Clinical Research Nursing and Advanced Practice

1. Clinical Research Nursingand Advanced Practice Helen Pidd and Gail Holmes

2. Overview of presentation • National Context • What is Advanced Practice? • Manchester Context – why and how • MSc in Advanced Practice Health and Social care – an overview

4. Where’s the starting point? • Benefits of the Job • The conduct of research to international standards • Travelling to investigator meetings and conferences nationally and internationally • Eating at good restaurants to discuss the research project/s and to network • No shift work • Drawbacks of the Job • Drowning in a sea of research jargon • Frequently working in isolation • Other nurses view the CRN as a data collector • Short term contracts • Sometimes have to arrange holidays around studies in progress

5. Historically • Worked in isolation from their professional colleagues • Convenient whilst raising a family, not having to work weekends and evenings • Mere data collectors • Short term contracts • Lack of line management support • Invisible to trust personnel systems • Extended and specialised role

6. Birmingham • Manchester • Cambridge • Southampton • Newcastle • London • McMichael Centre • UCLH • Somers GOSH • Guy’s & St Thomas’ • Hull York • Manchester Children’s • Sheffield • Sheffield Children’s • Birmingham Children’s • Oxford • Peninsula • Brighton • Surrey • Aberdeen • Edinburgh • Glasgow • Inverness • Tayside Dundee • Belfast • Dublin • Galway • Cork • Cardiff Clinical Research Facilities Biomedical Research Centres • Aberdeen • Dundee • Glasgow • Edinburgh • Newcastle • Manchester • Liverpool • Cambridge • Oxford • London • Great Ormond St • Guy’s & St Thomas’ • Imperial • Moorfields • Royal Marsden • UCL Inverness Aberdeen Dundee Glasgow Edinburgh Newcastle Belfast Galway York Dublin Hull Leeds Manchester Liverpool Sheffield Biomedical Research Units Nottingham • Leeds • Liverpool • Sheffield • Nottingham • Leicester • Birmingham • Oxford • Bristol • London • Royal Brompton • Barts • Southampton Experimental Cancer Medicine Centres Cork Birmingham Leicester • Edinburgh • Glasgow • Belfast • Newcastle • Leeds • Manchester • Liverpool • Sheffield • Leicester • Birmingham • Cambridge • Oxford • London • Barts • ICR • Imperial • KCL • UCL • Southampton Cambridge Oxford Cardiff Bristol London Surrey Southampton Peninsula Brighton

7. NIHR Clinical Research Networks NIHR Clinical Research Networks NIHR Dementias & Neurodegenerative Diseases Research Network NIHR Diabetes Research Network NIHR Medicines for Children Research Network NIHR Mental Health Research Network NIHR National Cancer Research Network NIHR Primary Care Research Network NIHR Stroke Research Network NIHR Comprehensive Clinical Research Network

8. NIHR Comprehensive Research Network

9. Clinical Research Nurses Newcastle year n 2006 - 93 2007 - 120 2008 - 140 2009 - 180 100% Increase over 3 years

10. Similar Picture Across the Country NURSES • Cambridge 148 • Sheffield 173 • Manchester 168 • Norfolk & Norwich 56 • Newcastle 180 • Birmingham 87 (Trust) • Scotland 411 AHP/STUDY COORDINATORS • Cambridge 26 • Sheffield 21 • Manchester 13 • Norfolk & Norwich 8 NUMBERS INCREASING YEAR ON YEAR 2012/13 10,000

11. Changes since 2001 • National:- including Developing the Best Research Professionals (Finch) 2007, Competency document – version 2, Training – GCP, Informed Consent, new roles emerging • Networks:- Induction Portfolios, local training, information sharing - UKCRF Network – www.ukcrfnetwork.co.uk • Trust:- Lead Nurse Appointments, Local Training

12. Opportunities Clinical Academic Management

14. Advanced Practitioner • The definition used widely by the DOH outlines that an advanced practitioner is a clinically autonomous practitioner, defines the scope of practice of others and continuously develops clinical practice within a defined field. • Experienced non-medical registered professional who has developed his or her knowledge to a very high standard in a specific and often high level of practice. This high standard is such that not only is the individual the expert in the base domain:-but can also accept the full responsibilities for providing those services hitherto supplied by others, in defined circumstances. (J. Sargent 2003)

15. Core Characteristics of Advanced Practice • Work across organisations and different agencies • Provide advanced levels of practice, knowledge and skills • Clinical focus - Clinically autonomous. • Empowered to make high-level decisions. • Be self directed, manage risk, have high levels of communication skills and be a member of a wider clinical/ service team. • In many cases the person will have their own patient/client caseload with decision making responsibilities • In many cases manage medications including assessment, review and prescribing. • Undertake a physical examination and history taking, diagnosis and plan care and treatment.

