Defining Optimal Transitions of Care in Advanced Kidney Disease: Conservative Management vs. Dialysis Approaches

定义晚期肾病护理的最佳转变：保守治疗与透析方法

• 批准号: 10264944
• 负责人: Kamyar Kalantar-Zadeh
• 金额: $ 64.9万
• 依托单位: UNIVERSITY OF CALIFORNIA-IRVINE
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-15 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10264944
• 关键词: Address; Admission activity; American; Attenuated; Biochemical; California; Caring; Characteristics; Chronic Kidney Failure; Clinic; Clinical; Data; Data Collection; Data Sources; Databases; Dialysis patients; Dialysis procedure; Elderly; End stage renal failure; Guidelines; Health; Health Care Costs; Healthcare; Hospitalization; Human Activities; Individual; Inflammation; Information Systems; Integrated Health Care Systems; Intensive Care; Intensive Care Units; Kidney; Kidney Diseases; Kidney Failure; Kidney Transplantation; Knowledge; Link; Malnutrition; Medicare; Modeling; National Institute of Diabetes and Digestive and Kidney Diseases; Nutritional; Nutritional status; Outcome; Pathway interactions; Patient Care; Patient-Focused Outcomes; Patients; Physical Performance; Physical activity; Policies; Population; Preparation; Professional Organizations; Prospective cohort; Protocols documentation; Quality of life; Renal function; Research; Residual state; Resources; Skilled Nursing Facilities; Subgroup; Surveys; Survival Rate; Symptoms; Time; Transplantation; Treatment Cost; Uncertainty; United States; United States Department of Veterans Affairs; United States National Institutes of Health; Universities; Withdrawal; alternative treatment; associated symptom; base; clinical practice; cohort; comorbidity; comparative; comparative effectiveness; disorder subtype; functional decline; health related quality of life; improved; indexing; innovation; instrument; interest; mortality; nutrition; patient oriented; predictive modeling; preservation; primary outcome; prognostic model; programs; prospective; recruit; secondary analysis; secondary outcome; shared decision making; tool; treatment center; treatment strategy

PROJECT SUMMARY/ABSTRACT The 1972 Medicare End-Stage Renal Disease (ESRD) program has led to near-universal access to dialysis in order to extend the survival of advanced chronic kidney disease (CKD) patients progressing to ESRD. Each year ~120,000 patients in the US transition to dialysis as the dominant yet costly treatment paradigm for uremic, biochemical, and volume derangements. However, in the past 4½ decades, there has been little progress or innovation in developing patient-centered treatment options for advanced CKD beyond dialysis. Pioneering research led by our team under the NIH U01 “Transitions of Care in CKD” (TCCKD) United States Renal Data System (USRDS) Special Study Center have shown that transition to dialysis is associated with 1) high mortality particularly in the 1st year of treatment, 2) frequent hospitalizations, 3) poor health-related quality of life (HRQOL), 4) loss of independence, 5) functional decline, and 6) high withdrawal dates, particularly in elderly and comorbid patients. This has prompted rising interest and pressing urgency for conservative dialysis-free management as an alternative treatment option. Yet this strategy remains under-utilized due to major uncertainties regarding 1) the comparative effectiveness of conservative management vs. dialysis on hard outcomes and patient-centered endpoints, and 2) which patients will benefit from dialysis-free treatment. Our Multiple-PI R01 proposal will address these knowledge gaps by using innovative longitudinal data sources from two of the largest US integrated healthcare systems, namely OptumLabs (United Healthcare) and national Veterans Affairs (VA) data linked to Medicare and USRDS resources (2007-18), paired with a well- defined prospective CKD cohort in the largest study of conservative management vs. dialysis transition to date. Using propensity score matching, Aim 1 will examine associations of conservative management vs. dialysis transition with mortality and hospitalization (co-primary outcomes), and skilled nursing facility placement, intensive care admissions, and healthcare costs (secondary outcomes) in two large OptumLabs and VA cohorts each with >0.5 million advanced CKD (eGFR <25ml/min/1.73m2) patients. In these two cohorts, Aim 2 will develop clinical prognostic models that predict an individual’s likelihood of survival and hospitalization with conservative management vs. dialysis. In a prospective cohort of 116 stage 4-5 CKD patients, Aim 3 will compare the impact of conservative management vs. dialysis preparation on the longitudinal trajectory of HRQOL (primary outcome) and physical performance/activity, symptoms, and nutrition (secondary outcomes) using rigorous protocolized data collection with validated instruments. Our findings will have substantial impact on patient care and policy by 1) expanding patient-centered treatment options for the vast CKD population, 2) generating rigorous evidence for clinical guidelines by identifying which patients are optimal candidates for conservative management, and 3) informing clinical practice models aspiring to provide dialysis-free treatment as an approach aligned with patient choice based on the US Advancing American Kidney Health Initiative.

项目总结/摘要 1972年的医疗保险终末期肾病（ESRD）计划使透析几乎普及 以延长进展为ESRD的晚期慢性肾病（CKD）患者的生存期。每个 美国约120，000例患者过渡到透析作为主要但昂贵的治疗模式， 尿毒症生化和容量紊乱然而，在过去的4.5年里， 在开发以患者为中心的治疗方案以治疗透析以外的晚期CKD方面取得的进展或创新。 我们的团队在NIH U 01“CKD护理转变”（TCCKD）下领导的开创性研究美国 肾脏数据系统（USRDS）特殊研究中心显示，过渡到透析与1） 死亡率高，特别是在治疗的第一年，2）频繁住院，3）与健康有关的质量差 生活质量（HRQOL），4）丧失独立性，5）功能下降，和6）高退出日期，特别是在 老年和合并症患者。这促使人们对保守派的兴趣越来越大， 免透析管理作为替代治疗选择。然而，这一战略仍然没有得到充分利用， 主要不确定性：1）保守治疗与透析治疗的比较有效性 硬结局和以患者为中心的终点，以及2）哪些患者将受益于免透析治疗。 我们的Multiple-PI R 01提案将通过使用创新的纵向数据来解决这些知识差距 来自美国两个最大的综合医疗保健系统，即OptumLabs（联合医疗保健）和 国家退伍军人事务部（VA）数据与医疗保险和USRDS资源（2007-18），与一个良好的配对， 在迄今为止最大规模的保守治疗与透析过渡研究中定义的前瞻性CKD队列。 使用倾向评分匹配，目标1将检查保守治疗与透析治疗的相关性 死亡率和住院（共同主要结局）的过渡，以及熟练护理机构的安置， 两个大型OptumLabs和VA中的重症监护入院和医疗费用（次要结局） 每个队列有> 50万晚期CKD（eGFR <25 ml/min/1.73m2）患者。在这两个队列中，目标2 将开发临床预后模型，预测个人的生存和住院的可能性， 保守治疗与透析。在116例4-5期CKD患者的前瞻性队列中，Aim 3将 比较保守治疗与透析准备对纵向轨迹的影响， HRQOL（主要结局）和体能/活动、症状和营养（次要结局） 使用经过验证的仪器进行严格的协议化数据收集。我们的发现将对 通过1）为广大CKD人群扩大以患者为中心的治疗选择，2） 通过确定哪些患者是最佳候选人， 保守治疗，以及3）告知期望提供免透析治疗的临床实践模型 作为一种基于美国推进美国肾脏健康倡议的与患者选择一致的方法。