A Patient-centered, System-based Approach to Improve Informed Dialysis Choice and Outcomes in Veterans with CKD

背景：慢性肾脏病是退伍军人中第四常见的诊断。每年有13,000名退伍军人过渡 转到ESRD。VHA支持超过52,000名ESRD退伍军人进行透析。CKD的护理花费了VHA超过180亿美元 每年1美元。这些退伍军人的过渡护理是不协调的，而且不是最好的，因为大多数人都接受了他们的前 VHA内的ESRD护理，但超过90%的透析是按费用外包的。因此，大多数人 进入ESRD的退伍军人对CKD及其管理选项的认识有限，包括 透析方式。这导致家庭透析(HOD)的严重使用不足(7%)。专业肾脏学会和 VHA国家CKD计划倡导知情的透析选择，并为所有患者更多地使用HOD 正在过渡到ESRD。欧洲和加拿大的报告显示，CPE使患者能够在知情的情况下选择透析， 增加HOD使用率，并提高CKD护理质量。然而，在VHA内CPE的可用性是有限的 而且HOD利用率很低。为了解决这些问题，我们开发了一个简明的CPE模型并进行了试点测试 在两所不同的大学和佛罗里达州和阿肯色州的附属退伍军人管理局。我们的初步研究结果表明，CPE 改善患者知情的透析选择，将HOD选择增加到74%，HOD使用增加到61%。在一个 单独的试点研究，我们发现TELE-CPE与F2F-CPE一样有效。目标：本项目的总体目标 RCT是为了调查CPE对患者知识和信心、HOD选择和使用的影响，以及 一组被诊断为慢性肾脏病的退伍军人的患者报告、健康服务和临床结果 并接受北佛罗里达州/南乔治亚州退伍军人健康系统(NF/SG VHS)的CKD治疗。这个 这项研究与HSR&D的主要研究重点保持一致，包括“以患者为中心的护理、护理管理和 “促进健康”和“医疗保健系统改变”。4个具体目标是：目标1：比较 CPE对退伍军人慢性肾脏病知识、对透析决策的信心及选择治疗方案的影响 透析方式，在CPE组和常规护理组之间。目标2：比较退伍军人对住房的实际使用情况 (主要结果)CPE组和常规护理组之间的差异。目标3：检查退伍军人的满意度 通过CPE，了解他们对F2F或Tele-CPE的偏好，并调查 选择和使用他们喜欢的透析方式。(定性)目标4：比较以下ESRD后 CPE组和常规护理组之间的次要结果。患者报告的结果：1)与健康相关 生活质量和对透析的满意度；临床结果：3)终末期肾病的时间，4)估计的肾小球 ESRD时的滤过率，5)住院患者开始透析的需要，以及6)ESRD时的血管通路状况； 卫生服务利用结果：7)住院次数，8)门诊次数，从 注册至ESRD后90天。方法：在这种混合方法RCT中，我们将招收800名退伍军人和 4期或5期慢性肾脏病，≥18岁，会说英语，尚未接受透析，接受慢性肾脏病治疗 NF/SG VHS。按照1：1的比例，所有同意的退伍军人将被随机分配到干预(CPE)或 对照组(加强日常护理或EUC)。对于目标1，将对模型进行多元回归分析 风险调整后干预后CKD知识和信心对退伍军人透析决策的影响 目的2.运用Logistic回归分析比较CPE和EUC在HOD选择和使用上的差异 组。目标3将是一项定性研究，使用半结构化访谈来获得关于退伍军人的深入数据 对CPE的满意度、对CPE交付的偏好以及选择和使用的障碍和促进者 透析。对于目标4，将使用多元回归分析来模拟CPE、HOD、 结果上的群体-通道交互作用。预期结果：我们预计CPE将增强 退伍军人对知情透析选择的CKD知识和信心，并增加HOD的使用，导致 改善退伍军人和卫生服务的结果。下一步：如果成功，这项研究可能会提供一个 推出战略，以满足退伍军人的CKD护理需求，并降低VHA医疗成本。

Background: CKD is the 4th most common diagnosis among Veterans. Each year 13,000 Veterans transition to ESRD. VHA supports over 52,000 ESRD Veterans on dialysis. The care of CKD costs VHA over $18 billion dollars annually. Transition care of these Veterans is uncoordinated and suboptimal as most receive their pre- ESRD care within VHA but over 90% are outsourced for their dialysis, on fee-basis. Thus, the majority of Veterans progressing to ESRD have limited awareness of CKD and its management options including the dialysis modalities. This leads to gross underuse (7%) of home dialysis (HoD). Professional renal societies and VHA national CKD program advocate informed dialysis choice, and greater use of HoD for all patients transitioning to ESRD. European and Canadian reports show that CPE empowers informed choice of dialysis, increases HoD use, and improves the quality of CKD care. However, availability of CPE within VHA is limited and HoD utilization is low. To address these issues, we have developed and pilot-tested a concise CPE model in two different universities and affiliated VA in Florida and Arkansas. Our preliminary findings show that CPE improves patient informed dialysis choice, and increases HoD selection to 74% and HoD use to 61%. In a separate pilot study, we found that tele-CPE is