numbers of research studies and numbers of participants, since the Trust became research active a decade previously. Such continued participation in clinical research activity has demonstrated the Trust s on-going commitment to improving the quality of care offered, and to making a contribution to wider health improvement. Indeed, research findings are used to inform clinical service developments where such evidence is available.
3 2.0 Research Policy, Strategy, PID & RDOCS A copy of the approved Research and Development (R&D) Policy v3.0 can be obtained from the Trust website within the Clinical Quality Directorate/ Research Support Services (RSS) folder. It should be noted that this version is due for review shortly. The R&D Strategy Sustaining Growth set out the vision for development of robust research systems throughout the Trust, as well as development of capacity and competence required to sustain research growth. A copy of the approved strategy can be obtained on the Trust website within the Clinical Quality Directorate/RSS folder. It should be noted that research is now considered core Trust business, therefore an overarching direction of travel will be developed instead of a further 4-year Strategy. In line with recent research legislation, Trust performance in initiating and delivering research (PID) reports are published quarterly on the Trust website within the Clinical Quality Directorate/RSS folder. Finally, R&D management arrangements, organisational study capabilities, and R&D interests are available via the R&D Operational Capability Statement (RDOCS) v4.0 on the Trust website within the Clinical Quality Directorate/RSS folder. 3.0 Research Networking Activity Clinical Research Networks (CRNs) are responsible for allocating National Institute for Health Research (NIHR) monies to support delivery of NIHR portfolio research activity. The Trust has maintained partner organisation status with CRN-Eastern throughout the reporting The National Ambulance Research Steering Group (NARSG) has continued to meet regularly, and the Trust maintained and developed closer links with this important group for pre-hospital ambulance research. RSS also maintained membership of a variety of local academic and research network groups from which it sought guidance, support and linkages to researchers. 4.0 Health Research Authority (HRA) Approval 2015 saw the start of the phased roll out of the HRA Approval process, the new system for approving research in the NHS led from England. HRA Approval provides a single approval for research, consisting of assessments by HRA staff alongside the independent Research Ethics Committee (REC) opinion where required. This replaced the need for local permission and assurances; instead NHS Trusts need to assess their capacity and capability to deliver studies, before allowing them to start if feasible.
4 The RSS team have been trained to undertake the capacity and capability assessments, ensuring all arrangements are in place to deliver a study via: Review of costings / research contracts / agreements (as necessary) Liaison with support department Advice regarding issuing of honorary research contracts or letters of access Provision of guidance on HRA requirements and applications Review of impact of amendments to existing studies From 1 st April 2016 HRA Approval was fully implemented and is now the only process for gaining approval. The Trust has worked through the transition period, to full implementation of the new HRA process. 5.0 Research Project Activity 2015 to 2017 Six studies which commenced in previous reporting periods remained active during 2015 to One of these (the RODES study) was conducted with the Collaboration for Leadership in Applied Health Research and Care (CLAHRC). Four studies were NIHR Portfolio projects, one of which (VAN) closed to recruitment during this reporting period, and three (OHCAO, PIONEERS and AIRWAYS-2) remain on-going. One study was a student-level piece of research being undertaken by a Trust member of staff. RSS received a total of 15 new research study proposals, for participation consideration during 2015 to Four of these were NIHR Portfolio projects, and 1 was a new CLAHRC study. RSS offer mentorship of student-level (MSc and PhD) research within the Trust, as secondary support of University supervisors. Four such student-level projects were forthcoming. All 15 studies were given either Trust or HRA approval to proceed. A summary of research projects with activity in the reporting period is presented in Table 1 below. Table 1 demonstrates the breadth of research that the Trust is capable of supporting. There are large randomised-controlled clinical studies like AIRWAYS-2 and RIGHT-2, big data studies such as OHCAO, VAN, closed, and HOMEWARD, and many smaller qualitative and quantitative projects. Details about all research activity can be obtained from the Trust website within the Clinical Quality Directorate/RSS folder, or from RSS.
5 Table 1. Research projects which had activity undertaken in reporting period Project title Sponsor Status & Notes Out of Hospital Cardiac Arrest registry - OHCAO (NIHR Portfolio) Warwick University On-going from previous reporting Integrated care PIONEERS evaluation (NIHR Portfolio) LSHTM On-going from previous reporting Research into older people with dementia RODES study. CLAHRC On-going from previous reporting Variation in non-conveyance VAN study (NIHR Portfolio) Sheffield University On-going from previous reporting AIRWAYS-2 (NIHR Portfolio) SWASFT On-going from previous reporting Ambulance clinician attitude towards discharge of care (student) University of Hertfordshire On-going from previous reporting Mental health training for emergency first Middlesex University Permission to proceed April responders DNACPR study CLAHRC Permission to proceed June Blue Light Resilience Programme research University of Oxford Permission to proceed June Inter-agency working and adult safeguarding NHS South Norfolk CCG Permission to proceed August Exploration of ambulance performance measures (student) University of Hertfordshire Permission to proceed October Carbon monoxide - COPS study Trust Commenced recruitment October Sustainability within ambulance service practice (student) Plymouth University Permission to proceed October RIGHT-2 (NIHR Portfolio) Nottingham University Permission to proceed November Impact of closing EDs closed (NIHR Portfolio) Sheffield University Permission to proceed February Safeguarding adults research NNUH Permission to proceed April Ambulance staff suicide research EMAS Permission to proceed June CBRN decision making study (student) Loughborough University Permission to proceed August Dementia fallers intervention DIFRID study (NIHR Portfolio) University of Newcastle Permission to proceed November 2016 Dementia multi-morbidities study HOMEWARD (NIHR Portfolio) University of West of England Permission to proceed November Excited delirium: an extended literature review (student) Cardiff University Approval not required as a literature review.
