Protocol for a randomised controlled trial evaluating the impact of a community pharmacy discharge medication reconciliation service on unplanned hospital readmissions – The DCMedsRec trial

Introduction: A substantial proportion of hospital admissions and readmissions are directly attributable to preventable medication-related harm. Interventions that reduce these harms could avert significant suffering and healthcare costs. Objectives: The Discharge Medications Reconciliation (DCMedsRec) trial will evaluate a structured medication reconciliation service by community pharmacists post hospital discharge on the risk of 30-day unplanned readmission. Electronic access to the Hospital Discharge Summary via My Health Record will underpin this service. Methods: DCMedsRec is a non-blinded randomised controlled trial of an intervention by community pharmacists within 30 days of hospital discharge in Melbourne, Australia. Patients discharged from hospital will be assessed by a hospital pharmacist for trial eligibility. If eligible, patients will be randomised to either a control or intervention group by sequentially marked sealed envelopes. Intervention patients receive an invitation to the DCMedsRec service at a participating community pharmacy, who will be reimbursed. Control patients will receive usual care. A Number Needed to Treat of 20 will require 293 DCMedsRec interventions to achieve 80% power. With a predicted 30% uptake, a minimum sample of 977 in the intervention arm is required. Outcomes: The primary outcome will be the rate of 30-day unplanned hospital readmission in intervention (DCMedsRec) versus usual care groups. Secondary analyses will evaluate the economic impact of the intervention and a qualitative thematic analysis of the experience and value of the service for both patients and service providers (community pharmacists). Analysis: An intention-to-treat analysis will be used to assess intervention efficacy and results will be reported using risk ratios with 95% confidence intervals. Cost-effectiveness analysis will compare within-trial costs and outcomes of the DCMedsRec versus usual care from a health-system perspective. Trial registration and funding: This trial is registered with the Australian and New Zealand Clinical Trials Register and funded by the Australian Digital Health Agency.