SOMERSET PARTNERSHIP NHS FOUNDATION TRUST CLINICAL RESEARCH REPORT Report to the Trust Board 25 July 2017 Sponsoring Director: Author: Purpose of the report: Key Issues and Recommendations: Medical Director Head of Research and Clinical Effectiveness. To update the Board on clinical research activity and initiatives and implementation of the NIHR Clinical Research Network: South West Peninsula Annual Business Plan. In 2016/17, the Trust actively participated in 23 national portfolio studies and recruited 321 participants. Total income generated: 222,618, plus a Stroke Research Nurse post (0.2 WTE) funded by South Petherton Hospital League of Friends. The Trust has sponsored its first NIHR portfolio study - Patient-centred physiotherapy: a qualitative study (Chief Investigator: Rob Stenner, Consultant Physiotherapist) The Trust is an active partner organisation within both the CRN: SWP and PenCLAHRC. The Trust is leading on the development of the Somerset Research Collaboration - a collaborative agreement with Taunton and Somerset NHS Foundation Trust and Yeovil District Hospital NHS Foundation Trust to facilitate increased clinical research. Actions required by the Board: The Board is asked to note this report. July 2017 Public Board - 1 -
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SOMERSET PARTNERSHIP NHS FOUNDATION TRUST R CLINICAL RESEARCH REPORT 1. BACKGROUND 1.1 The NHS Constitution for England (DH March 2013) is committed to innovation and to the promotion, conduct and use of research to improve the current and future health and care of the population. (Principle 3.) There is also a commitment to patients and the public to inform you of research studies in which you may be eligible to participate (Pledge 3a). 1.2 To help fulfil this commitment, clinical research in the UK is supported through the National Institute for Health Research (NIHR) and the infrastructure of Local Clinical Research Networks. Somerset Partnership, along with all the NHS organisation in Devon, Cornwall and Somerset is part of the Clinical Research Network: South West Peninsula (CRN: SWP). 1.3 As a member of NIHR CRN: SWP, Somerset Partnership receives a funding allocation from the network to cover the management and approval of nationally recognised and funded research studies ( portfolio studies ), and to cover the costs of supporting the delivery of portfolio studies. 1.4 The Trust submits an Annual Business Plan to the CRN: SWP which identifies how the Trust is supporting the CRN: SWP in meeting the NIHR CRN High Level Objectives, and at the end of the year reports on the outcomes of the annual plan (see Appendix A). 1.5 Somerset Partnership is also a partner organisation in the South West Peninsula Collaboration for Leadership in Applied Health Research and Care (PenCLAHRC). The Head of Research and Clinical Effectiveness represents the Trust on the management board and the Strategic Executive Group, and there has been some good collaboration on identifying and prioritising clinical research questions. 1.6 Although not exclusively related to clinical research, the Trust is also a partner organisation in the South West Academic Health Science Network (AHSN) which is engaged in a number of innovation and evaluation projects, including evaluation of Somerset CCG s Test and Learn projects implementing new models of Person Centred Integrated Care. July 2017 Public Board - 3 -
2. TRUST PERFORMANCE 2.1 Since April 2014 the CRN: SWP has not set Trust recruitment targets, preferring instead to monitor recruitment performance across the network in order to encourage collaborative working between member Trusts. 2.2 However, in 2016/17, the Trust opened 21 national portfolio studies, actively participated in 23 national portfolio studies and recruited 321 participants. This compares with actively participating in 20 national portfolio studies and recruiting 252 participants in 2015/16. In addition the Trust acted as a Patient Identification Centre (PIC) for four further studies or supported collaborative studies where other Somerset NHS organisations took the lead for which no recruitment is credited. 2.3 Currently (17 July 2017) the Trust is participating in 31 national portfolio studies including a commercial study (sponsored by Nutricia). 2.4 The contribution of the Trust in recruiting to national portfolio studies is recognised and acknowledged by CRN: SWP. The letter following the Annual Trust review on 12 June 2017 states: The recruitment attained by the Trust during 2016/17 was excellent, achieving an overall trust target of 321. This was great performance as many of the studies had recruitment challenges. 