Assessment of Accuracy and Safety of LabTest Checker

Not Applicable

Completed

• Conditions: Abnormalities in the Blood Test Results
• Interventions: Device: LabTest Checker

• Registration Number: NCT05813938
• Lead Sponsor: Labplus Sp. z o.o.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-22
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Status Verified: 2023-04
• Study First Submitted: 2023-04-03
• Study First Submitted QC: 2023-04-03
• Last Update Submitted: 2023-04-03
• Study First Posted: 2023-04-14
• Last Update Posted: 2023-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

• adult
• requires laboratory test investigation

Exclusion Criteria

• under 18 years old
• pregnant
• no need for laboratory test investigation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention arm	LabTest Checker	-

Primary Outcome Measures

Name	Time	Method
accuracy	7 days	the ratio of the number of patients for whom the LTC correctly assigned triage category to the total number of patients
sensivity to emergency	7 days	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	7 days	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	7 days	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

Name	Time	Method
reduction of unnecessary visits	7 days	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

Trial Locations

Locations (1)

Oddział Chorób Wewnętrznych i Chemioterapii Onkologicznej, Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mielęckiego Śląskiego Uniwersytetu Medycznego w Katowicach; 🇵🇱 Katowice, Poland