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October 11, 2017 Development and delivery of a cluster randomised controlled trial to determine both its effectiveness and cost- effectiveness Principal Investigators Professor David Wright, School of Pharmacy, UEA Professor Richard Holland, School of Medicine, UEArch Network (NIHR CRN) Blue text slide with orange bullet points
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October 11, 2017 CHIPPS UEA, University of Aberdeen, Queen’s University, Belfast and University of Leeds South Norfolk CCG National Institute of Health Research (NIHR) Five-year research programme Blue text slide with orange bullet points
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Service specification
October 11, 2017 Programme design WP1 WP2 WP3 WP4 WP5 WP6 Year 1 May 15 – April 16 Service specification Outcome measures Training package Year 2 May 16 – April 17 Economic modelling Feasibility study Year 3 May 17 – April 18 Definitive study Year 4 May 18 – April 19 Year 5 May 19 – April 20 Blue text slide with orange bullet points
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Presentation Rationale for study Service specification development
Research outcome measures Pharmacist training package Summary Next steps October 11, 2017October 11, 2017
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Rationale October 11, 2017
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CAREMED Multidisciplinary team review (n=800)
October 11, 2017 CAREMED Multidisciplinary team review (n=800) Cluster Randomised Controlled Trial Improved medication appropriateness p<0.05 No reduction in falls p>0.05 No cost saving Money saved on medicines counterbalanced by Cost of intervention Cost of monitoring Additional GP workload Blue text slide with orange bullet points
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October 11, 2017 CHUMS 70% residents in care homes experience medication errors on daily basis Prescribing Administration Recommendation One person responsible for medicines management within the home Blue text slide with orange bullet points 1. Barber ND, Alldred DP, Raynor DK, Dickinson R, Garfield S, Jesson B et al. Care homes’ use of medicines study: prevalence, causes and potential for harm of medication errors in care homes for older people. Qual Saf Health Care 2009; 18: 341-6
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GP / Pharmacist / Nurse Medication review
Medicines administration Medicines reconciliation Medicines ordering and storage October 11, 2017
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Pharmacist Independent Prescriber
Medication review Medicines administration Medicines reconciliation Medicines ordering and storage October 11, 2017
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CHIPPS Prescribing pharmacist
October 11, 2017 CHIPPS Prescribing pharmacist Responsible for medicines management & medicines optimisation through management of repeat prescriptions Actual detail undecided Blue text slide with orange bullet points
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Service Specification
October 11, 2017
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Aims Determine stakeholder views on the utility and acceptability of pharmacist independent prescribers (PIPs) assuming responsibility for medicines management within care homes Describe how best to implement and deliver such a service.
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Method Focus groups with stakeholders Service redesign
Consensus panels Service draft finalised
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October 11, 2017 Residents & relatives PIPs might be more accessible than a GP, potentially improving communication with relatives Recognition of pharmacists specialist knowledge Potential anxieties need to be allayed by ensuring clarity of PIP role and remit I think there’s sometimes a bit of blockage between the GP …and the relatives because often the residents can’t pass on the information that the relatives would like to know.
