Norfolk and Suffolk Primary and Community Care Research Office Annual Report 2015/16

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1 Norfolk & Suffolk Primary & Community Care Research Office Hosted by: South Norfolk CCG Norfolk and Suffolk Primary and Community Care Research Office Annual Report 2015/16

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3 Contents Glossary of Terms Eecutive Summary Introduction Strategic Overview Norfolk and Suffolk Primary and Community Care Steering Group Clinical Research Network (CRN: Eastern) National and Regional Work Research Development Grant Proposal Development Research Capability Funding (RCF) Grant Proposal Development timelines from inception to project initiation Research Bursary Scheme The relaunched Primary and Community Care Early Researcher Bursary Scheme Developing Research across Organisations Public and Patient Involvement in Research CRN: Eastern Patient Eperience Questionnaire Public and Patient Involvement in Research (PPIRes) Sponsorship of Research Studies Research Management Health Research Authority (HRA) Approval Assessment of Capability and Capacity Local NHS Permission / Assurance Human Resource (HR) arrangements for Research Research Delivery Profile of Studies in Norfolk & Suffolk Recruitment to Portfolio Studies Research Site Initiative Scheme Payment of Research Support Costs Preparing Practices for Study Delivery in Norfolk and Waveney Research Nurse Support Study Delivery in Suffolk Primary Care Feedback to Research Office from Practices and Study Teams Research Dissemination P a g e

4 10. Looking Forward to 2016/ Strategic: Development: Management: Delivery: Appendi 1 Norfolk and Suffolk Primary and Community Care Research Office Team Structure (June 16). 44 Appendi 2 South Norfolk CCG Sponsored Studies Appendi 3 Publications and Presentations of Completed Norfolk CCG Sponsored Studies Appendi 4 Active Studies in 2015/ P a g e

5 Glossary of Terms AHSN Academic Health Science Networks organisations whereby the NHS and universities can work with industry, with the goal of improving patient and population health outcomes by translating research into practice. CRN: Eastern NIHR Clinical Research Network for the Eastern region, providing researchers with practical support they need to make clinical studies happen across the NHS supporting the set up and delivery of studies through the funding of some R&D governance and delivery team staff costs and payment of research support costs. CRN: Eastern replaced the previous research networks in the east of England on 1 April CLAHRC - Collaborations for Leadership in Applied Health Research and Care bring together a collaboration of the local providers of NHS services and NHS commissioners, universities, other relevant local organisations and the relevant AHSN. DH Department of Health ECCH East Coast Community Healthcare CIC HRA - The Health Research Authority was established in December 2011 to protect and promote the interests of patients and the public in health research, and to streamline the regulation of research. In 2015/16 HRA Approval was introduced to centralize the process of approval of research in the NHS. HS&DR - NIHR Health Services and Delivery Research Programme funds research to produce evidence on the quality, accessibility and organisation of health services. HTA NIHR Health Technology Assessment Programme is the largest of the NIHR funding programmes. HTA funds independent research about the effectiveness, costs and broader impact of healthcare treatments and tests for those who plan, provide or receive care in the NHS. National Portfolio Studies on the national portfolio are those which are deemed of national importance to the NHS. They can be non-commercial (project needs to be awarded a grant through a funding body which is open to national competition and applications are peer-reviewed) or commercial (need to have a valid research question with a possible future benefit for patients as its objective). Portfolio studies receive CRN support not available to non-portfolio studies such as access to CRN Research Nurses and support funding. NCH&C Norfolk Community Health and Care NHS Trust NIHR National Institute for Health Research Organisation which is aiming to maintain a health research system in which the NHS supports leading edge health research, focused on the needs of patients and the public. NIHR ODP NIHR Open Data Platform national database of recruitment by organisation for portfolio studies. Updated on a weekly basis. PIC Participant Identification Centre Practices or community teams will help identify and approach patients who are potentially eligible for a study, but recruitment and all other study procedures will be done at another site (commonly an acute Trust). PPIRes Public and Patient Involvement in Research a patient group run by the office which provides researchers with the facility to access patient and public involvement. 4 P a g e

6 ReDA This is a database the office uses to manage all projects that come through the office. It is shared with Norfolk & Norwich University Hospitals NHS Foundation Trust. RCF Research Capability Funding. DH funds allocated to research-active NHS organisations to maintain capability and capacity for research. Funding is awarded in proportion to the total amount of other NIHR income received by that organisation (grant-related RCF), or on recruitment of more than 500 participants to NIHR research in the previous reporting year (Sept-Sept; recruitment-related RCF). Organisations receive either grant-related or recruitment-related RCF, not both. RfPB Research for Patient Benefit. This is a NIHR grant funding stream which allows funding up to 350k. It is open to national competition and all applications undergo peer review. RSI Research Site Initiative Scheme CRN scheme whereby practices receive funding to support research infrastructure and delivery on portfolio studies. The scheme is run annually and funding is tied to performance. SCH Suffolk Community Healthcare from October 2015 provided by a partnership of West Suffolk NHS Foundation Trust, Ipswich Hospital NHS Trust and NCH&C UEA - University of East Anglia 5 P a g e

7 1. Eecutive Summary In 2015/16 the Norfolk and Suffolk Primary and Community Care Research Office (the Research Office) undertook research design, management and supported delivery services for primary and community care in research for the seven Norfolk and Suffolk CCGs, Norfolk Community Health & Care NHS Trust and East Coast Community Healthcare CIC. In collaboration with the Norfolk and Suffolk Primary and Community Care Steering Group partners, the Research Office is working to deliver the 5 year research strategy that has been adopted by Norfolk and Waveney CCGs. This report contains 2015/16 activity information relating to the lifecycle of research studies being developed, managed and delivered across Norfolk and Suffolk. It gives a series of case studies to help illustrate the scope and richness of the work undertaken by clinicians, patients, practices, and academics in relation to research. A full list of all research studies underway across Norfolk and Suffolk during this period is included in Appendi 4 Active Studies in 2015/16. Key Achievements for 2015/16 include: Awarded a research grant from NIHR s Health Services and Delivery Research funding stream in 2015 for the project, entitled Dementia undetected or undiagnosed in primary care: the prevalence, causes and consequences (CADDY). The total research funds associated with this are 343,674 over 2 years. A Research for Patient Benefit application for the project Goal-setting in care planning for people with multi-morbidity: feasibility study and intervention refinement (Goal Plan) was recommended for funding. The total research funds associated with this are 242,786 over 21 months. Recruitment of 8423 participants to 74 portfolio research studies across primary and community care in Norfolk & Suffolk. Achieving ecellent practice participation rates across Norfolk (91%) and Suffolk (approimately 50%). The team supported the first study ever to achieve approval via the new system for gaining permission for research in the UK HRA Approval. In 2015/16 NHS South Norfolk CCG received 70,386 of grant-related Research Capability Funding (RCF) from the Department of Health in recognition of the research grants it holds on behalf of the Norfolk and Waveney CCGs. Four other CCGs in Norfolk and Suffolk each received 20,000 of RCF for recruiting more than 500 patients via their GP practices, to participate in research. From these funds NHS Norwich, NHS North Norfolk and NHS Great Yarmouth and Waveney CCGs pooled resources with NHS South Norfolk CCG to commission the development of 4 research proposals by UEA, to be submitted to the National Institute for Health Research. Managed grant funding income totalling 398,000 for the year and Sponsorship for four Department of Health funded studies on: care home medicines management; unplanned hospital admissions; diagnosis and non-diagnosis of dementia in primary care; and goal-setting for people with multimorbidity. Si CCGs in Norfolk and Suffolk have recruited more than 500 patients into NIHR studies in 2015 and as a result five were awarded 20,000 of recruitment-related RCF for 2016/17; NHS South Norfolk CCG 6 P a g e

8 (one of the si) will receive 110,560 of grant-related RCF on behalf of the Norfolk and Waveney CCGs and NCH&C as a result of grant income. These funds will be used in line with DH rules to support the development of patient and NHS relevant research of importance to the CCGs and to partially fund members of the R&D team. The PPIRes team supported a panel of 66 members from Norfolk and Suffolk, and supported the researchers and PPIRes members on 35 studies. This included reviewing grant proposals, ethics applications and being part of steering/management groups. 7 P a g e

9 2. Introduction The Norfolk and Suffolk Primary and Community Care Research Office (The Research Office) is hosted by NHS South Norfolk CCG and continues to support the lifecycle of research projects across primary and community care. Norfolk and Suffolk have a long-standing reputation of being high performing areas with engaged clinicians. This is supported by close collaborations between the Research Office, CCGs, local Trusts, NHS professionals, practices and the NIHR Clinical Research Network (CRN) Eastern. Research is core business for the NHS, bringing benefits to patients, clinicians and the NHS Organisation (Bo 1). Principle 3 of the NHS Constitution is that The NHS aspires to the highest standards of ecellence 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). Bo 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: Findings from research: Results in better treatment for patients Improves use of scarce NHS resources Enables fair use of resources For healthcare professionals: Involvement in research: Helps clinicians to understand evidence and use this in their clinical practice Increases clinical skills Improves job satisfaction Encourages team working For healthcare organisations: Involvement in research helps organisations: Attract more forward looking clinical staff Meet NHS performance indicators Increase the number of clinicians with epertise in research Drive the development of research relevant to the local population Over the last 3 years, the Norfolk and Suffolk Primary and Community Care Research Steering Group, (Steering Group) has overseen the delivery of the Research Strategy, Research Office Workplan and national research targets in line with the joint CCG Memorandum of Understanding (MOU), which outlines the services and structures provided by the Research Office. The MOU arrangements have been in operation since 2013, and were renewed by CCGs in 2016 and will run until March The Research Office is split into three distinct teams Research Development, Research Management and Research Delivery (Appendi 1 Norfolk and Suffolk Primary and Community Care Research Office Team Structure (June 16)). All teams work closely together to enable providers to give patients in Norfolk and Suffolk increasing opportunities to participate in research which in turn will generate evidence-based practice, enhance clinical practice and improve health of the local population. In order to achieve this, the Research Office works to develop the culture, organisation and infrastructure of research across primary and 8 P a g e

