Abstract
BACKGROUND: In non-nephrology settings, specialty palliative care (PC) improves decision making, patient's quality of life (QoL), advance care planning, and certain indicators of the quality of end-of-life (EoL) care. This pilot randomized control trial (RCT) explored the feasibility and acceptability of a PC intervention, CKD-EDU, for adults aged 75 years and older with eGFR ≤25 ml/min and their caregivers. METHODS: Participants randomized to the control group received standard nephrology care and routine kidney therapy education, whereas those randomized to CKD-EDU received a decision aid and met with a PC clinician up to three times to discuss kidney therapy decisions and EoL planning. Patients were assessed at baseline, 4–6, 12–14, and 24–26 weeks. Main outcomes included intervention feasibility and acceptability, decision conflict, and patient QoL. The mediating effects of reduced decision conflict on improved QoL were explored, as were the effects of CKD-EDU on advance care planning, EoL treatment intensity, and 6-month hospitalization. Statistical analyses encompassed descriptive analyses, adjusted repeated-measure models, mediation analyses, and logistic regression models. RESULTS: Among the 127 eligible patients screened, 58 (46%) consented: 30 were randomized to CKD-EDU and 28 to the control arm. All patients completed baseline assessments and 89% completed at least 1 intervention session (n=26/29), underscoring intervention adherence and feasibility. Similarly, assessment completion rates at 4 (83%, n=45/54), 12 (93%, n=42/45), and 24 (95%, n=40/42) weeks were high. The intervention received over 85% acceptability ratings for all questions. Patients exposed to CKD-EDU exhibited significant improvement in Decisional Conflict Scale scores (P = 0.003) at 4–6 weeks and improvements in QoL at 24–26 weeks (P = 0.02). Exploratory analyses were not statistically significant in this pilot study, but all effect sizes were in the predicted direction. CONCLUSIONS: This study demonstrates the feasibility and acceptability of CKD-EDU. A larger scale trial is warranted to assess its effectiveness in improving key outcomes important to patients and families.