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.

项目总结 这份重新提交的K23申请描述了申请人申纳的背景和经历 Gazaway博士，RN和她计划获得必要的技能，成为一名领先的独立科学家 重点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，以改进 慢性肾病(CKD)患者及其家庭照顾者的上游决策。这个 拟议的研究是至关重要的，因为：1)CKD患者及其家庭成员有许多 与健康相关的决策相关的未得到满足的需求，以及2)稀少的先前工作检查了 健康相关决策的基础机制或调查哪些利益攸关方知情 干预组件可以产生积极的效果，同时也是可扩展的。具体的培训目标 K23的目的是在以下方面获得高级专业知识和技能：1)领导设计、实施和统计分析 在多阶段优化策略(MOST)框架内优化临床试验；2)开发 利益攸关方知情的、针对高级CKD人群的早期决策支持干预；以及3)培训 人类受试者研究中的高级伦理。实现这些培训目标将使Gazaway博士能够 实现K23的总体目标，即进行试点随机23因素试验，以测试 早期健康相关决策支持培训干预-传授(改善CKD决策伙伴关系 对于患有4期慢性肾脏病的成年人和他们的照顾者。传授的目标将是训练CKD二元体 具备在激活状态下驾驭高级CKD所需的决策、合作伙伴关系和沟通技能 在面临与健康有关的重大决定(例如，肾脏移植、透析、临终决定)之前，应与合作伙伴合作。一个 在高年级导师团队的指导下，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，正式的课程/研讨会，临床 试验观察和出席会议。与6人利益相关者小组(CKD)合作 患者、护理者和临床医生)，我们将最终确定用于试验的传授组件和组件级别。这个 本K23的具体目标是：1)确定精细化干预组件的可接受性和可行性 在超过24周的二联体样本中，使用先导析因设计和2)来探索其初步疗效 个体干预成分对患者和照顾者在24周内决策冲突结果的影响 (主要结果)。这些拟议活动的结果将直接支持R01应用程序 进行一项完全有效的最大因素试验，以测试个别给药成分对CKD患者的影响 和照顾者的结果。

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.