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2013/14 Clinical Research Annual Report November 2014 Public Board - 1 -

SOMERSET PARTNERSHIP NHS FOUNDATION TRUST

CLINICAL RESEARCH

Report to the Trust Board – November 2014

Sponsoring Director: Director of Nursing and Patient Safety.

Author: Head of Research and Clinical Effectiveness.

Purpose of the report: Update the Trust board on research activity and implementation of the Trust Research Strategy.

Key Issues and Recommendations:

In 2013/14, the Trust actively participated in fourteen national portfolio studies and recruited 150 participants and secured funding of £101,494 from the Clinical Research Network plus research grants to the value of £44,998, including £42k from Roche for participation in a very successful commercial trial. From April 2014 Somerset Partnership is a member of the South West Peninsula Clinical Research Network (covering the counties of Cornwall, Devon and Somerset). To date, the Trust has secured funding of £121,709 for 2014/15 from SWP: CRN to support research, and is receiving funding from the South Petherton League of Friends to employ a WTE 0.2 Band 6 Stroke Research Nurse. The Trust is actively participating in 13 portfolio studies, the National Confidential Inquiry into Suicide and Homicide and a number of own account studies The Board are asked to note the concerns regarding excess treatment costs (paragraph 3.8).

Actions required by the Board:

The Board are asked to note this report.

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SOMERSET PARTNERSHIP NHS FOUNDATION TRUST

CLINICAL RESEARCH REPORT 1. BACKGROUND 1.1 The Trust has identified research as a key business objective within the

Innovation theme, with a commitment to: “Develop the Trust’s arrangements for research and strengthen academic links”.

1.2 To support this the Board approved a Research Strategy in November 2014 (see Appendix A), and the Clinical Research Group (a sub group of the Clinical and Social Care Effectiveness Group) has been monitoring progress against this strategy.

1.3 From April 2014, the network to support clinical research was restructured. In practice this means that Comprehensive Local Research Networks and topic specific research networks were replaced by a smaller number of Local Clinical Research Networks (LCRN) through which the National Institute for Health Research (NIHR) allocate funding to NHS Trusts who are participating in nationally recognised and funded research studies (“portfolio studies”). Somerset, along with Devon and Cornwall is part of the Clinical Research Network: South West Peninsula (CRN: SWP). The five year contract to host the CRN: SWP was awarded to the Royal Devon and Exeter NHS Foundation Trust.

1.4 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.

1.5 Following the restructuring of NIHR networks, Somerset Partnership is now a member of the South West Peninsula Collaboration for Leadership in Applied Health Research and Care (PenCLAHRC) which is a consortium of NHS organisations and Universities in the region. The Head of Research and Clinical Effectiveness represents the Trust on the management board, 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 pre-research projects, including a mapping of services provided to people with dementia with which the clinical research team is assisting.

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2. TRUST PERFORMANCE 2.1 In 2013/14, the Trust actively participated in fourteen national portfolio

studies and recruited 150 participants to national portfolio studies. This was 25% over the target. This compares with participating in sixteen national portfolio studies and recruiting 106 participants in 2012/13. In addition the Trust acted as a Patient Identification Centre (PIC) for a number of studies for which no recruitment is credited.

2.2 All new portfolio studies were approved (following rigorous governance checks) within the target set of 30 days.

2.3 Since April 2014 the CRN: SWP have not set Trust recruitment targets, preferring instead to monitor recruitment performance across the network in order to encourage collaborative working between member Trusts.

2.4 A highlight of the past year has been the successful involvement in a commercial trail sponsored by Roche. “Impact of Illness” was a cross sectional survey and retrospective review of patients with persistent symptoms of schizophrenia to estimate their medical resource utilisation and burden of illness. The Principal Investigator was Dr Philip Van Driel who, with the support of the Clinical Research team, recruited the required number of patients within the timescale required and generated £41,848 of income for the Trust.

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 successfully negotiated an increase in funding for 2014/15 compared to 2013/14 – see the table below.

