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EmergenciesTIAGONCT05382000

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

A study testing Advanced triage tool for Gynecology and Obstetrics emergencies based on artificial intelligence algorithms. in people with Emergencies, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Emergencies
What is being tested?
Advanced triage tool for Gynecology and Obstetrics emergencies based on artificial intelligence algorithms.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
1 siteSpain
Study dates
11 May 2022to 1 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site
  • Hospital de la Santa Creu i Sant Pau

    Barcelona

Other trials in Spain

About this study

Official title: Evaluation of an Advanced Triage Tool for Gynecology and Obstetrics Emergencies Based on Artificial Intelligence Algorithms

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).

Read the detailed description

Prospective interventional, comparative study to determine the validity of the Mediktor ® Triage and its effectiveness with respect to "Model Andorra of Triage" (MAT) system and the "gold standard" (doctor's diagnosis).

Obtaining informed consent. Participation in the study will be offered to all those patients who attend the Emergency Department of Gynecology and Obstetrics of the Hospital de la Santa Creu i Sant Pau during the study period and who meet the inclusion criteria. An information sheet on the study will also be provided to each patient.

Sequential triage Once the patient's consent has been obtained, the patient will be assessed sequentially in the same triage space. Initially, a nurse from the Gynecology and Obstetrics Service 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 triage in the same space, both professionals being blind to the result of each of the tools. In the event that the first triage performed with MAT gave the investigators an emergency level 1, the triage with the Mediktor tool would not be performed, since in this case the immediate care of the patient would be prioritized.

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.

Data recovery and entry in Data Recovery Form (DRF) All data of the study variables will be retrieved from the emergency report issued in the area of Gynecology and Obstetrics Emergencies and will be entered in an electronic DRF for further analysis and processing.

Evaluation of Effectiveness

Main evaluation variables Level of triage assigned by MAT, Level of triage assigned by Mediktor Hospital

Secondary evaluation variables

  • Affiliation variables (administrative): Date of birth, sex, residence, financing, date and time of arrival in the emergency room or administrative record, form of arrival in the emergency room (own foot, ambulance, etc.…), reason for the urgency ( common illness, traffic accident, school…).
  • Triage variables: Triage date and time, triage duration time, coded clinical reason for consultation, readmission within 72 hours, readmission reason, triage level, number of reevaluations, triage level of each reevaluation.
  • Care variables: date and time of the emergency room visit, request for additional test, type of additional test, analytical parameters requested (if applicable), diagnosis according to International Classification of Diseases (ICD) (primary and secondary), most important procedures performed, patient admission > 24h), date and time of admission, urgent surgery, time of stay in the emergency room (LOS) which is the time that the patient remains in the emergency room from the time of admission to the hospital until the patient is discharged or hospitalized. Number of patients admitted to the hospital and number of patients discharged. Number of emergency consultations / revisits in the first 72 hours after discharge.
  • Variables of discharge: circumstance of discharge or reason for emergency discharge (home discharge, hospital admission, transfer to another center, voluntary discharge, escape, exit…), identification of the transfer center, date and time of discharge, date and time of administrative discharge, departure transport, cause of success, time spent in emergencies, registration canceled
Conditions
Emergencies
Being tested
Advanced triage tool for Gynecology and Obstetrics emergencies based on artificial intelligence algorithms.
Medical subject headings
Emergencies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Advanced triage tool for Gynecology and Obstetrics emergencies based on artificial intelligence algorithms.Diagnostic test

    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.

Study groups in NCT05382000
Study groupRoleWhat they receive
InterventionOtherInclusion 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.
Receives: Diagnostic Test: Advanced triage tool for Gynecology and Obstetrics emergencies based on artificial intelligence algorithms.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with equivalence between emergency triage classifications

    Correspondence of emergency grading between Advanced IA Triage Tool (Mediktor Hospital) and the current triage system.

    Measured: 3 days

Secondary outcomes (2)
  1. Number of patients with the same diagnosis on advanced triage tool and emergency discharge report (gold-standard)

    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.

    Measured: 3 days

  2. Number of patients with good correlation between complimentary tests requested by the advanced triage tool with gold-standard

    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.

