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

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

Interventions

OTHER

Control Group

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.

OTHER

Intervention Group

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.

Sponsors & Collaborators

• Koç University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-09-15

Primary Completion

2027-03-15

Completion

2027-07-15

Countries

• Turkey (Türkiye)

Study Locations