Although the contemporary use of immunosuppression regimens have dramatically reduced the incidence of acute rejection, long-term graft survival continues to be suboptimal in kidney transplantation. Studies suggest that adverse drug events and medication errors, both of which encompass medication safety issues, may be a predominant cause of graft loss. However, despite kidney transplant recipients being at high-risk for medication safety events, there is limited information surrounding the incidence, etiologies and outcomes of medication errors and adverse drug events within this population. Our preliminary research has demonstrated that significant medication errors, predominantly due to patient-related factors, occur in nearly two-thirds of kidney transplant recipients, leading to hospitalization in one out of every eight patients. Recipients that develop clinically significant medication errors are at considerably higher risk of deleterious clinical outcomes, most significantly graft loss; these patients also develop substantially more adverse drug events, readmissions and acute rejections. Researchers have also demonstrated feasibility and high acceptability of mobile health (mHealth) technology use to bridge communication gaps that often lead to medication safety issues. Smartphone and home-based monitoring technology has a very high penetration rate within this population. These studies establish that a pharmacist-empowered, patient-centered, mHealth-based intervention provides an innovative and highly promising opportunity to improve medication safety in kidney transplantation. It is within this context that the investigators propose to conduct the Improving Transplant Medication Safety through a Pharmacist-Empowered, Patient-Centered, mHealth-Based Intervention (TRANSAFE Rx) study. The primary goal of the TRANSAFE Rx study is to demonstrate significant reductions in medication safety issues leading to reduced healthcare resource utilization in kidney transplantation through a pharmacist-led, mHealth-enabled, intervention. Conducting this study will provide detailed and novel information on the incidence, etiologies and outcomes of medication errors and adverse drug events in this high-risk population; while also demonstrating the effectiveness of this intervention on reducing the incidence and impact of medication safety issues in kidney transplantation. The enduring goals of this study are to demonstrate a highly effective, efficient and deployable method to improve medication safety in high risk patient populations with the long-term objective of disseminating this promising technology and intervention across multiple patient types and healthcare environments.

Public Health Relevance

Due to the complexities and toxicities associated with their immunosuppressive medication regimens, kidney transplant recipients are at high-risk of developing medication safety issues which can lead to hospitalization, increased healthcare expenditures and ultimately, graft loss. Founded on preliminary information, the use of pharmacists and mHeatlh technology provide a promising and innovative approach to improve medication safety in high-risk patients. The ultimate goal of this research is to demonstrate how patients, pharmacists and technology can work hand-in-hand to optimize medication-related outcomes and reduce healthcare expenditures.

National Institute of Health (NIH)
Agency for Healthcare Research and Quality (AHRQ)
Research Demonstration and Dissemination Projects (R18)
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Healthcare Patient Safety and Quality Improvement Research (HSQR)
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Perfetto, Deborah
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Medical University of South Carolina
Schools of Medicine
United States
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Arms, Michelle A; Fleming, James; Sangani, Deep B et al. (2018) Incidence and impact of adverse drug events contributing to hospital readmissions in kidney transplant recipients. Surgery 163:430-435
Vranian Jr, Steven Craig; Covert, Kelly L; Mardis, Caitlin R et al. (2018) Assessment of risk factors for increased resource utilization in kidney transplantation. J Surg Res 222:195-202.e2
Fleming, James N; Treiber, Frank; McGillicuddy, John et al. (2018) Improving Transplant Medication Safety Through a Pharmacist-Empowered, Patient-Centered, mHealth-Based Intervention: TRANSAFE Rx Study Protocol. JMIR Res Protoc 7:e59