Development of a Nursing Care Bundle to Prevent Pressure Injuries and Its Impact on Rates and Costs

NCT ID: NCT06770686

Last Updated: 2025-01-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-04-01

Brief Summary

Pressure injuries (PIs) represent a significant clinical complication for patients worldwide and pose financial and quality challenges for healthcare systems. These wounds, which are highly challenging to treat and care for both patients and caregivers, lead to physical and psychological trauma, negatively affect daily life activities, reduce quality of life, and increase care costs (Padula et al., 2019; Yilmazer & Tüzer, 2022). Moreover, the expenses associated with treatment are 2.5 times higher than those for prevention (Lyder & Ayello, 2007). Additionally, they often prolong hospital stays and increase the time nurses spend on care (Yilmazer & Tüzer, 2022).

According to the National Pressure Injury Advisory Panel (NPIAP, 2019), providing high-quality care for patients with PIs requires adopting a multidisciplinary, standardized care approach tailored to the specific needs of patients (Heasler, 2019). Past and current literature supports the use of evidence-based care bundles to reduce PIs (Coyer et al., 2015; Chaboyer et al., 2015; Amr et al., 2017; Deakin et al., 2020; Yilmazer & Tüzer, 2022; Wang et al., 2023). A care bundle is a critical element for standardizing and enhancing the quality of nursing care through the utilization of evidence-based clinical practice guidelines by healthcare professionals. Therefore, adopting these evidence-based approaches will improve the consistency and quality of nursing care, enhance patient outcomes, and reduce institutional costs. Moreover, the use of care bundles during interventions promotes teamwork and collaboration while supporting the development of a common language (Anderson et al., 2015; Institute for Healthcare Improvement, 2021).

This study aims to reduce PIs, enhance the quality of patient care, lower healthcare costs, and improve overall patient outcomes through the development and implementation of a nursing care bundle based on evidence in the literature. The widespread use of the care bundle, grounded in achieved outcomes, will contribute to the prevention of PIs. Additionally, it will serve as a supportive tool for nurses to improve the quality of care.

Conditions

Pressure Injury; Hospital Acquired Pressure Ulcer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Standard Care

Patients in the control group will receive routine care related to pressure injury prevention administered by the institution. Routine care includes standard interventions such as checking pressure points at twice-daily shift changes, positioning every 2 hours, skin assessment, and wound assessment.

Group Type: ACTIVE_COMPARATOR

Control Group

Intervention Type: OTHER

They will receive standard care

Care Bundle Group

A nursing care bundle will be applied to patients in the intervention group. The implementation status of the nursing interventions included in the care bundle for each patient will be observed by the researcher and recorded on the "Care Bundle Observer Form." Recording of the applications performed on the monitoring form will be encouraged.

Group Type: EXPERIMENTAL

Intervention Group

Intervention Type: OTHER

A nursing care bundle will be applied to patients in the intervention group. The implementation status of the nursing interventions included in the care bundle for each patient will be observed by the researcher and recorded on the "Care Bundle Observer Form." Recording of the applications performed on the monitoring form will be encouraged.

Interventions

Intervention Group

A nursing care bundle will be applied to patients in the intervention group. The implementation status of the nursing interventions included in the care bundle for each patient will be observed by the researcher and recorded on the "Care Bundle Observer Form." Recording of the applications performed on the monitoring form will be encouraged.

Intervention Type: OTHER

Control Group

They will receive standard care

Intervention Type: OTHER

Other Intervention Names

Maintenance bundle care group

Eligibility Criteria

Inclusion Criteria

• Being 18 years of age or older
• Patients who fall into all risk categories assessed by the Braden scale
• Not having developed a pressure injury anywhere on their body
• Expectation of a minimum of 24 hours or more in the intensive care unit

Exclusion Criteria

• Being 18 years of age or younger
• Having and developing a pressure injury anywhere on their body
• Expectation of a less than 24-hour stay in the intensive care unit

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Koç University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Ayşe Sılanur Demir Demir

Role: CONTACT

aysedemir20@ku.edu.tr

+90 552 5801815

References

Wang LP, Gao MM, Wang XQ, Gu MM, Qi QD. Effects of bundle-care interventions on pressure ulcers in patients with stroke: A meta-analysis. Int Wound J. 2023 Oct 18;21(2):e14432. doi: 10.1111/iwj.14432. Online ahead of print.

Reference Type: BACKGROUND

PMID: 37853846 (View on PubMed)

Coyer F, Gardner A, Doubrovsky A, Cole R, Ryan FM, Allen C, McNamara G. Reducing pressure injuries in critically ill patients by using a patient skin integrity care bundle (InSPiRE). Am J Crit Care. 2015 May;24(3):199-209. doi: 10.4037/ajcc2015930.

Reference Type: BACKGROUND

PMID: 25934716 (View on PubMed)

Other Identifiers

2024.066.IRB2.039

Identifier Type: -

Identifier Source: org_study_id