Cleveland COPE-AKI Clinical Center

克利夫兰 COPE-AKI 临床中心

基本信息

批准号：
10296272
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/10296272
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 regulation 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.

项目摘要急性肾脏损伤（AKI）是住院患者的常见且令人衰弱的并发症。但是，Aki幸存者之后医院出院通常会接受零散的医疗保健。这增加了长期发展的可能性重大不良肾脏事件（Make），定义为事件或进行性慢性肾脏疾病，末期肾脏疾病和全因死亡率。经历严重AKI的患者（每个Kdigo分类第2阶段和第3阶段）甚至处于由于更高的持续损害倾向表现为较低的肾脏，包括制造的不良结果的风险更高功能和蛋白尿。此外，AKI幸存者报告的生活质量差，表现丰富至少一年后 Aki事件。为了克服严重的AKI管理中的差距，我们假设筛查和密集监控以及通过肾素 - 血管紧张素系统阻断和体积优化的血压和蛋白尿的管理（遵循KDIGO指南）降低了2年内的制造率，改善患者报告的结果并减少医疗保健费用。因此，克利夫兰诊所和甲都有健康系统开发了克利夫兰Cope-Aki临床中心试验将通常的护理标准与强化，管理的护理途径（称为Champion Care Pathway）进行比较。这 Champion Care Pathway团队将在肾脏科医生的监督下组成一个虚拟/远程护士 - 纳维格人得到患者咨询委员会的支持。结构化的纵向门诊护理途径将通过多层促进远程患者监测，针对AKI阶段第2和3个幸存者的危险因素。入学的患者冠军护理途径臂将通过提供他们的健康管理的积极参与者。出院后的前三个月，自己的血压，体重，肾功能和蛋白尿数据并在出院后2年以预定义的时间间隔。这些数据将使冠军护理团队能够减轻门诊环境中改变健康状况发作的改变。计划的自适应试验设计将允许这项干预措施针对患者最有风险的患者肾脏特异性事件。因此，具体克利夫兰Cope-Aki临床中心的目的是确定冠军护理途径的影响1）在2年之前制作2）患者报告的结果和3）成本效益。分析将确定是否长期护理的连续性降低了AKI阶段2和3患者的发病率和死亡率，降低了医疗保健成本并改善长期AKI的福祉第2和3阶段幸存者。此外，克利夫兰Cope-Aki临床中心将有效与科学数据和研究中心以及其他参与的临床中心进行协作制定专门为研究干预措施和定期生物测试采样设计的常见政策和方案以贡献到整个Cope-Aki联盟。