OPTimising MEDicine information handover after Discharge (OPTMED-D): a stepped wedge cluster randomised controlled trial

A three-phased multi-method study will leverage existing transition of care strategies (e.g., discharge summaries) whilst introducing targeted innovations, namely a structured medicine handover process mediated by a digital solution, to improve medicine handover when patients are discharge from hospital. The trial registration record primary describes Phase 3 of the study. Phase 1 is the Co-design of intervention with stakeholders and end-users over nine-month period. Key learnings from previous studies and workshops will be used to co-design and integrate the perspectives of hospital and primary care clinicians (GPs, community and credentialed pharmacists), consumers/patients and other relevant stakeholders. Phase 2 is the development of the intervention over 12-month period. Building on the results of the Phase 1 workshops, this phase will develop infrastructure and resources to streamline medicine information handover from hospital to the community setting. This phase involves four primary tasks: developing handover guidelines, developing and pilot testing a digital solution,, training and customising the intervention, and defining the clusters for the Phase 3 intervention. Phase 3 is the stepped wedge cluster randomised controlled trial (SW-CRT) over 12-month period. The SW-CRT design will be used to assess the effects of the multifaceted intervention over a 30-day follow-up period following hospital discharge. The proposed intervention will commence in hospital, during discharge planning, with an active medicine handover from a hospital pharmacist navigator at each of the trial hospitals who will work with the patient to connect with the patient’s nominated community pharmacy and general practitioner (GP). The navigators will be paid through the project funding. They will liaise with the hospital pharmacists to identify patients at risk of potential medication-related harm post-discharge through the use of a validated tool (e.g. the PRIME tool) and criteria identified during Phases 1 and 2. The patient’s risk score will inform the handover to primary care clinicians: high risk will prompt a phone call in addition to secure emailing of the discharge medicine list whereas patients with a moderate risk will have secure email of their discharge medicine lists. We estimate the handover to take approx. 20 minutes, depending on how many medicines the patient is on, their risk score and the number of high-risk medicines. Through established Medication Management Review (MMR) services, the patient’s medicines will be reconciled at the primary care level in the community pharmacy or in the patient’s home and follow-up actions communicated to the GP. Patients with a high risk will be recommended for a Home Medicine Review in the patient’s home with a credentialed pharmacist whereas medium risk will include a recommendation for a post-discharge MedsCheck in the patient’s nominated community pharmacy. The pharmacist navigators will record which patients are part of the trial through a note in the electronic medical record system and will also keep a spreadsheet of which interventions were provided. An innovative digital solution will prompt clinicians of actions being performed throughout the transition of care through asynchronous communication provided through a digital platform linking community pharmacists, GPs and patients. Phase 2 of the study will focus on the development of the digital solution. It is envisaged that the digital solution will integrate with existing prescribing and dispensing software and that GPs and community pharmacists will be prompted when there is updated information. We will use platform usage data to monitor how often it is used. An existing community pharmacy patient phone App will be modified for patients to enable them to make an appointment for a post-discharge MedsCheck with their community pharmacy before patients leave the hospital. The intervention will be delivered at the level of the patient’s nominated community pharmacy and cluster randomisation will be used to allow for randomisation to occur at the level of the cluster (community pharmacy hub) instead of the participant. A one-month lead in phase is included, where the pharmacy cluster is not considered as being in the control or intervention phase, and the data collected during this time will not contribute to the final outcome analysis. Interventions will be implemented for new clusters monthly. The SW-CRT design will enable the intervention to be provided to every community pharmacy cluster by the end of the study period, to measure possible underlying temporal trends (such as seasonal variation in admissions) and to prevent potential direct/indirect educational effects of the intervention carrying over to the control phase (which precludes a crossover design). Phase 3 will incorporate an evaluation of the impact of the intervention on key outcomes, a process evaluation and an economic evaluation.