Background Prescribing, monitoring and administration of medicines in care homes could be significantly improved. Research has identified the need for one person to assume overall responsibility for medicines management within care homes. The advent of pharmacist independent prescribers (PIPs) provides an opportunity for pharmacists to assume this role. Although this approach is already being implemented, there has been no testing of effectiveness. This cluster randomised controlled trial (RCT) sets out to establish effectiveness and cost-effectiveness of PIPs.

Methods A cluster RCT across 90 care homes in England, Scotland and Northern Ireland with an internal pilot. The trial was designed following a programme of developmental and feasibility work in accordance with the MRC framework for developing and evaluating a complex intervention. The unit of randomisation is a triad (a PIP, a GP practice and a care home(s)). In the intervention group, the PIP is responsible for providing medication review, pharmaceutical care planning, prescribing and deprescribing for care home residents; supports the care home and optimises communication between GPs, care homes, and supplying pharmacy. The primary outcome is resident falls at 6 months. Secondary outcomes include resident health-related quality of life, medication burden, mortality and hospitalisation. Sample size is 880 residents across 44 triads to provide 80% power to detect a 20% decrease in fall rate from 1.5/resident to 1.178 with an ICC of 0.05 or less. We have conducted a parallel process evaluation including in-depth qualitative interviews with stakeholders.

Results The internal pilot study confirmed feasibility of the RCT with no significant adverse events. The trial completed recruitment to its sample size in October 2019, and follow-up will complete in March 2020. Characteristics of all residents recruited are: mean age 85 years; 70% female; 13% had capacity to consent; median number medications 7; fall rate 0.55/three months; mean Drug Burden Index 0.64; Charlson Morbidity Index 5.98; proxy EQ-5D 0.32; Barthel index 7.51. Full trial results will be available at the SSM Annual Scientific Meeting. Preliminary analysis of qualitative stakeholder interviews suggests changing professional roles need to be actively managed and effective communication systems implemented.

Conclusion As yet we do not know the trial outcome. A positive finding would support the provision of PIP-type interventions in care homes, whilst a negative finding would imply pharmacist resources may be better directed elsewhere. Either will be of great significance for UK pharmacy practice.

On behalf of CHIPPS investigators.