Abstract
OBJECTIVES: The benefits of a collaborative approach to medication management between pharmacists and clinicians in secondary care on patient safety has been demonstrated in clinical trials. However, less is known about the benefit of such collaboration in real-world settings. This study assessed the effectiveness of a collaborative model of pharmaceutical care including pharmacist collaborative prescribing, on discharge medication error, and explored the intervention fidelity. METHODS: This stepped wedge cluster-randomised controlled trial was undertaken at a university hospital in Dublin, Ireland. A cluster was one or more medical or surgical specialty, or part thereof, delivering acute care. Adult patients, using five plus regular medicines pre-admission, receiving care from a participating cluster, and discharged alive from that cluster were eligible for inclusion. Patients previously admitted during the study period and enrolled were excluded. The intervention saw a pharmacist aligned to a specialty, delivering collaborative services to patients: medication history taking, admission medication reconciliation, inpatient medication optimisation, discharge medication reconciliation and collaborative prescribing. The comparator was ward-based pharmacist care. Sample size accounting for study design, attrition and effect size in discharge medication error was calculated as 430 participants. The primary analysis was undertaken by the intention-to-treat (ITT) principle and multilevel logistic regression through the Generalised Linear Mixed Model (GLMM) procedure, was used to account for the effect of clustering and adjust for confounders. RESULTS: Eighty-six of 432 (19.9 %) assessable patients experienced a clinically significant discharge medication error, 37 (43 %) of whom were intervention group patients. Intention-to-treat analysis suggested no difference in the likelihood of experiencing this primary outcome between study groups (adjusted odds ratio 1.24, 95 % confidence interval 0.53-2.88). This finding was consistent in the extreme sensitivity and per protocol analyses. Intervention fidelity was poor with six (2.4 %) intervention patients receiving discharge medication reconciliation. CONCLUSION: Under real-world conditions, this collaborative model of pharmaceutical care including medication reconciliation and collaborative prescribing was equivalent to standard care in protecting against clinically significant discharge medication error. Future research should employ an implementation science framework to better understand how pharmaceutical care at discharge can be spread.