Severance Hospital, Wound Ostomy Team
Seoul, South Korea
NCT Number: NCT07132320
This clinical trial aims to develop a pressure ulcer nursing AI mobile application based on a clinical judgment model and verify its effectiveness among clinical nurses. The study consists of algorithm development, application design, implementation, and a comparative evaluation of nurses using the AI app versus a control group not given the application. Outcomes include clinical judgment, knowledge in pressure ulcer nursing, educational satisfaction, and pressure ulcer incidence. The investigators expect the AI-driven intervention to improve practical nursing skills, reduce pressure ulcer occurrence, and contribute to patient-centered care in hospital settings.
Looking for future studies?
Notify Me20 year and older
All sexes
Interventional
Not applicable
Seoul, South Korea
"1.Background and Rationale Pressure injuries, also referred to as pressure ulcers, are a global healthcare issue, particularly severe among elderly and chronically ill patients. The prevalence is rising due to an aging population, prolonged hospital stays, and chronic disease incidence. Conventional prevention and treatment are often based on subjective nursing judgment and personal clinical experience, which limits consistency and efficiency across care settings.
Recent advancements in artificial intelligence (AI) enable integration of evidence-based decision-making tools into clinical workflows. Existing AI solutions for wound care tend to be rule-based and expert-driven, which constrains their adaptability in real clinical environments.
The clinical judgment model offers a systematic decision-making pathway: observing, interpreting, responding, and reflecting. Integrating this model into an AI mobile application for pressure injury nursing can provide consistent, evidence-based, and context-responsive guidance to nurses, improving patient safety and quality of care. This prospective study aims to develop such an AI-based application and evaluate its clinical educational effectiveness among hospital nurses.
To evaluate the effect of an AI nursing application, based on the clinical judgment model, on nurses' clinical judgment competencies in pressure injury care.
To measure changes in nurses' knowledge of pressure injury nursing. To assess satisfaction with the AI-based education program. To monitor any change in pressure injury incidence in patients under the care of participating nurses.
This is a prospective, randomized controlled, parallel-group study. Nurses will be allocated to either:
The development follows the ADDIE instructional design framework:
Review five evidence-based guidelines:
Compare recommendations on prevention, staging, diagnosis, risk assessment, and treatment.
Conduct in-depth, semi-structured interviews (~1 hour each) with 15 wound/ostomy continence nurses with ≥3 years' experience. Topics include risk factors, clinical decision criteria, education improvement needs, and expectations for AI.
Include stages: prevention, diagnosis/staging, treatment selection, evaluation. Ensure flexibility for varied patient conditions and institutional settings. Validate through expert panel review.
Design an intuitive, efficient UI/UX. Embed visual wound classification tools and context-specific alerts.
Intervention group: 2-hour AI-assisted education plus application practice. Control group: Same duration of lecture-based standard education without AI.
Assessments:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Clinical nurses receive training and guidance via an AI application designed for pressure ulcer nursing based on a clinical judgment model.
Clinical nurses receive conventional pressure ulcer nursing education not involving the developed AI application.
Time frame: Baseline, Post-intervention (approximately 2 weeks)
The difference in clinical judgment score measured by the modified Lasater Clinical Judgment Rubric specific for pressure ulcer management.
Time frame: Baseline, Post-intervention (approximately 2 weeks)
Difference in nurses' knowledge scores measured by the PZ-PUKT tool.
Time frame: Baseline, Post-intervention (approximately 2 weeks)
Difference in nurses' educational satisfaction scores after intervention.
Time frame: Baseline, Post-intervention (approximately 2 weeks)
Incidence rate of pressure ulcers among patients during the study period.
Yonsei University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06294327
Decubitus Ulcer, Pressure Injury
Sint-Niklaas, East Flanders, Belgium
View Trial DetailsNCT07255937
Arterial Leg Ulcer, Burns
Madrid, Spain
View Trial DetailsNCT07586748
Cardiovascular Diseases, Embolism and Thrombosis
View Trial DetailsNCT06465225
Pressure Ulcer, Skin Diseases
Multiple Locations, France
View Trial Details