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

3.3 Depending on the nature of individual studies, the Trust may

additionally receive funding from specific study grants (including

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commercial trials) to cover research costs and can apply to the CRN: SWP for “contingency funding” to cover service support costs.

3.4 In 2013/14, in addition to the NIHR funding of £101,494, the Trust received research grants to the value of £44,998 for participation in:

a commercial trial “Impact of Illness” sponsored by Roche £41,848;

a Parkinson’s Disease study at Taunton and Somerset NHS

Foundation Trust where Somerset Partnership Speech and Language Therapist provided the research intervention £2,400;

a non-portfolio study into a Therapeutic Engagement Questionnaire

in mental health inpatient services, part funded by Dept. of Health £750.

3.5 In 2014/15, contingency funding to the value of £13,793 has been

successfully negotiated with the network bringing the total funding from the CRN: SWP of £121,709. This contingency funding will enable support of: Big Cactus, a Speech and Language Therapy study;

extras, a Stroke study; e-Sibling, a psychosis study; EMAS, a memory assessment service study; a renal dietetics study.

3.6 The Department of Health publication “Attributing the costs of health

and social care Research & Development” (AcoRD) published in May 2012 (Gateway reference 17533) identifies NHS Treatment Costs as “the patient care costs which would continue to be incurred if the patient care service in question continued to be provided after the R&D activity had stopped.” These costs must be met by the NHS, with the cost of any treatment provided over and above “standard care” regarded as “excess treatment costs” (ETCs).

3.7 From 1 April 2013 all Clinical Commissioning Groups (CCGs) have a duty to "ensure the treatment costs for patients who are taking part in research are covered" although a framework to fund ETCs is still being developed. Somerset Partnership has applied to Somerset Clinical Commissioning Group for ETCs relating to several non-commercial portfolio studies since April 2014 without success. It should be noted that other CCGs have funded ETCs for the same studies being undertaken in other NHS organisations.

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3.8 The Trust is working with Somerset CCG to agree a process for the

consideration and agreement of ETCs. The Board are asked to note that the Trust will maintain a record of all excess treatment costs incurred and are working with the SWP: CRN to address this issue.

4. STAFFING

4.1 The current staffing complement is as follows: Head of Research & Clinical Effectiveness (0.2 WTE);

Lead Research Nurse (full time) appointed August 2014; Research Governance Officer (0.7 WTE) appointed October

2014; Clinical Studies Officer (full time).

In addition, from April 2014 the League of Friends of South Petherton Hospital has funded a Stroke Research Nurse post (0.2 WTE). 5. RESEARCH SEMINARS

5.1 To encourage and promote interest in research within the Trust,

Research Seminars are held twice per year; in April and October.

5.2 The April 2014 seminar at Canalside, Bridgwater was attended by 36 delegates from a variety of professional and service backgrounds. Speakers included: Professor Stuart Logan, chair of PenCLAHRC; Su Craddock of University Hospitals of Leicester NHS Trust researching the DESMOND programme; Professor Chris Dickens, University of Exeter outlining the STEPWISE programme; Kanch Sharma, Neurology Research Registrar at Frenchay Hospital on dementia research; Dr Lucy Knight, Specialist Registrar in Old Age Psychiatry outlining her own research into domestic abuse after the onset of dementia; Heather Tinkler, Clinical Studies Officer for the Trust on the success of the Impact of Illness commercial trail; Ralph Hammond, Clinical Specialist Physiotherapist on “Professional identity post Francis report”.

