A Hybrid Type 1 Effectiveness-Implementation Study of Education Strategies for Vascular Access Creation in Advanced Kidney Disease

晚期肾病血管通路创建教育策略的混合 1 型有效性实施研究

• 批准号: 10583058
• 负责人: DEIDRA CANDICE CREWS
• 金额: $ 73.49万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-01-01 至 2027-12-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10583058
• 关键词: Acceleration; Address; Adherence; Adoption; Black race; Blood Vessels; Caring; Catheters; Cessation of life; Characteristics; Chronic Disease; Chronic Kidney Failure; Clinic; Cohort Studies; Complex; Consensus; Counseling; Data; Data Coordinating Center; Dedications; Dialysis procedure; Disparity; Education; Effectiveness; Elements; Emotional; Emotions; Enrollment; Equity; Evaluation; Fistula; Fright; Funding; General Population; Guidelines; Health; Health Services Accessibility; Health behavior; Health system; Healthcare Systems; Hemodialysis; Hospitalization; Hybrids; Intervention; Kidney Diseases; Kidney Failure; Knowledge; Methods; Mission; Morbidity - disease rate; National Institute of Diabetes and Digestive and Kidney Diseases; Needles; North Carolina; Operative Surgical Procedures; Outcome; Pain; Patient Education; Patient Outcomes Assessments; Patient-Focused Outcomes; Patients; Pennsylvania; Persons; Population; Population Heterogeneity; Process; Provider; Race; Randomized, Controlled Trials; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Readiness; Recommendation; Reporting; Research; Screening for cancer; Self Efficacy; System; Testing; Translations; Uncertainty; Vaccines; Venous; arm; black patient; combat; comorbidity; compare effectiveness; coping; design; dietary; education access; effectiveness/implementation study; evidence base; evidence based guidelines; experience; health disparity; implementation evaluation; implementation strategy; improved; intrinsic motivation; mortality; motivational enhancement therapy; primary outcome; programs; racial disparity; racial minority population; randomized trial; secondary outcome; sociodemographics; treatment as usual; uptake

7. PROJECT SUMMARY/ ABSTRACT Over 750,000 people in the US have kidney failure, and most are treated with hemodialysis. Despite evidence- based guidelines recommending hemodialysis initiation via an arteriovenous (AV) vascular access (fistula or graft), 80% of US patients start hemodialysis with a central venous catheter, resulting in significant morbidity, mortality, and healthcare system expense. Additionally, there are stark racial disparities in the timely creation of AV access. Black patients are 20% less likely than White patients to start hemodialysis with a fistula despite, on average, being younger and having fewer comorbidities. Patients report delaying AV access surgery because of fear, reluctance to start dialysis, and worries about disfigurement, needles, and pain, as well as having an insufficient understanding of vascular access. To date, interventions aiming to increase uptake of the evidence-based recommendation for pre-dialysis AV access creation have focused on systems rather than patients, leaving unmet the well-documented educational and emotional needs of patients. Our central hypothesis is that strengthening patient preparedness through tailored AV access education and support will improve rates of AV access creation prior to hemodialysis initiation and reduce racial disparities. Applying well- established frameworks, we will conduct a hybrid type 1 effectiveness-implementation study of a user-tested, efficacious education package that provides vascular access health information and validates common patient emotions, with and without augmentation through motivational interviewing (MI). Specifically, we will conduct a 3-arm, parallel group, randomized trial of 3 education strategies: focused vascular access education (Education), MI-enhanced vascular access education (Education-Plus), and no focused vascular access education (Usual Care) among patients with advanced CKD at two health systems to 1) compare the effectiveness of Education, Education-Plus, and Usual Care for increasing the proportion of patients with pre- dialysis AV access creation, and 2) identify factors influencing the implementation of the education strategies in order to guide their equitable translation to the non-trial setting. We will evaluate the education strategies by examining relevant elements of the RE-AIM framework: Reach, Effectiveness, and Implementation. Importantly, we will determine whether and why these elements differ for Black and White patients. This research will yield critical effectiveness data about patient-focused education strategies to improve vascular access outcomes, and actionable information about implementation that will accelerate the equitable uptake of our findings, address disparities in vascular access care, and inform the delivery of other education content to patients with advanced CKD.

7。项目摘要/摘要 在美国，超过75万人患有肾衰竭，大多数人都接受了血液透析治疗。尽管有证据 - 基于基于动静脉（AV）血管通道（瘘管或瘘管或 移植物），美国80％的患者开始使用中央静脉导管开始血液透析，导致明显的发病率， 死亡率和医疗保健系统费用。此外，及时创造的种族差异很明显 AV访问。黑人患者的可能性比白人患者低20％，尽管 平均年轻，合并症更少。患者报告延迟AV访问手术 由于恐惧，不愿开始透析以及担心毁容，针和痛苦以及 对血管通道的了解不足。迄今为止，旨在增加吸收的干预措施 基于证据的透析前AV访问创建的建议专注于系统，而不是 患者留下了未满足患者的据可记录的教育和情感需求。我们的中心 假设是通过量身定制的AV访问教育加强患者的准备 提高血液透析启动之前的AV访问率并降低种族差异。应用良好 既定的框架，我们将对经过用户测试的，一个型1型有效性研究研究 有效的教育计划，提供血管访问健康信息并验证常见患者 通过动机访谈（MI），情绪，没有增强。具体来说，我们将进行 3臂，平行组，3种教育策略的随机试验：重点血管通道教育 （教育），MI增强血管通道教育（教育程度），没有集中的血管通道 在两个卫生系统的高级CKD患者中的教育（通常护理）与1）比较 教育的有效性，教育加和通常的护理，以增加患有前的患者的比例 透析AV访问创建，以及2）确定影响教育策略实施的因素 为了指导其公平的翻译为非试验环境。我们将通过 检查RE-AIM框架的相关要素：覆盖范围，有效性和实施。 重要的是，我们将确定黑白患者这些元素是否有所不同。这 研究将产生有关以患者为中心的教育策略的关键有效性数据，以改善血管 访问结果以及有关实施的可行信息，这些信息将加速 我们的发现，解决血管访问护理中的差异，并告知其他教育内容的交付 晚期CKD患者。