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: 10436989
• 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/10436989
• 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; clinical prognostic; 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; programs; prospective; recruit; secondary analysis; secondary outcome; shared decision making; tool; treatment center; treatment strategy; 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; clinical prognostic; 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; 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.

项目摘要/摘要 1972年的Medicare终末期肾脏疾病（ESRD）计划已导致透析几乎通用 为了扩展晚期慢性肾脏疾病（CKD）患者的生存率。每个 美国在美国向透析过渡的120,000名患者是主要但昂贵的治疗范例 尿毒症，生化和体积演变。但是，在过去的4½十年中，几乎没有 在透析以外的晚期CKD开发以患者为中心的治疗方案的进展或创新。 我们团队在NIH U01“ CKD的过渡”（TCCKD）美国领导的开创性研究 肾脏数据系统（USRDS）特别学习中心表明，向透析的过渡与1相关 高死亡率，特别是在治疗的第一年，2）经常住院，3）与健康相关的质量差 生命（HRQOL），4）失去独立性，5）功能下降，6）高戒断日期，特别是在 老年人和合并症患者。这促使人们的兴趣不断上升，并紧迫的保守派紧迫 无透析管理作为替代治疗选择。然而，由于 关于1）保守管理与透析的比较有效性 硬结局和以患者为中心的终点，以及2）患者将从无透析治疗中受益。 我们的多PI R01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的来源，即optumlabs（联合医疗保健）和 与Medicare和USRDS Resources（2007-18）相关的国家退伍军人事务（VA）数据，与一个很好的 迄今为止，保守管理与透析过渡的最大研究中定义了预期的CKD队列。 使用倾向得分匹配，AIM 1将检查保守管理与透析的关联 死亡率和住院过渡（共同成果）和熟练的护士设施， 两个大型optumlabs和VA的重症监护入院和医疗保健费用（次要结果） 每人均与> 50万晚期CKD（EGFR <25ml/min/1.73m2）患者。在这两个队列中，目标2 将开发临床预后模型，以预测个人的生存和住院可能性 保守管理与透析。在预期的116阶段4-5 ckd患者中，AIM 3将 比较保守管理与透析准备对纵向轨迹的影响 HRQOL（主要结果）和身体表现/活动，症状和营养（次要结果） 使用严格的协议数据收集和经过验证的仪器。我们的发现将产生重大影响 关于患者护理和政策的1）扩大了大量CKD人群中心的以患者为中心的治疗方案，2） 通过确定哪些患者是最佳候选者来为临床准则生成严格的证据 保守管理和3）通知渴望提供无透析治疗的临床实践模型 作为一种与美国肾脏健康计划的患者选择保持一致的方法。