The Pittsburgh Scientific and Data Research Center for the COPE-AKI Consortium (Pitt-SDRC)

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ABSTRACT Acute kidney injury (AKI) and chronic kidney disease (CKD) are “interconnected” syndromes in which each influences the other. CKD is a risk factor for AKI and AKI contributes to the development or progression of CKD, end-stage renal disease (ESRD), cardiovascular symptoms, and death, not to mention recurrent AKI episodes and impaired health-related quality of life (HRQoL). Processes of care after AKI hospitalization have been found to be suboptimal, with lack of continuity of care, delayed follow-up and suboptimal medication management exacerbating the risks of adverse outcomes. In addition, optimal pharmacologic therapy, such as blockade of the renin-angiotensin-aldosterone system (RAAS) or sodium-glucose cotransporter type 2 (SGLT2), has not been defined. The Caring for OutPatiEnts after Acute Kidney Injury (COPE-AKI) Consortium will address these important gaps in knowledge of optimal management of patients surviving an episode of moderate (stage 2) or severe (stage 3) AKI. The goal of the COPE-AKI Consortium will be to develop and test interventions to optimize processes of care and identify key pharmacologic and non-pharmacologic interventions to reduce morbidity among these high-risk patients. The Center for Clinical Trials & Data Coordination (CCDC) at the University of Pittsburgh is well poised to serve as the Scientific and Data Research Center (SDRC) for the COPE-AKI Consortium. Our multidisciplinary investigative team has a history of collaboration, wealth of experience and expertise, including expertise in acute and chronic kidney disease, critical and translational care, medication management, design of clinical trials, telehealth, clinical and data coordination, project administration support, biostatistics, measurement of patient-reported outcomes, health services research and patient engagement. Our goal is to serve as the Scientific and Data Research Center for the COPE-AKI Consortium. Specifically, we will 1) establish an efficient and rigorous process for designing the Consortium study, including protocol development and adaptation of an existing web-based data collection system; 2) provide comprehensive expertise for data management and analysis within the Consortium; and 3) provide program coordination and administrative support throughout all phases of the study.