Research and Development Annual Report: 2023-2024

Author: Theresa Foster, Head of Research

Report period: April 2023 to March 2024

Version 1.0

The East of England Ambulance Service NHS Trust (EEAST) is committed to improving the care and experience of our patients and staff through the undertaking of high-quality sponsored and hosted research and evaluations. We believe that all our patients and staff should be given the opportunity to participate in research and contribute to the evidence base that informs and improves emergency medical health and social care.

Research is considered core business for the NHS, bringing benefits to patients, clinicians, and the NHS Organisation (Box 1). The NHS Long Term Plan launched in January 2019(1) highlights the need for “Research and innovation to drive future outcomes improvement” and states that “Patients benefit enormously from research and innovation, with breakthroughs enabling prevention of ill-health, earlier diagnosis, more effective treatments, better outcomes and faster recovery.” Indeed, the Care Quality Commission incorporated clinical research enquiries into its Well-Led Framework(2).

The EEAST Research Support Service (RSS) has developed strong links and works in partnership with a range of academic institutions, other ambulance services, our NHS and other health and social care partners, and the National Ambulance Research Steering Group (NARSG) to develop, support, and promote research as a core part of service provision. RSS has worked hard to ensure that EEAST patients and staff continued to have every opportunity to participate safely in relevant pre-hospital ambulance research.

Benefits of research

For our patients:

• Improved health outcomes for all not just those participating in research
• Most patients want to take part in clinical research for new knowledge
• 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 and reduces inequalities

For healthcare clinicians:

• Involvement in research increases clinical skills
• Helps clinicians to understand evidence and use this in 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

This report presents an overview of clinical research activity and achievements within EEAST during the timeframe April 2023 to March 2024. Such continued participation in high quality clinical research activity has demonstrated EEAST’s on-going commitment to improving the care it offers, in addition to contributing to wider health improvement. Research findings are used to inform clinical and other service developments, where such evidence is available.

A copy of the current approved Research and Development (R&D) Policy v6.0 can be viewed here.

The aim of this Policy is to advise the conduct of research activity within EEAST to ensure compliance with good research practice as detailed in the UK Policy Framework for Health and Social Care Research(3). The Policy is reviewed and updated every two years.

The principle aim of the Research and Innovation Enabling Strategy 2020-2024 was to provide a credible and ambitious direction to the EEAST research function. A copy is available within the Clinical Directorate / RSS folder. It should be noted that a new Strategy will be considered and developed during 2024-2025.

EEAST R&D management arrangements, organisational study capabilities, and R&D interests are available via the R&D Operational Capability Statement (RDOCS) on the Trust website within the Clinical Directorate / RSS folder. This document signposts interested parties to the best person to contact within EEAST for differing research enquiries, for example capacity and capability assessments, research passports, contracts, etc. It is reviewed and updated every two years.

Clinical Research Networks (CRNs) are responsible for allocating NIHR monies to support delivery of NIHR Portfolio-adopted research activity. EEAST maintained Partner Organisation status with CRN-East of England, and regularly attended associated meetings throughout the reporting period. In addition, CRN-North Thames continued their financial support which has enabled the delivery of research in their area of the Trust region.

The National Ambulance Research Steering Group (NARSG) continued to meet bi-monthly and EEAST was actively involved, and represented NARSG at National Trauma & Emergency Care Research meetings. The group continues to share good practice in research, as well as encouraging collaboration with external partners including academia, commercial organisations and other health and social care providers to inform research funding bids. NARSG is accountable to, and a sub-group of, the Association of Ambulance Chief Executives (AACE).

RSS team members also attended a variety of academic and research network groups, from which was sought guidance, support and linkages to researchers and other resources.

Examples of such activity included CRN East of England Stroke Specialty group, regional Research Managers meetings, College of Paramedics events, and Council for Allied Health Professions Research East Anglia group.

