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

January 7, 2025 updated by: Koç University

Development of Nursing Care Bundle for the Prevention of Pressure Injuries, the Impact on the Rate and Cost of Pressure Injuries

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Other: Control Group
They will receive standard care
Experimental: 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.
Other: 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.
Other Names:
  • Maintenance bundle care group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hospital-acquired pressure injuries rate
Time Frame: For 3 months
For 3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Cost analysis results
Time Frame: For 3 months
For 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Koç University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

January 7, 2025

First Submitted That Met QC Criteria

January 7, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 7, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024.066.IRB2.039

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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