Improving Pragmatic Clinical Trials in the Hemodialysis Population: Ancillary Study of the HiLo Trial

Hemodialysis (HD) patients are a unique and vulnerable population with many comorbidities, high mortality, and poor quality of life. Impactful medical research to help HD patients is needed, yet many previous HD randomized clinical trials (RCTs) have been plagued by small sample sizes, poor adherence, and methodological issues that have limited their applicability. Moreover, focus on biochemical markers in end-stage renal disease care, such as phosphate or hemoglobin, often supplants more meaningful endpoints such as quality of life and symptoms. Patient-reported outcomes (PROs) can be used in RCTs to capture patients’ experiences with study interventions and promote patient-centered care, yet few RCTs in HD have successfully utilized PROs as study outcomes. Successful implementation of PROs into RCTs may demonstrate feasibility and increase the use of PROs by the nephrology research community. In addition, to ensure RCT quality, we need high enrollment rates among dialysis patients to maximize generalizability and ensure accuracy of results. There have been few studies in nephrology analyzing the characteristics of participants vs. non-participants in trials and the reasons behind patients’ non-participation. Identifying barriers to trial participation in the HD population would enable interventions to increase trial enrollment and retention. In this proposal, we aim to: 1. Incorporate PROs into the HiLo pragmatic clinical trial to evaluate the effects of phosphate levels on GI symptoms and kidney disease burden. We will administer surveys at baseline, 6 months, and 12 months. The surveys will be conducted via email or telephone according to patient preference. We will assess feasibility based on recruitment and drop-out rates. 2. Investigate predictors of HD patient participation in the HiLo Trial and barriers to enrollment. We propose to analyze patient-specific factors that predict study enrollment, conduct focus groups of research staff to explore thei