Cleveland COPE-AKI Clinical Center

Project summary Acute kidney injury (AKI) is a frequent and debilitating complication in hospitalized patients; however, AKI survivors after hospital discharge often receive fragmented health care. This increases the likelihood for the development of long-term major adverse kidney events (MAKE), defined as incident or progressive chronic kidney disease, end-stage kidney disease and all-cause mortality. Patients who experience severe AKI (stages 2 and 3 per the KDIGO classification) are at even higher risk for poor outcomes including MAKE, due to higher propensity for persistent damage manifested as lower renal function and proteinuria. In addition, AKI survivors report poor quality of life and exhibit frailty for at least a year after the AKI incident. To overcome the gaps in severe AKI management, we hypothesize that screening and intensive monitoring and management of blood pressure and proteinuria via renin-angiotensin system blockade and volume optimization (following KDIGO guidelines) reduces the rate of MAKE within 2 years, improves patient-reported outcomes, and reduces healthcare costs. Thus, Cleveland Clinic and MetroHealth System have developed the Cleveland COPE-AKI Clinical Center trial to compare the usual standard of care with an intensive, managed care pathway, called Champion Care Pathway. The Champion Care Pathway team will comprise a virtual/remote nurse-navigator under the supervision of a nephrologist and supported by a Patient Advisory Council. The structured longitudinal outpatient care pathway will be facilitated by multi-level remote patient monitoring, targeting the risk factors for MAKE in AKI stages 2 and 3 survivors. Patients enrolled to the Champion Care Pathway arm will be empowered to be active participants in their health management by providing their own blood pressure, weight, kidney function, and albuminuria data for the first three months after their hospital discharge and at predefined time intervals thereafter for 2 years post discharge. This data will allow the Champion Care team to mitigate changing health status episodes in an outpatient setting. The planned adaptive trial design will allow the focus of the intervention to be directed toward the patients most at risk for post-discharge kidney-specific incidents. Thus, the specific aims of the Cleveland COPE-AKI Clinical Center are to determine the impact of the Champion Care Pathway on 1) time to MAKE by 2 years 2) patient-reported outcomes and 3) cost effectiveness. Analyses will determine whether long-term continuity of care reduces morbidity and mortality for AKI stages 2 and 3 patients, reduces healthcare costs and improves the well-being of long-term AKI stages 2 and 3 survivors. In addition, the Cleveland COPE-AKI Clinical Center will work collaboratively and closely with the scientific data and research center along with other participating clinical centers to develop common policies and protocols designed for study interventions and periodic biospecimen sampling for contribution to the entire COPE-AKI consortium.