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申请重新提交描述了申请人Shena的背景和经验 Gazaway博士，RN，以及她计划获得必要的技能，成为一名领先的独立科学家 侧重于开发和测试利益攸关方，与健康有关的早期决策支持干预措施，以改善 慢性肾脏病（CKD）患者及其家庭照顾者的上游决策。的 建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 未满足的需求与卫生相关的决策，2）稀疏的先前的工作已经审查了 健康相关决策的基础机制或调查机制， 干预组成部分可以产生积极的效果，同时也是可扩展的。具体培训目标 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人群进行知情的早期决策支持干预;以及3） 人类研究中的先进伦理。满足这些培训目标将使Gazaway博士能够 实现K23的总体目标，进行一项试点随机23析因试验，以测试 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 二对）的成人生活与阶段4 CKD和他们的照顾者。ImPart的目标是训练CKD二联体 具有必要的决策伙伴关系和沟通技能，以在激活时驾驭高级CKD 在面临与健康有关的重大决定之前（例如，肾移植、透析、生命终结决定）。一 在资深导师团队的指导下， 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 审判权和会议出席率。与一个由6名成员组成的利益相关者小组（CKD）合作 患者、护理人员和临床医生），我们将最终确定ImPart组件和组件级别以进行试点。的 本K23的具体目标是：1）确定改进的干预组件的可接受性和可行性 使用试点析因设计在24周内对64个二元组进行样本分析; 2）探索初步疗效 在24周内，个体干预成分对患者和护理人员决策冲突的影响 （主要成果）。这些建议活动的结果将直接支持R 01应用程序， 进行一项充分把握度的MOST析因试验，以测试单个ImPart组件对CKD患者的影响 和照顾者的结果。