A Randomized Controlled Clinical Trial

Background and objectivesMedication safety events are predominant contributors to suboptimal graft outcomes in kidney transplant recipients. The goal of this studywas to examine the efficacy of improvingmedication safety through a pharmacist-led, mobile health–based intervention. Design, setting, participants, &measurements Thiswas a 12-month, single-center, prospective, parallel, two-arm, single-blind, randomized controlled trial. Adult kidney recipients 6–36 months post-transplant were eligible. Participants randomized to intervention received supplemental clinical pharmacist–led medication therapy monitoring and management via a mobile health–based application, integrated with risk-guided televisits and home-based BP and glucose monitoring. The application provided an accurate medication regimen, timely reminders, and side effect surveys. Both the control and intervention arms received usual care, including serial laboratorymonitoring and regular clinic visits. The coprimary outcomeswere to assess the incidence and severity of medication errors and adverse events. Results In total, 136 kidney transplant recipients were included, 68 in each arm. The mean age was 51 years, 57%weremale, and 64%were Black individuals. Participants receiving the intervention experienced a significant reduction in medication errors (61% reduction in the risk rate; incident risk ratio, 0.39; 95% confidence interval, 0.28 to 0.55; P,0.001) and a significantly lower incidence risk of Grade 3 or higher adverse events (incident risk ratio, 0.55, 95% confidence interval, 0.30 to 0.99; P50.05). For the secondary outcome of hospitalizations, the intervention arm demonstrated significantly lower rates of hospitalizations (incident risk ratio, 0.46; 95% confidence interval, 0.27 to 0.77; P50.005). ConclusionsWe demonstrated a significant reduction in medication errors, adverse events, and hospitalizations using a pharmacist-led, mobile health–based intervention. CJASN 16: 776–784, 2021. doi: https://doi.org/10.2215/CJN.15911020 Introduction Kidney transplantation is the preferred treatment option over dialysis for patients with kidney failure, due to its beneficial effect on cost and patient survival. With the total number of kidney transplant recipients alive today approaching 250,000, follow-up care has becomemore complex due to increasing age and chronic health conditions, coupled with the fragmented health care system in the United States. The use of contemporary immunosuppression has produced a substantial decrease in the incidence of acute rejection, which has dropped to a current 1-year rate of roughly 8%. However, improvements in long-term graft survival have remained relatively stagnant (1–3). Immunosuppression adverse events (AEs) and rejection as a result of medication nonadherence are among the chief contributors to suboptimal graft survival (4–6). Although modern immunosuppressive agents are highly effective, the toxicity burden and relative complexity of these regimens leave transplant recipients vulnerable to developing AEs and medication safety issues, including medication errors (7). Previous research demonstrated that medication errors occur in as many as two thirds of kidney transplant recipients, and result in the hospitalization of one in every eight recipients (2,8). Further, clinically significant medication errors were linked to a considerably higher risk of graft loss, AEs, readmissions, and acute rejections (9). We demonstrated a correlation between medication errors and immunosuppression AEs, with patients experiencing medication errors at 2.3-fold higher risk of developing multiple AEs (P50.02) (8). These studies highlight the need for innovative approaches to improve medication safety in patients who are high risk, such as kidney transplant recipients. Supplemental support of medical and public health practices using mobile devices, such as mobile phones, has emerged as a new pathway for Department of