Objective: To evaluate the impact of an individualized nutrition intervention package on pressure injury healing rates, prevention of new pressure injuries, complications, quality of life, and cost-effectiveness in adult on home nursing care with pressure injuries staged II and above in Singapore. Study

Design: A two-group, non-blinded, randomized, pragmatic clinical trial with a cost-effectiveness analysis. Location/ Setting: Community Participants: Adults (aged 21 years and above) receiving home nursing care with at least one pressure injury (Stage II, III, IV, or Unstageable). 190 subjects per arm Intervention: The intervention group will receive an individualized nutrition intervention package consisting of individualized nutritional supplementation, specialized nutritional education pamphlets, regular dietetic support via home visits or telehealth, and home nursing care by nurses trained in nutrition care. The control group will receive specialized nutritional educational pamphlets, and home nursing care by nurses trained in nutrition care, with or without nutritional supplementation. Outcome Measures: Main outcomes of wound area reduction, and proportion of participants with \>40% area reduction at 30 days, 60 days and 90 days. Secondary outcomes include proportion of participants and wounds with increasing severity of PI stages (e.g., stage II to stage III), improvement in Health-Related Quality of Life (HRQOL) and nutritional status, and incidence of wound infections at 30 days, 60 days and 90 days, proportion of participants with complete healing, mortality and unplanned hospital admissions. Economic Evaluation: The primary economic outcome will be the incremental cost-effectiveness ratio (ICER) per pressure injury prevented, with a time horizon of 1 year for intervention versus control during the period of intervention (3-months) and up to a year. Statistical Analyses: Individual patient level analysis will be performed as per our primary analysis, and we will also perform cluster level analysis. Hazard ratios (HR) will be determined using Cox proportional hazards models and their corresponding 95% Confidence Intervals (95%CI). Imbalances in individual level data will be accounted for using statistical adjustment in a Mixed-Effects Cox Regression model. Hypothesis: This study aims to provide evidence on the effectiveness and cost-effectiveness of a individualized and protocolized nutrition intervention package for pressure injury management in home care patients. The findings could inform the development of evidence-based guidelines and recommendations for nutritional care and education in this vulnerable population, ultimately leading to improved patient outcomes and reduced healthcare costs associated with pressure injuries.