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Artificial Intelligence (IA) Advanced Triage Tool for G&O Emergencies (TIAGO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05382000
Recruitment Status : Active, not recruiting
First Posted : May 19, 2022
Last Update Posted : May 20, 2024
Sponsor:
Information provided by (Responsible Party):
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary:

Triage represents the first opportunity to classify patients who come to an Emergency Department (ED) and to be able to identify, prioritize high-risk patients and efficiently allocate the limited resources that are available. Therefore, the purpose of triage in the ED is to prioritize patients, detecting those that are urgent (that cannot wait to be attended). Urgency is defined as that clinical situation with the capacity to generate deterioration or danger to the health or life of the patient, depending on the time elapsed between its appearance and the establishment of an effective treatment, which determines a healthcare episode with significant intervention needs in a short period of time. There are currently six triage systems or models systematically structured into 5 levels.

Although simple in concept, the practice of triage is challenging due to time pressure, the limitations of available information, the various medical conditions of the patients, and a great reliance on intuition on the part of the professionals who perform it. which conditions a great variability in it. On the other hand, almost half of adult ED visits nationwide are classified as level 3 in a 5-level structured triage system, which makes level 3 a heterogeneous group with patients with diverse pathologies, in which triage is not capable of accurately differentiating them, and this inability poses safety risks for the most severely ill patients ("under-triage") and may influence the accuracy and efficiency in resource allocation when patients with low acuity are overrated. Therefore, it seems necessary to develop new triage procedures that allow us to improve their accuracy and reduce inter-individual variability.

TIAGO is a prospective, single-center, observational, comparative study to determine the validity of the Mediktor ® Triage and its effectiveness with respect to the current triage system and the "gold standard" (physician's diagnosis).


Condition or disease Intervention/treatment Phase
Emergencies Diagnostic Test: Advanced triage tool for Gynecology and Obstetrics emergencies based on artificial intelligence algorithms. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 450 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

Once the patient's consent has been obtained, the patient will be assessed sequentially in the same triage space. Initially, a nurse will classify the patient in the triage box using the MAT system according to the usual practice. Then, another professional from the center, trained in the use of the Mediktor Hospital ® tool, and who has not been present in the conventional sorting, will perform the advanced IA triage in the same space, both professionals being blind to the result of each of the tools.

Attention in the Emergency Service Once the sequential triage is completed, the patient will return to the Gynecology and Obstetrics Emergency Room. The patient's care will be performed according to usual clinical practice, following the triage assessment performed with the MAT system.

Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of an Advanced Triage Tool for Gynecology and Obstetrics Emergencies Based on Artificial Intelligence Algorithms
Actual Study Start Date : May 11, 2022
Estimated Primary Completion Date : August 1, 2024
Estimated Study Completion Date : December 1, 2024

Arm Intervention/treatment
Intervention

Inclusion in the study will be proposed to all patients who come to the Emergency Department of the Gynecology and Obstetrics Service

The planned procedures for this group are as follows:

  1. Obtaining informed consent.
  2. Sequential triage - Patients will be evaluated sequentially using the MAT system according to standard practice. Next, another professional from the center, trained in the use of the Mediktor Hospital ® tool, will perform the advanced triage in the same space, both professionals being blind to the result of each of the tools.
  3. Once the sequential triage is finished, the patient's care will be carried out according to usual clinical practice, following the triage assessment carried out with the MAT system.
  4. Retrieval and introduction of data in DRF - Data of the study variables will be retrieved from the emergency report issued in the Gynecology and Obstetrics Emergency area and will be entered into an electronic DRF for subsequent analysis and processing.
Diagnostic Test: Advanced triage tool for Gynecology and Obstetrics emergencies based on artificial intelligence algorithms.

After the conventional triage, a second independent doctor will make the suit with the Mediktor Hospital tool.. In less than 3 minutes and with an average of 14 questions, Mediktor performs an interrogation very similar to what an emergency doctor would do. The professional version allows the health professional to modify the course of the questions in the middle of the evaluation, if he considers it necessary to go deeper into some aspect of the anamnesis. The system allows you to see in real time the diseases that Mediktor considers possible during the evaluation.

At the end of the triage process, Mediktor offers the level of urgency and a list of possible diagnoses based on the signs and symptoms answered. The professional can change the level of urgency if he considers it beneficial for the patient.

Once the two triages (Conventional and Mediktor) have been carried out, the patient will be seen according to the care protocols of the center.





Primary Outcome Measures :
  1. Number of patients with equivalence between emergency triage classifications [ Time Frame: 3 days ]
    Correspondence of emergency grading between Advanced IA Triage Tool (Mediktor Hospital) and the current triage system.


Secondary Outcome Measures :
  1. Number of patients with the same diagnosis on advanced triage tool and emergency discharge report (gold-standard) [ Time Frame: 3 days ]
    Assess the correlation between the pre-diagnosis provided by the advanced triage tool and the diagnosis offered by the physician in the emergency discharge report.

  2. Number of patients with good correlation between complimentary tests requested by the advanced triage tool with gold-standard [ Time Frame: 3 days ]
    Assess the correlation between the complementary tests proposed by the advanced triage tool and those requested by the doctors during the emergency room visit, following the care protocols of the center.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Being over 18 years
  • Understand and accept the study procedures
  • Sign the informed consent.

Exclusion Criteria:

  • Not being able to understand the nature of the study and/or the procedures to be followed
  • Not signing the informed consent
  • Be under 18 years of age
  • Emergency level 1 through current triage system

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05382000


Locations
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Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Sponsors and Collaborators
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Investigators
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Principal Investigator: Josep Estadella Tarriel Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Publications:

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Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT05382000    
Other Study ID Numbers: IIBSP-TIA-2021-81
First Posted: May 19, 2022    Key Record Dates
Last Update Posted: May 20, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All data that underlie results in a publication will be available once the data analysis is completed and the publication have been published.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: All data will be available once the study is published . It will be available for 5 years after publication date.
Access Criteria: Requests will be reviewed by Primary Investigator.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes