Language BarrierENTENTENCT06414772
Evaluation of an E-tool Designed to Facilitate Communication Between Allophone Patients and Pediatricians in Emergency Departments.
A study testing Use of MARTI application in addition with a classical consultation/support in people with Language Barrier, run by Centre Hospitalier Universitaire de Besancon at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Language Barrier
- What is being tested?
- Use of MARTI application in addition with a classical consultation/support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- Jun 2024to Jun 2025
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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".
Trial locations and contacts
2 sites in 1 country.
Jean-Baptiste Pretalli, PhD contact
France2 sites
CHU de Besançon
Besançon, 25000
Kristina Mouyabi, 33 3 81 21 83 56, kmouyabi@chu-besancon.fr
Justine Mirete, MD
Hôpital Nord Franche-Comté
Trévenans
Thibaut Pégeot, MD
About this study
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.
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.
Read more
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
- Language Barrier
- Being tested
- Use of MARTI application in addition with a classical consultation/support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of MARTI application in addition with a classical consultation/supportOther
Participants will use MARTI in order to establish the medical history during their waiting time.
| Study group | Role | What they receive |
|---|---|---|
| With MARTI e-tool | Experimental | Not described Receives: Other: Use of MARTI application in addition with a classical consultation/support |
| Without MARTI e-tool | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study startJun 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Language BarrierStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06414772
- Sponsor's protocol ID
- 2022/739
- Acronym
- ENTENTE
- Status last verified
- May 2024
- First submitted
- 10 Jan 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06414772
- Acronym / sponsor ID
- ENTENTE / 2022/739
- Conditions
- Language Barrier
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With MARTI e-tool | Experimental | Other: Use of MARTI application in addition with a classical consultation/support |
| Without MARTI e-tool | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of MARTI application in addition with a classical consultation/supportParticipants will use MARTI in order to establish the medical history during their waiting time. | Other | With MARTI e-tool |
Primary outcome
Quality of communication
Time frame: Day 1
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No
Related trials for Language Barrier
Active, not recruiting
The Patient and Family Centered I-PASS LISTEN Study: Language, Inclusion, Safety, and Teamwork for Equity Now
Communication
Enrolling by invitation
The Value of the Turkish Translation of the Four-Dimensional Symptom Questionnaire for Turkish-speaking Patients With Psychological Complaints and Language Barriers.
Depression Anxiety Disorder
Active, not recruiting
Mobile Video Interpretation to Optimize Communication Across Language Barriers
Limited English Proficiency
RecruitingObservational study
Options for Lowering the Threshold to Brussels Out-of-hours Primary Care Services for Dutch Speaking Citizens
Communication Barriers, Language
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Baptiste Pretalli, PhD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of MARTI application in addition with a classical consultation/support in people with Language Barrier, run by Centre Hospitalier Universitaire de Besancon at 2 sites in France.
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 6 inclusion and 6 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 16 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 2 sites in France. 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?
Contact Justine Mirete, MD (33 3 81 93 31, jmirete@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of communication (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2024.