Evaluate the Feasibility and Effectiveness of a Community-based Care Bundle in Managing and Preventing Pressure Injuries
Evaluate the Feasibility and Effectiveness of a Community-based Care Bundle in Managing and Preventing Pressure Injuries
Community-acquired pressure injuries are pressure injuries that developed outside of hospital, typically in the patient's own home environment. Pressure injuries (PI) used to be commonly known as bedsores or pressure ulcers.
The goal of this clinical trial is to evaluate if a community-based pressure injury (PI) care bundle is effective in treating and preventing pressure injuries in home settings. It will also assess how feasible it is to implement this care bundle in Singapore's community care context.
The main questions it aims to answer are:
The investigators will compare the PI care bundle to routine care (control group) to see if the care bundle works better for managing pressure injuries at home. Success will be measured using the PUSH tool, which scores pressure injuries from 0 (completely healed) to 17 (most severe). A reduction of at least 3 points on this scale will indicate meaningful improvement.
Participants and their caregivers will:
Be split into two groups - one group will use the new care plan (receive the PI care bundle), and the other will continue with their routine care.
Have their pressure injuries checked regularly for 6 weeks. Have their caregivers learn about pressure injury care. Answer questions about how well the care plan works for them.
The investigator hopes this study will help find better ways to treat or prevent pressure injuries at home and support the caregivers at home.
STUDY DESIGN and METHODOLOGY
This is a randomized controlled trial evaluating a community-based pressure injury (PI) care bundle versus routine care. The study employs a waitlist-control design with a 6-week intervention period.
OUTCOME MEASUREMENTS
Primary Outcome:
Secondary Outcomes:
Feasibility metrics including:
TECHNICAL COMPONENTS OF CARE BUNDLE
The intervention group will receive:
DATA COLLECTION AND ANALYSIS
Standardized assessment tools for PI staging- PI staging follows National Pressure Injury Advisory Panel (NPIAP) standardized system.
Validated KAP questionnaires Feasibility assessment metrics Protocol adherence monitoring Dropout rate tracking
Statistical analysis comparing intervention versus control outcomes.
The study design incorporates rigorous methodology to evaluate both clinical effectiveness and implementation feasibility in the community setting, with specific attention to the unique challenges of home-based PI care management.
Inclusion Criteria
Exclusion Criteria
fazila.abu.bakar.aloweni@sgh.com.sg+65 6326 5796