Abstract
BACKGROUND: Most randomized controlled trials (RCTs) on advance care planning (ACP) focus on advanced cancer, while evidence for dialysis patients with end-stage renal disease (ESRD) remains limited. This study aimed to evaluate the effectiveness of a structured educational intervention in enhancing ACP engagement among dialysis patients. METHODS: The VOICE study, an RCT, was conducted at the Central Hospital of Wuhan. Initially, 117 patients were enrolled; ultimately, data from 50 participants in the intervention group and 52 in the control group were included in the final analysis. Patients in the control group received standard care, while those in the intervention group received a structured ACP intervention specifically tailored to the needs of ESRD patients. The primary outcome assessed in the study was decisional conflict, evaluated through the use of the Decisional Conflict Scale (DCS). Secondary outcomes included ACP engagement (ACPES), attitudes toward death (DAP-R), and quality of life (KDQOL-36™). RESULTS: After six weeks, the intervention group showed significant but small reductions in the DCS Uncertainty subscale (P = 0.001, Cohen's d=-0.17), and improvements in the Informed (P = 0.049, Cohen's d=-0.12), Values Clarity (P = 0.003, Cohen's d=-0.11), and Effective Decision (P = 0.012, Cohen's d=-0.12) subscales. Regarding secondary outcomes, the intervention group demonstrated significantly higher scores across all ACP engagement domains (P < 0.05), reduced fear of death and death avoidance, and greater natural acceptance of death (all P < 0.05). Moreover, the intervention group reported significantly better quality of life, particularly in the Effects of Kidney Disease and Burden of Kidney Disease subscales (P < 0.05). CONCLUSION: The VOICE ACP intervention improved short-term ACP engagement and led to modest improvements in several domains of decisional conflict in dialysis patients. Future multicenter, longitudinal trials are warranted to evaluate the sustainability and cost-effectiveness of such interventions. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR2500097890. Registered 27 February 2025.