Protocol for a cluster randomised controlled trial to determine the effectiveness and cost-effectiveness of independent pharmacist prescribing in care homes: the CHIPPS study

Abstract

Background: Prescribing, monitoring and administration of medicines in care homes could be improved. Research has identified the need for one person to assume overall responsibility for the management of medicines within each care home. and shown that a pharmacist independent prescriber service is feasible in this context. Aims and objectives: To conduct a cluster randomised controlled trial to determine the effectiveness and costeffectiveness of a pharmacist-independent prescribing service in care homes compared to usual general practitioner (GP)-led care. Objectives: To perform a definitive randomised controlled trial (RCT) with an internal pilot to determine the intervention's effectiveness and cost-effectiveness and enable modelling beyond the end of the trial. Methods: This protocol is for a cluster RCT with a 3-month internal pilot to confirm that recruitment is achievable, and there are no safety concerns. The unit of randomisation is a triad comprising a pharmacist-independent prescriber (PIP) based in a GP practice with sufficient registered patients resident in one or more care homes to allow recruitment of an average of 20 participants. In the intervention group, the PIP will, in collaboration with the GP: assume responsibility for prescribing and managing residents' medicines including medication review and pharmaceutical care planning; support systematic ordering and administration in the care home, GP practice and supplying pharmacy; train care home and GP practice staff; communicate with GP practice, care home, supplying community pharmacy and study team. The intervention will last 6 months. The primary outcome will be resident falls at 6 months. Secondary outcomes include resident health-related quality of life, falls at 3 months, medication burden, medication appropriateness, mortality and hospitalisations. A full health economic analysis will be 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.

Psychotropic medication use patterns in home-based primary care: A scoping review

“… 16 - 19 Considering pharmacists' proven benefit in the primary care setting, a randomized controlled trial in the United Kingdom is underway to evaluate the effectiveness and cost-effectiveness of a pharmacist-independent prescribing service compared to usual general practitioner–led care in the home care setting. 20 Although psychiatric pharmacists do not currently have independent prescriptive authority outside of collaborative practice agreements, they are able to assist with medication management follow-up appointments, particularly once initial diagnoses and treatment plans have been developed by a consulting psychiatrist. As such, expanding partnerships to board-certified psychiatric pharmacists with expertise in psychiatric medication management could help address the shortage of psychiatric specialty care support in HBPC settings.…”

Protocol for the process evaluation of a cluster randomised controlled trial to determine the effectiveness and cost-effectiveness of independent pharmacist prescribing in care home: the CHIPPS study

“…The definitive RCT is evaluating the efficacy and efficiency of implementing and delivering a PIP service and comparing outcomes for care home residents who receive the PIP service with outcomes for residents who continue to receive usual care [13]. In total 44 GP/PIP/care home groups (subsequently referred to as triads) and 880 patients will be included in four geographical areas of East Anglia, Leeds, North East Scotland and Northern Ireland.…”

“…Requests for access to the data will be considered, and approved in writing where appropriate, after formal application to the Trial Management Committee/Programme Steering Committee [13]. Considerations for approving access are documented in the Project Management Group/ Programme Steering Committee Terms of Reference [13].…”

“…The definitive RCT was approved by ethics committees in England and Scotland, and registered with the ISRCTN registry (registration number ISRCTN 17847169). A protocol paper (protocol version 5 1.7.18) for the main trial, following SPIRIT guidance, has been submitted to BMC Trials [13]. This current article describes the protocol for the Process Evaluation Protocol that accompanies the definitive RCT; it follows the 2014 guidance on process evaluations [14,15] and details are in Process Evaluation Protocol version 4 11.12.18 available from the authors on request.…”

Protocol for the process evaluation of a cluster randomised controlled trial to determine the effectiveness and cost-effectiveness of independent pharmacist prescribing in care home: the CHIPPS study

“…It has been suggested that errors would be reduced if a single person took on overall responsibility for the medicines management in care homes. Our team proposed this should be an independent prescribing pharmacist (PIP) linked to the care home, and are undertaking a programme of work which has identified logistical and professional barriers to a PIP care home service, and devised solutions to address them 10 , devised a training programme for the PIPs to ensure they have the requisite competencies to deliver the service, and identified provisional measures of outcome 11 in preparation for a definitive cluster randomised controlled trial (RCT) to compare the outcomes from the PIP service with usual care. A mixed methods non-randomised feasibility study 12 confirmed the acceptability and feasibility of the processes for participant identification, recruitment and informed consent.…”