Title: Care Homes Independent Pharmacist Prescribing Service (CHIPPS): Development and delivery of a cluster randomised controlled trial to determine both its effectiveness and cost-effectiveness
Funder: Department of Health and Social Care

Abstract: Background Prescribing, monitoring and administration of medicines in care homes could be significantly improved, increasing residents quality and quantity of life and improving use of NHS resources. Research has identified the need for one person to assume overall responsibility for the management of medicines within each care home. We propose that this role could be undertaken by a pharmacist independent prescriber who primarily assumes responsibility for the authorisation of repeat medicines. In line with MRC guidance for development and delivery of complex interventions, we propose a programme of research to develop, optimise and test this innovative service model. Aims and Objectives To determine the effectiveness and cost-effectiveness of pharmacist independent prescribing in care homes Objectives In the care home environment, with a proposed service model of pharmacist independent prescriber (PIP) assuming responsibility for overall medicines management (MM), the high level objectives are to: Prepare, refine and test the feasibility of a new model of care Evaluate and identify the most appropriate outcome measures Develop and optimise a PIP training package to enhance intervention effectiveness and ensure fidelity Perform a definitive RCT with an internal pilot to determine the intervention s effectiveness and cost-effectiveness and enable modelling beyond the end of the trial. Research plan The programme consists of 6 work packages (WPs), to be carried out in four sites: England (Norwich/Bradford) Scotland (Aberdeen) and Northern Ireland (Belfast). WP1 (Month 1-12) Phase 1: Literature update to identify new evidence which has emerged since recent systematic reviews and relevant evidence based guidelines regarding prescribing practices in care homes. Phase 2: Obtain stakeholder opinions on how best to deliver the new service and WP2-6 via focus groups and interviews. Phase 3: Triangulate data from phases 1 & 2 through a multi-professional stakeholder consensus panel. Thematic analysis will be used for all qualitative elements. WP2 (Month 1-12) will consider the appropriateness of different outcome measures, identified within WP1 as regularly used, which may be employed to measure the impact of the proposed intervention. Outcome measures which capture morbidity, quality of life, prescribing quality and quality of care will be reviewed, critiqued and rated according to sensitivity, reliability, validity, third party completion, efficiency, quality of completion and resident-centredness. WP3 (Month 13-60) is designed to identify all costs associated with the intervention and develop the tools necessary for effective capture. It is anticipated that EQ-5D will be utilised to enable a cost per QALY to be estimated. Other tools to capture quality of life may be utilised (WP2). The cost-effectiveness of the intervention will be determined via data provided from WP6 and modelling beyond the end of the trial. WP4 (Month 13-36) will design, test and refine the PIP training package. Multiprofessional focus groups will be held to identify the training needs and preferred methods for delivery. The training package will be designed for delivery in the feasibility testing stage (WP5), and will be refined following detailed feedback and observation of its delivery, for utilisation in WP6. WP5 (Month 13-30) will test the proposed service specification and research processes through four care homes stratified by ownership status and resident type. Four PIPs will be trained and will deliver the service to 10-15 residents, in one home each, for 3 months. Intervention delivery/quality and data collection processes will be assessed. Stakeholders will be interviewed to review the process. The service specification and research processes will be refined as necessary. WP6 (Month 31-60) will be a cluster RCT with a 3 month internal pilot to confirm recruitment is achievable. We estimate that 900 residents (90 homes, 22/23 per site) will be required for the trial as this will enable a small effect of around 0.3 standard deviations to be detected with 90% power assuming the ICC is no greater than 0.07. Approximately 6 PIPs will be recruited at each site to deliver the service to 11 intervention homes over 6 months. Projected outputs Service specification outlining service set up and delivery process Outcomes guidance for COMET database Training package Publications Review of appropriate outcome measures for use within care homes Evaluation and development of training package service Outcome from feasibility testing of PIPMM service Testing PIP MM in care homes Effect of PIP MM service: A cluster RCT Estimate of cost-effectiveness of PIP MM in the immediate and long term Dissemination events Local dissemination at each site, three national and two international conferences Benefits to patients and the NHS Regular review of medicines should optimise therapeutic choices, minimise the potential for errors and result in more immediate discontinuation of therapy. We believe that the intervention will improve the quantity and quality of life of residents. Known adverse events such as falls and confusion, which can increase the likelihood of hospitalisation and premature death, should be reduced. Better selection and management of medicines should improve the use of NHS resources.

Lay abstract: The use of medicines in care homes could be improved and as a result the health of resident s would be better. Pharmacist prescribers (i.e. pharmacists specifically trained to prescribe in a similar way to doctors), have been shown to provide high quality care in other patient groups, which is safe and well received. We propose to test if making pharmacist prescribers part of the care home team, working alongside general practitioners, could improve the use of medicines and the care of residents. These pharmacist prescribers could sign and order monthly prescriptions whilst carefully monitoring how each resident responds. We believe that such a change to the management of medicines in care homes is likely to be a good use of NHS money. However, to develop and test this idea in the best way possible we need to undertake a number of smaller linked projects. We will start by updating our knowledge of the research on how best to prescribe and use medicines in care homes. We will then use the expertise of those working in care homes to find out how best to introduce and use pharmacist prescribers so that they become an effective member of the team. At the same time, we need to find the best ways to measure the effect of these pharmacists on residents, staff and the home. To do that, we will need to look at how other researchers have measured the effect of changes in prescribing and rank those methods for suitability. Once we have identified how we think it will be best to introduce, run and test this new service, we will use this information, along with the views of experts, to design a training package to prepare pharmacists for this new prescribing role. We will test the training package and then the service itself in four homes. This will allow us to begin to establish how both work, and to enable us to develop the prescribing service and the training package further. We will then carry out a study to test whether this new service works. In that study we will aim to recruit care homes and randomise them (i.e. like flipping a coin), to either receive the new service with the pharmacist prescriber or their usual care. That study will begin with a smaller pilot to make sure that we can recruit enough doctors, care homes and residents. If this works we will recruit 900 residents in total from n homes spread evenly across four different parts of the UK. After six months we will compare how residents, staff and care homes have done in the two different groups and determine the value of the service for residents and the NHS.

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: GENERIC HEALTH RELEVANCE