6 6.0 Recruitment of Research Subjects 2015/16 and 2016/17 The Trust recruited more than 1,050 subjects to participate in high quality research in 2015/16. This level of activity was markedly higher than the previous reporting period, when very few studies had been available for participation. During 2016/17, research activity remained high, and the Trust enrolled more than 720 subjects into high quality research. The vast majority of this activity arose from Trust participation in the AIRWAYS-2 and RIGHT-2 studies. 7.0 Financial Support Financial support for research was obtained from successful research bids, and participation in numerous research studies during the reporting Over and above such contracted income, during 2015/16 the Trust received funding of approximately 30k from CRN-Eastern, and this increased to about 51k in 2016/17. CRN-Eastern funds were used to maintain the full-time Research Paramedic role within RSS, to support the Research Manager, and assist delivery of NIHR Portfolio research activity. CRN- Eastern support was utilised for HRA preparation, Local Project Management System implementation, and capacity building activities within the Trust. 8.0 Capacity Building Activity Research awareness and knowledge raising activity within the Trust utilised face-to-face discussions with staff, dissemination of research findings on the website, and at Clinical Development and Effectiveness Meetings, and articles in Trust publications. Wider dissemination of the findings from research activities has been achieved through presentation of posters at external peer-reviewed meetings, for example the College of Paramedics, 999 EMS Research Forum, and the Diabetes UK Professional Conference. There have also been publications in peer-reviewed journals during the reporting period, copies of which can be obtained through RSS. Trust staff undertaking graduate or post-graduate studies with a research element, whether financially supported by the Trust or not, continued to be encouraged to contact RSS for mentoring and support. Since the autumn of 2014, all student paramedics within the Trust have undertaken a research training module, which requires them to complete an Introduction to Good Clinical Practice (GCP) e- learning course. Similarly, all clinicians involved in research studies are expected to successfully obtain a GCP certificate. To date, more than 900 clinicians have become research ready throughout the Trust.
7 9.0 Publications Prothero, L.S. and Foster, T. (2015) Can the pre-hospital care of patients with comorbidity of sepsis and hyperglycaemia be improved? Diabetes Medicine, 32(S1), 199. Buswell, M., Amador, S., Goodman, C., Williams, J., Fleming, J., Lumbard, P. and Prothero, L. (2015) Does dementia matter: is dementia an important factor in 999 call-outs to older people? Emergency Medical Journal, 32(6), e14 - e15. Buswell, M., Fleming, J., Lumbard, P., Prothero, L., Amador, S. and Goodman, C. (2015) Difference between how ambulance service personnel use paper and electronic patient care records when attending older people at home, European Journal of Emergency Medicine, 22(2), Buswell, M., Martin, S., Lee, C., Lumbard, P. and Prothero, L. (2015) Unplanned, urgent and emergency care: What are the roles EMS provide for older people with dementia? A literature review and narrative synthesis, Emergency Medical Journal, 32(5), e4. Prothero, L.S. and Cooke, P. (2016) Mental health crisis in the pre-hospital setting, Emergency Medical Journal, Emergency Medical Journal, 33, e8 - e9. Zasa, M., Flowers, N., Zideman, D., Hodgetts, T. and Harris, T. (2016) A torso model comparison of temperature preservation devices for use in the prehospital environment. Emergency Medical Journal, 33: Presentations 999 EMS Research Forum (2015) Hypoglycaemia Referral Improvement Project (IMPACT ASCQI) (Poster). Understanding ModernGov: Effectively Identifying and Tackling Sepsis (2016) Pre-Hospital Settings: How to Recognise the Signs of Sepsis (Oral). Clinical Research Network: Eastern Stroke Education Meeting (2016) RIGHT-2: First experiences (Oral). Sepsis Unplugged (2016) 'Missed opportunities in ambulance sepsis care?' (Poster). Sepsis Unplugged (2016) 'Sepsis Management in Pre-Hospital and Hospital Care' (Poster).
8 11.0 Research Misconduct, Fraud and Complaints No concerns or incidences have been reported Future Direction Resources allowing, the Trust will successfully deliver the large-scale and smaller research projects it is committed to. It will also endeavour to open new studies when the opportunities arise. Expressions of interest to be involved in numerous studies awaiting funding outcomes have been submitted, and the Trust will continue to drive the development of large research grant applications in areas of importance to Trust patients and staff. The Trust will maintain and improve the links it enjoys with academic institutions within and external to the region, with the explicit aim of increasing the number of grant applications for research the Trust would subsequently host. Resources allowing, RSS will endeavour to ensure that outputs of completed studies within the Trust are disseminated through appropriate channels more frequently.
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