Evaluation of Mobile App to Assist in Pediatric Triage

NCT ID: NCT05363124

Last Updated: 2023-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2025-06-30

Brief Summary

Each ED manages a wide variety of pathologies ranging from a simple general consultation to a life-threatening emergency. Patients require prioritization and triaging as soon as they reach the ED and cannot be seen purely in the order of arrival. This triage is mostly carried out by a nurse at the triage zone who must quickly identify high-emergency patients requiring immediate care and organize their care pathway. The triage nurse uses a decision support tool known as a triage tool.

In 2000, the PED of the University Hospital of Nice (France) created a 5-level pediatric triage tool - the pediaTRI - based on clinical items of inspection, interview, and analysis of vital signs.

In a pediatric ED (PED) setting, a high-level emergency corresponds to a child presenting an immediate life-threatening risk that could lead to cardio-respiratory arrest or a related emergency, and thus requires rapid intervention. These patients, for whom a Level 1 or 2 is usually assigned by commonly used pediatric triage tools, can also be screened using warning scores that are predictive of clinical deterioration within 24 hours after visiting the PED. Among them, the Pediatric Early Warning System (PEWS) system, created in 2001, is considered to be efficient, easy to use, and reliable. According to the literature, the optimal cutoff level to calculate the sensitivity and specificity for admission to an ICU, defined as a high-level emergency, is ≥ 4/9. Vitals signs used to calculate the PEWS are usually collected by the nurse at the triage zone. However, new technology such as mobile application may be also used to capture those vital signs (i-Virtual).

Since the parameters of the PEWS system may be evaluate by parents using the application, the investigators want to analyze their ability to assess the level of severity of their children by scoring PEWS in a pediatric emergency department using the mobile application Caducy® (i-Virtual)

Detailed Description

The number of visits to emergency departments (ED) has been rising steadily for both adult and pediatric patients over the past decades. resulting in an increase in waiting and care times. Each ED manages a wide variety of pathologies ranging from a simple general consultation to a life-threatening emergency. However, overcrowding in the ED as well as difficulties in monitoring patients waiting for clinical examination, can endanger patient safety. Patients require prioritization and triaging as soon as they reach the ED and cannot be seen purely in the order of arrival. An ideal triage system should be able to identify those who require immediate care (high-level emergency) from those who can wait or those who will not require emergency care (intermediate- to low-level emergency). This triage is mostly carried out by a nurse at the triage zone who must quickly identify high-emergency patients requiring immediate care and organize their care pathway. The triage nurse uses a decision support tool known as a triage tool.

In France, there is no gold standard in pediatric triage and each hospital uses their own "home-made" triage system. In 2000, the PED of the University Hospital of Nice (France) created a 5-level pediatric triage tool - the pediaTRI - based on clinical items of inspection, interview, and analysis of vital signs. In a pediatric ED (PED) setting, a high-level emergency corresponds to a child presenting an immediate life-threatening risk that could lead to cardio-respiratory arrest or a related emergency, and thus requires rapid intervention. These patients, for whom a Level 1 or 2 is usually assigned by commonly used pediatric triage tools, can also be screened using warning scores that are predictive of clinical deterioration within 24 hours after visiting the PED. Among them, the Pediatric Early Warning System (PEWS) system, created in 2001, is considered to be efficient, easy to use, and reliable. The PEWS system is based on three main components each given a 3-point rating as follows: (a) behavior and early signs of shock, recognizable and assessable by the parents; (b) skin tone and capillary refill time to assess the cardiovascular system; (c) and respiratory rate and oxygen dependence to assess the respiratory system. According to the literature, the optimal cutoff level to calculate the sensitivity and specificity for admission to an ICU, defined as a high-level emergency, is ≥ 4/9. Vitals signs used to calculate the PEWS are usually collected by the nurse at the triage zone. However, new technology such as mobile application may be also used to capture those vital signs (i-Virtual).

Since the parameters of the PEWS system may be evaluate by parents using the application, the investigators want to analyze their ability to assess the level of severity of their children by scoring PEWS in our pediatric emergency department using the mobile application Caducy® (i-Virtual).

Conditions

Pediatric Triage in a Pediatric Emergency Department

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

PEWS calculation

PEWS calculation by parents using AI-based smartphone app PEWS calculation by nurse using conventional procedure

Group Type: EXPERIMENTAL

PEWS calculation by parents using AI-based smartphone app

Intervention Type: OTHER

After patient registration, the patient will be installed in the nursing office with one of his parents . After screening a potential life-threatening patient for which treatment would be started first of all, the nurse will collect the signed parental consent for participating to the study. Explanations will be given to the parents regarding the use of the application and the way to calculate the PEWS through a very brief and standardized education. Parents should then proceed to the calculation of PEWS, as far as possible before the intervention of the nurse, using the Caducy® appl with a smartphone dedicated to the study .

PEWS calculation by nurse using conventional procedure

Intervention Type: OTHER

After patient registration, the patient will be installed in the nursing office with one of his parents . After screening a potential life-threatening patient for which treatment would be started first of all, the nurse will collect the signed parental consent for participating to the study. the nurse proceed to the calculation of PEWS in blind of parents and to triage process by priorityzing patient in 5 level of gravity (from 1-vital emergency to 5-nonurgent patient). If the medical examination was not proceeded directly after the triage process, nurses were asked to proceed a new triage if the optimal delay of the medical examination was passed.

Interventions

PEWS calculation by parents using AI-based smartphone app

After patient registration, the patient will be installed in the nursing office with one of his parents . After screening a potential life-threatening patient for which treatment would be started first of all, the nurse will collect the signed parental consent for participating to the study. Explanations will be given to the parents regarding the use of the application and the way to calculate the PEWS through a very brief and standardized education. Parents should then proceed to the calculation of PEWS, as far as possible before the intervention of the nurse, using the Caducy® appl with a smartphone dedicated to the study .

Intervention Type: OTHER

PEWS calculation by nurse using conventional procedure

After patient registration, the patient will be installed in the nursing office with one of his parents . After screening a potential life-threatening patient for which treatment would be started first of all, the nurse will collect the signed parental consent for participating to the study. the nurse proceed to the calculation of PEWS in blind of parents and to triage process by priorityzing patient in 5 level of gravity (from 1-vital emergency to 5-nonurgent patient). If the medical examination was not proceeded directly after the triage process, nurses were asked to proceed a new triage if the optimal delay of the medical examination was passed.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• patients under 18
• visited the PED of Lenval Children's Hospital for medical reason
• Parental consent signed

Exclusion Criteria

• Patients visited the PED of Lenval Children's Hospital for a reason other than medical
• A sign (s) of vital distress
• Patients who were called back,
• Patients treated in prehospital care,
• Patients who left without an assigned triage level
• Non-French speaking parents

• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Lenval

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpitaux Pédiatriques de Nice CHU-Lenval

Nice, , France

Countries

France

Central Contacts

Antoine TRAN, MD

Role: CONTACT

tran.a@pediatrie-chulenval-nice.fr

0492030442 ext. +33

Dominique DONZEAU

Role: CONTACT

donzeau.d@chu-nice.fr

0492034560

Facility Contacts

Antoine TRAN

Role: primary

tran.a@pediatrie-chulenval-nice.fr

0492030442

Dominique DONZEAU

Role: backup

donzeau.d@chu-nice.fr

Other Identifiers

21-HPNCL-05

Identifier Type: -

Identifier Source: org_study_id