Health Research Authority (HRA) Approval provides a single governance approval for all NHS research, consisting of assessments by HRA staff alongside the independent Research Ethics Committee (REC) opinion where required. NHS Trusts assess their capacity and capability to deliver HRA Approved studies, before giving permission to start if feasible. Up to date HRA guidance is available via https://www.hra.nhs.uk/.

RSS team members have been trained to undertake the capacity and capability assessments, ensuring all arrangements are in place to successfully deliver a study via:

• Review of costings / research contracts / agreements (as necessary)
• Liaison with required support department(s)
• Advice regarding issuing of Research Passports or Letters of Access
• Provision of guidance on HRA requirements and applications
• Review of impact of amendments to existing studies

A summary of research projects with delivery activity in the reporting period is presented in Table 1 below. Further details can be obtained from the Trust website within the Clinical Quality / RSS folder, or from RSS directly.

This reporting period has continued to be busy, notably with more large-scale studies. Six studies which commenced in previous reporting periods remained active during 2023-24.

In addition, RSS received a total of 11 new research study proposals requiring capacity and capability assessments during 2023-24, all of which were given approval to proceed, with 1 pending final feasibility checks. Seven of the 11 new studies were NIHR Portfolio projects, and there was 1 MSc student project and 1 PhD study.

Of note is the continuation of the Trust acting as Sponsor for homegrown research activity in the form of the EVOLVED vitamin D study, as well as the range of organisations that EEAST has collaborated with throughout the year. This reporting period has included an international linkage alongside regional and national partners.

However, during this reporting period RSS have noticed an increase in researchers approaching the Trust without HRA approvals in place, for instance attempting to gain data through Freedom of Information requests. Where such activity involves students, the relevant University Supervisor is advised of the correct approach route. NARSG discussion has revealed this to be a national issue affecting capacity to deliver student studies.

Table 1. Research projects which had delivery activity in reporting period 2023 to 2024

During 2023-24 EEAST recruited 638 participants (patients and Trust staff) as a site into high quality research studies approved by a Research Ethics Committee, a similar number to the previous year. Of note for accruals were the following:

• NHS staff retention survey n=249
• Pre-Alerts survey n=149
• PARAMEDIC-3 n=96
• ParAid survey n=93
• EVOLVED n=40 It should be noted that where EEAST acts as a Participant Identification Centre (PIC) or hosts smaller-scale student level projects being undertaken by Trust staff and external parties, the recruitment to such activity is not routinely captured.

Research impact is the effect / change / contribution / benefit of research to patients, the public, society, or the economy. For the NIHR, research impact is therefore how knowledge generated from research benefits peoples' health and wellbeing, how health and care services are delivered, and how these can bring about benefits to our society and economy. Examples of types of research impact include:

a. an increase or decrease in something (e.g. speed of intervention uptake) b. the cost of a treatment decreasing c. an increase in the number of follow-up visits d. starting or stopping something (such as the development of a new service) e. stopping a treatment option or policy f. changing a way of working g. changing the way people think or behave h. making no change due to equipoise of treatment/service.

The CESSATION findings were shared with several AACE groups. A commitment to share good practice and move towards a consistent approach across the UK ambulance Trusts was achieved. In addition, there was a willingness to seek Menopause Friendly Accreditation across the sector.

The KARMA2 study design and findings have been used to inform the 2023 JRCALC Glycaemic Emergencies update (September 2023), which now includes detailed DKA management and blood ketone testing guidance.

RSS continued to share the findings from high-quality research at Clinical Best Practice Group (CBPG) meetings, to inform recommendations for decisions about future direction of clinical practice.

Financial support for the RSS function was obtained from contracted income related to delivery of some of the research studies during the reporting period. Over and above such income, the Trust received Research Capability Funding and monies from the CRNs amounting to approximately £165k, a slight increased level of support from previous years.

CRN funds maintained the full-time Advanced Research Paramedic role, one full-time Research Paramedic, and the Head of Research role within RSS, to facilitate delivery and development of NIHR Portfolio research activities. CRN East of England support was also utilised for Local Project Management System (EDGE) training, NHS Number capturing for research participants, and capacity building activities within the Trust. Contracted income supported a further 3 full-time Research Paramedics on secondments.

