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Evaluation of Mobile App to Assist in Pediatric Triage (PEWSAPP)

Primary Purpose

Pediatric Triage in a Pediatric Emergency Department

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PEWS calculation by parents using AI-based smartphone app
PEWS calculation by nurse using conventional procedure
Sponsored by
Fondation Lenval
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Pediatric Triage in a Pediatric Emergency Department

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpitaux Pédiatriques de Nice CHU-Lenval

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PEWS calculation

Arm Description

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

Outcomes

Primary Outcome Measures

Pediatric Early Warning System (PEWS) calculated by parent using smartphone app
The Pediatric Early Warning System (PEWS) 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. the PEWS score is calculated by parent using smartphone app and According to the score, patients will be classified as follows: PEWS [0-2] = no risk PEWS[3-4] = moderate risk PEWS [5-9] = High risk
Pediatric Early Warning System calculated by nurse
the PEWS score is calculated by nurse using conventional procedure. he Pediatric Early Warning System (PEWS) 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 score, patients will be classified as follows: PEWS [0-2] = no risk PEWS[3-4] = moderate risk PEWS [5-9] = High risk

Secondary Outcome Measures

PEWS calculated by parents after triage process
PEWS is calculated again by parent using smartphone app If the medical examination was not proceeded directly after the triage process, nurses were asked to proceed a new triage of the patient if the optimal delay of the medical examination was passed. The delays after which a new triage process should be performed by the nurse are defined according to the triage level given by the nurse using the triage tool as follows: Level 1: < 5 min Level 2: < 20 min Level 3: <60 min Level 4: <120 min Level 5: < 240 min
PEWS calculated by nurse after triage process
PEWS is calculated again by nurse If the medical examination was not proceeded directly after the triage process
PEWS calculated by doctor
PEWS is calculated by the doctor before the medical examination.
Agreement between PEWS and final orientation
Agreement (yes/no) between parents using Artificial Intelligent (AI)-based smartphone app and the nurse will be evaluated at the first and the last assessment of PEWS according to the final orientation as follows: discharged, hospitalization, operating room, intensive care unit
Agreement between PEWS and group of chief complaint at the triage
Agreement (yes/no) between parents using AI-based smartphone app and the nurse will be evaluated at the first assessment of PEWS according to the group of chief complaint at the triage as follows: medical complaints (categorized as: ear, nose and throat (ENT), pulmonary, cardiovascular, neurology, digestive, urology-nephrology, gynecology, dermatology, endocrinology-metabolism, infectious diseases, rheumatology and pain, hematology, poisoning, and others), surgical complaints (categorized as head and neck trauma, upper and lower limb trauma, trauma of the trunk-pelvis-urogenital apparatus, burns, and others).
Agreement between PEWS and diagnosis
Agreement between parents using AI-based smartphone app and the nurse will be evaluated at the first assessment of PEWS according to the group of diagnosis as follows: medical diagnosis and surgical
Agreement between PEWS and day period
Agreement (yes/no) between parents using AI-based smartphone app and the nurse will be evaluated at the first assessment of PEWS according to the time when patients have been firstly triaged by the nurse, as follows: opened days and hours (from monday to Friday 08 am to 20pm and Saturday morning 08am to 12pm), on-call (out of the range of time and day defined previously)
Agreement between PEWS and patient age
Agreement (yes/no) between parents using AI-based smartphone app and the nurse will be evaluated at the first assessment of PEWS according to the age groups classified as follows: 0 - 27 days, 28 days - 3 months, 3 months - 1 year, 1 - 3 years, 3 - 7 years, 7 - 12 years, and 12 - 18 years
parental satisfaction
assessment of parental satisfaction by Likert scale from 1 (totally useless) to 5 (totally useful)

Full Information

First Posted
May 2, 2022
Last Updated
March 16, 2023
Sponsor
Fondation Lenval
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1. Study Identification

Unique Protocol Identification Number
NCT05363124
Brief Title
Evaluation of Mobile App to Assist in Pediatric Triage
Acronym
PEWSAPP
Official Title
Evaluation of Mobile App to Assist in Pediatric Triage in a Pediatric Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2024 (Anticipated)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Lenval

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Triage in a Pediatric Emergency Department

