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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.

项目总结/文摘