    Measured: 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2022
  2. Study start11 May 2022
  3. Primary completion1 Aug 2024 (estimated)
  4. Study completion1 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05382000
Sponsor's protocol ID
IIBSP-TIA-2021-81
Acronym
TIAGO
Status last verified
May 2024
First submitted
28 Apr 2022
Last updated
17 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All data that underlie results in a publication will be available once the data analysis is completed and the publication have been published.

Publications

  • Mueller B, Kinoshita T, Peebles A, Graber MA, Lee S. Artificial intelligence and machine learning in emergency medicine: a narrative review. Acute Med Surg. 2022 Mar 1;9(1):e740. doi: 10.1002/ams2.740. eCollection 2022 Jan-Dec.

    PubMed 35251669
  • Berlyand Y, Raja AS, Dorner SC, Prabhakar AM, Sonis JD, Gottumukkala RV, Succi MD, Yun BJ. How artificial intelligence could transform emergency department operations. Am J Emerg Med. 2018 Aug;36(8):1515-1517. doi: 10.1016/j.ajem.2018.01.017. Epub 2018 Jan 4. No abstract available.

    PubMed 29321109
  • Raita Y, Goto T, Faridi MK, Brown DFM, Camargo CA Jr, Hasegawa K. Emergency department triage prediction of clinical outcomes using machine learning models. Crit Care. 2019 Feb 22;23(1):64. doi: 10.1186/s13054-019-2351-7.

    PubMed 30795786
  • Levin S, Toerper M, Hamrock E, Hinson JS, Barnes S, Gardner H, Dugas A, Linton B, Kirsch T, Kelen G. Machine-Learning-Based Electronic Triage More Accurately Differentiates Patients With Respect to Clinical Outcomes Compared With the Emergency Severity Index. Ann Emerg Med. 2018 May;71(5):565-574.e2. doi: 10.1016/j.annemergmed.2017.08.005. Epub 2017 Sep 6.

    PubMed 28888332
  • Moreno Barriga E, Pueyo Ferrer I, Sanchez Sanchez M, Martin Baranera M, Masip Utset J. [A new artificial intelligence tool for assessing symptoms in patients seeking emergency department care: the Mediktor application]. Emergencias. 2017 Dic;29(6):391-396. Spanish.

    PubMed 29188913
  • Kuriyama A, Urushidani S, Nakayama T. Five-level emergency triage systems: variation in assessment of validity. Emerg Med J. 2017 Nov;34(11):703-710. doi: 10.1136/emermed-2016-206295. Epub 2017 Jul 27.

    PubMed 28751363
  • Julian-Jimenez A, Palomo de los Reyes MJ, Lain Teres N. [Coment on the original article: modelo predictor de ingreso hospitalario a la llegada al servicio de Urgencias]. An Sist Sanit Navar. 2012 Sep-Dec;35(3):493-6; author reply 497-9. doi: 10.23938/ASSN.0113. No abstract available. Spanish.

    PubMed 23296233
  • Elias P, Damle A, Casale M, Branson K, Churi C, Komatireddy R, Feramisco J. A Web-Based Tool for Patient Triage in Emergency Department Settings: Validation Using the Emergency Severity Index. JMIR Med Inform. 2015 Jun 10;3(2):e23. doi: 10.2196/medinform.3508.

    PubMed 26063343
  • Storm-Versloot MN, Ubbink DT, Kappelhof J, Luitse JS. Comparison of an informally structured triage system, the emergency severity index, and the manchester triage system to distinguish patient priority in the emergency department. Acad Emerg Med. 2011 Aug;18(8):822-9. doi: 10.1111/j.1553-2712.2011.01122.x.

    PubMed 21843217
  • Moll HA. Challenges in the validation of triage systems at emergency departments. J Clin Epidemiol. 2010 Apr;63(4):384-8. doi: 10.1016/j.jclinepi.2009.07.009. Epub 2009 Oct 28.

    PubMed 19875271

Questions about this trial

What is this clinical trial studying?

A study testing Advanced triage tool for Gynecology and Obstetrics emergencies based on artificial intelligence algorithms. in people with Emergencies, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with equivalence between emergency triage classifications (time frame: 3 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05382000, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.

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