2.5 Reports are submitted quarterly to the NIHR regarding the Trust s performance in relation to the initiating and delivering of clinical trials (not all clinical research). There is a requirement to also provide this information on the Trust s public website: www.sompar.nhs.uk/who-weare/clinical-research/clinical-trials-performance 3. FUNDING 3.1 The conducting of high quality, nationally recognised research within the NHS is intended to be cost-neutral for NHS organisations. Funding is available from the NIHR CRN: SWP to support the provision of research management and governance and additional funding is awarded to Trusts in order to support the delivery of portfolio studies. 3.2 In spite of a general reduction in the allocation of funds to member organisations since 2013, Somerset Partnership continues to successfully negotiate increased funding see the table below. July 2017 Public Board - 4 -
NIHR funding received 2009/10 15,920 2010/11 79,865 2011/12 99,750 2012/13 114,467 2013/14 101,494 2014/15 107,916 2015/16 121,285 2016/17 140,513 2017/18 * 141,367 * Schedule 1 allocation; additional contingency funding may be made available during the year. 3.3 Depending on the nature of individual studies, the Trust may additionally receive funding from specific study grants (including commercial trials) to cover research costs and can apply to the CRN: SWP for contingency funding to cover service support costs. 3.4 In 2016/17, in addition to the NIHR CRN: SWP core funding of 111,144, the Trust received additional CRN funding to the value of 29,369 to fund Dr Lucy Knight as Dementia sub-specialty lead for Somerset (0.5 p.a), to fund an Assistant Psychologist post in relation to the Somerset Research Collaborative and to provide contingency funding for the Big Cactus study and others. 3.5 In 2016/17 the Trust sponsored its first NIHR portfolio study Patientcentered physiotherapy (CI: Rob Stenner, Consultant Physiotherapist), attracting a research grant of 50,565 from the Chartered Society of Physiotherapists. 3.6 In 2016/17 specific funding of research costs to relation to other studies (INTENSE, Fluenz, Stepwise, Pressure 2, Big Cactus, UNITE, MAS, QuICN, Scimitar, ImprovE, Respect MESO) totalled 31,540. 3.7 Total income from research in 2016/17 was 222,618. 4. STAFFING 4.1 The current staffing complement is as follows: Head of Research & Clinical Effectiveness (0.2 WTE funded by CRN: SWP); Lead Research Nurse (full time); Clinical Studies Officer (full time); Research Governance Officer (0.6 WTE); July 2017 Public Board - 5 -
Somerset Research Collaborative Assistant Psychologist (full time FTC). 4.2 In addition, since April 2014 the League of Friends of South Petherton Hospital has funded a Stroke Research Practitioner post (0.2 WTE). 5. RESEARCH SEMINARS 5.1 To encourage and promote interest in research within the Trust, Research Seminars have been organised by the Clinical Research Team twice per year. 5.2 The April 2016 seminar at Canalside, Bridgwater was attended by 52 delegates from a variety of professional and service backgrounds. Dr Nick Broughton (recently appointed CEO at the time) was the keynote speaker, and highlighted that research: informs and helps improve the quality and effectiveness of care for patients and service users; stimulates staff and helps with the recruitment and retaining of high calibre staff; provides a source of income which can contribute to investment and improvements to care and services. 5.3 Feedback from the event was generally positive and included the following comments: All presentations were informative and I have learned a lot Great opportunity to talk to people who are enthusiastic about research and in different settings. Better understanding about what research is happening in Somerset Partnership and how we can work collaboratively. Well done - really good event. 5.4 At the April 2017 research seminar, Dr Nick Broughton proposed that the next event should be bigger and better - combining research with quality improvement initiatives and innovation. Therefore, in October 2016, the research seminar was extended into an all-day Quality Improvement, Research and Innovation Conference. 70 people attended a blend of presentations (including 13 poster presentations), and workshops. There were also display stands manned by NIHR Clinical Research Network: South West Peninsula; PenCLAHRC (The National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care: South West Peninsula); South West Academic Health Science Network (SW AHSN) as well as the Trust s Clinical Audit and Clinical Research teams. 5.5 Feedback from the event was very positive and included the following comments: July 2017 Public Board - 6 -
