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.项目总结/摘要 在美国，超过75万人患有肾衰竭，大多数人接受血液透析治疗。尽管有证据- 基于指南，建议通过动静脉（AV）血管通路（瘘或 移植物），80%的美国患者使用中心静脉导管开始血液透析，导致显著的发病率， 死亡率和医疗保健系统费用。此外，在及时创造的过程中， AV访问。黑人患者比白色患者开始使用瘘管进行血液透析的可能性低20%， 平均而言，更年轻，合并症更少。患者报告AV入路手术延迟 因为害怕，不愿意开始透析，担心毁容，针头和疼痛，以及 对血管通路的理解不足。迄今为止，旨在增加对《公约》 透析前AV通路创建的循证建议侧重于系统，而不是 病人的教育和情感需求得不到满足。我们的中央 假设通过量身定制的AV接入教育和支持来加强患者准备， 提高血液透析开始前AV通路建立率并减少种族差异。应用良好- 建立的框架，我们将进行一个混合类型1的有效性，实施研究的用户测试， 提供血管通路健康信息并验证普通患者的有效教育包 情绪，有和没有通过动机访谈（MI）增强。具体而言，我们将进行一项 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（教育+）和无重点血管通路 在两个卫生系统的晚期CKD患者中进行教育（家庭护理），1）比较 教育、教育+和家庭护理在增加产前疾病患者比例方面的有效性 建立透析AV通路，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战略： 审查RE-AIM框架的相关要素：覆盖范围、有效性和实施。 重要的是，我们将确定这些元素是否以及为什么在黑人和白色患者中存在差异。这 研究将产生关于以患者为中心的教育策略的关键有效性数据， 获得成果，以及关于执行情况的可采取行动的信息，这些信息将加速公平地吸收 我们的研究结果，解决血管通路护理的差距，并告知其他教育内容的交付， 晚期CKD患者。