Evaluate the Feasibility and Effectiveness of a Community-based Care Bundle in Managing and Preventing Pressure Injuries

Summary

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:

1. Does the PI care bundle help improve pressure injury healing (shown by at least a 3-point reduction on the PUSH score)?
2. Can the care bundle prevent the development of new pressure injuries?
3. How well do caregivers learn and apply PI care knowledge after receiving the educational intervention?
4. How practical and acceptable is this care bundle for use in home settings?

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.

Conditions

• Pressure Injuries
• Caregiver
• Community Dwelling Older Adult

Interventions

OTHER

community-based PI care bundle

The PI care bundle follows the aSSKINg model and is delivered in addition to routine care. Key components include: Assessment Pre-discharge evaluation Ongoing skin, nutrition, and hydration monitoring Caregiver training for home assessment Equipment and Resources Customized provision of necessary devices based on needs: Sliding sheets Repositioning cushions Skin barriers Moisturizers Pressure-relieving overlays Alternating air mattresses Implementation Caregivers demonstrate device usage competency Documentation checklist for monitoring Regular follow-up by community nurses Professional Support Community nurses trained by PI specialists Standardized care protocols Regular effectiveness assessment All participants receive routine care including: Pre-discharge nutrition assessment Dietician referral if needed Educational materials Basic wound care referrals Hospital-to-home team support for complex cases The intervention provides structured, comprehensive support beyond standard care.

OTHER

Wait-list

During hospitalisation: Patient's nutritional status assessed. Referred to a dietician before discharge if needed. Nurse assesses caregiver training needs and arranges training if required. At discharge: Patients receive PI educational pamphlets (hardcopy or softcopy). Emphasis on regular repositioning, skin inspection, proper nutrition, and hydration. Patients with PI wounds: Referred to home nursing or polyclinics for wound care. Only those with complex PI (stage \>3) receive up to two follow-ups by the H2H care team. H2H team supports general care transition, not PI-specific follow-up alone. Any signs of PI deterioration will be monitored weekly throughout the waiting period for safety and ethical considerations. If the index PI advances to a higher stage and reports increased pain after a week, the investigator will refer them to a community wound care nurse and record this as a deterioration and will start PI care bundle

Sponsors & Collaborators

• Duke-NUS Graduate Medical School

  collaborator OTHER

• Singapore Institute of Technology

  collaborator OTHER

• Singapore General Hospital

  lead OTHER

Principal Investigators

• Fazila Aloweni, MSci · Singapore General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-26

Primary Completion

2027-09-30

Completion

2028-06-30

Countries

• Singapore

Study Locations