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

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).

We conducted a pilot feasibility RCT comparing kidney palliative care (KPC) integrated with CKD care with usual CKD care.

English and Spanish speakers aged ≥18 years with CKD stage IV and V, or receiving dialysis, seen at an urban safety-net hospital.

Participants were randomized to usual CKD care or to usual CKD care plus 6-monthly ambulatory KPC visits.

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.

Feasibility outcomes are reported as proportions and clinical outcomes as descriptive summaries of change in scores.

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.

Small sample size and limited number of providers to assess generalizability.

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.