5.3 Feedback form the event was very positive and included the following comments: “Great half day with informative presentations”;

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“Much improved on last year, as it was less theoretical and based on real-life research projects. Good mix of internal and external speakers.”;

“Wasn’t aware of all the research activity within the Trust. Need

to make junior doctors more aware.” 5.4 The October 2014 seminar at the Education Centre, South Petherton

Hospital was attended by 38 delegates from a variety of professional and service backgrounds. Speakers included: Mike Visick, Divisional Manager for CRN:SWP about the support provided from the NIHR Clinical Research Network; Ian Evans, Consultant Nurse and Tania Collin, Stroke Research Nurse on stroke research at South Petherton; Carinna Vickers, Lead Research Nurse on research in Somerset Partnership; a carer (via video) on how participating in research helped her mum; Andy Harewood on the Suicide and Homicide NCI – 2014 Report. Sarah Dean and other colleagues from PenCLAHRC also led a workshop on “Turning clinical uncertainties into research questions.

5.5 All those who responded to an evaluation questionnaire stated that the seminar provided information that they didn’t know before and gave an idea of what research the Trust is doing. 94% stated that the seminar had increased their interest in research and that they would recommend the Research Seminar to their colleagues. The following positive comments were added: “Excellent seminar, always enthused by the excellent attendance

of Sompar staff.”; “PenCLARHC session was excellent.”; “Well done - a really good informative morning. It was well

structured and well-paced. Thank you.” 6. CURRENT RESEARCH ACTIVITY 6.1 There are currently 13 portfolio studies*1 approved, open and recruiting

in Somerset Partnership and a further two in set up. There are a number of other commercial and non-commercial portfolio studies under consideration and review. *1 Portfolio Studies are projects that: are funded by national funding organisations (i.e. the National Institute for Health Research, the Research Council or charities); have undergone rigorous peer review; are of clear benefit to NHS patients; are registered on the Integrated Research Application System - IRAS. The projects normally recruit from across the UK.

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6.2 List of current portfolio studies:

*2 PI/LC = Principal Investigator/Local Collaborator SPT No.

Title Status PI/LC *2

011 Detecting susceptibility genes for late onset Alzheimer's disease

Open Dr Antony Christopher

062 Brains for Dementia Research: Longitudinal assessment of potential brain donors – brain bank initiative


072 DPIM: DNA Polymorphism in Mental Illness: Genetic case control & brain imaging studies of schizophrenia, bi polar and also a healthy control arm to provide a comparison to the other recruited arms in order to discover if genetic “markers” can be found in people with mental illness.

Open Dr Waqar Ahmed

110 DNA in LD: DNA variation in adults with Learning Disability

Open Dr Jayne Kerridge

132 Molecular Genetics of Adverse Drug Reactions: Defining the genetic and non-genetic risk factors predisposing to adverse drug reactions in order to develop strategies for individualisation of drug therapy to maximise benefits and minimise harms.

Open Dr Rosemary Brook

136 PRESSURE 2: Pressure Relieving Support Surfaces: a Randomised Evaluation 2

Open Sally Irving

138 RADAR: Reducing pathology in Alzheimer’s Disease through angiotensin targeting


142 Effect of Passive Immunisation on the Progression of Mild Alzheimer’s Disease: Solanezumab Vs Placebo (RICE)

Open Dr Kim Porter

144 EXTRAS: A trial to evaluate an extended rehabilitation service for stroke patients.

Open Ian Evans

147 STAMP-2: Sedentary Time and Metabolic Health in People with type 2 diabetes.

Open Su Down

149 E-Sibling: An online information and peer support resource for siblings of individuals affected by first episode psychosis

Open Dr Frank Burbach

151 Renal Nutrition: Prospective Investigation of Patient-centred and medical outcomes in the Elderly with advanced Renal disease: Improving Outcomes in Older Adults with reduced Kidney disease.

Open Linda Carter

154 MAS: Evaluation of Memory Assessment Services Open

Karen Mackie

150 Big Cactus: A study to assess the clinical and cost effectiveness of aphasia computer treatment versus usual stimulation or attention control long term post stroke

In set up

Adult SLT service

133 STEPWISE: A multicentre, open labelled, individually randomised trial of a group lifestyle education programme in people with schizophrenia including those with first episode psychosis

In set up

Dr Mike Campbell

6.3 In addition the Trust supports the National Confidential Inquiry into

Suicide and Homicide hosted by the University of Manchester, by providing information on request regarding patients who have

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committed suicide or homicide. The information collected and analysed is used in a number of different research studies with the aim of lowering the number of suicides and homicides by people receiving mental health care, and improving mental health services for all patients.

