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

以患者为中心、基于系统的方法，改善 CKD 退伍军人的知情透析选择和结果

• 批准号: 10376724
• 负责人: Huanguang Jia
• 金额: --
• 依托单位: VETERANS HEALTH ADMINISTRATION
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-03-01 至 2025-09-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10376724
• 关键词: 18 year old; Address; Advocate; Arkansas; Awareness; Blood Vessels; Canada; Caring; Chronic Care; Chronic Kidney Failure; Clinical; Clinical Services; Consent; Cost of Illness; Data; Decision Making; Diagnosis; Dialysis procedure; Disease; Disease Outcome; Education; Educational Intervention; Effectiveness; End stage renal failure; Enrollment; Europe; European; Fees; Florida; Glomerular Filtration Rate; Goals; Health Care Costs; Health Promotion; Health Services; Health Services Accessibility; Health system; Healthcare; Healthcare Systems; Home; Improve Access; Inpatients; Intervention; Interview; Kidney; Knowledge; Lead; Learning; Logistic Regressions; Methods; Modality; Modeling; Outcome; Outpatients; Patient Education; Patient Outcomes Assessments; Patient-Centered Care; Patients; Persons; Pilot Projects; Preparation; Protocols documentation; Regression Analysis; Reporting; Research Priority; Risk; Services; Societies; Structure; System; Telemedicine; Time; Universities; Veterans; Visit; base; care costs; cohort; cost; empowered; evidence base; health related quality of life; health service use; improved; meetings; mortality; patient oriented; pilot test; post intervention; preference; primary outcome; programs; prospective; rural area; satisfaction; secondary outcome; treatment as usual; urban area

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.

背景：CKD 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。 VHA 支持超过 52,000 名 ESRD 退伍军人接受透析治疗 CKD 的费用超过 180 亿美元。 这些退伍军人的过渡护理不协调且欠佳，因为大多数人都接受了预护理。 ESRD 护理在 VHA 内进行，但 90% 以上的透析是按收费外包的。 进展至 ESRD 的退伍军人对 CKD 及其管理方案（包括 这导致家庭透析 (HoD) 的使用严重不足 (7%)。 VHA 国家 CKD 计划提倡知情的透析选择，并为所有患者更多地使用 HoD 欧洲和加拿大的报告表明，CPE 有助于明智地选择透析， 增加 HoD 的使用，并提高 CKD 护理的质量 然而，VHA 内 CPE 的可用性有限。 为了解决这些问题，我们开发并试点了一个简洁的CPE模型。 我们的初步调查结果表明，CPE 是在佛罗里达州和阿肯色州的两所不同的大学和附属 VA 中进行的。 改善患者知情的透析选择，并将 HoD 选择率提高到 74%，HoD 使用率提高到 61%。 在单独的试点研究中，我们发现远程 CPE 与 F2F-CPE 一样有效。 目标： 本次的总体目标。 RCT 旨在调查 CPE 对患者知识和信心、HoD 选择和使用以及 被诊断患有 CKD 的退伍军人队列中的患者报告、卫生服务和临床结果 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。 该研究与 HSR&D 的主要研究重点相一致，包括“以患者为中心的护理、护理管理和 “健康促进”和“医疗保健系统变革”。这 4 个具体目标是： 目标 1：比较 CPE 了解退伍军人对 CKD 的了解、他们对透析决策的信心以及他们的选择 目标 2：比较退伍军人对 HoD 的实际使用情况。 CPE 和常规护理小组之间的（主要结果）目标 3：检查退伍军人的感知满意度。 与 CPE 合作，探索他们对 F2F 或远程 CPE 的偏好，并调查该过程中的障碍和促进因素 选择和使用他们首选的透析方式（定性） 目标 4：比较以下 ESRD 后的情况。 CPE 和常规护理组之间的次要结果：1) 与健康相关的结果。 生活质量和 2) 透析满意度；3) 终末期肾病 (ESRD) 时间，4) 估计肾小球 ESRD 时的滤过率，5) 住院患者开始透析的需要，以及 6) ESRD 时的血管通路状态；以及 卫生服务利用结果：7) 住院人数，以及 8) 门诊就诊人数，从 方法：在这个混合方法随机对照试验中，我们将招募 800 名退伍军人 4 期或 5 期 CKD、≥18 岁、会说英语、尚未接受透析且接受 CKD 护理的 NF/SG VHS 按 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 对于目标 1，将对对照组（强化常规护理或 EUC）组应用多元回归分析。 风险调整后干预后 CKD 知识和退伍军人透析决策的信心； 目标2，逻辑回归将用于比较CPE和EUC之间的HoD选择和使用 目标 3 将是一项定性研究，使用半结构化访谈来获取有关退伍军人的深入数据。 对 CPE 的满意度、对 CPE 交付的偏好以及 HoD 选择和使用的障碍和促进因素 对于目标 4，将应用多元回归分析来模拟 CPE、HoD、 预期结果：我们预计 CPE 将增强。 退伍军人的 CKD 知识和信心，有助于明智地选择透析，并增加 HoD 的使用，从而导致 改善退伍军人和医疗服务结果：如果成功，这项研究可能会提供一个准备。 推出战略以满足退伍军人的 CKD 护理需求并降低 VHA 医疗费用。