During 2023-24 the substantive RSS function remained at 3.0 Whole Time Equivalent (WTE) staff, supported during the year by seconded Research Paramedic roles on fixed-term contracts for delivery of the PARAMEDIC-3, RAPID-2, and CRASH4 studies.

Research awareness and knowledge-raising activity throughout the Trust involved dissemination of research findings on the Trust website, discussion at CBPG, Medicine Management and Clinical Directorate meetings, as well as regular articles in Trust publications.

Wider dissemination of the findings from research activities has been achieved through oral and poster presentations at external peer-reviewed meetings and conferences, as well as publications in peer-reviewed journals, copies of which can be obtained from 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 alongside their Higher Education Institution supervision.

It is anticipated that all student paramedics within the Trust have undertaken an introduction to research module during their university training. Similarly, all clinicians participating in research studies are expected to successfully complete appropriate Good Clinical Practice training.

The national NIHR Participant in Research Experience Survey is a CRN High Level Objective, and promoted by them as a feedback mechanism to Trusts regarding their research delivery. Due to the PRES for Ambulance Trusts no longer being available from the NIHR, EEAST utilised the paper version of the adult PRES for patients, and the online PRES for adults for staff that participated in suitable studies during 2023-24.

As in previous years a disappointingly low response to PRES was achieved with only 16 surveys returned to CRN for EEAST. Positive research experiences were reported generally, but the response rate this year has once again not given any substantial learning to inform RSS practice. It should be noted that few studies were suitable for PRES activity this year, but it is anticipated that the number will increase given the studies in set up and development.

The Research Involvement Group (RIG) held its first hybrid face-to-face and online meeting at the Trust HQ during this reporting period and continues to be a useful forum for EEAST to engage with patient and public members and to receive on-going objective feedback about research that it wishes to undertake and deliver.

Individual RIG members have volunteered to take a special interest in all the studies being delivered in EEAST to give a local PPI perspective. In addition, the group have agreed to participate in development of poster presentations for conferences and engage in development of new research and strategy for 2024-25 onwards.

EEAST subscribes to the Library & Knowledge Service for NHS Ambulance Services in England (LKS ASE). The subscription provides all employed EEAST staff with access to library services including document supply, literature searching, current awareness, and guides and help on various aspects of information skills. The LKS ASE can be contacted directly by staff via email Matt.Holland@nwas.nhs.uk or by using one of the online forms on the website https://ambulance.libguides.com/home1/home. This reporting period has seen substantially increased usage of the LKS ASE following sustained promotion by RSS.

The RSS Newsletter has continued to be produced at least twice a year. Current and future studies are showcased, and relevant findings shared. The RSS Newsletter has been cascaded using Need to Know / EAST24 as well as hard copy via internal post, and copies can be obtained on the Trust website Research Newsletters or by contacting RSS.

Foster, T., Prothero, L., Noakes, T. and Brown, S. (2023) An In-depth Qualitative Interview Study of Female Ambulance Staff Experiences of the Menopause Transition (CESSATION – Phase 3). Emergency Medicine Journal, 40, A10.

Brown, S., Noakes, T., Foster, T. and Prothero, L. An in-depth qualitative interview study of female ambulance staff experiences of the menopause transition (CESSATION phase 3). British Paramedic Journal 2023, Vol. 8(3) 20-26.

Prothero, L., Strudwick, T., Foster, T., Dhatariya, K., Lake, A., Boyle, A., Williams, J. and Rayman, G. (2023) A stepped-wedge controlled feasibility study examining blood ketone meter use by ambulance clinicians for diabetic ketoacidosis (DKA) recognition and commencement of fluid therapy in the emergency pre-hospital setting. Diabetic Medicine, 40(S1), P265

Prothero, L., Strudwick, T., Foster, T., Dhatariya, K., Boyle, A., Lake, A., Williams, J. and Rayman, G. (2023) Exploring ambulance and emergency department clinician experiences of capillary blood ketone meter use in the ambulance setting: semi-structured interviews. Emergency Medical Journal, 40, A12-A13.