6.4 The Trust also approves “Own Account” studies – that is projects that are not supported by the UK Clinical Research Network (UKCRN). The Trust will act as sponsor for these studies when undertaken by a member of Trust staff (usually as part of an academic course), and will consider own account studies undertaken by others if there is interest/support from Trust clinicians/services.

7. SUMMARY 7.1 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.

7.2 The Trust has established a good reputation and working relationship with CRN: SWP and a number of commercial, NHS and University research centres.

7.3 Further work is needed before clinical research activity becomes

“normal business” for all clinical disciplines within the organisation.

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RESEARCH STRATEGY 2014-2017 Introduction The purpose of this strategy is to outline the intention of Somerset Partnership NHS Foundation Trust to develop a research active culture that improves and enhances current services and the patient and staff experience. By developing a research programme that addresses patients’ needs, the Partnership is put at the forefront of delivering evidence based and innovative treatments and services. This helps to ensure that Somerset Partnership learns through evaluating the services it provides, and offers patients choice and opportunities to be involved in their care and to influence future care/treatment options. The development of a quality research active organisation is also vital in attracting new business and opportunities and retaining high calibre, motivated staff that are proud to be part of such an organisation. This strategy sets out the goals Somerset Partnership aims to achieve and maintain over the next three years. Research in the NHS Research and Development (R&D) is at the heart of delivering excellence in healthcare and is a requirement of all Foundation Trusts: “NHS Foundation Trusts will be required to provide certain essential services including research” (DH, 2006). 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). For research to be of value the design, methodology and conduct has to be of high quality. This is assured through adherence to the Research Governance Framework for Health and Social Care (2005) and the national health research strategy: Best Research for Best Health: A new national health research strategy (2006). This strategy states “Health research provides us with the means to tackle the increasing challenges that disease and ill health are placing on our society. It also provides a key role in the knowledge economy of our country through its contribution to international competitiveness and economic growth”. Research in the Trust is supported through the National Institute for Health Research (NIHR) and Local Research Networks. The NIHR was established in April 2006 to provide the framework through which the Department of Health can position, maintain and manage research, research staff and research infrastructure of the NHS in England as a national research facility. The NIHR funds leading-edge scientific research and a number of research programmes and initiatives to ensure that patients and the public benefit from the most up-to-date and cost effective health interventions and treatments and works in partnership with many sectors, including other Government funders,

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academia, charities and industry. Research studies supported by the NIHR are termed “Portfolio Studies”, and attract specific funding that enables NHS organisations to participate without diverting funds from normal patient care. In addition, the NIHR provides infrastructure funding to NHS Provider Trusts and Clinical Research Networks. Somerset Partnership has forged close links with the Mental Health, Stroke and Diabetes Research Networks and DeNDRoN (the dementia and neurodegenerative disease network). Aims and Objectives The Trust’s vision statement is: “Somerset Partnership NHS Foundation Trust will be the leading provider of Community Health and Mental Health services in Somerset and the surrounding area. We will work in partnership to improve the health and wellbeing of patients and their families by providing safe and responsive services of the highest quality.” The Trust’s fifth strategic objective is: “Promote innovation and service redesign based on best practice and working with partner organisations, to maximise efficiency and effective care in response to the major financial challenges facing the Trust, the wider NHS and other public and voluntary sector organisations.” The conducting of good quality, relevant research is essential to provide reliable evidence to inform key areas of health and social care policy and practice. This research strategy aims to improve the health and wellbeing of patients through research that is not only high quality, inclusive and locally relevant, but which also has national and international significance. The following goals have been identified in order to achieve the objectives of this strategy within the timeframe specified (2014-2017): 1. Research activity to become normal business for professionals of all

disciplines within the organisation. 2. Somerset Partnership to be recognised as an NHS research centre and

attract funding for studies from the NIHR and commercial organisations. 3. Increase awareness of the opportunity to participate in research among

staff, patients, carers and members of the Trust. 4. Implement research governance processes that ensure the efficient,

effective and safe approval and conducting of research within the Trust.

