Pressure InjuryNCT06770686
Development of a Nursing Care Bundle to Prevent Pressure Injuries and Its Impact on Rates and Costs
A study testing Intervention Group in people with Pressure Injury and Hospital Acquired Pressure Ulcer, run by Koç University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pressure Injury, Hospital Acquired Pressure Ulcer
- What is being tested?
- Intervention Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Pressure Injury, Hospital Acquired Pressure Ulcer
- Being tested
- Intervention Group, Control Group
- Keywords
- Care Bundles, Cost
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention GroupOther
Also called Maintenance bundle care 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.
Control GroupOther
They will receive standard care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital-acquired pressure injuries rate
Measured: For 3 months
Secondary outcomes (1)
Cost analysis results
Measured: For 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start1 Jan 2025 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pressure InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770686
- Sponsor's protocol ID
- 2024.066.IRB2.039
- Status last verified
- Jan 2025
- First submitted
- 7 Jan 2025
- Last updated
- 13 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang LP, Gao MM, Wang XQ, Gu MM, Qi QD. RETRACTED: Effects of bundle-care interventions on pressure ulcers in patients with stroke: A meta-analysis. Int Wound J. 2024 Feb;21(2):e14432. doi: 10.1111/iwj.14432. Epub 2023 Oct 18.
PubMed 37853846Coyer 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.
PubMed 25934716
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Nursing Care Bundle for the Prevention of Pressure Injuries, the Impact on the Rate and Cost of Pressure Injuries
- ClinicalTrials.gov ID
- NCT06770686
- Acronym / sponsor ID
- 2024.066.IRB2.039
- Conditions
- Pressure Injury, Hospital Acquired Pressure Ulcer
- Keywords
- Care Bundles, Cost
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Active comparator | Other: Control GroupPatients 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. |
| Care Bundle Group | Experimental | Other: Intervention GroupA 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention GroupAlso: Maintenance bundle care groupA 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 | Care Bundle Group |
| Control GroupThey will receive standard care | Other | Standard Care |
Primary outcome
Hospital-acquired pressure injuries rate
Time frame: For 3 months
1 secondary outcome
Cost analysis results
Time frame: For 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2025.
- Results publication: PubMed 37853846Wang LP, Gao MM, Wang XQ, Gu MM, Qi QD. RETRACTED: Effects of bundle-care interventions on pressure ulcers in patients with stroke: A meta-analysis. Int Wound J. 2024 Feb;21(2):e14432. doi: 10.1111/iwj.14432. Epub 2023 Oct 18.
- Results publication: PubMed 25934716Coyer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Group in people with Pressure Injury and Hospital Acquired Pressure Ulcer, run by Koç University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ayşe Sılanur Demir Demir (+90 552 5801815, aysedemir20@ku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital-acquired pressure injuries rate (time frame: For 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06770686, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2025.