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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：
10670203
负责人：
Sevag Demirjian
金额：
$ 64.76万
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/10670203
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 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 Periodicals Personal Satisfaction Pharmacologic Substance Policies Population Preparation 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 care fragmentation clinical center cost cost effectiveness design economic outcome empowerment experience frailty health care service utilization health management high risk improved innovation mortality mortality risk participant enrollment patient navigation personalized care prevent process improvement 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.

项目总结急性肾损伤(AKI)是住院患者常见的和令人衰弱的并发症；然而，AKI幸存者在医院出院后往往会得到零散的医疗服务。这增加了长期发展的可能性主要不良肾脏事件(MAKE)，定义为偶发或进行性慢性肾脏疾病、终末期肾脏疾病以及各种原因造成的死亡。经历严重AKI(根据KDIGO分类为2期和3期)的患者平均较高的不良结局风险，包括MAKE，因为较高的持续性损害倾向表现为较低的肾脏功能和蛋白尿。此外，AKI的幸存者报告说，他们的生活质量很差，并在术后至少一年内表现出虚弱秋木事件。为了克服严重急性心肌梗死治疗中的空白，我们假设筛查和密集监测通过阻断肾素-血管紧张素系统和优化容量来管理血压和蛋白尿 (遵循KDIGO指南)降低2年内的成功率，改善患者报告的结果，并减少医疗保健成本。因此，克利夫兰诊所和MetroHealth系统开发了克利夫兰COP-AKI临床中心试验将通常的护理标准与一种称为冠军护理路径的重症监护路径进行比较。这个冠军护理路径团队将包括一名虚拟/远程护士-导航员，由一名肾科医生监督和由患者咨询委员会提供支持。结构化纵向门诊路径将由多层次促进远程患者监测，针对AKI 2期和3期幸存者的危险因素。患者登记参加冠军关怀路径ARM将被授权积极参与其健康管理，通过提供其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。这些数据将使冠军关怀团队能够减少门诊环境中不断变化的健康状况事件。计划中的适应性试验设计将使重点针对出院后肾脏特殊事件风险最高的患者进行干预。因此，具体的克利夫兰COP-AKI临床中心的目标是确定冠军护理路径对1)时间的影响 2)患者报告的结果和3)成本效益。分析将决定长期的连续性护理降低了AKI 2期和3期患者的发病率和死亡率，降低了医疗成本并改善了长期AKI阶段2和3幸存者的幸福感。此外，克利夫兰COPE-AKI临床中心将工作与科学数据和研究中心以及其他参与的临床中心密切合作，以为研究干预和定期生物样品采样制定共同的政策和协议，以促进贡献给整个COPE-AKI财团。