## Protocol Section
### Identification Module
**NCT ID:** NCT06414772

**Acronym:** ENTENTE

**Brief Title:** Evaluation of an E-tool Designed to Facilitate Communication Between Allophone Patients and Pediatricians in Emergency Departments.

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

#### Organization Study ID Info
**ID:** 2022/739
#### Organization
**Class:** OTHER
**Full Name:** Centre Hospitalier Universitaire de Besancon
### Status Module
#### Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-10
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Centre Hospitalier Universitaire de Besancon

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- Language Barrier

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** OTHER

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Other: Use of MARTI application in addition with a classical consultation/support

**Label:** With MARTI e-tool

**Type:** EXPERIMENTAL

#### Arm Group 2

**Label:** Without MARTI e-tool

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- With MARTI e-tool

**Description:** Participants will use MARTI in order to establish the medical history during their waiting time.

**Name:** Use of MARTI application in addition with a classical consultation/support

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Quality of communication

**Time Frame:** Day 1

### Eligibility Module

**Eligibility Criteria:** 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".

**Healthy Volunteers:** True

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jmirete@chu-besancon.fr

**Name:** Justine Mirete, MD

**Phone:** 33 3 81 93 31

**Role:** CONTACT

**Contact 2:**

**Name:** Jean-Baptiste Pretalli, PhD

**Phone:** 33 3 81 21 81 27

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Besançon

**Contacts:**

***Contact 1:***

- **Email:** kmouyabi@chu-besancon.fr

- **Name:** Kristina Mouyabi

- **Phone:** 33 3 81 21 83 56

- **Role:** CONTACT

***Contact 2:***

- **Name:** Justine Mirete, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** France

**Facility:** CHU de Besançon

**Zip:** 25000

**Location 2:**

**City:** Trévenans

**Contacts:**

***Contact 1:***

- **Name:** Thibaut Pégeot, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** France

**Facility:** Hôpital Nord Franche-Comté

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7796

- Name: Emergencies

- Relevance: HIGH

- As Found: Emergency

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000004630

- Term: Emergencies

### Misc Info Module

- Version Holder: 2024-05-31
