Storyboard submission

Transcription

1 Storyboard submission Follow the detailed instructions in this template for writing a description of your storyboard. Type your information in each section below and save this completed storyboard document as a Microsoft Word file. Please spell check your storyboard before submission as it will be published on the NHS Wales Awards website. Please note: The storyboard should be between words maximum (including references but excluding headings, images or graphs) Submit your storyboard using the online submission system at by Friday 25 January Storyboard submission 1. Storyboard Title Transforming Good Clinical Practice training in Wales to support excellence in clinical research 2. Brief Outline of Context (Where this improvement work was done; what sort of unit/department; what staff/client groups were involved) Good Clinical Practice (GCP) principles are an internationally-recognised set of standards which are important in clinical research to protect the safety and wellbeing of patients and ensure rigorous research to influence healthcare practice. The GCP principles are enshrined in EU and UK law, and detail the set-up of clinical research in the NHS, the responsibilities of organisations and the study team, informed consent of patients, data collection, safety reporting and record-keeping. The National Institute for Social Care and Health Research Clinical Research Centre (NISCHR CRC) is hosted by Velindre NHS Trust and is contracted by NISCHR, Welsh Government, to provide a high quality research training programme for health and

2 social care researchers across Wales. GCP training is a core component of this programme, and, as funding for health researchers in Wales has expanded, the demand for training has increased dramatically. This submission describes an all- Wales initiative to respond to the increasing demand for high-quality GCP training. 3. Brief Outline of Problem (Statement of problem; how they set out to tackle it; how it affected patient/client care) In 2009, the NHS in Wales and NISCHR CRC were reliant upon the commissioning of private providers for the provision of GCP training. The training varied between providers and opportunities for research teams to problem-solve together and receive ongoing support were limited. The growth of health and social care research in Wales meant that demand for GCP training was rising sharply. The need for a more effective and sustainable model of training was identified. NISCHR CRC collaborated with the National Institute for Health Research Clinical Research Network (NIHR CRN) in England to develop a one day Introduction to GCP course and a three-hour GCP Refresher course, based around group activities and real case examples. We then trained a number of our own staff to deliver the new courses, commencing in Spring Assessment of Problem and Analysis of its Causes (Quantified problem; staff involvement; assessment of the cause of problem; solutions/changes needed to make improvements) Assessment of problem Analysis of cause Changes needed / solution GCP courses oversubscribed and waiting lists in place. Reliance on a limited pool of expert providers from outside Wales for GCP training Quality assurance Inequitable access to training for clinical research teams Unsustainable costs of training Increasing numbers of research studies and patients recruited to clinical trials within the NHS No strategic plan to develop GCP training and expertise from within the Welsh research workforce Different courses were being run by different providers.this meant variation in content and relevance to practice. Reliance on the ability of private providers to travel to all areas of Wales Rising costs due to the UK demand for private trainers Increase the provision of GCP courses over 3 years Develop trainers within Wales Collaborate with NIHR CRN to develop courses. Quality assure with industry, the regulators (MHRA) and aim for accreditation. Link to the real issues that researchers in the NHS face. Increase the number of sites offering GCP training. Make online access available Develop in-house trainers

3 5. Strategy for Change (How the proposed change was implemented; clear client or staff group described; explain how they disseminated the results of the analysis and plans for change to the groups involved with/affected by the planned change; include a timetable for change) September June 2011 COLLABORATION with NIHR CRN, industry and regulatory bodies to develop a one day Introduction to GCP course and a three-hour GCP Refresher course, including online access. February November 2012 DEVELOPMENT of the GCP training facilitators to deliver the new courses. Facilitator training was provided by NIHR CRN and we now have nine staff members across Wales delivering GCP training. February 2010-ongoing SUPPORT for the professional development of the new GCP facilitators to deliver training. The facilitators are supported with resources via the NISCHR CRC website, group bulletins from both NIHR CRN and NISCHR CRC and an annual away day. April 2010 ongoing DELIVERY AND EVALUATION is monitored by quarterly review of course provision, delegate access, feedback from delegates, facilitator feedback and costs. 6. Measurement of Improvement (Details of how the effects of the planned changes were measured) Financial Year 08/09 09/10 10/11 11/12 12/13 Number of NISCHR CRC Facilitators Number of GCP courses provided Number of sites providing training in Wales Number of GCP delegates places already taken or reserved

4 Percentage of delegates rating the training as good or excellent Accreditation (Royal College of Physicians and Royal College of Nursing) No No No NISCHR CRC Introduction to GCP All NISCHR CRC GCP courses External trainer fee costs Estimated external trainer fee cost savings 9,610 12,620 12,900 12,040 5,100* 0 0 5,000 12,000 32,000 *This sum will reduce to zero in the 2013/14 financial year. 7. Effects of Changes (Statement of the effects of the change; how far these changes resolve the problem that triggered the work; how this improved patient/client care; the problems encountered with the process of changes or with the changes) The effects of the GCP initiative have exceeded expectations in terms of the benefits of collaboration, budget efficiencies, improving access, accreditation and recognition of NISCHR CRC as the GCP provider of choice for the NHS in Wales. However, the greatest achievement has to be about learning and impact on practice. This has enabled us to positively contribute to the development of a competent research workforce in Wales across research teams that include medics, multidisciplinary teams, research nurses, research assistants and clinical staff caring for patients participating in research. There is massive strength in the interaction between a diverse group of delegates from many specialities including cancer, mental health, stroke research, emergency care and diabetes. Comments have included: Patient case studies were very powerful. Best GCP course I have been on. Like coming out of a dark room into daylight Have now got a great insight (on ethics and consent). Shows how "real" GCP is. Influenced me tremendously Examples of influence on practice included: Accuracy and attention to detail in terms of reporting patient symptoms Improved informed consent and information to patient Ensure the team are trained, kept informed and updated Importance of checking the patient eligibility criteria before clinical trial drug prescription.

5 Will review the way we give information to patients Will examine how patient data is recorded. It will influence the design of my PhD The final effect is the professional development of the facilitators. The learning curve has been steep and a powerful shared journey. The GCP facilitators in Wales now bring a valuable resource to the NHS to contribute to the vision of NISCHR CRC to support today s research to develop and deliver tomorrow s best care. 8. Lessons Learnt (Statement of lessons learnt from the work; what would be done differently next time) Collaborating with stakeholders from the outset helps problem-solving further down the line Development of facilitator confidence and expertise takes time support and nurture each other through the tough times! 9. Message for Others (Statement of the main message they would like to convey to others, based on the experience described) Start with small steps, review as you go and keep your defined quality indicators central to the whole change process. Submission word count: 1048