Back to resultsAssessment of Accuracy and Safety of LabTest Checker (LTC-AI)
Primary Purpose
Abnormalities in the Blood Test Results
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
LabTest Checker
Sponsored by
About this trial
This is an interventional diagnostic trial for Abnormalities in the Blood Test Results focused on measuring laboratory test interpretation, artificial intelligence, clinical decision support system, clinical implementation
Eligibility Criteria
Inclusion Criteria: adult requires laboratory test investigation Exclusion Criteria: under 18 years old pregnant no need for laboratory test investigation
Sites / Locations
- Oddział Chorób Wewnętrznych i Chemioterapii Onkologicznej, Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mielęckiego Śląskiego Uniwersytetu Medycznego w Katowicach
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intervention arm
Arm Description
Outcomes
Primary Outcome Measures
accuracy
the ratio of the number of patients for whom the LTC correctly assigned triage category to the total number of patients
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
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
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05813938
Brief Title
Assessment of Accuracy and Safety of LabTest Checker
Acronym
LTC-AI
Official Title
Assessment of Accuracy and Safety of LabTest Checker - Clinical Evaluation of a Patient-centered Clinical Decision Support System Based on AI
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
December 22, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Actual)
Study Completion Date
March 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Labplus Sp. z o.o.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abnormalities in the Blood Test Results
Keywords
laboratory test interpretation, artificial intelligence, clinical decision support system, clinical implementation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
LabTest Checker
Intervention Description
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.
Primary Outcome Measure Information:
Title
accuracy
Description
the ratio of the number of patients for whom the LTC correctly assigned triage category to the total number of patients
Time Frame
7 days
Title
sensivity to emergency
Description
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
Time Frame
7 days
Title
sensivity to urgency
Description
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
Time Frame
7 days
Title
safety
Description
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
Time Frame
7 days
Secondary Outcome Measure Information:
Title
reduction of unnecessary visits
Description
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
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult
requires laboratory test investigation
Exclusion Criteria:
under 18 years old
pregnant
no need for laboratory test investigation
Facility Information:
Facility Name
Oddział Chorób Wewnętrznych i Chemioterapii Onkologicznej, Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mielęckiego Śląskiego Uniwersytetu Medycznego w Katowicach
City
Katowice
ZIP/Postal Code
40-027
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
Assessment of Accuracy and Safety of LabTest Checker
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