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

NCT06770686 | Not Yet Recruiting

• 1 other identifier: 2024.066.IRB2.039
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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

Keywords

Care Bundles; Cost

Outcome Measures

Primary Outcomes (1)

• Hospital-acquired pressure injuries rate

  For 3 months

Secondary Outcomes (1)

• Cost analysis results

  For 3 months

Study Arms (2)

Standard Care

ACTIVE COMPARATOR

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.

Other: Control Group

Care Bundle Group

EXPERIMENTAL

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.

Other: Intervention Group

Interventions

Intervention Group 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.

Also known as: Maintenance bundle care group

Care Bundle Group

Control Group OTHER

They will receive standard care

Standard Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Koç University: lead

Related Publications (2)

• 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.

  PMID: 37853846 BACKGROUND

• 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.

  PMID: 25934716 BACKGROUND

MeSH Terms

Conditions

Pressure Ulcer

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Ayşe Sılanur Demir Demir

CONTACT

+90 552 5801815; aysedemir20@ku.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 13, 2025
• Study Start: January 1, 2025
• Primary Completion: March 1, 2025
• Study Completion: April 1, 2025
• Last Updated: January 13, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share