The CHIPPS study: a cluster randomised controlled trial to determine the effectiveness and cost-effectiveness of independent pharmacist prescribing in care homes
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 the management of medicines within each care home. The advent of pharmacist independent prescribers (PIPs) provides an opportunity for pharmacists to assume this role. Although this approach is being implemented in practice there has been no randomised controlled trial demonstrating its effectiveness.
The approach was to conduct a three nation randomised controlled trial, with internal pilot, to determine the effectiveness and cost-effectiveness of pharmacist independent prescribing in care homes compared to usual GP led care. The trial was designed following a programme of developmental and feasibility work conducted in accordance with the Medical Research Council framework for developing and evaluating a complex intervention. The unit of randomisation is a triad (a pharmacist-independent prescriber (PIP), a GP practice and a care home(s)). In the intervention group, the PIP will, for 6 months, collaborating with the GP: assume responsibility for prescribing and managing residents’ medicines (medication review, pharmaceutical care planning, prescribing and deprescribing); support the care home and optimise communication between the GP, care home, and supplying community pharmacy. The primary outcome is resident falls at 6 months. Secondary outcomes include resident health-related quality of life, falls at 3 months, medication burden, mortality and hospitalisations. A full health economic analysis is being undertaken. The target sample size is 880 residents (440) in each arm) from 44 triads. This number is sufficient to detect a decrease in fall rate from 1.5 per individual to 1.178 (relative reduction of 21%) with 80% power and an ICC of 0.05 or less. There is a parallel process evaluation including in depth qualitative interviews with stakeholders.
The trial has recruited to target and will complete in March 2020. The internal pilot study confirmed feasibility of the RCT and no safety concerns. Baseline data showed intervention and control groups are well matched. Characteristics of all residents recruited are: mean age 85 years; 30% male,;13% had capacity to consent; median number medications 7; fall rate 0.55; mean drug burden index 0.64; Charlson Morbidity Index 5.98; proxy EQ 5D utility score 0.32; Barthel index 7.51. Full trial results will be available, for the first time, at the ASM. Preliminary analysis of qualitative stakeholder interviews suggest changing professional roles need to be acknowledged and actively managed and effective communication systems implemented.
We do not currently know the trial outcome, but whether or not we demonstrate a ‘positive’ finding based on the primary outcome, we will report new information on working practices, PIP roles in care homes and barriers and enablers to placing PIPs into care homes.