16. Advanced Practice in Manchester • Modernising workforce • European working time directive • Patient centred seamless care • PARTNERSHIP 2004 • Strategic Health Authority • 13 Acute and • Mental health Trusts • University of Bolton (primary care) • University of Salford (acute)

17. Advanced Practice in Manchester • Greater Manchester SHA initiative – Delivering the Workforce • Advanced and Assistant Practitioners • Need identified by Trust, application to GMSHE • Trainee roles commissioned and funded through GMSHA • Supported by an education programme

18. Application Process • Rigorous process • Trust and WTCRF commitment to the role • Detailed proposal form submitted to SHA • Decision to support application sits with SHA

19. The Proposal • Executive sign off • Role description • Reason for developing role • Needs analysis • Skills and competencies • Facilitation of WBL • Identification of mentor/assessor/line manager • Safety, effectiveness. governance • Funding arrangements and sustainability • Organisational track record

20. The Role - Overview • To develop advanced knowledge and skills in the identified theme areas and assist both new and established investigators to efficiently carry out their studies and enable them to achieve study targets by providing continuity of service. • In partnership with the Clinical team manager provide clinical leadership to the team of nurses, focusing on enhanced practice development • To develop nurse led research and support the development of clinical academic roles.

21. The Role - Expectations • Lead on participant care for the duration of a study, including assessment for inclusion in a study, medical history taking, medical examinations, management of drug infusions, prescribing and reviewing and refining participant care throughout the study • Provide medical cover for identified cardiovascular and paediatric studies • Undertake informed consent for Clinical Trials of Investigational Medicinal Products

22. Demonstrate enhanced clinical skills including arterial bloods, biopsies, management of central lines, minor surgical procedures, ultrasound in the vascular system, management of anaphylaxis, pulse wave analysis, analysis and decisions relating to test results • Lead on the development of nurse led research and enhanced clinical practice • Provide advice and guidance to PI’s on study efficacy and safety • Participate in the development and testing of new devices and approaches to health care for patient benefit

23. MSc - Programme • 2 years (part time) • 45 weeks per year (3 semesters). • 2 learning days per week. Thursdays taught day. Thursdays and some Fridays sem 1 and 2 Attendance at University greatly reduced year 2. - WBL • Second day student choice for clinical/work based needs. • 90 days per year clinical application.

24. University of Salford, MSc Advanced practice (Health and Social Care Pathway) Programme Overview

25. Portfolio of EvidenceYear 1 • Job description • Individual Learning Pathway • Clinical Skills Learning Agreement • Bespoke Skills identified and agreed • Objective and subjective evidence for sub elements of the Elements of Advanced Practice • Achievement of skills at level 2 on Taxonomy of Achievement • Organisational pathway analysis • 360 degree feedback

26. Portfolio of EvidenceYear 2 • Cases (formative and summative) • Triangulated evidence for many sub-element of Elements of Advanced Practice • Completed skills log (core and bespoke) at level 2 and 3 • 40 case assessments • Completion of Individual Learning Pathway • 180 credits at level M

27. Programme Support • Mentors • Stay with student for 2 years • Understand programme and learning requirements • Advocate in Trust on behalf of student • Assessors • Objective judgement on performance throughout 2 years • May delegate some work to supervisors of appropriate standing

28. Trust Mentor Line Manager Assessors Supervisors University Personal Tutor Academic Supervisor Programme lead Student Life Programme Support Learning Facilitator

29. Where are we now • Successful SHA application – 2 posts • Successfully recruited through internal secondment – band 7 in training, 8a once qualified • Steering group in place • 2 trainees commenced Sept 2011