RESUMO
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. This 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, and 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. This 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.
Assuntos
Pacotes de Assistência ao Paciente , Úlcera por Pressão , Adulto , Humanos , Idoso , Adulto Jovem , Análise Custo-Benefício , Análise de Custo-Efetividade , Úlcera por Pressão/prevenção & controle , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
Purpose: Multiple falls preventions exercise programs have been rolled out globally, however, few studies have explored the factors necessary for their implementation. This study aimed to investigate the factors influencing the implementation of "Steady Feet" (SF), a 12-week community fall prevention exercise intervention, for older adults living in Singapore. Material and Methods: This study utilized purposive sampling to recruit two participant groups: (i) older adults who declined or withdrew from the program and (ii) providers of the program (eg, instructors). We conducted 22 semi-structured interviews, recordings were transcribed and translated, followed by thematic analysis. Data collection and analysis were informed by the PRECEDE-PROCEED framework, focusing on predisposing, enabling, and reinforcing factors. Results: Findings revealed two predisposing, four enabling, and two reinforcing themes. Predisposing themes encompassed (i) knowledge, attitudes, and practices of older adults towards exercises and falls prevention, and (ii) perceptions and attitudes of providers towards SF. Both older adults and providers identified several enabling elements in implementing SF, emphasizing the significance of (i) accessibility, availability, and affordability. Providers highlighted (ii) tools and structural support for continual engagement, (iii) minimizing variations in capabilities through a competency development program, and (iv) fostering synergistic partnerships. Positive reinforcement included (i) the role of providers in engaging and promoting participation, (ii) family support, social networks, and (iii) incentives for older adults. Conversely, both groups highlighted negative reinforcements, including (iv) communication issues and (v) repetitive exercises, while providers specifically identified (vi) labor constraints as a deterrent for implementation. Conclusion: Findings indicate that effective implementation necessitates a multifaceted approach. Promoting participation involves engaging instructors, emphasizing social bonds and family involvement, offering incentives, and providing subsidized or free classes. A competency development program proved effective in reducing variations in providers' capabilities. Strengthening community partnerships, with management support, was crucial for ensuring the availability and accessibility of falls prevention programs.