10 community care providers and commissioners. The Research Office is involved with managing all stages of a project from developing a research idea through to funding application submission, to guiding and assisting researchers with the ethical and governance processes, to rolling out studies for clinical teams to deliver, and facilitating the dissemination of research information and study results. Practices in the Norfolk and Suffolk CCGs are currently amongst the highest recruiting practices in the country for a number of different national studies. For the last 15 years, NHS Organisations have been required to give organisational approval for research and have been required to check that the research complies with all legislation. On 11 May 2015 the Health Research Authority (HRA) started a phased roll out of the new centralised system for approving research in the NHS led from England: HRA Approval. This has had a significant impact on the operation of the Research Management Team, who supported the first ever project through this new system. This report gives an overview of the activity of the Research Office for 2015/ P a g e

11 3. Strategic Overview 3.1. Norfolk and Suffolk Primary and Community Care Steering Group The Research Office is overseen by the Norfolk and Suffolk Primary and Community Care Research Steering Group, membership of which includes representation from all CCGs in Norfolk and Suffolk; partner organisations with whom we hold an SLA for Research Management Services; together with the senior managers from the Research Office, NHS England, Public Health and UEA. The Steering Group is chaired by Antek Lejk, Chief Officer, NHS South Norfolk CCG. Throughout 2015/16, the Steering Group has overseen the roll out of the 5 year research strategy and delivery of the 2015/16 Workplan, enhanced the performance monitoring of research delivery and development and championed improvements to research communication and dissemination with CCG teams, local NHS trusts and Institute of Food Research. Reporting to partner CCGs has been by way of an annual report, quarterly bulletins, Steering Group reports and through presentation to CCG Governing and Eecutive bodies. 2016/17 will see a review of the terms of reference of this group to ensure it continues to meet the needs of all stakeholders, and takes account of the opportunities presented by the new collaborations that are emerging across the health system as a result of the Transformation and Sustainability Plan Clinical Research Network (CRN: Eastern) CRN: Eastern is one of 15 research networks that operate across the UK. These networks support the delivery of research and drive local performance on research delivery to allocate research funding to NHS and other health care organisations. This funding covers: infrastructure research, e.g. nurses, and NHS support costs along with network management staff. CRN: Eastern is composed of 6 Divisions with primary care research part of Division 5. South Norfolk CCG as host of the Research Office holds a partnership agreement with the Norfolk and Norwich University Hospital as host of CRN: Eastern, which has been in place since the inception of the current network in 2014 and the Chief Officer and the Head of Research sits on the CRN: Eastern Partnership Group. The Research Office and CCGs continue to work with the Clinical Research Network: Eastern (CRN: Eastern) to ensure primary care research is seen as an integral part of the research activity in the region and specifically to develop year on year investment plans. The Research Office collaborates closely with the Cambridgeshire and Peterborough Primary Research Office to ensure that there is complete and consistent coverage for primary care research activity across the entire CRN: Eastern area. The CRN has confirmed its funding model where the cost per patient is calculated for each Trust with the intention of bringing funding parity across the system. This has led to some Trusts receiving funding cuts. For 2015/16 the overall cost per patient for primary care was in the middle group of Trusts. The CRN has maintained funding into primary care across the region through 2015/16 and into 2016/17 and recognise the importance of a strong primary care research infrastructure to the success of the entire research system. In 2014/15 CRN Eastern centralised the practice payment system for primary care across the eastern area. These arrangements have settled in to place with the Research Office preparing all payment schedules for practices in line with the research activity being undertaken at individual sites, and monies being paid from NNUH. We have worked closely with NNUH to sort individual practice difficulties, and have overseen the development of a new system for allocating payments to practices based on performance. 10 P a g e

12 3.3. National and Regional Work The Head of Research and Development is the Research Champion for all Norfolk and Suffolk NHS Trusts and contributes with other area champions to national policy development by Department of Health and Health Research Authority (HRA). In addition, the Research Governance Manager is on the National Primary Care Research Working Group and has been closely involved in the development of the new national system for streamlining NHS research permission by the HRA. Locally we continue to have strong working relationships with CCGs across Norfolk and Suffolk, UEA, secondary, community and the mental health care Trusts. Increasingly, the Research Office is working with partners across the East of England in line with the CRN:Eastern footprint. The Research Design Lead now chairs the East of England Research Design Service Management Group that oversees research development support across academic and NHS organisations in the East of England. The Research Office in developing closer engagement with National Institute for Health Research (NIHR) Collaborations for Leadership in Applied Health Research and Care (CLAHRC) for the East of England. CLAHRCs are partnerships between universities, health and other organisations which have come together to conduct ground breaking research that aim to have a direct impact on the health of patients with long term conditions and on the health of the public. CLAHRC have strengthened their links with the Steering Group and regularly communicate events and funding that is available to managers and commissioners across the health system. In September 15, CLAHRC were involved in facilitating groups at a Research Summit in Great Yarmouth and Waveney. 11 P a g e

13 4. Research Development The Development team currently comprises the Research Design Lead, a Research Grants Advisor and an Administrator. The team works closely with academics from (primarily) UEA and local clinicians and commissioners to submit grant applications in line with local health priorities. Key achievements in 2015/2016 include: The award of a research grant from NIHR s Health Services and Delivery Research funding stream in June 2015 with NHS South Norfolk CCG as lead organisation, in partnership with UEA. This was submitted as a full application in February 2015 following a successful outline submission in September The development of the application was supported by RCF from NHS South Norfolk CCG s allocation. The project, entitled Dementia undetected or undiagnosed in primary care: the prevalence, causes and consequences and known by the acronym CADDY (Cognitive Function and Ageing Study II: Dementia Diagnosis StudY), started running in February The total research funds associated with this are 343,674 over 2 years. A Research for Patient Benefit application on goal setting in primary care for older people with multimorbid conditions was recommended for funding. Anticipated start date, 01 November Collaborative working with the UEA to develop and submit proposals for funding NHS South Norfolk CCG was the lead organisation for twelve grant applications submitted in 2015/16. Research Design Lead: working co-operatively with research leaders at the Institute of Food Research, UEA and clinicians in primary and community care as part of Primary and Community Care Gut Health Research Consultation Group, eploring how to develop primary and community care research in these areas, particularly as gut health relates to obesity and allergy; also continues to act as Chair of the East of England Research Design Service Management Board. Redesign and relaunch of the Primary and Community Care Early Researcher Bursary Scheme. The scheme aims to build research capability by providing the funds to cover clinical back fill so applicants can acquire and develop their research skills, for eample by attending a research relevant course or via a secondment to the Research Office Grant Proposal Development The team has worked on 46 discrete grant proposals this year, always in collaboration with academic, NHS and other healthcare partners. This year has again seen an increase in the number and proportion of grant applications led by NHS South Norfolk CCG on behalf of all the CCGs in Norfolk and Waveney (Table 1). Grant Proposals SNCCG Led Supported other NHS organisations or UEA Proposals still in active development at end of financial year Total 2015/ / / Table 1- Grant proposals worked on by Development team 12 P a g e

14 Research grant submission is a very competitive process, now usually with two rounds of selection. All applications are epected to be nationally competitive and generalisable to the whole NHS. The twelve grant proposals submitted in the financial year 2015/16, for which NHS South Norfolk CCG was the lead, are listed in Table 2 below. Funding stream Lead applicant Title Health Technology Assessment (HTA)- Epression of Interest (EoI) Professor Fujian Song Dr Toby Smith Research for Patient Benefit (RfPB) old format; single stage process Health Service and Delivery Research (HS&DR) outline stage Research for Patient Benefit (RfPB) new 2 stage format; submissions to Stage 1 Dr Michael Twigg Dr Debi Bhattacharya Professor Nick Steel Dr Simon Horton Dr Anne Killett Dr Michael Twigg Professor Nick Steel Dr Caitlin Notley Dr Pippa Humphreys Dr Simon Horton Effect of preoperative smoking cessation interventions on postoperative complications and smoking cessation. Not recommended to proceed to full application Eercise and physical activity for Care Home residents with Osteoarthritis: a feasibility randomised controlled trial (ECHO). Not recommended to proceed to full application A new model to support Patients with UncontroLled Long term conditions with integrated community Pharmacy services (the PULLUP study): a feasibility study to inform the design of an RCT. Not recommended for funding Medication administration Assistive Technology Selector (MATS): Development and proof of concept testing of an evidence based information tool for use by patients, healthcare professionals and researchers. Not recommended for funding Goal-setting in care planning for people with multimorbidity: feasibility study and intervention refinement. Recommended for funding OnliNe peer-support for stroke survivors to prevent social IsolatioN, promote well-being and reduce Emotional distress: a proof of concept study (ONLINE). Not recommended for funding, invited to resubmit Drinking well in dementia: Developing and disseminating a communication based intervention. Not recommended for funding A definitive RCT of the effectiveness and cost-effectiveness of pharmacy student-led medication reviews on glycaemic control of patients with type 2 diabetes. Not recommended to proceed to full application General Practice Recruitment Facilitator in hard to recruit areas: intervention refinement and feasibility study. Not recommended to proceed to full application Evaluation of Smoking Cessation in Prisons (the SCiP study). Commissioned call; brief recalled by DH following submission Attachment security for all: Developing a valid measure of attachment security for children who have intellectual disabilities and have been referred onto mental health care pathways. Not recommended to proceed to Stage 2 application OnliNe peer-support for stroke survivors to prevent social IsolatioN, promote well-being and reduce Emotional distress: a proof of concept study (ONLINE). Recommended to proceed to Stage 2 application Table 2 - The funding stream, lead applicants and titles of research proposals submitted during 2015/16 where NHS South Norfolk CCG was lead organisation. With the redesign of the NIHR Research for Patient Benefit Programme in the second half of 2015/16, most researcher-led and commissioned funding streams to which we support applications are now a 2-stage 13 P a g e

