A Pilot Randomized Controlled Trial of Integrated Nephrology and Palliative Care Implemented at a Safety-Net Hospital

Rationale & Objective Randomized controlled trials (RCTs) show that integrated palliative care can improve symptoms compared with usual care in many serious illnesses, yet there are no comparable RCTs in chronic kidney disease (CKD). Study Design We conducted a pilot feasibility RCT comparing kidney palliative care (KPC) integrated with CKD care with usual CKD care. Setting & Participants English and Spanish speakers aged ≥18 years with CKD stage IV and V, or receiving dialysis, seen at an urban safety-net hospital. Exposures Participants were randomized to usual CKD care or to usual CKD care plus 6-monthly ambulatory KPC visits. Outcomes Primary outcomes were feasibility of recruitment, retention, intervention delivery, and data collection. Secondary outcomes included change in symptom burden at 6 months, measured by the Integrated Palliative Outcome Scale (IPOS)-Renal (lower scores represent lower burden), quality of life measured by the Kidney Disease Quality of Life 36-item survey, and engagement in advance care planning. Analytical Approach Feasibility outcomes are reported as proportions and clinical outcomes as descriptive summaries of change in scores. Results Of the 146 people approached, 84 (56%) consented, 75 (89%) were randomized, and 57 (76%) completed the trial. 56% of participants were Hispanic and 32% were Black, with 49% on Medicaid and 13% uninsured. The mean age of participants was 61 years, and 31% were receiving dialysis. A mean of 4-6 intervention visits was attended. At 6 months, the intervention group had a 4.1-point decrease in IPOS score (standard deviation 13.4), whereas the mean IPOS score of the control group increased by 0.6 points (standard deviation 7.8) from baseline. Limitations Small sample size and limited number of providers to assess generalizability. Conclusions We demonstrate the feasibility of an RCT comparing integrated KPC with usual CKD care in a safety-net hospital. Although this study was not powered to detect significance in change of clinical outcomes, our findings suggest that there is value in testing KPC in efficacy trials and that these are feasible. Plain-Language Summary Chronic kidney disease (CKD) causes a substantial number of symptoms that can impair quality of life. Palliative care, a specialty that provides symptom management and assists with complex medical decisions, has been shown to improve symptoms in non--kidney-disease serious illnesses; however, there is no comparable evidence in CKD. To address this, we conducted a randomized controlled pilot feasibility trial comparing integrated palliative and CKD care with usual CKD care in a safety-net hospital among 75 diverse individuals with advanced CKD. We found that this approach was feasible, meeting thresholds for recruitment retention and data collection, setting the foundation for future, larger efficacy trials.