as efficacious as F2F-CPE. Objectives: The overall goal of this RCT is to investigate the impact of CPE on patient knowledge and confidence, HoD selection and use, and patient-reported, health services and clinical outcomes in a cohort of Veterans who were diagnosed with CKD and receive CKD treatment from the North Florida/South Georgia Veterans Health System (NF/SG VHS). The study aligns with HSR&D major research priorities including “patient-centered care, care management, and health promotion” and “health care systems change.” The 4 Specific Aims are: Aim 1: Compare the impact of CPE on Veterans’ knowledge of CKD, their confidence in dialysis decision making, and their selection of dialysis modality, between the CPE and usual care groups. Aim 2: Compare Veterans’ actual use of HoD (Primary Outcome) between the CPE and usual care groups. Aim 3: Examine Veterans’ perceived satisfaction with CPE, explore their preferences for F2F- or Tele-CPE, and investigate barriers and facilitators in the selection and use of their preferred dialysis modality. (Qualitative) Aim 4: Compare the following post-ESRD secondary outcomes between the CPE and usual care groups. Patient reported outcomes: 1) health-related quality of life and 2) satisfaction with dialysis; clinical outcomes: 3) time to ESRD, 4) estimated glomerular filtration rate at ESRD, 5) need for inpatient initiation of dialysis, and 6) vascular access status at ESRD; and health services utilization outcomes: 7) number of inpatient stays, and 8) number of outpatient visits, from enrollment to 90-day post ESRD period. Methods: In this mixed method RCT, we will enroll 800 Veterans with stage 4 or 5 CKD, ≥18 years of age, English speaking, and not yet on dialysis who receive CKD care from NF/SG VHS. In 1:1 ratio, all the consented Veterans will be randomly allocated into intervention (CPE) or control (enhanced usual care or EUC) group. For Aim 1, multiple regression analysis will be applied to model the risk-adjusted post-intervention CKD knowledge and confidence in Veteran dialysis decision making; For Aim 2, logistic regression will be used to compare the HoD selection and use between the CPE and EUC groups. Aim 3 will be a qualitative study using semi-structured interviews to obtain in-depth data on Veterans’ satisfaction with CPE, preference for CPE delivery, and barriers and facilitators to HoD selection and use as a dialysis. For Aim 4, multiple regression analysis will be applied to model the risk-adjusted effects of CPE, HoD, and the group-modality interaction on outcomes. Expected Results: We anticipate that CPE will enhance Veterans’ CKD knowledge and confidence for informed dialysis selection, and increase HoD use, leading to improved Veterans’ and health services outcomes. Next Step: If successful, this study may deliver a ready to roll-out strategy to meet the CKD care needs of the Veterans and reduce VHA healthcare costs.