15 process. NIHR s stated intention is that this will speed up the decision-making process and avoid unnecessary peer review of applications that clearly have a low likelihood of success. The detail of how this works will become clear over the net 12 months. The Research Design Lead has continued to proactively encourage the development of a number of larger grant proposals, including programme grants with UEA academics, where NHS organisations can be the lead, therefore increasing the potential grant-related Research Capability Funding (RCF) into the local system, if the applications are successful. At the end of the 2015/16 financial year there were 18 grant applications in various stages of development, of which 16 are likely to have a Norfolk and Waveney CCG or NCH&C as lead organisation and contractor. Of those 16 grant applications, two are for Programme Grants for Applied Research applications, with potential research income of up to 2,500,000 each Research Capability Funding (RCF) RCF is allocated annually to research-active NHS organisations in England to enable them to maintain research capacity and capability. NHS organisations can be awarded RCF in 2 different ways: Research grant-related RCF organisations receive proportional funds to reflect the amount of NIHR research grant income they have received as lead organisation in the previous year Where an organisation does not reach a threshold of 20,000 of RCF based on research grant income, they can receive a fied amount (currently 20,000) if they have recruited at least 500 patients into NIHR Portfolio studies. In 2015/16, NHS South Norfolk received grant-related RCF. NHS Great Yarmouth and Waveney, NHS North Norfolk, NHS Norwich, and NHS Ipswich and East Suffolk CCGs received recruitment-related RCF. The Research Office supported NHS Great Yarmouth and Waveney, NHS North Norfolk, NHS Norwich and NHS South Norfolk CCGs to manage the monies in line with Department of Health rules. The Norfolk and Waveney CCGs agreed to pool some of their RCF and worked with the Research Design Lead to issue a call to UEA researchers to apply for funds to develop research proposals addressing the overarching theme of meeting the challenges of primary and community care. Funds have been awarded to develop research applications in the following areas: Dementia diagnosis and integrated care pathways Smoking cessation in children and young people Monographs to support de-prescribing of medication Optimising medicines in housebound patients Funding from NHS South Norfolk CCG s grant-related RCF has also been used to support UEA support staff between grants so that important skills in the system are not lost RCF from both recruitment-related RCF and grant-related RCF in the system has been used to support members of the Research Office team whose work is related to the development and maintenance of research capability, as per DH guidelines. The Research Design Lead has promoted the use of RCF through university networks and oversees the development of the grant proposals. A productive working relationship with UEA is in place and the Research Office is now represented by the Research Design Lead on the UEA internal NIHR committee, which reviews all grants where UEA are involved, prior to submission to NIHR funding streams. 14 P a g e

16 4.3. Grant Proposal Development timelines from inception to project initiation The process of developing a robust and competitive grant application can be long and labour intensive, sometimes taking as long as 3 years from when the Development Team starts working with researchers to the point of project initiation. Often, but not always, the more comple the proposed study, the longer the process. The timeline can also be affected by initial applications being rejected by one funding stream and being successful upon resubmission to the same or another funding stream as appropriate. Figure 1-3 illustrate the (sometimes far from linear) process that has taken place in the 3 most recent successful applications. In all cases, the Development Team contributed design epertise, identified research team members and assisted with IP, budget and contract negotiations, working across teams within this Research Office at later stages. The Research Office also awarded funds in the form of RCF on behalf of the CCGs to support the initial applications, the resubmissions (where necessary) and to, for eample, bridge-fund the eventual programme managers for the Programme Grant and other staff for the RfPB. Figure 1 - The development process for the funded Programme Grants Care Homes Independent Pharmacist Prescribing Service (CHIPPS): Development and delivery of a cluster randomised controlled trial to determine both its effectiveness and cost-effectiveness (~ 2,000,000) 15 P a g e

17 Figure 2 - The development process for the funded HS&DR project Cognitive Function and Ageing Study II: Dementia Diagnosis Study (CADDY) (~ 343,674) Figure 3 - The development process for the RfPB Goal-setting in care planning for people with multimorbidity: feasibility study and intervention refinement (Goal Plan) recommended for funding (~ 242,786) 16 P a g e

18 4.4. Research Bursary Scheme The Primary Care Research Bursary scheme has traditionally been used to help clinicians develop research proposals together with academics. Currently, 3 recipients of funds under the old scheme are developing their research ideas (Table 3). Recipient Area of study Progress John Havard; GP, Samundham Indwelling urinary catheters in the community the design of a new model to reduce repeated encrustation. See case study 1 (Bo 2 below) Prototype catheter in development Kate Lee; Senior Specialist Physiotherapist NCH&C The effect of posture on arousal levels in patients with disorders of consciousness: a comparison of Coma Recovery Scale - Revised (CSR-R) scores in lying, sitting and standing. Data gathered from patients; progress towards NIHR Fellowship (PhD) application Pippa Humphreys; LD team, NCH&C A measure of attachment for use with children with learning difficulties and mental health issues to support treatment decisions Table 3 Summary of Bursaries in progress at end of financial year 2015/16 Stage 1 Research for Patient Benefit application submitted in March 2016 Bo 2 - Case Study 1 - Eample of a bursary awarded to a Suffolk GP Indwelling urinary catheters in the community the design of a new model to reduce repeated encrustation May 2013: A bursary was awarded to John Harvard, a GP in Suffolk, 6000 to be paid on delivery of milestones first instalment of 1200 awarded to support design and development efforts. Meetings between recipient and Research Design Lead commence and continue. January 2014: UK patent filed and granted. April 2014: BMJ article published Time to change the catheter making the case for the need for a revised design of the Foley catheter : working with universities, venture capitalists and companies to find ways to develop a prototype that could be tested, working out how to test the prototype in a lab and planning a future clinical trial June 2015: further 4800 of initial bursary funds plus etra 2200 awarded to support the laboratory testing of a prototype at the Bristol Urological Institute. June 2016: work continues on getting a prototype developed in silicone and planning a randomised controlled trial. A recent review of this scheme with current and past recipients determined that it does not always provide the most appropriate support to those with little or no previous research eperience. The Development team reviewed the process, aims and future possibilities of the scheme with UEA and NCH&C. A paper presented to the Norfolk and Suffolk Primary and Community Care Research Office Steering Group in April 2015 received support and feedback for a new model of the scheme, to support the development of research capability for a range clinicians and allied health professionals. 17 P a g e

19 4.5. The relaunched Primary and Community Care Early Researcher Bursary Scheme The Early Researcher Bursary Scheme is open to anyone providing NHS services in Primary or Community Care in Norfolk and Suffolk and any employee of Public Health organisations. The Bursary Scheme enables individuals to: Acquire research skills suitable for those new to research or with little research eperience Develop research skills suitable for those who have done some research training or courses and want to hone their skills in working with published literature Apply research skills for those who have significant eperience and are interested in developing a research career or contributing significantly to a research application. The scheme has three tiers. Each tier has different amounts of funding and epected outcomes, as detailed in Table 4: Tier 1 Acquire skills Tier 2 Develop acquired skills The scheme Funding available Epected outputs Attend course; mentorship from Development team. 3 6 months one day per week secondment to the Research Office to develop reviewing and analytical skills. Up to 3,000 per award The Research Office would cover some or all the costs of providing clinical back fill, the employing organisation covers the cost of the course using CPD funds. Up to 7,000 per award Full or partial costs of clinical back fill covered. Supervision from the Development team. Brief report on eperience and progress, and ideas for net steps. Preparation of a briefing document, report or full literature review; identification of research / evidence gaps to inform research design. Tier 3 Apply developed skills Secondment of 1 day/ week for up to 1 year to a UEA research team and academic mentor. Up to 12,000 per award Full or partial costs of clinical back fill covered and 1hr per week of an academic mentor. Development and submission of NIHR research proposal with the appropriate NHS organisation as lead/sponsor OR submission of NIHR doctoral research fellowship. Table 4 - The three Tiers of the Primary and Community Care Early Researcher Bursary Scheme The Development Team have engaged with community care trust partners to advertise this scheme and there has been some interest in Tiers 1 and 2. Tier 3 requires much more input from our academic partners, which is currently being eplored and developed Developing Research across Organisations The Research Office continues to work in partnership with a wide range of local organisations to drive the development of research studies that meet the needs of the local populations. During 2015/16 Research Leads from NHS Great Yarmouth and Waveney CCG, James Paget University NHS Foundation Hospital (JPUH), 18 P a g e