Really good day varied, excellent turnout and a good buzz in the room. It was good to see the range of research and innovation activity going on across the Trust and a wide range of service areas represented. The workshops in the afternoon were really engaging and a good balance to the morning's content. The posters were excellent and the stands very useful. 6. RESEARCH ACTIVITY 6.1 The Somerset Research Collaborative established with the two acute Trusts in Somerset, Yeovil District Hospital NHS Foundation Trust and Taunton and Somerset NHS Foundation Trust has continued to make steady progress. Two collaborative studies are open and a number of others (including commercial trials) are in setup/under active consideration. This helps to meet the section 4.2 of the Trust s Business Action Plan: Develop appropriate collaborative approaches to working across health and social care including joint ventures and other partnerships to improve patient care and make the best use of our resources as well as complementing the Somerset NHS Sustainable Transformation Plan. 6.2 Dr Lucy Knight, Consultant Psychiatrist and Clinical Director for East Division was appointed as Dementia Clinical Research Sub-specialty Lead for Somerset by the NIHR Clinical Research Network: South West Peninsula (1 PA per week) in July 2016. One of her first actions was to set up a Dementia Research Forum for Somerset, inviting partners from the acute trusts in Somerset as well colleagues from within the Trust, and Professor Clive Ballard (Executive Dean of University of Exeter Medical School and globally-renowned dementia and ageing expert) spoke at the first Forum meeting in June 2017. 6.3 Brief details of clinical research studies open to recruitment within the Trust are displayed on the Trust internet: www.sompar.nhs.uk/who-weare/clinical-research/current-studies/. However, the following studies are worthy of particular mention. 6.4 Patient-centred physiotherapy: Rob Stenner (Consultant Physiotherapist) successfully applied for a research grant from the Chartered Society of Physiotherapy Charitable Trust ( 50k) to conduct qualitative research into Patient-centred physiotherapy with coinvestigator Ralph Hammond (Physiotherapist). With support from the Head of Research, the study received ethical approval and a submission for the study to be adopted onto the NIHR portfolio* was successful. This is the first NIHR portfolio study sponsored by Somerset Partnership NHS Foundation Trust. July 2017 Public Board - 7 -
* The NIHR portfolio consists of studies that: are funded by national funding organisations (i.e. the National Institute for Health Research, the Research Council or specific charities); have undergone rigorous peer review; are of clear benefit to NHS patients; are registered on the Integrated Research Application System - IRAS. 6.5 INTENSE: a commercial observational cohort study sponsored by SANOFI that was aiming to assess the effectiveness of treatment intensification in patients with type 2 diabetes inadequately controlled with basal insulin (with/without oral anti-diabetic drugs). Su Down, Nurse Consultant for Diabetes acted as Principal Investigator and recruited 4 participants before the study was closed prematurely by the sponsors. 6.6 FLUENZ: a study to collect information on the safety of the nasal flu vaccine in children and teenagers supported by the School nursing service. Philip Wells acted as Principal Investigator and the team handed out 680 Safety Report cards to young people receiving the nasal flu vaccine at the end of 2016. This research study attracted income of over 2,000, and feedback from the study team was very positive: the experience of working with SOMPAR was excellent from my perspective. I didn t have to chase anyone for figures or information and Philip was very efficient and helpful. so thank you! Lorna Hazell, Senior Research Fellow, DSRU Education and Research Ltd. 6.7 L&D Service Evaluation: RAND Europe have been commissioned under the Department of Health Policy Research Programme to assess whether the National Model for Liaison and Diversion (L&D) services has any impact on reconviction rates, diversion from the criminal justice system or the use of health services, particularly, A&E, drug treatment, mental health treatment, inpatient and outpatient services. The Trust s Forensic team recruited 50 participants in 2016/17. 6.8 MAS: a study commissioned by the Department of Health in collaboration with the London School of Hygiene and Tropical Medicine and the Alzheimer s Society to evaluate the effectiveness and costeffectiveness of memory assessment services (MAS) in the UK and to explore the feasibility of measuring routinely the quality of life of people with dementia. The Trust s research team recruited 61 participants to the 24 month follow up in 2016/17. 6.9 AD Genetics: A study led by Cardiff University and sponsored by Alzheimers Research UK and the Medical Research Council trying to understand how certain genes affect the chance of developing Alzheimer s disease. The Trust s research team recruited 29 participants in 2016/17. July 2017 Public Board - 8 -