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Strengths and Opportunities Somerset Partnership is a diverse and geographically spread organisation and this provides the opportunity to conduct research over a broad range of clinical areas such as mental health, stroke, diabetes, end of life care and dental services. The Partnership has a Research Sub Group which meets quarterly and reports to the Clinical and Social Care Effectiveness Group (and ultimately to the Trust Board). The Sub Group includes membership from research, information governance and a wide range of clinical disciplines. The purpose of the group is to review progress on current studies, review and recommend studies and assist in the development of a positive research culture within the Trust. Somerset Partnership has the ability to collaborate on research projects with two local acute Trusts: Yeovil District Hospital NHS Foundation Trust and Taunton and Somerset NHS Foundation Trust. Working collaboratively enables the Trust to participate in clinical trials involving investigational medicinal products (CTIMPs) and studies that span a patient’s pathway across primary and secondary care. As the Trust has no internal dispensing pharmacy service, the Research team has developed an agreement with YDH to provide research pharmacy services where these are a requirement for participation in portfolio/commercial CTIMPs. In order to further expand the potential to participate in CTIMPs, the Research team is looking at ways to access pathology services so that the capacity to take trial-specific blood samples requiring centrifuging and storage is available. This collaborative approach with other NHS organisations will be enhanced when the Trust is affiliated to the South West Peninsula Clinical Research Network from April 2014. Challenges and Threats The wide geographical area covered by the Trust can be a disadvantage due to travelling times and distances. This can have a bearing on the uptake of research by participants who may be elderly or have mental health issues. Research staff also need to spend considerable time travelling to meet potential participants either in ward or home settings. The Research team is very aware of the time pressures for clinical staff in their day to day work. Clinical staff are under increasing pressure to meet operational priorities and government targets, and although the team does not wish to add to this burden, there is also a responsibility to offer suitable studies to the patients and members of the Trust. Participation in national portfolio research studies is still a relatively new concept for the Trust, so there needs to be an ongoing programme of awareness raising activities to ensure research become part of normal business and the rewards and benefits of research participation become known.

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Action Plan 1. Research activity to become usual business for professionals of all

disciplines within the organisation. 1.1. Communication is vital to integrate research into daily practice and the

research team will seek invites to ward/team educational meetings as a means of doing this.

1.2. Recruitment of research coordinators across the Partnership whose task

is to provide a link role between their team and the Research team. 1.3. Organise twice yearly research seminars to promote research activity

within the Trust and to provide a forum for discussion and networking. This also provides a forum for external and internal researchers to present their research findings.

1.4. Support the branch of the Allied Health Professionals Research Network

recently set up in the Partnership by members of the physiotherapy team. The group is open to podiatrists, dietitians, occupational therapists, speech and language therapists and other allied health professionals.

1.5. Publish Clinical Research in Somerset Partnership (CRiSP), a quarterly

newsletter distributed via global email. This newsletter details research studies, staff involvement, funding and training.

1.6. Distribution of a study feedback questionnaire to capture the thoughts and

feelings of staff who have been involved in a study. This is particularly valuable when a study has not recruited well to provide feedback on the management and coordination of studies within the Trust.

1.7. Recognise the Trust’s strong audit and service evaluation programme and

build on this starting point to encourage clinicians to progress onto research studies.

1.8. Scrutinise proposals for service evaluations to ensure a research

opportunity is not missed. 1.9. In conjunction with Universities, support students undertaking Masters

and Doctorate studies to conduct their research within the Somerset Partnership which may lead onto further research opportunities.

1.10. Encourage clinical staff to attend Good Clinical Practice (GCP) training as

preparation to become the Chief Investigators and Principal Investigators of the future.

