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.

项目概要 这份K23申请重新提交描述了申请人Shena的背景和经历 Gazaway 博士、注册护士以及她获得成为领先独立科学家所需技能的计划 专注于开发和测试利益相关者的早期健康相关决策支持干预措施，以改善 慢性肾脏病（CKD）患者及其家庭护理人员的上游决策。 拟议的研究至关重要，因为：1）慢性肾病患者及其家庭成员有许多 与健康相关的决策相关的未满足的需求，以及 2) 稀疏的先前工作已经审查了 健康相关决策的潜在机制或调查了哪些利益相关者知情 干预措施可以产生积极的效果，同时也可以扩展具体的培训目标。 K23 的目标是获得以下方面的高级专业知识和技能：1) 领导设计、实施和统计分析 多阶段优化策略 (MOST) 框架内的优化临床试验 2) 开发； 对晚期 CKD 人群进行利益相关者知情的早期决策支持干预；以及 3) 培训； 满足这些培训目标将使 Gazaway 博士能够 实现 K23 的总体目标，进行试点随机 23 因子试验来测试 早期健康相关决策支持培训干预 –ImPart（改善 CKD 的决策伙伴关系） ImPart 的目标是培训 CKD 双人组。 具有激活高级 CKD 所需的决策伙伴关系和沟通技巧 在面临重大健康相关决策（例如肾移植、透析、临终决策）之前与合作伙伴进行沟通 A。 在资深导师团队的指导下制定了全面的培训计划 该计划包括密集的一对一指导、正式课程/研讨会、临床。 与 6 名利益相关者团体 (CKD) 合作进行试验观察和参加会议。 患者、护理人员和圣徒），我们将最终确定用于试点的 ImPart 组件和组件级别。 K23 的具体目标是 - 1) 确定改进的干预措施的可接受性和可行性 在 24 周内使用试点因子设计对 64 个二元组进行样本分析，并 2) 探索初步功效 24 周内个体干预措施对患者和护理人员决策冲突结果的影响 （主要成果）。这些拟议活动的结果将直接支持 R01 申请。 进行全面的 MOST 析因试验，以测试各个 ImPart 组件对 CKD 患者的影响 和护理人员的结果。