Evaluation of an E-tool Designed to Facilitate Communication Between Allophone Patients and Pediatricians in Emergency Departments. (ENTENTE)

Evaluation of an Electronic Tool Designed to Facilitate Communication Between Allophone Patients or Patients With Communication Difficulties and Physicians in Pediatric Emergency Departments.

In France, over 21 million people visit emergency departments every year, 10% of whom speak little or no French. The language barrier is a problem for patient safety and quality of care. Ethical and financial aspects are also affected. Unnecessary tests are more frequent, hospital stays more numerous and longer. Patient's management may be inappropriate. Patients are less satisfied, understand and adhere less to cmanagement and recommendations.

Some solutions are available to the emergency physician, but their contribution is limited. A professional interpreter is reliable and takes cultural aspects into account, but his or her cost is high and availability incompatible with emergency care. Translation by a close relative poses the problem of confidentiality. Telephone interpreting is available at any time, but is expensive and less satisfying than direct interaction. Computerized machine translation is economical and easy to access, but does not take into account all medical terms. It also poses a data protection problem. Phraselators translate predefined phrases with precision, but are time-consuming and unsophisticated.

In addition, these aids are used during the consultation. They are therefore difficult to combine and take up care time.

This care time is mainly devoted to establishing medical history essential for the diagnosis, prognosis and treatment decisions.

MARTI is a digital tool for pediatric emergency room consultations. Its aim is to enable the emergency physician to start the consultation with a medical history completed autonomously by the parents during their waiting time. Its content has been developed by emergency physicians.

Language and cultural barriers are overcome through the use of simple phrases and pictograms developed with linguists, language schools and Immigrant organizations.

MARTI was used in a pediatric emergency department. Feedback from patients and carers indicates that it is ready to be tested in real-life conditions.

This pilot study is designed to evaluate how MARTI improves communication with an allophone or a person with comprehension difficulties, according to the emergency physician in charge of the consultation.

Study Overview

• Status: Not yet recruiting
• Conditions: Language Barrier
• Intervention / Treatment: Other: Use of MARTI application in addition with a classical consultation/support

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Justine Mirete, MD; Phone Number: 33 3 81 93 31; Email: jmirete@chu-besancon.fr
• Study Contact Backup: Name: Jean-Baptiste Pretalli, PhD; Phone Number: 33 3 81 21 81 27

Study Locations

• France
  • Besançon, France, 25000
    • CHU de Besançon
    • Contact: Kristina Mouyabi; Phone Number: 33 3 81 21 83 56; Email: kmouyabi@chu-besancon.fr
    • Principal Investigator: Justine Mirete, MD
  • Trévenans, France
    • Hôpital Nord Franche-Comté
    • Principal Investigator: Thibaut Pégeot, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adult
• Person responsible for a child admitted to pediatric emergency.
• Person with a language barrier.
• Person speaking one of the 11 languages proposed by MARTI.
• Signed informed consent indicating that the subject has understood the purpose and procedures of the study and agrees to participate in the study and to abide by the requirements and restrictions inherent in the study.
• Affiliation with a health insurance

Exclusion Criteria:

• Person who shares a common language with the physician.
• Illiterate person.
• Person accompanying a child with a life-threatening emergency.
• Subject without health insurance.
• Pregnant women.
• Subject in the exclusion period of another study or in the "national volunteer file".

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: With MARTI e-tool	Other: Use of MARTI application in addition with a classical consultation/support; Participants will use MARTI in order to establish the medical history during their waiting time.
No Intervention: Without MARTI e-tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of communication	The quality of communication will be assessed using a Likert-type scale to be completed by the emergency physician at the end of the consultation (whether MARTI was used or not). Originally, Likert scale is a rating scale that assesses opinions, attitudes, or behaviors quantitatively in five point expressed as follows: strongly agree, agree, neutral, disagree, strongly disagree. These points have been kept for the scale of the study, which was adapted with items like "Using MARTI app reduced my anxiety" (for caregivers), "The app is easy to use" (for parents), etc.	Day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: January 10, 2024
• First Submitted That Met QC Criteria: May 13, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: 2022/739

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No