The Care Home Independent Pharmacist Prescriber Study (CHIPPS): development and implementation of an RCT to estimate safety, effectiveness and cost-effectiveness

Abstract

Background Medicine prescribing, monitoring and administration in care homes can be significantly enhanced. Effective interventions to improve pharmaceutical care and resident outcomes are required. The enablement of pharmacists to prescribe provides an opportunity for pharmacist independent prescribers to assume responsibility for improving pharmaceutical care, medication-related outcomes and resident safety whilst reducing general practitioner workload. Objective(s) To determine the effectiveness and cost-effectiveness of pharmacist independent prescribing in care homes. Design Development work was undertaken through five work packages before the delivery of the definitive trial. Triads of pharmacist independent prescribers, care home and general practice with responsibility over 20 care home residents were recruited and cluster randomised to intervention or usual care for 6 months. Researchers were blinded at recruitment stage only. Recruitment of 880 residents was required to provide 80% statistical power, to show a 21% reduction in falls over 6 months, assuming 20% attrition. Randomisation was undertaken electronically at triad level, stratified by geographical area. Intention-to-treat analysis undertaken using a negative binomial model. Parameters were estimated using a generalised estimating equation approach. Costs were captured from an NHS perspective. Quality of life (EuroQol; five domain; five level) was collected by proxy to enable cost/quality-adjusted life-year estimation. A concurrent process evaluation was performed. Safety was monitored through a review of pharmacist independent prescriber activities, independent concerns reporting and review of adverse events. Participants Forty-nine triads of general practitioners, pharmacist independent prescribers and care homes were recruited with 454 residents allocated to the intervention arm and 428 to the control arm. Intervention Medication review and care planning, medication reconciliation, staff training, support with care home medication-related procedures, deprescribing and authorisation of monthly prescriptions. Main outcome measure Fall rate per person over 6 months. Results Data for 449 intervention and 427 control residents available for final analysis. The 6-month fall rate ratio in favour of intervention was 0.91 (95% confidence interval 0.66 to 1.26; p=0.58). No significant difference in secondary outcomes was identified except Drug Burden Index (rate ratio 0.83, 95% confidence interval 0.75 to 0.92; p<0.001). No harms were identified. One quarter of medication-related interventions were associated with a reduced risk of falls. The intervention was positively received. Limitations Participant self-selection bias may have affected the generalisability of findings. Open-label cluster randomised controlled trial limited by 6-month follow-up. Potential ceiling effect due to concurrent pharmacist-led interventions. Falls potentially insufficiently proximal to the intervention. Conclusions To enhance effectiveness and acceptance of the proposed model, effective integration into care home and general practitioner teams was identified as a central requirement. A core outcome set and a training package were developed. The final model of care, whilst being safe and well received and resulting in a reduction in drug burden, demonstrated no improvement in the primary outcome of falls. With no improvement in quality-adjusted life-years identified, the pharmacist independent prescriber intervention was not estimated to be cost-effective. Future work To develop and evaluate better models of care for enhancing medication outcomes and safety in care homes or re-test with a longer intervention and follow-up period and a stronger primary outcome. Trial registration This trial is registered as ISRCTN10663852, definitive trial: ISRCTN17847169. Study registration This study is registered as PROSPERO CRD20150907. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research programme (NIHR award ref: RP-PG-0613-20007) and is published in full in Programme Grants for Applied Research; Vol. 11, No. 10. See the NIHR Funding and Awards website for further award information.