An Optimization trial of a stakeholder-enhanced intervention to improve the decisional partnership of Chronic Kidney Disease dyads using the multiphase optimization strategy: Project ImPart.

一项利益相关者增强干预的优化试验，旨在使用多阶段优化策略改善慢性肾脏病二人组的决策伙伴关系：Project ImPart。

• 批准号: 10739401
• 负责人: Shena Gazaway
• 金额: $ 17.07万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-01 至 2028-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10739401
• 关键词: Adult; Anxiety; Biopsy; Black race; Caregivers; Caring; Chronic Kidney Failure; Clinical Trials; Communication; Conflict (Psychology); Creatinine; Data; Data Collection; Decision Making; Dialysis procedure; Diet and Nutrition; Disease; Disease Management; Distress; Doctor of Philosophy; Educational Intervention; Educational workshop; Effectiveness; Equation; Equipment and supply inventories; Ethics; Exclusion; Family; Family Caregiver; Family member; Friends; Future; Glomerular Filtration Rate; Goals; Health; Hospitals; Human Subject Research; Individual; Intervention; Interview; Kidney Diseases; Kidney Transplantation; Knowledge; Literature; Measures; Medical; Mental Depression; Mentorship; National Institute of Diabetes and Digestive and Kidney Diseases; Newly Diagnosed; Outcome; Participant; Patient Education; Patients; Persons; Pharmaceutical Preparations; Population; Protocols documentation; Quality of life; Race; Randomized; Regimen; Reporting; Research; Resources; Sampling; Scientist; Social support; Statistical Data Interpretation; Testing; Training; Training Support; Trust; Vision; Work; advanced disease; burden of illness; care preference; caregiving; coping; design; dyadic interaction; end of life; expectation; experience; family support; improved; intervention refinement; meetings; member; multiphase optimization strategy; perceived discrimination; pilot test; post intervention; primary outcome; psychoeducation; psychoeducational; racial disparity; recruit; secondary outcome; shared decision making; skills; symposium; systematic review; telehealth; therapy design; therapy development

PROJECT SUMMARY This K23 application resubmission describes the background and experience of the applicant, Shena Gazaway, PhD, RN, and her plan to acquire the necessary skills to become a leading independent scientist focused on developing and testing stakeholder, early health-related decision support interventions to improve upstream decision-making among patients with chronic kidney disease (CKD) and their family caregivers. The proposed research is critical because: 1) persons living with CKD and their family members have numerous unmet needs related to health-related decision-making, and 2) sparse prior work has examined the mechanisms underlying health-related decision-making or investigated which stakeholder-informed intervention components can result in positive effects while also being scalable. The specific training objectives for the K23 are to gain advanced expertise and skills in: 1) leading the design, conduct, and statistical analysis of optimization clinical trials within the Multiphase Optimization Strategy (MOST) framework; 2) developing stakeholder-informed, early decision support interventions with advanced CKD populations; and 3) training in advanced ethics in human subjects research. Meeting these training objectives will enable Dr. Gazaway to achieve the overall goal of the K23 to conduct a pilot randomized 23 factorial trial to test components of an early health-related decision support training intervention –ImPart (Improving Decisional Partnership for CKD dyads) for adults living with stage 4 CKD and their caregivers. The goal of ImPart will be to train the CKD dyad with the decision partnership and communication skills necessary to navigate advanced CKD as activated partners before facing major health-related decisions (e.g., kidney transplant, dialysis, end-of-life decisions). A comprehensive training plan has been developed under the guidance of the mentorship team of senior research experts. The plan includes intensive one-on-one mentorship, formal coursework/workshops, clinical trial observerships, and conference attendance. In partnership with a 6-member stakeholder group (CKD patients, caregivers, and clinicians), we will finalize ImPart components and component levels for piloting. The specific aims of this K23 are - 1) to determine acceptability & feasibility of the refined intervention components in a sample of 64 dyads over 24 weeks using a pilot factorial design and 2) to explore the preliminary efficacy of individual intervention components on patient and caregiver outcomes over 24 weeks on decisional conflict (primary outcome). The results from these proposed activities will directly support an R01 application to conduct a fully powered MOST factorial trial to test the effects of individual ImPart components on CKD patient and caregiver outcomes.

项目摘要 此K23应用程序重新提交描述了该应用程序的背景和经验Shena Gazaway，PhD，RN以及她的计划，旨在获得必要的技能，成为领先的独立科学家 致力于开发和测试利益相关者，早期与健康相关的决策支持干预措施改善 慢性肾脏疾病（CKD）及其家庭护理人员的上游决策。这 拟议的研究至关重要，因为：1）与CKD及其家人在一起的人有很多 与健康相关的决策有关的未满足需求，以及2）稀疏的先前工作检查了 与健康相关的决策或调查了哪些利益相关者信息的机制 干预组件可能会产生积极影响，同时也可以扩展。特定的培训目标 因为K23将获得高级专业知识和技能：1）领导设计，行为和统计分析 在多相优化策略（大多数）框架内的优化临床试验； 2）发展 利益相关者信息的早期决策支持干预措施与高级CKD人群； 3）培训 人类受试者研究中的先进伦理学。达到这些培训目标将使Gazaway博士能够 实现K23的总体目标，以进行飞行员随机23阶乘试验，以测试一个组件 早期与健康有关的决策支持培训干预措施 - IMPART（改善CKD的决策合作伙伴关系 二元组）适用于与第4阶段CKD及其护理人员一起生活的成年人。授予的目标是训练CKD Dyad 凭借激活的高级CKD导航所需的决策伙伴关系和沟通技巧 在面对与健康相关的重大决定之前（例如，肾脏移植，透析，临终决定）之前的合作伙伴。 在高级训练团队的指导下制定了全面的培训计划 研究专家。该计划包括密集的一对一指导，正式课程/讲习班，临床 审判观察者和会议出席。与6人的利益相关者组（CKD）合作 患者，护理人员和临床医生），我们将最终确定授予企业的组件和组件水平。 该K23的具体目的是-1）确定精制干预组件的可接受性和可行性 在24周内使用试验阶乘设计的64个二元组样本和2）探索初步效率 在决定性冲突的24周内，对患者和照料者结果的个人干预组件的个人干预组件 （主要结果）。这些提议的活动的结果将直接支持R01应用程序 进行完全动力的大多数阶乘试验，以测试单个赋予组件对CKD患者的影响 和护理人员的结果。