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

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 hom