An Electronic Health Record–Integrated Application for Standardizing Care and Monitoring Patients With Autosomal Dominant Polycystic Kidney Disease Enrolled in a Tolvaptan Clinic: Design and Implementation Study

Abstract

Background: Tolvaptan is the only FDA-approved drug to slow the progression of autosomal dominant polycystic kidney disease (ADPKD) but requires strict clinical monitoring due to potential serious adverse events. Objective: We share our experience in developing and implementing an electronic health record (EHR) based application to monitor patients with ADPKD initiated on Tolvaptan. Methods: The application was developed in collaboration with clinical informatics based on our clinical protocol with frequent laboratory test monitoring to detect early drug-related toxicity. The application streamlines clinical workflow and enables our nursing team to take appropriate actions in real-time to prevent drug-related serious adverse events. We retrospectively analyzed the characteristics of enrolled patients. Results: As of September 2022, 214 patients were enrolled in the Tolvaptan program across all Mayo Clinic sites. Of these, 126 were enrolled in the “Tolvaptan monitoring application” and 88 in the “Past Tolvaptan patients’ application”. The mean age at enrollment was 43.1±9.9 years. A total of 20 (9.3%) developed liver toxicity but only 5 (2.3%) had to discontinue the drug. The two EHR-based applications allow consolidation of all necessary patient information and real-time data management at the individual or population level. This approach facilitates efficient staff workflow, monitoring of drug-related adverse events, and timely prescription renewal. Conclusions: Our study highlights the feasibility of integrating digital applications into the EHR workflow, to facilitate efficient and safe care delivery for patients enrolled in a Tolvaptan program. This workflow needs further validation but could be extended to other healthcare systems managing chronic disease requiring drug monitoring.