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| ID | Type | Description | Link |
|---|---|---|---|
| Research Ethics Committee | Other Identifier | King Faisal Specialist Hospital and Research Center - Jeddah |
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The goal of this clinical trial is to learn whether an artificial intelligence (AI)-assisted skin assessment tool can improve the accuracy of pressure-injury staging in critical-care nurses. The study also aims to understand whether the AI tool increases nurses' knowledge and confidence in performing skin assessments. The main questions it aims to answer are:
Does AI-assisted assessment improve the accuracy of pressure-injury staging compared with standard visual assessment?
Does the use of AI improve nurses' knowledge and confidence related to skin assessment and pressure-injury staging?
Researchers will compare nurses who use an AI-assisted mobile application with nurses who perform standard manual assessments to see whether the AI tool improves staging accuracy and supports early identification of pressure injuries.
Participants will:
Complete brief questionnaires about their knowledge and confidence before and after training
Perform skin assessments on their assigned ICU patients using either standard methods or the AI tool.
Have their assessments compared with those of a blinded wound-care specialist, who will determine the most accurate staging
Pressure injuries remain a significant and largely preventable complication among critically ill patients, with ICU populations at particularly high risk due to immobility, hemodynamic instability, and complex medical needs. At KFSHRC-Jeddah, more than half of all hospital-acquired pressure injuries reported in 2024 occurred in critical-care settings, underscoring ongoing challenges in early detection and consistent staging. Although the organization follows evidence-based practices and uses tools such as the Braden Scale and NPIAP staging guidelines, variability in nurses' knowledge, skill, and confidence continues to influence prevention quality and accuracy of assessment.
Traditional skin assessment relies primarily on visual inspection and clinical judgement, which can lead to inconsistent interpretation of early tissue changes, particularly in darker skin tones, deep tissue injuries, and moisture-associated skin damage. These limitations highlight the need for innovative approaches that support more consistent and objective staging.
Artificial intelligence (AI)-assisted image recognition has emerged as a potentially valuable adjunct to standard nursing assessment. By analyzing skin characteristics such as color, texture, and contour, AI tools may assist nurses in identifying early-stage changes and provide decision support aligned with NPIAP criteria. Integrating AI into routine practice has the potential to enhance early detection, improve staging accuracy, and reduce practice variation.
This randomized controlled trial evaluates the use of an AI-assisted mobile application compared with standard manual skin assessment performed by critical-care nurses. The intervention uses an image-recognition tool that analyzes standardized photographs of high-risk skin areas and provides staging recommendations based on NPIAP definitions. Nurses in the control group will continue performing traditional visual and palpation-based assessments according to existing hospital protocols.
All participating nurses will receive pre-intervention education on pressure injury prevention, comprehensive skin assessment, and NPIAP staging to establish a consistent baseline. The intervention group will undergo additional training on standardized image capture to ensure appropriate lighting, distance, and positioning. A blinded wound-care specialist will independently review all assessments and images; this external review serves as the reference standard for evaluating accuracy and inter-rater reliability.