7. SUMMARY 7.1 The Trust can celebrate the achievement of sponsoring its first NIHR portfolio study and successfully recruiting 321 participants to 23 different NIHR portfolio studies. 7.2 The Trust has continued to make good progress in raising awareness of clinical research and increasing clinical research activity across a range of clinical areas. 7.3 The Trust has established a good reputation and working relationship with CRN: SWP, PenCLAHRC and a number of commercial, NHS and University research centres. 7.4 The Trust recognises the value of coordinating the Trust s approach to quality improvement, clinical effectiveness, patient safety, innovation and research and the organisation of the Quality Improvement, Research and Innovation Conference in October 2016 was the first step in progressing this agenda. The Research team (and the Clinical Research Network) recognise that any initiatives that encourage and embed innovation, quality improvement and evidence-based practice into clinical and operational practice will also motivate and equip Trust staff to engage with clinical research. A repeat of an all-day Quality Improvement, Research and Innovation Conference is planned for 18 October 2017, to which all Board members and governors are invited. 7.5 It is recognised that the Somerset Research Collaborative will support the Sustainability and Transformation Plans (STP) for greater cooperation and collaboration between the three NHS Trusts in Somerset. July 2017 Public Board - 9 -
SOMERSET PARTNERSHIP plans and goals in support of the NIHR CRN High Level Objectives 2016-17 with outcomes HLO Measure Goal Three Key Actions / Initiatives Outcome 1 Increase the number of participants Total recruited: 316 recruited to NIHR portfolio studies See projected recruitment across 7 specialty areas. 200 in total. 1. Implementation of Trust Research Strategy. 1. Key objective to sponsor an NIHR portfolio study achieve CPMS 32935 Patient centred practice within physiotherapy. 2 Increase the proportion of studies in the NIHR CRN portfolio delivering recruitment to time and to target. 2. Continuation of funding for a Stroke research nurse appointment funded by the League of Friends in order to develop South Petherton Community Hospital as a centre for stroke research. 3. Further development of Somerset Research collaboration with T&S and YDH 80% of all studies 1. To ensure a thorough feasibility is conducted in order to state an achievable recruitment target 2. To involve the relevant teams early on so they are primed and ready to recruit 2. Funding for Stroke Research Practitioner (currently an SLT) continued 0.2 WTE for a further 12 months (post holder has supported both stroke and dermatology NIHR studies) 3. Sompar has driven the development of the Somerset Research collaborative, submitting numerous EoI on behalf of the collaborative, although unfortunately very few have been converted into actual studies. 1. and 2. Lead Research Nurse has been trained in the DRIVE initiative and has initiated processes to improve feasibility and early engagement with clinical teams. July 2017 Public Board - 10 -
3. To publicise available research studies on the Trust patient and public internet site and have posters in waiting areas. 3. Current studies are advertised on public web site; more work to be done by newly appointed CSO to advertise in patient waiting areas. 3 Increase the number of commercial studies 1 to 4 4. Work with RDM to monitor T2T data, identify studies flagged as amber/red or closing within 6 months and implement changes to recruitment plans as required in order to meet T2T metrics. 4. 100% of clinical trials recruited to time and target. Participated in two commercial studies in 2016/17 1. Submit EoI at every opportunity. 1. 100% of EoIs sent to Sompar by CRN: SWP received a response (the only partner organisation to do so). 4 Reduce the time taken to start up studies. 5 Reduce the time taken to recruit the first patient to NIHR portfolio studies 80% of all studies achieve ready to start confirmation within 40 calendar days 80% of studies recruit first patient within 30 calendar days of NHS permission or site initiation 2. Work with Somerset Research Collaboration to offer greater resources and experience to potential sponsors. Currently achieving 100% so the action is to continue with current practices 1. Explore use of CRN:SWP feasibility tool to streamline processes, including virtual study walk through 2. Trawl for potential participants via searches 2. See 1.3 above No delays caused by Sompar delays tend to be as a result of sponsor arrangements/ amendments. See 2.1 above July 2017 Public Board - 11 -
