Evaluating the effectiveness of the Smart About Meds (SAM) mobile application among patients discharged from hospital: protocol of a randomised controlled trial.

Introduction: Almost half of patients discharged from hospital are readmitted or return to the emergency department (ED) within 90 days. Non-adherence to medication changes made during hospitalisation and the use of potentially inappropriate medications (PIMs) both contribute to postdischarge adverse events. We developed Smart About Meds (SAM), a patient-centred mobile application that targets medication non-adherence and PIMs use. This protocol describes a randomised controlled trial (RCT) to evaluate SAM.

Methods And Analysis: A pragmatic, stratified RCT will evaluate SAM among 3250 adult patients discharged from hospital. At discharge, consenting participants will be randomised 1:1 to usual care or SAM. SAM integrates novel patient-centred features with pharmacist monitoring to manage non-adherence to new medication regimens. SAM also notifies patients of PIMs in their regimen, with advice to discuss with their physician.Following discharge, patients will be followed for 90 days to measure the primary composite outcome of ED visits, hospital readmissions and death. Secondary outcomes will include primary adherence to medication changes, secondary adherence to disease-modifying medications, patient empowerment and health-related quality of life.The primary outcome will be analysed according to intention-to-treat. Multivariable logistic regression will estimate differences between treatment groups in the proportion of patients experiencing the primary outcome and will assess modification of intervention effects by hospital, unit, age, sex and comorbidity burden. With a sample size of 3250, the study will have 80% power to detect a 5% absolute reduction in the primary outcome. Binary and continuous secondary outcomes will be assessed using multivariable logistic and linear regression, respectively.

Ethics And Dissemination: The Research Ethics Board of the McGill University Health Centre in Montréal, Canada has approved this study. Results will be submitted for publication in a peer-reviewed journal and presented at scientific conferences. If effective, SAM will be made available in app stores.

Trial Registration Number: NCT05371548.