Clinical and Cost-Effectiveness of an AI-Synthesized Nursing Care Bundle for Preventing Medical Device-Related Pressure Injuries

NCT07789613 | Not Yet Recruiting

• 2 other identifiers: 2025.448.IRB2.202226S149
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

Medical device-related pressure injuries (MDRPIs) are an important and largely preventable patient safety problem, particularly in intensive care units where the use of medical devices is frequent and prolonged. A recent meta-analysis reported an MDRPI incidence of approximately 19% among adults in critical care settings (Zhang et al., 2024). Although evidence-based recommendations for MDRPI prevention are available, their consistent and sustainable integration into routine nursing care remains challenging. Care bundles may facilitate the translation of evidence into routine clinical practice; however, existing MDRPI prevention bundles vary considerably in their components and implementation strategies, and evidence regarding their clinical and economic effectiveness remains limited (Neill \& Martin, 2024). This study aims to develop an artificial intelligence (AI)-synthesized nursing care bundle for the prevention of MDRPIs and to evaluate its clinical effectiveness and cost-effectiveness compared with routine care. The care bundle will consist of 3-5 evidence-based components identified through a systematic review of the literature and AI-assisted evidence synthesis. The draft bundle will subsequently be evaluated and finalized through a two-round Delphi process involving experts with experience in MDRPI prevention. Before clinical implementation, participating nurses will receive standardized training, and their adherence to the care bundle will be assessed by the research team, with an adherence level of ≥95% required before implementation. The clinical effectiveness of the finalized care bundle will be evaluated in a randomized controlled trial conducted in an adult intensive care unit. A total of 220 patients will be allocated in a 1:1 ratio, using blocked stratified randomization based on MDRPI risk level, to either the intervention group receiving the AI-synthesized nursing care bundle or the control group receiving routine care. All medical devices in place at enrollment will be recorded, and participants will be followed for up to 14 days; the primary outcome will be the occurrence of an MDRPI related to these devices during the follow-up period. An economic evaluation will be conducted from the hospital perspective based on product utilization, nursing labor time, and hospitalization-related resource use, and the cost-effectiveness of the intervention will be assessed using the incremental cost-effectiveness ratio.

Conditions

Medical Device Related Pressure Ulcer (MDRPU); Pressure Injury

Keywords

care bundle; cost; medical devices related pressure injury; randomised controlled trial; nursing care bundle; artificial intelligence; evidence based practice

Outcome Measures

Primary Outcomes (1)

• Incidence of Medical device related pressure injury

  Occurrence of at least one MDRPI (yes/no) related to the medical devices in place at enrollment. Skin and mucosa under and around each device will be assessed during daily visits, and MDRPIs will be documented using the Medical Device Monitoring and Pressure Injury Event Follow-up Form and staged according to the NPIAP classification system. Incidence will be calculated as the proportion of patients developing an MDRPI among all patients with medical devices in each group.

  Up to 14 days after enrollment

Secondary Outcomes (1)

• Total cost per participant

  Up to 14 days after enrollment

Study Arms (2)

AI-Synthesized Nursing Care Bundle

EXPERIMENTAL

Participants allocated to this group will receive the AI-synthesized nursing care bundle for the prevention of medical device-related pressure injuries (MDRPIs), in addition to the routine care provided in the intensive care unit.

Other: Intervention Group

Routine Care

ACTIVE COMPARATOR

Participants allocated to this group will receive the routine care currently provided in the intensive care unit.

Other: Control Group

Interventions

Control Group OTHER

Routine care includes general pressure injury risk assessment, daily skin assessment, and protective or preventive care measures applied according to individual clinical needs. No structured or standardized medical device-specific monitoring or care protocol is currently implemented in routine clinical practice in the unit.

Also known as: Routine Care

Routine Care

Intervention Group OTHER

The intervention consists of a 3-5 component nursing care bundle developed through AI-assisted evidence synthesis and finalized through a two-round Delphi expert consensus process to prevent medical device-related pressure injuries (MDRPIs). The final bundle components and their implementation frequency will be defined before the clinical implementation phase and incorporated into the clinical protocol. The care bundle will be implemented by nurses who have completed standardized training and demonstrated an adherence rate of ≥95%, as assessed by the research team. Adherence to the care bundle will be monitored and documented using a standardized Care Bundle Monitoring Form throughout the intervention period.

Also known as: AI-Synthesized Nursing Care Bundle

AI-Synthesized Nursing Care Bundle

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 years or older
• Presence of at least one medical device placed for diagnostic or therapeutic purposes.
• No existing medical device-related pressure injury (MDRPI) at the time of study enrollment.
• Expected length of stay in the intensive care unit of at least 24 hours.
• Willingness to participate in the study and provision of written informed consent by the participant or their legal representative.

You may not qualify if:

• Presence of only a peripheral intravenous (IV) catheter as a medical device. (Peripheral IV catheters are excluded because they are routinely present in ICU patients and their replacement frequency and treatment-related use may vary rapidly and unpredictably)
• Presence of an existing MDRPI at the time of study enrollment.
• Expected intensive care unit stay of less than 24 hours.
• Refusal to participate, failure to provide informed consent, or withdrawal of consent during the study.

Sponsors & Collaborators

• Koç University: lead

Study Sites (1)

Koc University Hospital

Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

Location

Related Publications (2)

• Neill S, Martin D. Nursing care bundles in the prevention of medical device related pressure ulcers: An integrative review. J Tissue Viability. 2024 Aug;33(3):376-386. doi: 10.1016/j.jtv.2024.04.003. Epub 2024 Apr 10.

  PMID: 38641481 BACKGROUND

• Zhang N, Li Y, Li X, Li F, Jin Z, Li T, Ma J. Incidence of medical device-related pressure injuries: a meta-analysis. Eur J Med Res. 2024 Aug 19;29(1):425. doi: 10.1186/s40001-024-01986-2.

  PMID: 39155379 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

Aleyna Uçanbelen, PhD Candidate

CONTACT

+905317353003; aucanbelen23@ku.edu.tr

Ayişe Karadağ, Professor

CONTACT

akaradag@ku.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, nurses delivering the care bundle and the investigators cannot be blinded to group allocation. MDRPI outcomes will be assessed by a wound care nurse who is blinded to group allocation. Statistical analyses will also be performed by a statistician blinded to group allocation, with the groups coded as A and B.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): March 15, 2027
• Study Completion (Estimated): July 15, 2027
• Last Updated: August 27, 2026

Record last verified: 2026-08

Locations

TU (1)