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October 11, 2017 Care home staff PIPs will need induction to understand regulations governing medications in care homes and care home culture Staff training valuable PIP could improving timeliness of medicine delivery and address synchronisation problems. We put in requests [for interim meds] around 2 weeks in order to get them in time. We sometimes wait 8-9 days to get the script. …so a prescribing person on site would be very helpful
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Pharmacists Communication, trust, between GP and PIP key, as is membership of the practice team PIP medicines reviews would contribute to patient safety Clarity of role, remit and responsibility needed, esp. diagnosis PIPs will need access to patient records at home and practice If that pharmacist was in isolation from the GP practice then that could cause more trouble than it solves. I see the value of having a pharmacist linked to the practice. A good relationship between the GP [and pharmacist]; they’re accountable to the GP so they need to have trust in that pharmacist
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General Practitioners
October 11, 2017 General Practitioners Broad enthusiasm for service Concerns regarding medicine initiation Importance of relationships and building trust. Must be practice based Recognition of pharmacists’ specialist knowledge of medicines’ Concerns raised over confidentiality, governance, professional indemnity and pharmacists’ knowledge of older people’s medicine. There has to be something in it for me October 11, 2017October 11, 2017
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Service Specification
Based in medical practice Reviewing participant medication and developing and implementing a pharmaceutical care plan Assuming repeat prescribing responsibilities Supporting systematic ordering, prescribing and administration processes with each care home, GP practice and supplying pharmacy where needed Providing training to staff in care home and GP practice Communicating with GP practice, care home, supplying community pharmacy and study team
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Outcome measures 50%
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Methodology Systematic review of the literature to identify outcome measures commonly used in trial Reviewed by expert panel to identify main outcomes for selection Delphi Process Consensus methodology Multi-professional panel Two stages October 11, 2017
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Outcome measures Process STOPP/START (medication appropriateness)
Clinical Barthel Index (physical functioning) MMSE (cognitive functioning) Falls - as would normally be reported Adverse drug events - as would normally be reported Mortality Humanistic EQ-5D (quality of life) Care home staff job satisfaction Costs Health-service utilisation (and associated costs) October 11, 2017
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Training package 65%
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Proposal Development of competency framework
Personal development plan with mentor Self-directed development Assessment via mentor and independent assessor Identification of generic training requirements for all October 11, 2017
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Systematic review Very limited description of pharmacist training for role ‘Most prescribing decisions made by care staff’ Laxatives Sedatives Antipsychotics Pain control Antibiotics Prescribing quality and management related to care home culture Care home training used to change culture and develop working relationships October 11, 2017
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Generic training content
Trial design & delivery Managing antipsychotic prescribing Managing complexity Identify red flag Prescribing for residents without capacity Covert administration Care planning October 11, 2017
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Underpinning knowledge
Provided as a package (mainly abstracts & links) Conditions Parkinson’s Symptoms Delirium Non-Pharmacological therapy Wound dressings Pharmacological therapy Anti-coagulants Legislation Mental capacity Act October 11, 2017
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Competency framework Specific to care home environment Domains:
Prescribing Medicines Management Communication Managing complexity in later life Context Competencies (n=17) Behaviours (n=39) October 11, 2017
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Care home staff training
For all homes: Outline of PIP role Delivered as per identified home needs: Medicines administration Antipsychotic medicines Antibiotics Constipation and laxative use Pain management October 11, 2017
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Experiential learning
General Practitioner & medical practice (2 days) Visit to home to undertake joint review Care home (1 day) Observe medicines administration Community pharmacists (0.5 days) Optional meetings Local safety expert Care home pharmacist specialist Consultant geriatrician working in primary care Community matron with responsibilities for care homes Local CQC or national equivalent inspector District nurse (Dressings, catheter, barrier cream policies)
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Summary
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Summary Service designed Pharmacist part of medical practice team
Outcomes identified Primary outcome to be decided upon Training package Individualised Relationship building and culture transformation October 11, 2017October 11, 2017
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Next steps
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Next steps Resident recruitment started
October 11, 2017 Next steps Resident recruitment started Pharmacist training to finish end of November Service starts December 1st Feasibility stage finish May 2017 October 11, 2017October 11, 2017
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Patient and public involvement members
Research associates Annie Blyth Viv Maskrey Anna Millar Amrit Daffu-O’Reilly Jaqueline Inch Frances Notman Patient and public involvement members Pharmacists who have signed up for feasibility study Pharmacist mentor October 11, 2017October 11, 2017
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Co-Applicants C. Bond Professor of General Practice, University of Aberdeen F. Poland Professor of Social Research Methodology, UEA J. Desborough Senior Lecturer in Pharmacy Practice, UEA G. Barton Professor in Health Economics, University of East Anglia D.P. Alldred Associate Professor of Pharmacy Practice, University of Leeds C. Hughes Professor of Primary Care Pharmacy, Queens University N. Norris Professor of Applied Education Research, UEA A. Arthur Professor of Nursing Science, University of East Anglia J. Ford Consultant geriatrician, Norfolk and Norwich University Hospital A.Zermansky General Practitioner, University of Leeds P. Myint Professor of Old Age Medicine, University of Aberdeen D. Turner Senior Research Associate, Health Economics, UEA
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Acknowledgement This is a presentation of independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (Grant Reference Number RP-PG ). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. October 11, 2017
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Thanks for listening Any questions? October 11, 2017
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