20 Norfolk and Suffolk Foundation Trust (NSFT) and the Research Office have worked to create a local research community to: Increase co-ordinated leadership of research Support joint ownership of research development Strengthen connections between research leads Increase involvement by patients and clinicians Shape the future direction of research development Bo 3 below gives an eample how this operated in the Great Yarmouth and Waveney CCG area. Bo 3 - Case Study 2 - Great Yarmouth and Waveney Research Development Developing a Research Community for a CCG Area During 2015/16, the following work was undertaken by research leads from GY&WCCG, JPUH, NSFT and the Research Office: Developed and rolled out a research survey to identifying research priorities at personal, organisational and system wide levels that can feed into research development programmes Held a multi-agency research summit for the Great Yarmouth and Waveney area to improve the identification and prioritisation of local health issues, help the research workforce achieve a better understanding of the health needs of a local area to help develop more innovative and relevant research for the population and enable organisations to understand each other s research activity and enhance research collaboration Formulated a research plan for organisational boards that will grow strong health and academic collaborations to help develop and deliver the best research for the Great Yarmouth and Waveney population and build a research community. This cross organisational research plan is being presented to all organisational boards which serve the GY&W population for their endorsement and adoption in 16/ P a g e

21 5. Public and Patient Involvement in Research 5.1. CRN: Eastern Patient Eperience Questionnaire CRN: Eastern carried out a Patient Eperience Questionnaire for a second year running, from November 2015 to February 2016 to capture the patient eperience of research in multiple settings, organisations and research studies across the Eastern Region. A summary of the results has been published by the CRN, the highlights of which are shown in Bo 4. Patients were asked at the end of the questionnaire whether they would be willing to take part in an interview about their eperience. In-depth telephone interviews were conducted with willing participants, who had been recruited by primary care sites, about their eperience of being involved in either TASMIN (Telemonitoring and/or self-monitoring in Hypertension) or HEAT (Helicobacter Eradication vs Aspirin Toicity) clinical trials. Selected quotes from a recent CRN: Eastern report detailing the in-depth interviews are given in Bo 5. Bo 4 - Sections from CRN: Eastern Patient Eperience Questionnaire Why take part? Respondents were asked to tell us why you agreed to take part in the study. Out of the 391 respondents, 343 provided a variety of reasons, the main ones being to help find new treatments for patients and to make life better for others in the future. Respondents cited reasons such as: To help with research Find new treatments and a cure Make life better for other patients Improve life for myself For the aftercare Made me feel useful To improve the NHS To learn about my condition. 20 P a g e

22 Bo 5 - Quotes from CRN: Eastern In-depth Patient Eperience Interviews with TASMIN and HEAT Study participants. What would you say to anyone who might be thinking about participating in a trial? Go ahead, you have nothing to lose. My wife and I participated in a trial some years ago. I had a scan and it detected a large aneurism, they told me I could not take part but it saved my life. I was on the operating table 3 weeks later. Why did you decide to take part in the trial? I just felt that it was time to give something back, in a way I ve benefitted from the healthcare I ve had for many many years and I just felt that it was something I could do in a small way to contribute. I think we are all very fortunate to have the NHS and I think that anything we can do to improve the treatments, it has got to be a good thing. Were the clinical staff helpful? I ve never had anything other than etreme courtesy from people and everybody seems very appreciative of the fact that I was prepared to give up some time Public and Patient Involvement in Research (PPIRes) The PPIRes team provides PPI support for Health and Social researchers in Norfolk and Suffolk for all NHS Trusts and UEA. Since 2004 PPIRes volunteers have been involved in contributing to over 300 studies applying for NIHR and portfolio funding. The panel of volunteers is offered training and is supported to work with researchers to bring the patient, carer and public perspective to research ideas, design and outcomes. Discussions with UEA and NNUH have secured a three year funding plan for the PPIRes project. This will ensure the ability of patients and carers to input into research grants that are under development, as well as involvement in funded projects. The funding is secured until Key achievements in 2015/16 include: The PPIRes team has recruited 8 new volunteers and there is now a panel of 66 volunteers from Norfolk and Suffolk to engage with researchers on developing grant proposals and lay involvement with funded studies. Planning lunch time Public and Patient Involvement (PPI) session (in primary and secondary care settings) presented by the PPIRes project manager and a PPIRes volunteer to help health care professionals to involve patients and carers to develop their research proposals either through the PPIRes panel or giving PPI advice on how to approach specific patient/carer groups. The PPIRes team supported the researchers and PPIRes members on 35 studies. PPIRes members attended 9 pre-submission discussion groups. 34 PPIRes volunteers held 43 lay representative positions on steering/management groups for 13 NIHR funded locally led studies. PPIRes is collaborating with inspire (Norfolk & Suffolk Foundation Trust's service user group for mental health research) to develop a series of workshop to support the volunteers of both groups to effectively contribute to the research process. 14 volunteers attended two workshops on Ethical Decision Making in Research organised by PPIRes. PPIRes is part of a CLAHRC funded study called Impact of Patient and Public Involvement: Completing the Feedback Cycle. PPIRes supported local Trusts to initiate the Patient Research Ambassador role. 21 P a g e

23 PPIRes members hold lay representative positions on the UEA (MED) Ethics Committee and contribute to the Research Design Service (RDS) Bid Development Workshops (held three times a year) and attended the Research Summit in Great Yarmouth and Waveney. NCH&C Research Event Four PPIRes members attended this event, one member presented to the group about their involvement as part of a study team. Figure 4 shows an eample of how the PPIRes panel supports the development of a research study. Timescales vary for different NIHR funding streams. Until the funds are released for the research project to start (month 1 30) PPIRes supports the volunteers involvement and pays their travel, carer and child care epenses. Figure 4 - Flowchart showing a generic eample of PPIRes PPI in a research funding application from development through to a funded project. A PPIRes case study and feedback from a researcher on PPIRes involvement are highlighted in Bo 6. PPIRes funds and supports this involvement at no cost to the researcher. This enables the researcher to plan appropriate PPI to make their contribution effective. 22 P a g e

24 Bo 6 - Case Study 3 - PPIRes Involvement and Feedback Mr Carl Philpott, Senior Lecturer UEA, Hon. Senior Lecturer UCL, Hon. Consultant ENT Surgeon & Rhinologist, first approached PPIRes in August 2010, and since that date PPIRes has worked on 12 applications for NIHR and portfolio funding streams. Over the course of 6 years panel members have responded 85 times to invitations to be involved in these applications and as a result fourteen discussion group meetings have been organised and facilitated. This led to the panel members commenting on plain English summaries, participant information, funding applications and ethics applications. PPIRes provide an essential dimension to the research planning process in 3 critical phases: sounding out the research proposal and thus helping to formulate the finer details of the protocol and/or funding application Reviewing the relevant sections of a funding proposal such as the lay summary and PPI sections Giving essential feedback on patient info sheets and recruitment pathways In our eperience the above has been fundamental to our research proposals and in one case made a fundamental change to the trial proposals we had on the table. Mr Carl Philpott (joint lead on Defining best Management for Adults with Chronic RhinOsinusitis: the MACRO Programme, a 3.2 million NIHR programme grant awarded this year) 23 P a g e

25 6. Sponsorship of Research Studies The sponsor of a research project is the individual, or organisation that takes responsibility for confirming proper arrangements are put and kept in place for the initiation, management, monitoring, reporting and financing (or arranging the financing) of the study; satisfying itself that the study meets the relevant standards, and confirming that proper arrangements are put and kept in place for all the initiation, management, monitoring, reporting and finance of the study. During 2015/16 the Research Office managed four projects for which South Norfolk CCG holds Sponsorship responsibility: CHIPPS, a NIHR Programme Grant for Applied Research (PGfAR), eploring ways to improve medicines management in care homes. SEA (Can a practice based approach using Significant Event Audit identify key factors that might reduce avoidable non-elective hospital admissions?), a feasibility study eamining whether a practice based review of individual case notes can identify factors that might reduce unplanned hospital admissions. The development of a self-assessment tool to measure the effectiveness of inter-agency working in safeguarding adults work (NIHR Collaborations for Leadership in Applied Health Research and Care (CLAHRC) Fellow, Wendy Hicks). CADDY, a study eploring the diagnosis and non-diagnosis of dementia in primary care. Oversight of Sponsored studies is achieved through attendance at Project Management / Steering Group Meetings, general correspondence, and via progress reporting to the DH as funder. Details of the above studies can be seen in Appendi 2 South Norfolk CCG Sponsored Studiesand an eample of the Sponsorship activities carried out for the Safeguarding Adults project is highlighted in Bo ,000 of project related income was received in 2015/16 for these projects, which resulted in 110,560 of Research Capability Funding being awarded by DH for management by the Research Office on behalf of Norfolk and Waveney CCGs. The Research Office also undertook delegated Sponsor activities on behalf of NCH&C for one unfunded study on the effects of position on the awareness levels in patients with consciousness disorders (supported by a Research Bursary see Table 3), which completed during the year. South Norfolk CCG was successfully awarded a NIHR Research for Patient Benefit Grant for Goal Plan in 2015/16, a study looking at goal-setting in care planning for people with multimorbidity see section 4.1, Table 2. This is due to start in 2016/ P a g e

