Assessment of Accuracy and Safety of LabTest Checker

Study Overview
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Brief Summary
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The goal of this study is to assess performance of a new clinical decision support system named LabTest Checker in a cohort of adult patients reporting to the internal ward's emergency department. The main question it aims to answer is: • how accurate and safe is LabTest Checker. A set of blood laboratory tests will be ordered for each participant. Participants will use LabTest Checker to obtain an interpretation of their test results. The interpretation provided by LabTest Checker will then be compared with the interpretation given by an internal medicine specialist to assess the accuracy and safety of the tool.

Official Title
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Assessment of Accuracy and Safety of LabTest Checker - Clinical Evaluation of a Patient-centered Clinical Decision Support System Based on AI

Conditions
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Abnormalities in the Blood Test Results

Intervention / Treatment
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* Device: LabTest Checker


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult requires laboratory test investigation Exclusion Criteria: under 18 years old pregnant no need for laboratory test investigation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br> | Device: LabTest Checker<br>* A set of blood laboratory tests is ordered. Test results are recorded in the LabTest Checker. LabTest Checker's diagnostic engine automatically generates a personalized questionnaire that is filled out by the patient. After obtaining all necessary information, including the patient's chronic diseases, medications taken, and symptoms, the tool presents an interpretation of test results.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accuracy | the ratio of the number of patients for whom the LTC correctly assigned triage category to the total number of patients | 7 days | 
| sensivity to emergency | the ratio of the number of cases correctly identified as emergency by the LTC to the number of cases identified as emergency by the physician | 7 days | 
| sensivity to urgency | the ratio of the number of cases correctly identified as urgency by the LTC to the number of cases identified as urgency by the physician | 7 days | 
| safety | the ratio of the number of patients for whom a triage category assigned by the LTC was higher than or equal to the triage category assigned by the physician to the total number of cases | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of unnecessary visits | the ratio of the number of patients who will avoid at least one unnecessary consultation by following the LabTest Checkers recommendations to the total number of patients | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laboratory test interpretation, artificial intelligence, clinical decision support system, clinical implementation