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

基本信息

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
项目类别：
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

项目摘要

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.

项目概要/摘要 1972 年医疗保险终末期肾病 (ESRD) 计划几乎普及了透析服务为了延长进展为 ESRD 的晚期慢性肾脏病 (CKD) 患者的生存期。年美国约有 120,000 名患者转向透析作为主要但昂贵的治疗模式然而，在过去的 4.5 年里，几乎没有发生尿毒症、生化和容量紊乱。在开发以患者为中心的晚期 CKD 透析以外的治疗方案方面取得的进展或创新。我们的团队在美国 NIH U01“CKD 护理转变”(TCCKD) 下领导的开创性研究肾脏数据系统 (USRDS) 特别研究中心表明，过渡到透析与以下因素相关：1) 死亡率高，特别是在治疗的第一年，2) 频繁住院，3) 健康相关质量差生活质量 (HRQOL)，4) 丧失独立性，5) 功能衰退，以及 6) 停药日期较长，尤其是在这引起了保守派的兴趣和紧迫感。无透析治疗作为一种替代治疗选择，但由于以下原因仍未得到充分利用。主要不确定性在于 1) 保守治疗与透析的比较有效性硬性结果和以患者为中心的终点，2) 哪些患者将受益于免透析治疗。我们的 Multiple-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源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 资源相关联 (2007-18)，并与良好的在迄今为止最大规模的保守治疗与透析过渡研究中定义了前瞻性 CKD 队列。使用倾向评分匹配，目标 1 将检查保守治疗与透析之间的关联死亡率和住院治疗（共同主要结果）以及熟练护理设施安置的过渡，两个大型 OptumLabs 和 VA 的重症监护入院率和医疗费用（次要结果）每个队列都有超过 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来预测个体生存和住院的可能性在 116 名 4-5 期 CKD 患者的前瞻性队列中，目标 3 将是保守治疗与透析。比较保守治疗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）使用经过验证的仪器进行严格的协议数据收集，我们的研究结果将产生重大影响。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者，为临床指南提供严格的证据保守治疗，以及 3) 为渴望提供免透析治疗的临床实践模型提供信息作为一种与患者选择相一致的方法，该方法基于美国推进美国肾脏健康倡议。