Clinical Research Nursingand Advanced Practice

Helen Pidd and Gail Holmes

Overview of presentation

• National Context• What is Advanced Practice?• Manchester Context – why and how• MSc in Advanced Practice Health and Social care – an

overview

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

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

Cork

DublinGalway

Aberdeen

Inverness

Dundee

Hull

York

BrightonPeninsula

Cardiff

LeedsLiverpoolSheffieldNottinghamLeicesterBirminghamOxfordBristolLondon•Royal Brompton•BartsSouthampton

Biomedical Research Units

Bristol

Nottingham

Clinical Research Facilities

AberdeenDundeeGlasgowEdinburghNewcastleManchesterLiverpoolCambridgeOxfordLondon •Great Ormond St•Guy’s & St Thomas’•Imperial•Moorfields

• Royal Marsden• UCL

Biomedical Research Centres

Experimental Cancer Medicine Centres

EdinburghGlasgow

BelfastNewcastle

LeedsManchesterLiverpool

Sheffield

LeicesterBirmingham

CambridgeOxford

London

SurreySouthampton

NIHR Dementias & Neurodegenerative Diseases Research

Network

NIHR Diabetes Research Network

NIHR Medicines for Children Research

Network

NIHR Mental Health Research Network

NIHR Comprehensive Clinical Research

Network

NIHR Stroke Research Network

NIHR Primary Care Research Network

NIHR National Cancer Research Network

NIHR Clinical Research NetworksNIHR Clinical Research Networks

NIHR Comprehensive Research Network

Clinical Research Nurses

Newcastle

year n

2006 - 93

2007 - 120

2008 - 140

2009 - 180

100% 100% Increase over 3 yearsIncrease over 3 years

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

2012/1310,000

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

Opportunities

AcademicManagement

Clinical

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)

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.

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)

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

Application Process

• Rigorous process

• Trust and WTCRF commitment to the role

• Detailed proposal form submitted to SHA

• Decision to support application sits with SHA

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

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.

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

• 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

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 2Attendance at University greatly reduced year 2. - WBL

• Second day student choice for clinical/work based needs.

• 90 days per year clinical application.

University of Salford, MSc Advanced practice (Health and Social Care Pathway)

Programme Overview

Semester 1Semester 1 Semester Semester 22

Semester Semester 33

CreditsCredits

Year 1 Principles of Advanced Practice (30)

Application of Life Sciences (30)

Contextualising Advanced practice (30)

90

PortfolioPortfolio Individual Individual Learning Learning PathwayPathway

Tripartite Tripartite Agreement Agreement core and core and bespoke skillsbespoke skills

Organisational Organisational pathway pathway analysisanalysis

Year 2 Research Methods

(30)

AP1: Practitioner competence (30)AP2: Clinical Reasoning (30)

90

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

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

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

Programme Support

Trust

• Mentor• Line Manager• Assessors• Supervisors

University

• Personal Tutor• Academic Supervisor• Programme lead• Student Life

Learning Facilitator

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