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
700 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PEWS calculation
Arm Type
Experimental
Arm Description
PEWS calculation by parents using AI-based smartphone app PEWS calculation by nurse using conventional procedure
Intervention Type
Other
Intervention Name(s)
PEWS calculation by parents using AI-based smartphone app
Intervention Description
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
Intervention Name(s)
PEWS calculation by nurse using conventional procedure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pediatric Early Warning System (PEWS) calculated by parent using smartphone app
Description
The Pediatric Early Warning System (PEWS) 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. the PEWS score is calculated by parent using smartphone app and According to the score, patients will be classified as follows: PEWS [0-2] = no risk PEWS[3-4] = moderate risk PEWS [5-9] = High risk
Time Frame
at inclusion
Title
Pediatric Early Warning System calculated by nurse
Description
the PEWS score is calculated by nurse using conventional procedure. he Pediatric Early Warning System (PEWS) 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 score, patients will be classified as follows: PEWS [0-2] = no risk PEWS[3-4] = moderate risk PEWS [5-9] = High risk
Time Frame
at inclusion
Secondary Outcome Measure Information:
Title
PEWS calculated by parents after triage process
Description
PEWS is calculated again by parent using smartphone app If the medical examination was not proceeded directly after the triage process, nurses were asked to proceed a new triage of the patient if the optimal delay of the medical examination was passed. The delays after which a new triage process should be performed by the nurse are defined according to the triage level given by the nurse using the triage tool as follows: Level 1: < 5 min Level 2: < 20 min Level 3: <60 min Level 4: <120 min Level 5: < 240 min
Time Frame
until 240 minutes maximum from inclusion
Title
PEWS calculated by nurse after triage process
Description
PEWS is calculated again by nurse If the medical examination was not proceeded directly after the triage process
Time Frame
until 240 minutes maximum from inclusion
Title
PEWS calculated by doctor
Description
PEWS is calculated by the doctor before the medical examination.
Time Frame
until 4 hours from inclusion
Title
Agreement between PEWS and final orientation
Description
Agreement (yes/no) between parents using Artificial Intelligent (AI)-based smartphone app and the nurse will be evaluated at the first and the last assessment of PEWS according to the final orientation as follows: discharged, hospitalization, operating room, intensive care unit
Time Frame
through study completion, an average of 6 months
Title
Agreement between PEWS and group of chief complaint at the triage
Description
Agreement (yes/no) between parents using AI-based smartphone app and the nurse will be evaluated at the first assessment of PEWS according to the group of chief complaint at the triage as follows: medical complaints (categorized as: ear, nose and throat (ENT), pulmonary, cardiovascular, neurology, digestive, urology-nephrology, gynecology, dermatology, endocrinology-metabolism, infectious diseases, rheumatology and pain, hematology, poisoning, and others), surgical complaints (categorized as head and neck trauma, upper and lower limb trauma, trauma of the trunk-pelvis-urogenital apparatus, burns, and others).
Time Frame
through study completion, an average of 6 months
Title
Agreement between PEWS and diagnosis
Description
Agreement between parents using AI-based smartphone app and the nurse will be evaluated at the first assessment of PEWS according to the group of diagnosis as follows: medical diagnosis and surgical
Time Frame
through study completion, an average of 6 months
Title
Agreement between PEWS and day period
Description
Agreement (yes/no) between parents using AI-based smartphone app and the nurse will be evaluated at the first assessment of PEWS according to the time when patients have been firstly triaged by the nurse, as follows: opened days and hours (from monday to Friday 08 am to 20pm and Saturday morning 08am to 12pm), on-call (out of the range of time and day defined previously)
Time Frame
through study completion, an average of 6 months
Title
Agreement between PEWS and patient age
Description
Agreement (yes/no) between parents using AI-based smartphone app and the nurse will be evaluated at the first assessment of PEWS according to the age groups classified as follows: 0 - 27 days, 28 days - 3 months, 3 months - 1 year, 1 - 3 years, 3 - 7 years, 7 - 12 years, and 12 - 18 years
Time Frame
through study completion, an average of 6 months
Title
parental satisfaction
Description
assessment of parental satisfaction by Likert scale from 1 (totally useless) to 5 (totally useful)
Time Frame
at the end of patient participation, an average of 3 hours

10. Eligibility

Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antoine TRAN, MD
Phone
0492030442
Ext
+33
Email
tran.a@pediatrie-chulenval-nice.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Dominique DONZEAU
Phone
0492034560
Email
donzeau.d@chu-nice.fr
Facility Information:
Facility Name
Hôpitaux Pédiatriques de Nice CHU-Lenval
City
Nice
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antoine TRAN
Phone
0492030442
Email
tran.a@pediatrie-chulenval-nice.fr
First Name & Middle Initial & Last Name & Degree
Dominique DONZEAU
Email
donzeau.d@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Antoine TRAN, MD

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Mobile App to Assist in Pediatric Triage

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