26 Bo 7 - Case Study 4 - Study managed by South Norfolk CCG as Sponsor The development of a self-assessment tool to measure the effectiveness of interagency working in safeguarding adults work Wendy Hicks, Commissioning Manager, NHS South Norfolk Clinical Commissioning, funded via the CLAHRC East of England Fellowship Scheme Study details and outcomes The study sought to investigate the key enablers and barriers to effective collaboration between health, police and social care agencies, from the perspective of staff members involved in the work of the Safeguarding Adults Board (SAB) and staff from other agencies that are not required to be SAB members. The study collected data from semi-structured interviews with 18 participants from health agencies (including GPs), police, local authority, and other agencies not required to SAB members (voluntary and statutory organisations). The study findings were presented in the final report, April 2016 (see Appendi 2 South Norfolk CCG Sponsored Studies for more details) Sponsorship Activities included: Oversight and review of progress via regular informal meetings and ad hoc discussions Review and feedback on study protocol and supporting documents (e.g. information sheets) Support with HRA application and sign off of application as Sponsor Troubleshooting as necessary Review of findings and discussion of final report content and dissemination plans Feedback from Wendy Hicks Support of the R and D team was invaluable at each step of the project. It really helped that they were so responsive to my questions Publications and presentations resulting from completed sponsored studies are listed in Appendi 3 Publications and Presentations of Completed Norfolk CCG Sponsored Studies. 25 P a g e

27 7. Research Management The team undertakes research management functions on behalf of all seven CCGs in Norfolk and Suffolk, Norfolk Community Health and Care NHS Trust and East Coast Community Healthcare CIC and, with the Cambridgeshire Office, on behalf of North East Esse and Hertfordshire CCGs. The team also undertakes sponsorship and grant management of studies (see section 6), develops policy and manages finances 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 in the NHS in England, consisting of assessments by HRA staff alongside the independent Research Ethics Committee (REC) opinion where required. This replaces the need for local permission / assurances, instead, organisations need to assess their capability and capacity to deliver studies. From 1 April 2016 HRA Approval was fully implemented and is now the only process for gaining approval. The introduction of HRA Approval represented a significant and fundamental change from the previous system of local permissions / assurance which have been in operation for the last 15 years. During 2015/16 the local arrangements for gaining NHS Permission / Assurance operated alongside the phased implementation of HRA Approval, and systems were developed to support this transition and to ensure awareness of these changes within the NHS and the research community. The Research Office supported the first study ever to go through the HRA approvals process Assessment of Capability and Capacity Organisations hosting HRA approved studies are now required to assess their capability and capacity to host and ensure all arrangements are in place to deliver the study. The Research Office support organisations to do this via: Review of costings / contracts / agreements (as necessary) Liaison with support departments such as labs Review and issuing of honorary research contracts or letters of access for research as necessary Provision of training, support and guidance on HRA requirements and applications Maintenance of research database of all approved studies Review of impact of amendments to eisting studies Feedback to HRA to help refine processes For simple studies (such as staff questionnaires) a formal assessment of capability and capacity may not be required. Figure 5 and Figure 6 below give an overview of local activities in relation to capability and capacity. 26 P a g e

28 Figure 5 - Flowchart showing site and HRA Approval processes for studies requiring capability and capacity Figure 6 - Flowchart showing site and HRA Approval processes for studies NOT requiring capability and capacity 27 P a g e

29 Five HRA Approval letters were received by the Research Office during 2015/16. None of these studies required the participating organisation to confirm capability and capacity to host the research Local NHS Permission / Assurance The office continued to undertake governance checks and issue local NHS Permission / Assurance letters, for studies which did not go through the HRA Approval process, until 31 March letters were issued by the Norfolk and Suffolk Research Office in 2015/16, with 86% of these being for national portfolio studies (Table 5). Most non-portfolio studies are student projects. The Research Management Team continue to collaborate closely with the Cambridgeshire Primary and Community Care Research Office, sharing the responsibility for undertaking the governance review and issuing of a CRN: Eastern assurance letter for national portfolio primary care studies spanning both the CRN: Eastern east corridor (covered by Norfolk office) and west corridor (covered by the Cambridgeshire office). As Table 5 shows, a total of 79 study approvals and assurances were issued (i.e. N&S (62) and Cambridgeshire office letters (12) and HRA Approvals (5) for our region) during 2015/16 in comparison to the 95 letters issued in 2014/15, but given the national changes to the approvals process, comparisons with previous years are difficult. 12% of studies approved this year (by N&S and Cambridgeshire offices for our region) were PIC studies compared to 18% in 2014/15. The percentage of portfolio studies, which were approved by N&S and Cambridgeshire offices for our region, remains at similar at 82% compared to 81% in 2014/15. As for previous years we were measured against a 15 day target for permission for studies not going through HRA Approval, which 80% of studies epected to achieve permission within the 15 days. As can be seen from Table 5 and Figure 7, we fell marginally below this target at 79%. This is mainly as a result of the additional support required for student projects to bring the application up to a standard where permission can be granted. Number of assurance/permission letters issued 2014/15 Number of permission letters issued by N&S Research Office 2015/16 % approved within 15 days 2015/16 Number of Eastern wide permission letters issued by Cambridgeshire Office 2015/16 % PICs (N&S and Cambs letters issued) % Portfolio (N&S and Cambs letters issued) Number of HRA approved studies 2015/16 Primary Care (N&S) NCH&C SCH ECCH Total (including NEE) 81% (35 of 43) * 77% (10 of 13) 50% (1 of 2) 100% (3 of 3) 79% (49 of 62) % (9 of 55) 89% (49 of 55) % (7 of 13) 50% (1 of 2) 100% (3 of 3) 12% (9 of 74) 82% (61* of 74) ** Table 5 - Table showing the level of new study activity and approval percentages within primary & community care across Norfolk & Suffolk in 2015/16. Raw data collected from the ReDA. database.*includes issue of one assurance letter for the MS (Multiple Sclerosis) Therapy Centre. **HRA letter covers both primary and community care sites. 28 P a g e

30 April May June July August September October November December January February March 14/15 ALL 15/16 ALL Number of Letters issued, median time to permission and % within 15 days, by month and year to Number of Permission/Assurance Letters Issued % permission/assurance letters issued within 15 days of submission Median Time to Permission (days) Figure 7 - Graph showing number of permission or assurance letters issued, median time to permission and % within 15 days, by month for all studies in 2015/16. Raw data collected from the ReDA database 7.4. Human Resource (HR) arrangements for Research All researchers who undertake research work involving NHS patients or data, or have access to NHS premises are required to have a Letter of Access (LOA) or Honorary Research Contract (HRC) depending on their employer and the activities they are undertaking during the study. As in previous years LOAs and HRCs continue to be processed through the Research Office: 10 researchers, employed by NHS organisations, and 14 researchers, employed by non-nhs organisations, were issued with LOAs in 2015/16. However, with the implementation of HRA Approval, HR requirements are now outlined on the HRA approval letters to ensure consistency across the country over interpretation of the guidelines. 29 P a g e

31 8. Research Delivery Research delivery for portfolio studies across Norfolk and Suffolk in 2015/16 was coordinated by the Clinical Research Network (CRN). The Research Office host the CRN: Eastern primary care delivery team for Norfolk and Waveney with the Suffolk primary care team being based at Ipswich Hospital, and NCH&C hosting their own team supporting research in NCH&C and ECCH. The delivery team provide a link between research teams and practices/services, identifying practices/services willing to host research studies, and helping to get these studies up and running. Key achievements in 2015/16 include: Across Norfolk and Waveney, 91% of practices undertook some activity related to research. There were 49 Research Support Initiative (RSI) contracts awarded to practices in Norfolk and Waveney. Across Suffolk approimately 50% of practices are research active and 12 were on the RSI scheme in 2015/16. Recruitment of 8423 participants to 74 portfolio research studies across primary and community care in Norfolk & Suffolk. Relative to population size, Norfolk and Waveney practices are in the top 25% of all areas nationally in terms of numbers of people involved in research. Four studies each recruited more than 600 participants across all the N&S primary and community care sites in 2015/16: EPIC-Norfolk Fourth Health Check (1438 participants); Fun and Fit Norfolk (1288); Flei- Quest - Predictors of bowel scope screening participation (1116) and TIME - Treatment in Morning Versus Evening (666). Beccles Medical Centre (GY&W CCG) was the joint leading recruiting site in the UK for ALL-HEART (Allopurinol and cardiovascular outcomes in patients with ischaemic heart disease). Cromer Group Practice (NN CCG) was the highest recruiting site in the UK for the TIME (Treatment In the Morning versus Evening) study. Framfield House Surgery (I&ES) was the highest recruiting site in HEAT (Helicobacter Eradication vs Aspirin Toicity) in the UK. Wymondham Medical Partnership (SN CCG) was the second highest recruiting site in the country for the ATAFUTI (Alternative Treatments of Adult female Urinary Tract Infection: a double blind, placebo controlled, factorial randomised trial of Uva ursi and open pragmatic trial of ibuprofen) study. NCH&C was chosen from 30 sites across the UK to receive etra funding to support further roll out of PRESSURE 2. NCH&C was the third highest recruiting site to the study in 2015/16 with 75 participants recruited. North Norfolk CCG and West Norfolk CCG were the fifth and eighth highest of 24 recruiting organisations to PACE (Primary care use of a CReactive Protein (CRP) Point of Care Test (POCT) to help target antibiotic prescribing to patients with Acute Eacerbations of Chronic Obstructive Pulmonary Disease (AECOPD) who are most likely to benefit) Profile of Studies in Norfolk & Suffolk There were a total of 179 studies (portfolio and non-portfolio) active in primary and community care in Norfolk and Suffolk during 2015/16 (see Appendi 4 Active Studies in 2015/16 for the full list of studies), which is a similar to the level of activity in 2014/15 (188 studies). The profile of studies remains similar to that of previous years with high numbers of studies covering cardiovascular disease, diabetes and respiratory conditions (Figure 8). 30 P a g e

