Patient-Reported Outcome Measure (PROM) Utilization to Advance Patient Centered CKD Care - Project Summary Individuals living with chronic kidney disease (CKD) identify health-related quality of life (HRQOL), including symptom burden, as a top clinical and research priority; equal to, if not more important than death. Patient- reported outcome measures (PROMs) are tools to measure health status directly from the patient perspective. While existing PROMs validly and reliably measure symptoms and HRQOL in people with CKD, evidence demonstrating how regular use of such PROMs impacts biomedical and patient-reported outcomes is lacking, limiting the incorporation of PROMs into routine practice. This proposal seeks to demonstrate the clinical utility of PROMs in the care of persons with advanced CKD, thus facilitating the uptake of PROMs in practice and ultimately supporting more patient-centered care. We will examine PROM use across two specific domains: individualized risk stratification and symptom management. First, using data from two large, observational cohort studies of adults with CKD, we will develop and validate risk stratification models incorporating PROMs for use in persons with advanced CKD. Aim 1 will test the added predictive value of HRQOL indices to an existing CKD risk prediction tool for end-stage kidney disease and mortality. Aim 2 encompasses development and validation of a predictive model for HRQOL in the year following dialysis initiation as the outcome. The resulting models will enhance prediction of disease trajectory and promote shared decision-making. In the domain of symptom management, empirical support from other disciplines demonstrates improved HRQOL and decreased mortality among patients randomized to routine patient self-reporting of symptoms via use of electronic PROMs (ePROMs), with feedback of patient responses to clinicians. In Aim 3, we will conduct a randomized pilot trial assessing the implementation and preliminary efficacy of supported PROMs for regular symptom assessment among people with advanced CKD. 70 adult patients with advanced CKD (eGFR <20 mL/min/1.73m2) will be randomized (1:1) to an ePROM intervention or usual care. The ePROM intervention consists of patient symptom reporting using a validated PROM monthly for 12 months and feedback of responses to clinicians with guidance for symptom management. We will use quantitative and qualitative methods to evaluate implementation (reach, feasibility, acceptability) and preliminary efficacy (HRQOL) outcomes, with the long-term goal of optimizing the design of a larger, definitive trial testing the effectiveness of the ePROM intervention on HRQOL in non-dialysis CKD care. The research aims are integrated into a comprehensive training plan that includes practical mentored experiences and formal coursework to develop the PI’s skills in evaluating prediction models, designing and executing clinical trials, and performing mixed methods research with a specific focus on evaluating implementation outcomes. This skillset will build toward future independent patient-centered research of PROM- based interventions in pre-dialysis CKD management.