7 Increase recruitment to DeNDRoN studies of the electronic patient record to identify potential participants before study opens. 3. Ensure studies are communicated and advertised within the Partnership 4. Continue with research awareness activities through Staff newsletter and Research Seminars 25 1. Through development of Somerset Research collaboration with T&S and YDH 2. Through employment of Assistant Psychologist 110 recruited, although the majority not through collaborative studies (20146 MAS: 61; 3808 AD Genetics 29) Collaborative study 31632 DECIDE: 20. Recruitment - goal shown in black/actual in red: Specialty Goal/ Actual Specialty Goal/ Actual Specialty Goal/ Actual Specialty Goal/ Actual Ageing Diabetes 10/1 Injuries & Emergencies Public Health 5/0 Anaesthesia ENT Mental Health 60/127 Renal Cancer Gastroenterology Metabolic & Endocrine Reproductive Health & Childbirth Cardiovascular Genetics 1 Musculoskeletal 10/33 Respiratory Disorders Children Haematology Neurology Stroke 40/16 Critical Care HSR 20/0 Ophthalmology Surgery DeNDRoN 25/110 Hepatology Oral and Dental Dermatology 30/14 Infectious Diseases 12 Primary Care 2 Where actual falls short of goal please provide a commentary: Specialty Commentary Dermatology 14608 Pressure 2 target based on extension of recruitment period, but then national target reached Diabetes 16949 Intense closed early by sponsor, involvement in other studies but only as a PIC HSR Organisational studies anticipated in the light of STR, but not forthcoming Public health 20710 SafeTxt goal included here, but actual recorded under Infectious diseases Stroke 30510 Lots2Care start of recruitment delayed and 13701 OCS-Care amendment resulted in no further eligible participants July 2017 Public Board - 12 -
Specialty specific initiatives: Specialty Initiative Outcome DeNDRoN Somerset Research Collaborative On going Stroke South Petherton League of Friends funding of Research Practitioner 0.2 WTE Secured for further 12 months Please describe activities to promote equality of access and parity of opportunity to participate in research: Initiative Outcome International Clinical Trials Day 2016 Staff and patients invited to an OK to Ask day on 20 May 2016 at South Petherton Community Hospital with specific invitations sent to the League of Friends. Specialty specific initiatives: Specialty Initiative Projected outcome Timeline DeNDRoN Somerset Research Collaborative Increase in recruitment March 2017 Public Somerset Partnership is acquiring all Sexual Health services from 1 April 2016 will be actively seeking research opportunities in this area Potnetial recruitment into a new speciality for the Trust March 2017 Programmed activities (PA s) for medical time to be paid in advance as opposed to by results should be recorded in the table below with the funding justification for this provided for each PA (add lines as required): Specialty Name No. of PA s PA in job plan Justification n/a Yes / No July 2017 Public Board - 13 -
Links to Strategic Themes: Identify to which of the Somerset Partnership NHS Foundation Trust strategic themes this report relates by including a cross behind the relevant theme(s) Quality and Safety Sustainability and Transformation Service Delivery Culture and People Links to the Assurance Framework: Links to the Trust Values: Identify to which risks of the Assurance Framework this report relates none Identify which of the Trust values are covered by this report: Working together Making a Difference Everyone counts Links to CQC Domains: Identify which of the CQC domains are covered by this report by including a cross behind the relevant domain(s) Is it safe? Is it caring? Is it well-led? Is it effective? Is it responsive to people s needs? Equality: Identify whether the report has an impact on the protected characteristics set out below, including risks, and if so, say how these risks are to be managed. Only tick the relevant box for which there is an impact. Z Age Gender re-assignment Pregnancy and maternity Religion or Belief Sexual Orientation Disability Marriage and Civil Partnership Race Sex Learning July 2017 Public Board - 14 -
Disabilities Legal or statutory implications/ requirements: Public/Staff Involvement History: Previous Consideration: HRA Approval The new process for the NHS in England The National Institute for Health Research - an overview (July 2016). patient representative and cross section of staff representatives sit on the Clinical Research Group. none July 2017 Public Board - 15 -