PROJECT SUMMARY/ABSTRACT: RESOURCE DEVELOPMENT PROJECT Kidney stone disease affects nearly 10% of the US population and adds $5 billion in financial burden to the US healthcare system annually. The pathogenesis of urinary stones is likely multifactorial requiring an interdisciplinary, multi-institutional approach to understand its causes and develop new therapeutics. The traditional paradigm for collecting longitudinal clinical data on patient outcomes is stymied by excessive cost and time, limited investment in experienced information technology personnel, and most importantly, inaccurate data collection. Therefore, we propose to develop a novel automated clinical registry as a research resource that will facilitate innovative and transformative science on nephrolithiasis to improve care for the millions of individuals confronting this debilitating condition annually. We have designed and implemented a user-friendly clinical registry integrated with our electronic medical record system (EMR) called ReSKU (the Registry for Stones of the Kidney and Ureter) that has supported patient data collection and led to novel clinical studies. Our resource development project goal is to validate the efficacy of an automated clinical registry for improved, accurate, multi-institutional patient data collection. To accomplish our aims are: Aim 1: Implement ReSKU data capture clinic templates at 5 stone treatment centers, train providers in their use, and measure their impact on provider documentation time. Aim 2: Validate ReSKU by conducting a randomized, non-blinded crossover trial of ReSKU compared to a traditional manual entry registry to assess accurate data collection for nephrolithiasis patients. The significance of these proposed studies will be to establish a paradigm shift for collecting clinical data to trace the natural history of nephrolithiasis. If validated as a community research resource, ReSKU will support multi-institutional clinical and translational trials that will advance our understanding of urinary stone disease. We imagine a research community where clinical data for nephrolithiasis patients are collected in an ongoing manner by providers. Any research study, whether clinical, translational, or basic, can then be linked to this database from any participating center or across institutions. The innovation of the proposed study is to leverage an existing EMR system in a time-efficient, cost-effective manner to study a highly morbid disease. Validating that an automated registry holds significant benefit for clinical data collection will lay the groundwork for multi-institutional studies examining the natural history of urinary stone disease. Additionally, using ReSKU across multiple institutions will provide a means of creating infrastructure to support more effective future cross-institutional clinical studies. If successful, this infrastructure may serve as a model that can be easily replicated for the study of other diseases. This work will culminate in a novel resource that will be made available to the urology community and will provide the necessary scientific platform to launch a large intervention study in patients with recurrent kidney stone disease.
NIH ExPorter
NIH ExPorter