The Clinical and Cost-Effectiveness of an Individualised Nutritional CAre (INCA) Bundle Versus Standard Care for Adults with Pressure Injuries Receiving Home Nursing Services: a Protocol for a Cluster Randomised, Pragmatic Clinical Trial with an Economic Evaluation.
Research Square (Research Square)(2023)
Abstract
Abstract Background: Pressure injuries (PIs) represent a significant healthcare challenge in Singapore among the aging population. These injuries contribute to increased morbidity, mortality, and healthcare expenditure. Existing research predominantly explores single-component interventions in hospital environments, often yielding limited success. The INCA Trial aims to address this research gap by conducting a comprehensive, cluster-randomized controlled trial that integrates education, individualized nutritional support, and community nursing care. The study is designed to evaluate clinical and cost-effectiveness outcomes, focusing on PI wound area reduction and incremental costs associated with the intervention. Methods: The INCA Trial employs a two-group, non-blinded, cluster-randomized, pragmatic clinical trial design, recruiting 380 adult individuals (age ≥ 21 years) living in the community with stage II, III, IV, and unstageable PI(s), who are receiving home-nursing service in Singapore. Cluster randomization is stratified by postal codes to minimize treatment contamination. The intervention arm will receive an individualized nutrition and nursing care bundle (dietary education with nutritional supplementation), while the control arm will receive standard care. The 90-day intervention will be followed by outcome assessments extending over one year. Primary outcomes include changes in PI wound area and the proportion of participants achieving a ≥ 40% area reduction. Secondary outcomes include health-related quality of life (HRQOL), nutritional status, and hospitalization rates. Data analysis will be conducted on an intention-to-treat (ITT) basis, supplemented by interim analyses for efficacy and futility and pre-specified sensitivity and subgroup analyses. The primary outcome for the cost-effectiveness analysis will be based on the change to total costs compared to the change to health benefits, as measured by quality-adjusted life years (QALYs). Discussion: The INCA Trial serves as a pioneering effort in its approach to PI management in community settings. The study uniquely emphasizes both clinical and economic outcomes and melds education, intensive dietetic support, and community nursing care for a holistic approach to enhancing PI management. Trial Registration: The trial is registered at www.clinicaltrials.gov (NCT06078488, 10 th October 2023).
MoreTranslated text
Key words
individualised nutritional care,bundle versus standard care,home nursing services,pressure injuries,cost-effectiveness
AI Read Science
Must-Reading Tree
Example
![](https://originalfileserver.aminer.cn/sys/aminer/pubs/mrt_preview.jpeg)
Generate MRT to find the research sequence of this paper
Chat Paper
Summary is being generated by the instructions you defined