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.

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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.