32 Stroke Skin Respiratory Reproductive Health and Childbirth Renal and Urogenital Paediatrics Oral and Gastrointestinal Neurological Musculoskeletal Metabolic and Endocrine Mental Health Medicines for Children Injuries and Accidents Inflammatory and Immune System Infection Generic Health Relevance Eye Diabetes Dementias & Neurodegenerative Disease Congenital Disorders Cardiovascular Cancer Blood Number of Active Studies in 2015/16 Figure 8 - Graph demonstrating the areas of research of active studies in 2015/16, in primary and community care in Norfolk and Suffolk. Data obtained from ReDA database. Studies which have generic health relevance, which cross specific clinical areas, again make up the biggest proportion of active studies. Eamples of these types of studies include: Fun and Fit Norfolk, Evaluating Different Methods of Recruiting and Engaging Inactive Individuals into Sport The VBI Trial - A study to look at the efficacy and cost effectiveness of a Very Brief Intervention to increase physical activity among adults attending NHS Health Checks Care Homes Independent Pharmacist Prescribing Service: CHIPPS, eploring ways to improve medicines management in care homes Recruitment to Portfolio Studies Relative to list size, five of the seven Norfolk and Suffolk CCGs are ranked within the top 50 CCGs in the country in terms of recruitment to portfolio studies, with South Norfolk and North Norfolk ranked fourth and tenth, respectively. NCH&C is the seventh highest recruiting care trust in the country. Within CRN: Eastern, over 11,500 participants were recruited in primary care in 2015/16 (Figure 9) representing 31% of all recruitment across the CRN, with 8423 these from Norfolk and Suffolk. 31 P a g e

33 Participants recruited Figure 9 - Graph showing the number of patients recruited to portfolio studies in 2014/15 and 2015/16, for Trusts across CRN: Eastern. Data taken from NIHR ODP (15/05/16). Within Norfolk and Suffolk Primary and Community Care 8423 participants were recruited to 74 portfolio research studies. Figure 10 shows the total numbers of participants recruited to portfolio studies per organisation in 2014/15 and 2015/ SN CCG Norwich NN CCG CCG GYW CCG I&ES CCG WN CCG NCH&C WS CCG ECCH Figure 10 - Graph showing the number of participants recruited to portfolio studies in 2014/15 and 2015/16, by CCG organisations. Data taken from NIHR ODP (data cut 12/06/16). South Norfolk CCG benefitted in 2015/16 from two high recruiting studies which were dependant on the practice location: EPIC Norfolk Fourth Health Check and Flei-Quest, with 888 and 750 SNCCG recruits, 32 P a g e

34 respectively. EPIC is an ongoing study predominantly in the central Norfolk area and recruitment to Flei- Quest was related to bowel screening at NNUH. Please note that currently East Coast Community Healthcare falls within GY&WCCG. As a social enterprise, national systems are not currently set-up to manage recruitment to non-nhs organisations outside of primary care. ECCH recruitment contributed 51 participants in 2015/16. It is important to note that these figures do not take into account work of primary and community care for studies where they have identified and approached patients for secondary care studies. Also recruitment figures in Norfolk and Suffolk are heavily dependent on studies from outside the region as not many studies are initiated from local academic institutions Research Site Initiative Scheme The Research Office also manages the CRN Research Site Initiative (RSI) scheme for practices in Norfolk and Waveney which help to develop capability and capacity to undertake research. The RSI scheme is run annually and practices accepted onto the scheme receive funding in return for recruiting to portfolio studies and developing their research infrastructure and capability to undertake research. RSI agreements are overseen by a contracts manager. The RSI scheme was revamped in 2015/16 such that rather than fied quarterly payments as per previous years in return for taking on studies, payments were directly related to recruitment activity on those studies. As a result, performance from RSI practices increased from an average of 62 patients per practice in 2014/15 to 72 in 2016/17. A summary of RSI contracts and performance by CCG area is presented in Table 6 below. Please note that data on Suffolk practices is held by the CRN: Eastern Division 5 team based in Suffolk. No. RSI Practices 14/15 No. RSI Practices 2015/16 RSI Practice Recruitment 14/15 RSI Practice Recruitment 2015/16 NHS Great Yarmouth and Waveney CCG NHS North Norfolk CCG NHS Norwich CCG NHS South Norfolk CCG NHS West Norfolk CCG AVERAGE (Range) 62.1 (0-375) 71.7 (0-413) Table 6 - Table showing the distribution of RSI contracts across Norfolk & Waveney in 2015/16 and recruitment for RSI practices (ecluding EPIC study recruitment which does not qualify under the scheme) Payment of Research Support Costs Practices within CCGs are eligible to be paid network service support costs (SSCs) to reimburse their time for some elements of work undertaken for portfolio studies. In addition, practices on the scheme receive income from the network in return for supporting research and building research infrastructure (see Table 6, section 8.3). The Research Office manages the payment of these support and RSI payments for practices across Norfolk and Waveney. Payment to Suffolk Practices is managed via the CRN team in Suffolk and NCH&C manage their funding directly so these are not included in the figures below. In addition to this income, 33 P a g e

35 research active practices may also receive research monies 1 and commercial income direct from research Sponsors. The Research Office reviews funding prior to the start of a study to ensure costs and cost attribution is appropriate and ensure agreement of costs before studies start. In 2015/16 a total of 170k Service support costs were paid to practices in Norfolk and Waveney across 99 practices. As you can see from Table 7 below, the average payment per practice was around 1.5k, however payments ranged from 0 to almost 25k, with the vast majority (>90%) receiving less than 5k (Figure 11). Support Cost (SSC) Payments Research Site Initiative (RSI) Scheme Payments All Practices RSI Practices only Non- RSI Practices No. Practices Median 159 1, Mean 1,561 3, Range 0-24, , ,094 Median N/A 3,080 N/A Mean N/A 3,621 N/A Range N/A 1,000-15,405 N/A Note Practices may also receive payments to cover research costs and commercial income directly from the Sponsor of the research in addition to the SSC and RSI payments from the network Table 7 - Table showing payments to Practices Norfolk & Waveney 2015/16 As described in section 8.3 almost 50 practices in Norfolk & Waveney operate under the RSI scheme, and, nearly 180k was paid out under this scheme in 2015/16, with individual practices receiving 3.6k on average (Table 7). Given that RSI practices are more research active, as would be epected the distribution of RSI monies (Figure 12), broadly reflects the distribution of SSC monies (Figure 11) and recruitment (Figure 13), and the RSI scheme was updated in 2015/16 to more closely match payments to activity. This is however not an eact match as the activity across studies varies greatly as does the funding, not all studies that show recruitment attract support costs or RSI payments and support costs can be paid for non-recruiting activities such as patient identification work, taking bloods and follow-up work. Please note that EPIC recruitment has been ecluded from Figure 13 below (EPIC is a high recruiting study operating over central Norfolk which attracts no support or RSI payment due to the minimal workload of the study on practices) as inclusion would significantly skew the data. Figure 11 - Service support costs paid to N&W practices Figure 12 - RSI payments to N&W practices 1 DH guidance splits the costs of non-commercial research into Research Costs (the cost of doing the research, funded via the grant funder), Support Costs (the cost to the NHS of supporting research, funded via the Research Networks) and Treatment Costs / Ecess Treatment Costs (the cost of patient treatment, funded via normal commissioning arrangements for patient care) P a g e

36 Figure 13 - Recruitment into portfolio research studies 8.5. Preparing Practices for Study Delivery in Norfolk and Waveney The delivery team are involved in ensuring that practice staff have the correct skill set to enable research to be undertaken. This includes introduction and refresher Good Clinical Practice (GCP) training and informed consent training for clinical staff via an internally developed DVD as well as updates to the CRN practice manager guide. The ICH Good Clinical Practice (GCP) Guidelines are the gold standard for the conduct of research involving patients and the public. It is a legal requirement that the principles of GCP are followed for the conduct of drug trials and it is recommended that these principles are followed for any other clinical trial as well as other types of research. All Principal Investigators (PIs) on clinical trials are epected to have completed GCP training, and this is refreshed every 2 years. The NIHR runs both online and face to face GCP training courses for clinicians and healthcare practitioners involved in portfolio studies. The CRN Locality Manager for Norfolk and Waveney delivered 8 GCP courses across primary care in Norfolk & Waveney in 2015/16 with 70 members of staff trained. We are now in the process of training two members of staff to help deliver GCP training in primary care and new primary care GCP courses will be running across the CCGs in 2016/17. The team also run regular GP forums to share best practice in research, to disseminate changes to the research environment and to identify priorities and research issues of interest or concern; over 100 staff attended the si forums during 2015/16. In addition a practice research newsletter, Mather s Mouthpiece is circulated monthly to update practices on ongoing and new studies and to celebrate achievements. 70 staff attended the celebratory GP Forum which was held in March 2016 to mark Heather Leishman s final research event as the CRN Eastern Locality Manager. The team also support practices to become Royal College of General Practitioners (RCGP) Research Ready accredited. Research Ready is a quality assurance programme, intended for use by all research-active GP practices, designed in line with the Research Governance Framework s legal, ethical, professional, and patient safety requirements. Study workshops are also proving to aid study recruitment as highlighted in Bo 8. These have been organised across a number of studies to help boost recruitment and maintain interest. They give opportunities for practices to share learning, encourage collaboration and troubleshoot issues that may have arisen. 35 P a g e

