Effectiveness of a Mobile App (Meds@HOME) to Improve Medication Safety for Children with Medical Complexity: Protocol for a Randomized Control Trial (Preprint)

Abstract

Background: This study will pilot test the mobile phone application, Medication Safety @HOME-Meds@HOME intervention to improve medication administration accuracy, reduce preventable adverse drug events, and ultimately improve chronic care management for children with medical complexity (CMC). The Meds@Home app was co-designed with CMC families, caregivers and health professionals to support medication management for primary (PCG) and secondary (SCG) caregivers of CMC. We hypothesize that Meds@HOME will improve caregivers' medication administration accuracy, reduce preventable adverse drug events, and ultimately improve chronic care management.Objective: This study aims to evaluate the effectiveness of Meds@HOME on medication administration accuracy for PCGs and SCGs.Methods: This study will recruit up to 152 PCGs and 304 SCGs of CMC who are prescribed at least one scheduled high-risk medication and receive care at the University of Wisconsin (UW) American Family Children's Hospital. PCGs will be randomly assigned, for the 6-month trial, to either the control (not trialing Meds@HOME) or intervention group (trialing Meds@HOME) using 1:1 ratio. The Meds@HOME app allows caregivers to create a child profile, store medication and care instructions and receive reminders for upcoming and overdue care routines and medication refills. Surveys completed both at the start and end of the trial measure demographics, medication delivery knowledge, confidence in the CMC's caregiving network, and comfort with medical information. Univariate and multivariate generalized estimation equations will be used for primary statistical analysis. The primary outcome is the PCG's rate of medication administration accuracy measured as correct identification of each of the following for a randomly selected high-risk medication: indication, formulation, dose, frequency, and route at baseline and after 6-months.?Secondary outcomes include SCG medication accuracy, as defined above, count of UW hospital and emergency department encounters, PCG reported medication adherence, count of deaths, and PCG medication confidence and understanding.Results: Recruitment for this study began 11/29/2023. To date we have enrolled 94 (62%) PCGs. We expect recruitment to end by 8/1/2024, and the final participant will complete the study by 1/28/2025, at which point we will start analyzing the complete responses. We expect publication of results at the end of 2025.