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

Singapore Health Services (SingHealth)

Status: Not yet enrolling

Conditions: Pressure Injuries; Caregiver; Community Dwelling Older Adult

Treatments: Other: Wait-list; Other: community-based PI care bundle

Study type: Interventional

Funder types: Other

Identifiers

NCT07074743

2022/2406_CAPIcarebundle

Details and patient eligibility

About

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.

Full 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.

Enrollment: 216 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

216 participants in 2 patient groups

Wait-list

Active Comparator group

Description:

The wait-list group will receive routine care during the first six weeks and at seven weeks, the index PI will be restaged and if patient is still having PI- the PI care bundle will be provided for the next six weeks. However, PI care bundle can also be initiated if the index PI advances to higher stage had increased pain over PI site or when there is deterioration of the index PI at any point during the weekly follow up. Providing PI care bundle to wait-list control group after 6 week ensures ethical care while maintaining study integrity.

Treatment:

Other: Wait-list

Community-based PI care bundle

Experimental group

Description:

The community-based PI care bundle follows the aSSKINg model and is delivered in addition to routine care for six weeks.

Treatment:

Other: community-based PI care bundle