Assessment of Accuracy and Safety of LabTest Checker

NCT ID: NCT05813938

Last Updated: 2023-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-22

Study Completion Date

2023-03-31

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.

Detailed Description

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Conditions

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Abnormalities in the Blood Test Results

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Intervention arm

Group Type EXPERIMENTAL

LabTest Checker

Intervention Type DEVICE

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.

Interventions

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LabTest Checker

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.

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Labplus Sp. z o.o.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Katowice, , Poland

Site Status

Countries

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Poland

Other Identifiers

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LP001

Identifier Type: -

Identifier Source: org_study_id

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