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

Medical device‐related pressure injuries (MDRPIs) are an important and largelypreventable patient safety problem, particularly in intensive care units where the use ofmedical devices is frequent and prolonged. A recent meta‐analysis reported an MDRPIincidence of approximately 19% among adults in critical care settings (Zhang et al.,2024). Although evidence‐based recommendations for MDRPI prevention are available, theirconsistent 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 andimplementation strategies, and evidence regarding their clinical and economiceffectiveness remains limited (Neill & Martin, 2024).This study aims to develop an artificial intelligence (AI)‐synthesized nursing carebundle for the prevention of MDRPIs and to evaluate its clinical effectiveness andcost‐effectiveness compared with routine care. The care bundle will consist of 3‐5evidence‐based components identified through a systematic review of the literature andAI‐assisted evidence synthesis. The draft bundle will subsequently be evaluated andfinalized through a two‐round Delphi process involving experts with experience in MDRPIprevention. Before clinical implementation, participating nurses will receivestandardized training, and their adherence to the care bundle will be assessed by theresearch team, with an adherence level of ≥95% required before implementation.The clinical effectiveness of the finalized care bundle will be evaluated in a randomizedcontrolled trial conducted in an adult intensive care unit. A total of 220 patients willbe allocated in a 1:1 ratio, using blocked stratified randomization based on MDRPI risklevel, to either the intervention group receiving the AI‐synthesized nursing care bundleor the control group receiving routine care. All medical devices in place at enrollmentwill be recorded, and participants will be followed for up to 14 days; the primaryoutcome will be the occurrence of an MDRPI related to these devices during the follow‐upperiod. An economic evaluation will be conducted from the hospital perspective based onproduct utilization, nursing labor time, and hospitalization‐related resource use, andthe cost‐effectiveness of the intervention will be assessed using the incrementalcost‐effectiveness ratio.