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Cleveland COPE-AKI Clinical Center

克利夫兰 COPE-AKI 临床中心

基本信息

批准号：
10451789
负责人：
Sevag Demirjian
金额：
$ 66.67万
依托单位：
CLEVELAND CLINIC LERNER COM-CWRU
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-07-19 至 2026-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10451789
关键词：
Acute Renal Failure with Renal Papillary Necrosis Address Albuminuria Ambulatory Care Angiotensins Blood Blood Pressure Blood Vessels Caring Chronic Kidney Failure Classification Clinic Clinical Clinical Trials Complication Continuity of Patient Care Creatinine Critical Illness DNA Data Development Diagnosis Dialysis procedure Economics Emergency Care Emergency department visit End stage renal failure Enrollment Event Exhibits Feces Future Glomerular Filtration Rate Guidelines Health Care Costs Health Status Healthcare Heart failure Hospitalization Hospitals Internal Medicine Intervention Intervention Studies Investigation Kidney Kidney Diseases Link Lung diseases Managed Care Measurement Modeling Monitor Morbidity - disease rate Nephrology Nurses Operative Surgical Procedures Outcome Outpatients Participant Pathogenicity Pathway interactions Patient Monitoring Patient Outcomes Assessments Patient-Focused Outcomes Patients Periodicity Personal Satisfaction Pharmacologic Substance Policies Population Preparation Process Proteinuria Protocols documentation Quality of life Randomized Renal function Renin Renin-Angiotensin System Reporting Research Risk Risk Factors Sampling Serum Severities Site Structure Supervision Survivors System Testing Therapeutic Intervention Time United States National Institutes of Health Urine Visit Weight Work arm barrier to care biobank blood pressure control care coordination clinical center cost cost effectiveness design economic outcome empowered experience frailty health care service utilization health management high risk improved innovation mortality mortality risk personalized care prevent psychological distress readmission rates remote patient monitoring screening standard of care time interval treatment as usual trial design virtual

项目摘要

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.

项目摘要急性肾损伤（阿基）是住院患者中常见的使人衰弱的并发症;然而，出院后往往得到零散保健服务。这增加了长期发展的可能性。重大肾脏不良事件（MAKE），定义为偶发或进行性慢性肾脏疾病、终末期肾脏疾病和全因死亡率发生重度阿基（根据KDIGO分类为2期和3期）的患者不良结局（包括MAKE）的风险更高，因为持续性损伤的倾向更高，表现为肾功能降低功能和蛋白尿。此外，阿基幸存者报告生活质量差，并在治疗后至少一年内表现出虚弱。阿基事件为了克服严重阿基管理方面的差距，我们假设筛查和强化监测以及通过肾素-血管紧张素系统阻断和容量优化来管理血压和蛋白尿（遵循KDIGO指南）降低了2年内的MAKE发生率，改善了患者报告的结局，医疗费用。因此，克利夫兰诊所和MetroHealth系统开发了克利夫兰COPE-AKI临床中心这项试验旨在比较常规护理标准与重症监护路径（称为冠军护理路径）。的 Champion Care Pathway团队将由一名虚拟/远程护士导航员组成，由一名肾病学家监督，由病人咨询理事会支持。结构化纵向门诊护理路径将通过多层次的远程患者监测，针对阿基2期和3期幸存者中MAKE的风险因素。入组的患者 Champion Care Pathway手臂将被授权积极参与其健康管理，出院后前三个月的血压、体重、肾功能和蛋白尿数据并在出院后的2年内以预定的时间间隔进行。这些数据将使冠军护理团队能够减轻门诊患者健康状况的变化。计划的适应性试验设计将使重点针对最有可能发生出院后肾脏特异性事件的患者进行干预。因此，具体克利夫兰COPE-AKI临床中心的目标是确定冠军护理途径对以下方面的影响：1）时间， 2年MAKE 2）患者报告结局和3）成本效益。分析将确定是否长期连续性护理降低了阿基2期和3期患者的发病率和死亡率，降低了医疗保健成本，长期阿基2期和3期幸存者的福祉。此外，克利夫兰COPE-AKI临床中心将在与科学数据和研究中心沿着其他参与临床中心密切合作，为研究干预和定期生物样本采样制定共同政策和方案整个COPE-AKI财团