37 Bo 8 - Case Study 5 Workshops The CANDID (CANcer DIagnosis Decision rules) study The study aims to produce decision rules for use in the referral, or otherwise, of patients with suspected lung or bowel cancer. Patients with cancer in the UK present later and have lower chances of survival when compared to patients from other countries, which raises issues of how we respond to delays in diagnosing cancer, how to refer high risk patients first and how to reduce unnecessary investigations. Norfolk and Great Yarmouth and Waveney GP Practices had recruited 678 patients by the end of February 2016, with a target of 1000 to be recruited by September Workshop A workshop was held in March 2016 at Roundwell Medical Centre to help boost recruitment. Practices with falling recruitment as well as sites with high recruitment were invited to share good practice. Practices were invited via the R&D Monthly newsletter Mather s Mouthpiece 16 staff attended from 9 practices. The session was based on the study eperience of Cromer Medical Group, and covered many aspects of recruitment, including an emphasis on the benefits of sending letters and information leaflets to those patients who had recently attended the surgeries with symptoms that could be attributable to a cancer. Outcome During March and April the nine practices showed an increased recruitment rate compared to other Norfolk practices Research Nurse Support CRN: Eastern research nurses support portfolio research across the region, working closely with clinical teams to achieve successful delivery of studies. Nurses are deployed to support a range of studies across a number of practices. They not only support recruitment within practices by seeing patients for studies, but have a critical role in getting practices on board with studies, organising and delivering training on studies, maintaining recruitment and momentum and troubleshooting when issues arise. The nurses also, on occasion, will assist NCH&C clinical teams in undertaking study visits. The following case studies (Bo 9 and Bo 10) illustrate studies where the delivery team has assisted in effective set up and continued study support. 36 P a g e

38 Bo 9 - Case Study 6 Norfolk & Waveney CRN Nurse Support The TWICS Study: Theophylline with Inhaled Corticosteroid The TWICS study is a randomised controlled trial investigating the effectiveness of low dose oral theophylline as an adjunct to inhaled corticosteroids in preventing eacerbations of chronic obstructive pulmonary disease (COPD). Half of the participants in the study take low-dose theophylline and half of the participants take placebo for one year. The study is recruiting in both Primary and Secondary care sites and involves baseline, si and 12 months follow-ups with several telephone calls regarding medication compliance. 31 surgeries across Norfolk have recruited 177 participants to date: eceeding all other primary care areas as well as the secondary care sites with the eception of the host site, Aberdeen Royal Infirmary. Key Role of Norfolk Research Nurse Promoted the study to primary care practices in the area. Organised training days for primary care staff and visited practices to deliver the study training. Shadowed and supported practices new to research, helping them to build confidence in carrying out the research activities independently. Bo 10 - Case Study 7 Norfolk & Waveney CRN Nurse Support The PRIMROSE trial: Managing cardiovascular risk in patients with severe mental illnesses (SMI) The aim of this primary care cluster randomised trial is to determine the clinical and cost effectiveness of a primary care based intervention to lower cardiovascular disease (CVD) risk factors in people with severe mental illnesses. Potential participants with raised CVD risk factors were identified and invited to participate by the practice nurse. The research nurse conducted the baseline visits (including consent, clinical measurements, participant questionnaires, etensive notes review and data collection), 6 and 12- month visits, whilst the practice delivered the PRIMROSE intervention. The study is ongoing with the 12 month follow up visits due to complete in November Challenges Mental health is an under-researched area of healthcare and mental health service users are anecdotally difficult to engage in research. Challenges of this study included: establishing a rapport and relationship with the participants; managing the visit to ensure it was scheduled to meet the particular needs, preferences and sometimes fluctuating mental health of the participant; maimising follow up and minimising study withdrawals and non-attendance. The research nurse has dedicated time, effort and advanced communication skills to ensure participants have capacity to give ongoing consent, and to maintain the participants interest and cooperation so that the study visits are attended. Recruitment and follow up in the Eastern region The recruitment target (25) for the Eastern region was eceeded with a total of 31 participants being recruited, 22 of which were from Norfolk and Waveney practices (Castle Partnership, Wymondham and Beccles). Only 3 out of 22 Norfolk participants (13.6 %) were lost to follow up at 6 months compared to 21% nationally. 37 P a g e

39 8.7. Study Delivery in Suffolk Primary Care The Research Office supports the study delivery team in Suffolk CCGs that operates out of Ipswich hospital with research management and recruitment information, through its work with Suffolk CCG and CRN. The CRN: Eastern Primary Care Coordinator, who managed the delivery of studies across Suffolk practices, left the post in March CRN: Eastern are overseeing the management of the primary care research nurses, who are employed by Ipswich Hospital NHS Trust. Suffolk CCGs are actively lobbying the network to replace the delivery manager post. An eample of research study work underway in a Suffolk is presented in Bo 11. Bo 11 - Case Study 8 - Suffolk Coronary heart disease Risk in type 2 Diabetes CORDIA To compare the effectiveness of an evidence-based self-management intervention (SMI) alone, SMI plus personalised coronary heart disease (CHD) genetic risk information, with usual standard care on CHD risk and diabetes management in primary care patients with type 2 diabetes. The Peninsula Practice has published Collaborative Research using Hub-and-Spoke practices in Royal College of General Practitioners Bright Ideas, April The following highlights are taken from the article ( We were approached by the Cordia Team March 2013 and met for an initial study meeting together with other interested surgery teams. This session was very enlightening. We were relatively new kids on the block and felt very much part of the seeds of design stage being involved with feasibility practicalities and understanding how the theory (design) could be put into practice. We helped brain storm the logistics of implementing the study. This was both liberating and inspiring realising how us in a little surgery in rural Suffolk can engage and help shape studies that are so relevant to Primary Care and subsequently important in shaping service provision. It showed us how the process of studies evolves and how everyone no matter how eperienced or not in research can contribute to the optimisation of a good and robust study. Furthermore we were the hub for surgeries within the Deben Health Group - a collaborative group of local practices with whom we meet regularly to brain storm ideas and collaborative working to enhance the delivery of ecellent patient care. So with this positive and supportive relationship between surgeries there was already a good working relationship between us. By the end of the study the 6 Practices that collaborated recruited 63 out of the total 180 recruits onto this study, and that would undoubtedly have failed without this fleible approach to working the study. Since the study we have realised the importance of patient education and how perceptions that diabetic patients may have can determine their overall care. Feedback from the CORDIA Study Team Peninsula Practice played a key role in achieving recruitment targets for the Cordia study within Suffolk. The practice acted as the hub for multiple sites in the area; they were highly effective in recruiting spoke sites, and feeding participants into the study, such that they recruited the most participants to the study of all of our primary sites. 38 P a g e

40 8.8. Feedback to Research Office from Practices and Study Teams For 2015/16, a selection of research active practices and research teams were asked to give feedback on the Norfolk Research delivery team s performance; Bo 12 outlines some of the feedback received. This was a useful eercise which will be repeated in 16/17 when a more comprehensive survey of Research Office stakeholders will be undertaken. Bo 12 - Feedback from practices and study teams taking part in research Local Practices Since starting Research at Bridge Street Surgery it hasn't impacted the surgery as a whole but instead feels more like an undercurrent, a stand alone aspect of the surgery that we are all very proud of. Both myself and the whole of our research team enjoy the research projects allowing variety in our work and a continuation of learning in our profession. Our patients seem equally taken with the projects feeling special and important to the advances in medicine. The CRN Research Nurse has been brilliant, a constant source of support and guidance never too busy to take a call and always so approachable, we couldn't have asked for a better contact. GP, Bridge Street Surgery, Downham Market We are relatively new to research at Orchard Surgery and were delighted to achieve 7 th place in the county last year for our research related activity. Our patients have been very proactive in embracing research and we have had good rates of patient participation in the majority of studies we are working on. Research adds an etra dimension of interest to General Practice. We have received ecellent support and training from the CRN Research Nurse with the ALL HEART study, together with other members of the team who are involved with the studies we are working on and as a Practice we are very happy with how our role in research is progressing. Study Teams Clinical Systems & Data Manager, Orchard Surgery, Dereham The Norfolk teams, who have seen the bulk of our participants, have been an incredible asset - accommodating, fleible, efficient, and a delight to work with. Thank you [name of CRN Research Nurse] from the team here - my contribution was minimal. Thank you for taking such trouble with the study - ensuring that the participants feel valued and that others will be encouraged. London School of Hygiene and Tropical Medicine CURE-ME study team In particular, we have been delighted by the support that CRN Research Nurse has provided in the East of England. As an eperienced respiratory and research nurse, she has been a great ambassador for the study since it was launched in the Norfolk area in April The success of the study in Norfolk is testament to the Research Nurse s enthusiasm, knowledge and links with GP practices in the area. She has also been instrumental in supporting the study in Suffolk. TWICS Chief Investigator 39 P a g e

