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

Overview

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.

Detailed description

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:

* Clinical improvement measured using the Pressure Ulcer Scale for Healing (PUSH) tool. * Minimum clinically meaningful effect size established as 3-point reduction on PUSH score. * PUSH scoring ranges from 0 (healed) to 17 (most severe)

Secondary Outcomes:

* Incidence of new pressure injuries * Caregiver Knowledge, Attitudes, and Practices (KAP) assessment

Feasibility metrics including:

* Implementation appropriateness * Intervention acceptability * Protocol fidelity * Participation and retention rates * Adherence to prescribed prevention measures

TECHNICAL COMPONENTS OF CARE BUNDLE

The intervention group will receive:

* Using the aSSKINg framework, the investigators have co-design the content of PI prevention and management with the community nurses, WOC nurses and caregivers. * Delivered a structured caregiver education program- tailored to the patient and caregiver needs. * Weekly check in by the study team or community nurses * Documentation and tracking tools using electronic wound imaging system.

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.

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 comp
• 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 fo

Primary outcome measures

• Pressure injury healing [Time frame: at 6 weeks post randomisation]

Secondary outcome measures (1)

• Caregiver's Knowledge, Attitude and Practice (KAP) [Time frame: 6 weeks post randomisation]

Eligibility criteria

Inclusion criteria

• adult patients discharged from SGH with existing PI (any stages according to NPIAP and on any part of the body)
• have a family caregiver or FDH who will be managing the PI upon discharge
• patients will be discharged to home
• living within the SGH nursing community zones

Exclusion criteria

• previous or existing participation in this trial
• palliative or dying patients
• planned discharge to a nursing home or other hospital
• mobile inpatient care@home service
• patient or next-of-kin who refused to participate.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

Singapore · 2 centers

• Singapore General Hospital — Singapore
• Singapore General Hospital — Singapore

Identifiers

NCT: NCT07074743 · 2022/2406_CAPIcarebundle

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