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是退伍军人中第四最常见的诊断。每年有13,000名退伍军人过渡 到ESRD。 VHA在透析上支持超过52,000名ESRD退伍军人。 CKD的护理费用超过180亿美元 每年美元。这些退伍军人的过渡护理是不协调的，次优的 VHA内部的ESRD护理，但超过90％的透析外包在收费中。那是大多数 退伍军人晋级ESRD的认识及其管理方案的认识有限 透析方式。这导致家庭透析（HOD）的严重不足（7％）。专业肾脏社会和 VHA National CKD计划倡导者知情的透析选择，并为所有患者提供更多使用HOD 过渡到ESRD。欧洲和加拿大的报告显示，CPE赋予了知情的透析选择， 增加了HOD的使用，并提高了CKD护理的质量。但是，VHA中CPE的可用性有限 HOD利用率很低。为了解决这些问题，我们已经开发并进行了试点测试的简洁CPE模型 在两所不同的大学和佛罗里达州和阿肯色州的会员VA中。我们的初步发现表明CPE 改善患者知情的透析选择，并将HOD选择提高到74％，HOD使用到61％。在 单独的试点研究，我们发现Tele-CPE与F2F-CPE一样有效。目标：总体目标 RCT将研究CPE对患者知识和信心，选择和使用的影响，以及 被诊断为CKD的退伍军人队列中的患者报告，卫生服务和临床成果 并接受北佛罗里达州/佐治亚州退伍军人卫生系统（NF/SG VHS）的CKD治疗。这 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 健康促进”和“医疗保健系统的变化”。四个特定目的是：目标1：比较 CPE关于退伍军人对CKD的了解，他们对透析决策的信心以及选择 CPE和常规护理组之间的透析方式。目标2：比较退伍军人的实际使用 （主要结果）CPE和通常的护理组之间。目标3：检查退伍军人的感知满意度 使用CPE，探索他们对F2F-或Tele-CPE的偏好，并调查障碍和促进者 选择和使用其首选的透析方式。 （定性）目标4：比较以下之后 CPE和常规护理小组之间的次要结果。患者报告的结果：1）与健康有关 生活质量和2）对透析满意；临床结果：3）到ESRD的时间，4）估计的肾小球 ESRD的过滤速率，5）需要透析的住院入门，而6）ESRD的血管通道状态；和 卫生服务利用率：7）住院数量和8）门诊数量 ESRD后90天注册。方法：在这种混合方法RCT中，我们将注册800名退伍军人 第4阶段或5 ckd，≥18岁，英语说话，尚未从接受CKD护理的透析 NF/SG VHS。以1：1的比率，所有同意的退伍军人将被随机分配给干预措施（CPE）或 控制（增强的常规护理或EUC）组。对于AIM 1，将应用多元回归分析用于模型 经过风险调整后的干预后CKD知识和对退伍军人透析决策的信心；为了 AIM 2，逻辑回归将用于比较CPE和EUC之间的HOD选择和使用 组。 AIM 3将是使用半结构化访谈的定性研究，以获取有关退伍军人的深入数据 对CPE的满意度，对CPE交付的偏爱以及障碍和促进者选择HOD并用作 透析。对于AIM 4，将应用多元回归分析来建模CPE，HOD， 以及结果的群体模式互动。预期结果：我们预计CPE将会增强 退伍军人的CKD知识和信心，以了解知情的透析选择，并增加HOD的使用，从而导致 改善了退伍军人和卫生服务成果。下一步：如果成功，这项研究可能会准备好 推出策略，以满足退伍军人的CKD护理需求并降低VHA医疗保健成本。