41 9. Research Dissemination Through 2015/16, with the guidance of the organisations on the Research Steering Group, the office has overhauled its research dissemination process and has streamlined the following process for promoting research information and research results. Quarterly Research Briefings to CCGs Research Dissemination Reports GP Practice Bulletins (Mather s Mouthpiece) see 8.5 Local Conferences and Events International Clinical Trials and Public Events CCG Annual Reports The Research Office has implemented a process for following up completed studies in order to obtain copies of the study final reports. Final reports are disseminated to CCGs and community partners by way of quarterly CCG bulletins/ newsletters, review at Steering Groups and uploaded to the Research Office website. Where appropriate to commissioners, additional results that are coming in from CLAHRC & NIHR, are fed into the dissemination routes. Information on the outcomes of two local studies is given in Bo 13. Bo 13 - Outcomes from two local studies TASMIN-SR (Targets and self management for the control of blood pressure in stroke and other at-risk groups) A paper detailing results of the TASMIN-SR study was published in JAMA. 2014; 312 (8): Locally, si practices in Norfolk and Suffolk recruited 30 patients to this randomised controlled trial and undertook all study procedures. The aim of the study was to find out whether high blood pressure is better (or as well as) controlled if an individual has better understanding of their blood pressure and more control of their medication than they currently do when decisions are made purely by the GP or nurse. The study concluded that among patients with hypertension at high risk of cardiovascular disease, self-monitoring with selftitration of antihypertensive medication compared with usual care resulted in lower systolic blood pressure at 12 months. SCIP-R (Supported Communication to Improve Participation in Rehabilitation) The aim of the SCIP-R was to assess the feasibility and acceptability of training stroke service staff to provide supported communication for people with moderate-severe aphasia in an in-patient rehabilitation setting and to collect data for economic evaluation SCIP-R was led by Dr Simon Horton at University of East Anglia, in collaboration with Norfolk Community Health & Care NHS Trust, Addenbrookes Hospital and Norfolk Conversation Partners. SCIP-R was Sponsored by South Norfolk CCG and funded through the NIHR Research for Patient Benefit (RFPB) Programme. The study demonstrated the feasibility of staff recruitment to the intervention and of delivering the supported communication (SC) training to a multidisciplinary stroke team. It also designed simple methods for ongoing staff support such as reflective learning logs, nudges in a pocket guide form or pens as a reminder to use SC. The study provided the opportunity of tailoring an intervention to service users with moderate severe-aphasia. Presentations and publications resulting from this study are listed in Appendi P a g e

42 The Research Management Team presented a poster at the 2016 NHS R&D Forum Conference regarding dissemination and communication with CCGs and other stakeholders. There has been positive feedback from those receiving the Research Office Research Briefings and Dissemination Bulletins (Bo 14). Members of the Research Office also presented at the NCH&C annual research conference, and attended one of their quarterly Research Lunches to promote the work of the office and the support we provide to clinicians, presented the Research Strategy and Annual Report to CCG Governing Bodies and CCG eecutive teams, ran a workshop at UEA regarding HRA approval, and supported NIHR RDS workshops as well as promotion via the Office website and via stands at the Forum in Norwich and in Great Yarmouth to celebrate International Clinical Trials Day. Bo 14 - Feedback from Research Briefings and Dissemination Bulletin Following receipt of the Research Bulletin for Q3 2015/16 I have been asked to invite you to attend a couple of meetings at the CCG to present some information regarding research activity within the CCG area. The bulletin was discussed at the weekly eecutive meeting this morning and there was real enthusiasm from senior management to receive further information. Deputy Chief Nurse, HealthEast, Great Yarmouth and Waveney CCG Thanks this is very timely as will take to our patient safety and Clinical Quality meeting today. Deputy Head of Clinical Quality and Patient Safety, West Norfolk CCG Yes very useful to us. I forward it to Comms with the ones we have been involved in and it goes out in our Echange publication to all staff. The layout/wording is good for our purposes. Research Manager, NCH&C Ecellent we would strongly support this. A key element of our strategy or 2016 is communication so this would fit very well. Director of Research and Development, NNUH This is incredibly helpful and I'm sure that organisations who have assisted with the research will be grateful for the feedback. Deputy Research Delivery Manager, Dementias and Neurodegeneration (DeNDRoN), CRN: Eastern 41 P a g e

43 10. Looking Forward to 2016/17 The year 2016/17 is epected to bring a number of changes; the most significant will be the introduction of HRA approval, which is fully operational from 1 st April HRA approval will replace the current system of each organisation issuing NHS permission / assurance for research in their organisation. HRA approval will be issued once for the study and will incorporate an assessment of the regulatory compliance of the study and the NHS Ethics Committee review. Local organisations will only be required to assess their local capacity and capability to host the study. There has been a reduction in the number of research studies coming in from academic organisations across the UK throughout 2015/16, we are therefore epecting a reduction in research recruitment activity for practices and community Trusts during 2016/17. The reduction in the numbers of studies coming through the system reflects the changes to the national permissions system which have caused uncertainty for research teams, and increased competition for studies nationally as primary care networks in other areas of the UK have grown in their ability to host studies, and competition for funding has increased. We will be working with the local CRN network which has recently increased its capacity to bring primary care studies into the area. We have also included objectives for 2016/17 to improve Research Office mechanisms for searching the national portfolio and drawing down studies. Changes to a number of the NIHR stream timetables for research fund applications may also have effects on the flow of grant income as these embed. The objectives for 2016/17 are as follows: Strategic: Take a lead on promoting primary, community, secondary and mental health research to local commissioners and governing bodies across the health system and refresh the Research Office Work plan for 2016/17 to continue to deliver the 5 year research strategy. Review terms of reference of the Steering Group to accommodate the role of innovation and wider research agenda and the transformation and sustainability agenda. Undertake a stakeholder satisfaction survey for 2016/17. Increased engagement with Public Health, AHSN, and CLAHRC colleagues to increase involvement in research development initiatives. Eplore new ways of disseminating evidence to commissioners and GPs through innovative mechanisms e.g. National ELF Research programme, a website making evidence-based research more accessible and usable for health and social care professionals Development: Continue to drive the development of large research grant applications in areas of importance to the NHS and patients. Negotiate for a CCG to act as the contracting organisation on an increasing percentage of NIHR applications, to maimise potential RCF into the local system. Support the aspirations of staff to become researchers by promoting the Early Researcher Bursary Scheme and other opportunities, and mentoring as appropriate. Agreement on processes for strategically managing the more than 190,000 CCG Research Capability Funding received within Norfolk and Waveney, in line with commissioning priorities and DH rules. 42 P a g e

44 Working with clinicians, academics and commissioners to transform research ideas into robust grant applications, relevant to patients and the NHS. Work with UEA to eplore ways of involving clinical academic trainees to undertake projects in commissioning organisations. In addition, work with CCGs to look at the development of GP Fellowship Schemes which include research Management: Managing NHS South Norfolk CCG sponsored studies, including the newly funded RfPB Goal Plan study, looking at goal-setting in care planning for people with multi-morbidity. Development of a Sponsorship framework for research and agreement with UEA common principles around Sponsorship. Ensure the transition to HRA Approvals continues to run smoothly and that local researchers are kept informed of the changes. Assist with putting into place any capability and capacity requirements for HRA approved studies and consolidate all R&D Policies and procedures that are impacted by HRA. Ensuring that outputs of completed studies are disseminated through appropriate channels and in line with Research Office communication plan, through the Quarterly Bulletins, Dissemination Reports and opportunities taken through CCG training events. Review ecess treatment cost policy and mechanism Delivery: Put robust mechanisms in place to identify population relevant research from the national portfolio. Manage and coordinate the achievement of 500 patients recruited into research studies in each CCG. Work will include setting up a new performance monitoring systems to oversee the revamped Research Site Initiative scheme across research active practices. Implement a new system (Edge system) for managing recruitment at a practice level. Two members of the Research Office will complete GCP facilitator training to help deliver primary care GCP introduction and refresher courses across the CCGs in 2016/17. Report contributors: Sue Allen, Clinical Research Studies Nurse; Clifford Co, RSI Support Manager; Dr Judy Henwood, Research Design Lead; Kate McCloskey, CRN: Eastern Locality Manager; Gosia Majsak-Newman, R&D Officer; Dr Gisela Perez-Olivas, R&D Officer; Jacqueline Romero, PPIRes Project Manager; Dr Tracy Shalom, Head of Research and Development; Barbara Stewart, Clinical Research Studies Nurse; Clare Symms, Research Governance Manager and Dr Clara Yates, Research Grants Advisor. Report compiled by Helen Sutherland, R&D Officer with support from Lisa Osborne, R&D Administrator. Norfolk & Suffolk Primary & Community Care Research Office 43 P a g e

45 Appendi 1 Norfolk and Suffolk Primary and Community Care Research Office Team Structure (June 16) 44 P a g e