1.11. Review the research awareness strategies to ensure their effectiveness.

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2. Somerset Partnership to be recognised as an active NHS research centre and attract funding for studies from the NIHR and commercial organisations.

2.1. Build a strong research portfolio to attract further studies and funding,

actively seeking quality Band 3 portfolio studies.

2.2. Complete research governance processes and approvals for portfolio and commercial studies within the national target (currently 30 days)

2.3. Meet national target to recruit first participant to a portfolio study within a specific timescale (currently 30 days).

2.4. Develop Principal Investigators within the Trust and encourage the submission of NIHR funding applications so that Somerset Partnership is the lead NHS site for a national portfolio study.

2.5. Encourage staff undertaking their own research to publish their work in order to further promote research activity within the Partnership.

2.6. Build a strong link with the South West Peninsula Academic Health Science Network (AHSN) to extend the Trust’s research capability. (There are 15 designated AHSNs in England, with the aim of developing links between the NHS, universities, industry and the third sector in order to share cultures, learning, leadership and innovation to raise quality and standards.)

2.7. Develop relationships with the NIHR Collaboration for Leadership in Applied Health Research and Care (CLAHRC) for the South West Peninsula. This will enable access to expert advice, systematic reviews and the potential for bid for funding of small scale research/feasibility studies which may develop into national portfolio studies.

2.8. To actively seek opportunities to link with universities and collaborate on grant funded research studies.

3. Increase awareness of the opportunity to participate in research

among staff, patients, carers and members of the Trust.

3.1. Promote research being conducted in the Trust through display boards in waiting areas and staff rooms, on the Trust internet and intranet sites and through member communications.

3.2. Share findings of previous research undertaken within the Trust on the Trust internet and intranet sites and through communications to members.

3.3. Encourage participation in research through Patient and Public Involvement forums, Service User groups, Members Council and staff information events.

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3.4. Attend specific events such as League of Friends and community based meetings to inform of current research activity and to give feedback on previous projects.

4. Implement research governance processes that ensure the efficient,

effective and safe approval and conducting of research within the Trust.

4.1. Review the Research and Development Policy and supporting Standard

Operating Procedures (SOPs) which set out how governance processes are managed to ensure a thorough, but streamlined approach.

4.2. Develop a standard operational procedure (SOP) for each research study which clearly sets out the tasks and roles within a study and states who is responsible for each.

4.3. Ensure a management approval proforma (MAP) is completed and signed off by the relevant senior manager so that the commitment required by operational staff is understood, and any financial impact/benefit is clear.

Evaluation The actions against each of the four goals will be monitored by the Research Sub Group and reported to the Clinical and Social Care Effectiveness Group and the Trust Board. The number and complexity of active portfolio studies, the number of participants recruited to each study and the time taken to approve portfolio studies will be monitored by the Research Sub Group through the Performance Reports provided by the Local Clinical Research Network (LCRN). The funding received from the LCRN is dependant on participation and recruitment to portfolio studies in the previous financial year, so this provides an additional means of monitoring performance.

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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 X Innovation X

Viability and Growth Integration

Service Delivery X Culture and People

Links to the Assurance Framework:

Identify to which risks of the Assurance Framework this report relates

None

Links to the NHS Constitution and Trust Values:

Identify the Values to which the issues raised in this report relate by including a cross behind the relevant value(s

Working together for patients X

Compassion

Respect and dignity Improving lives X

Commitment to quality of care X

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? X Is it caring?

Is it well-led? X Is it effective? X

Is it responsive to people’s needs? X

Legal or statutory implications/

requirements:

Research Governance Framework for Health and Social Care (2005)

Best Research for Best Health: A new national health research strategy (2006).

(No new national, regulatory and/or mandatory guidance issued)

Public/Staff Involvement History:

Patient representative and cross section of staff representatives sit on the Clinical Research Group.

Previous Consideration:

an annual review of research activity is presented to the Board on an annual basis.

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