Evans, B.A. et al. Experiences and views of people who frequently call emergency ambulance services: a qualitative study of UK service users. Health Expectations 2023; 27: e13856.

Blake-Barnard, A. and Whitley, G. Factors that influence child conveyance decisions made by prehospital clinicians. Journal of Paramedic Practice 2024, Vol. 16(2) 64-71.

Duncan, E., Kingston, M. and Ford, S. Hip Hip Hooray! Introducing fascia iliaca compartment blocks to prehospital practice. Paramedic INSIGHT, March 2024 edition.

Barrett, J.W. et al. The COVID-19 ambulance response assessment (CARA) study: a national survey of ambulance service healthcare professionals’ preparedness and response to the COVID-19 pandemic. British Paramedic Journal 2024, Vol. 8(4) 10-20.

A stepped-wedge controlled feasibility study examining blood ketone meter use by ambulance clinicians for diabetic ketoacidosis (DKA) recognition and commencement of fluid therapy in the emergency pre-hospital setting (Poster). Diabetes UK Conference April 2023; Winner of Diabetes UK Nursing and Allied Healthcare Professional Diabetes Research Award.

Clinical and cost-effectiveness of paramedic administered fascia iliaca compartment block for emergency hip fracture (RAPID 2) (Poster and presentation). CAHPR East Anglia Annual Conference May 2023.

Challenges and Strategies in Paramedic Recruitment to the RAPID2 Intervention Trial (Poster). 999 EMS Research Forum Conference June 2023.

Is your service menopause-friendly? Analysis of UK ambulance services menopause guidance (Poster). College of Paramedics Conference June 2023.

Female Ambulance Staff Experiences of the Menopause Transition (CESSATION) (Poster and presentation). Yorkshire Ambulance Service Research Institute Conference March 2024.

Once again, no concerns or incidences have been raised in this reporting period.

In line with the Best Research for Best Health Strategy (2022)(4) the primary focus of RSS will continue to be on supporting and seeking funds to generate health-related research, which leads to improved outcomes for people (patients and staff). Additionally, the Trust will explore means to support more internal research projects for instance through collaborations with universities throughout the region. Any commercial activity will be mindful of the recently published Lord O’Shaughnessy review (2023)(5).

The Research & Innovation Enabling Strategy 2020-24 and corresponding action plan provided a framework for the advancement of research within the Trust. However, the research landscape has altered dramatically since the COVID-19 pandemic, so any future EEAST research strategy should be aligned to Trust and key stakeholder strategies. This will be reviewed during early 2024-25.

At a local, regional, and national level, the Trust will continue to attract high quality studies and drive the development of research grant applications in under-developed areas of pre-hospital ambulance research need and areas of importance to Trust patients and staff. Identified areas of focus include research into end-of-life care, frailty, dementia, children and young people, mental health, nutrition and impact of ambulances on air quality.

RSS will continue to communicate opportunities for research skills development throughout the Trust, to increase research knowledge, particularly at the senior management level.

1. Department of Health and Social Care (2019) The NHS Long-term Plan https://www.longtermplan.nhs.uk/publication/nhs-long-term-plan/

2. Care Quality Commission (2018) Key lines of enquiry, prompts and ratings characteristics for healthcare services https://www.cqc.org.uk/guidance-providers/healthcare/key-lines-enquiry-healthcare-services

3. Health Research Authority (Nov 2017) UK Policy Framework for Health and Social Care Research. https://www.hra.nhs.uk/planning-and-improving-research/policies-standards-legislation/uk-policy-framework-health-social-care-research/

4. Department of Health and Social Care (2022) Best research for best health. A new national health research strategy. Best research for best health: a new national health research strategy - GOV.UK

5. Department of Health and Social Care (2023) Commercial clinical trials in the UK: the Lord O’Shaughnessy review. Commercial clinical trials in the UK: the Lord O’Shaughnessy review - final report - GOV.UK