In addition to examining staging accuracy, the study will assess changes in nurses' knowledge and confidence before and after the intervention using validated instruments. It will also explore the feasibility and acceptability of integrating AI into ICU workflows. The findings are expected to inform how AI technology can support nursing practice, enhance clinical decision-making, and help reduce the incidence of hospital-acquired pressure injuries in critical-care environments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Assessment | No Intervention | Standard assessment | |
| ChatGPT-Assisted Skin Assessmen | Other | Nurses will use ChatGPT-based AI support to assist in skin assessment and staging. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ChatGPT Skin Assessment | Other | ChatGPT Skin Assessment |
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| Measure | Description | Time Frame |
|---|---|---|
| Agreement Between Nurse and Expert Skin Assessment and Pressure Injury Staging Using NPIAP Criteria | The primary outcome explicitly measures agreement between nurse-assigned and expert-assigned pressure injury stages using the National Pressure Injury Advisory Panel (NPIAP) staging criteria, rather than stating a study objective. Agreement will be quantified using Cohen's Kappa statistic, and accuracy will be summarized as the percentage of nurse-assigned stages that exactly match expert-assigned stages. Agreement analyses will be conducted separately for manual nurse assessments and AI-assisted nurse assessments, allowing clear and reportable comparison between study groups. Agreement outcomes will be summarized across individual assessment domains, including erythema, discoloration, edema, temperature, and overall pressure injury staging, using quantitative agreement metrics. The primary outcome will be assessed from Day 1 through 6 months. | Day 1 through 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Knowledge- Change From Baseline in Nurse Knowledge Score on the Pressure Ulcer Prevention Knowledge Assessment Instrument (PUPKAI) | Nurse knowledge related to pressure injury prevention and staging will be measured using the Pressure Ulcer Prevention Knowledge Assessment Instrument (PUPKAI), a validated 26-item multiple-choice questionnaire. Each correct response will be scored as one point, and item scores will be summed to generate a total knowledge score ranging from 0 to 26, with higher scores indicating greater knowledge. Total PUPKAI scores will be calculated at two prespecified time points: Day 1 (baseline, prior to the intervention) and Day 1 (immediately post-intervention). The outcome will be reported as change from baseline in total PUPKAI score, calculated as the post-intervention score minus the baseline score. For statistical analysis, descriptive statistics will be used to summarize baseline and post-intervention scores. Within-group changes in PUPKAI scores will be analyzed using paired statistical tests (paired t-test or Wilcoxon signed-rank test, depending on data distribution). |
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Inclusion criteria
Exclusion criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jennifer De Beer, PhD | Contact | +966559232671 | debeerj@kfshrc.edu.sa |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Faisal Specialist Hospital and Research Center- Jeddah | Recruiting | Jeddah | Mecca Region | 21423 | Saudi Arabia |
Individual participant data (IPD) will not be shared publicly because the dataset includes clinical images and sensitive nursing performance data collected within a single hospital site. These data could potentially identify participants, and institutional policy at King Faisal Specialist Hospital and Research Centre restricts the external sharing of raw clinical data. Aggregated and de-identified summary results will be available upon reasonable request following publication of study findings.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Research Proposal | Nov 16, 2025 | Dec 5, 2025 | Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Pre and Post Intervention Knowledge and Confidence Survey | Nov 16, 2025 | Dec 5, 2025 | Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent Patients | Nov 16, 2025 | Dec 5, 2025 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent Nurses | Nov 16, 2025 | Dec 5, 2025 | ICF_003.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent for Photography | Nov 16, 2025 | Dec 5, 2025 | ICF_004.pdf |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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A senior wound-care specialist, blinded to allocation, will independently review anonymized images and bedside assessments. Each assessment will be coded, and the expert's determinations will serve as the gold standard for inter-rater reliability testing
| Day 1 (Baseline) and Day 1 (Immediately Post-intervention) |
| Change From Baseline in Nurse Confidence Score on the Skin Assessment Confidence Scale (SACS) | Nurse confidence in skin assessment and pressure injury staging will be measured using the Skin Assessment Confidence Scale (SACS), a 10-item Likert-scale instrument. Each item is scored on a 5-point scale, and item scores are summed to generate a total confidence score ranging from 10 to 50, with higher scores indicating greater confidence in performing skin assessments and applying pressure injury staging criteria. Total SACS scores will be calculated at two prespecified time points: Day 1 (baseline, prior to the intervention) and Day 1 (immediately post-intervention). The outcome will be reported as change from baseline in total SACS score, calculated as the post-intervention score minus the baseline score. For statistical analysis, descriptive statistics will be used to summarize baseline and post-intervention confidence scores. Within-group changes in SACS scores will be analyzed using paired statistical tests (paired t-test or Wilcoxon signed-rank test, depending on data distr | Day 1 (Baseline) and Day 1 (Immediately Post-intervention) |