Acute kidney injury (AKI) incidence affects roughly 6.8/1000 population in the United States and contributes to the development or progression of chronic kidney disease, end-stage renal disease, cardiovascular symptoms, and death, as well as recurrent AKI episodes and impaired health-related quality of life. Processes of care after AKI hospitalization are largely suboptimal, with lack of continuity of care, delayed follow-up, and suboptimal medication management exacerbating the risks of adverse outcomes. Moreover, In addition, the best form of 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 to determine 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 enhance processes of care and identify key pharmacologic and non-pharmacologic interventions to reduce morbidity among these high-risk patients. To ensure scientific integrity, comprehensiveness, and robustness of the research design, biostatistics, and implementation, the Center for Clinical Trials & Data Coordination (CCDC) at the University of Pittsburgh will serve as the Scientific and Data Research Center (SDRC) for the COPE-AKI Consortium. Directed by Kaleab Abebe, PhD, the CCDC is comprised of a multidisciplinary investigative team with a history of collaboration and a wealth of experience and expertise, including knowledge 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. Drs. Paul Palevsky and Linda Fried, nephrologists within the Renal-Electrolyte Division at the University of Pittsburgh and VA Pittsburgh Healthcare System, as well as Dr. Sandra Kane-Gill (Department of Pharmacy and Therapeutics), will serve as Co-PIs with Dr. Abebe to oversee the Scientific and Data Research Center for the COPE-AKI Consortium. This cross-disciplinary collaboration will work to 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.