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. 项目概要/摘要 美国有超过 750,000 人患有肾衰竭，大多数人接受血液透析治疗。尽管有证据表明—— 基于指南建议通过动静脉 (AV) 血管通路（瘘管或 移植），80％的美国患者开始使用中心静脉导管进行血液透析，导致显着的发病率， 死亡率和医疗保健系统费用。此外，及时创作方面存在明显的种族差异 AV 访问。尽管黑人患者开始接受瘘管血液透析的可能性比白人患者低 20%， 平均而言，更年轻并且合并症更少。患者报告推迟了 AV 通路手术 因为恐惧、不愿意开始透析、担心毁容、针头和疼痛，以及 对血管通路了解不够。迄今为止，旨在增加对 透析前 AV 通路创建的基于证据的建议侧重于系统而不是 患者，未满足患者有据可查的教育和情感需求。我们的中央 假设通过量身定制的 AV 访问教育和支持来加强患者的准备将 提高血液透析开始前建立 AV 通道的比率并减少种族差异。运用得好—— 建立框架后，我们将对经过用户测试的、 有效的教育包，提供血管通路健康信息并验证普通患者 情绪，通过动机访谈（MI）增强或不增强。具体来说，我们将进行 3 组、平行组、3 种教育策略的随机试验：重点血管通路教育 （教育）、MI 增强血管通路教育 (Education-Plus)，以及无重点血管通路 对两个卫生系统的晚期 CKD 患者进行教育（常规护理），以 1) 比较 教育、教育强化和常规护理对于增加患有预科疾病的患者比例的有效性 透析 AV 通路的创建，以及 2) 确定影响教育策略实施的因素 以指导其公平地转化为非审判环境。我们将通过以下方式评估教育策略： 检查 RE-AIM 框架的相关要素：范围、有效性和实施。 重要的是，我们将确定这些元素对于黑人和白人患者是否以及为何不同。这 研究将产生以患者为中心的教育策略的关键有效性数据，以改善血管 获取成果以及有关实施的可行信息，这将加速公平采用 我们的研究结果，解决了血管通路护理方面的差异，并为其他教育内容的提供提供了信息 晚期 CKD 患者。