- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07726628
The Impact of Telemedicine, Using the Caller's Mobile Phone Camera, on the Quality of Care Provided to Adult Patients Contacting the 15 Centre for Acute Dyspnea (TELEDYS)
Dyspnea is the subjective sensation of difficult or uncomfortable breathing. It accounts for approximately 10% of emergency department visits and 8% of calls to Emergency Medical Communication Centers. Nearly half of patients presenting with dyspnea require hospital admission, 15% require ventilatory support, and approximately 5% die. Early recognition of signs of respiratory severity is therefore essential to accurately assess clinical urgency, guide diagnostic evaluation, and inform appropriate management decisions.
In France, patients are encouraged to contact an Emergency Medical Communication Centers before presenting to an emergency department. Calls are managed by an emergency physician responsible for medical regulation, who performs a remote clinical assessment and determines the most appropriate level of care. Depending on the clinical evaluation, the physician may provide medical advice, refer the patient to an emergency department, dispatch emergency medical services, or send a physician-staffed mobile intensive care unit for life-threatening emergencies.
The remote assessment of patients presenting with dyspnea is particularly challenging. The inability to directly observe or examine the patient, combined with the caller's difficulty in accurately describing the clinical situation, may impair the recognition of disease severity and result in inappropriate triage decisions, including under-triage and over-triage :
Under-triage, characterized by failure to dispatch appropriate emergency resources or to refer the patient to an emergency department when indicated, may delay treatment and increase the risk of adverse outcomes, including mortality.
Conversely, over-triage, defined as unnecessary referral to primary care or emergency departments or inappropriate dispatch of emergency resources, contributes to emergency department overcrowding, inefficient use of prehospital resources, and increased healthcare costs.
In a previous study, we demonstrated that video-assisted medical triage improved emergency physicians' ability to assess the severity of patients presenting with acute dyspnea. This telemedicine tool enables real-time transmission of a live video stream from the caller's smartphone camera to the emergency physician through a secure digital platform, providing direct visualization of the patient's clinical condition. By enhancing remote clinical assessment, video-assisted triage has the potential to reduce both under-triage and over-triage.
In the present stepped-wedge cluster randomized trial, we hypothesized that incorporating real-time video support into the medical regulation of adult patients contacting an Emergency Medical Communication Centers for acute dyspnea would improve the quality of medical decision-making compared with standard telephone triage alone.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Nicolas MARJANOVIC
- Número de teléfono: +33549441873
- Correo electrónico: nicolas.marjanovic@chu-poitiers.fr
Copia de seguridad de contactos de estudio
- Nombre: Sabrina SEGUIN
- Número de teléfono: +33549443229
- Correo electrónico: sabrina.seguin@chu-poitiers.fr
Ubicaciones de estudio
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Poitiers, Francia, 86021
- University Hospital of Poitiers
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Contacto:
- Nicolas MARJANOVIC
- Número de teléfono: +33549441873
- Correo electrónico: nicolas.marjanovic@chu-poitiers.fr
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Patients aged 18 or over
- Contacting the Emergency Medical Communication Center regarding acute dyspnea, respiratory distress or shortness of breath, as the main reason for the call, regardless of the underlying cause
- The patient or a bystander must have a mobile phone equipped with a camera and capable of making video calls
- Emergency inclusion authorized by the emergency physician responsible for medical regulation in accordance with the emergency consent procedure applicable at the time of the call
Exclusion Criteria:
- An immediate life-threatening emergency justifying the dispatch of an emergency response team on an automatic basis in accordance with local protocols
- Patient at the end of life or where a decision to limit treatment is known at the time of the call.
- Refusal to use telemedicine
- Lack of a telephone network enabling video consultation.
- Patient already included in the study.
- Individuals requiring enhanced protection, namely minors, pregnant or breastfeeding women, persons deprived of their liberty by a judicial or administrative decision, and adults under legal guardianship known at the time of the call
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Sin intervención: Standard medical dispatching process (Control group)
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Experimental: Addition of telemedecine to standard medical dispatching process (Experimental group)
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Patients included during the intervention phase will undergo video-assisted medical triage. Video-assisted triage will be performed using a secure web-based telemedicine hosted on a certified health data server. The emergency physician responsible for medical regulation will send a secure web link via SMS to the caller's smartphone or, when appropriate, to the smartphone of a relative or bystander. Once the link has been activated, a live video stream captured by the smartphone camera will be securely transmitted in real time to the physician's workstation at the Emergency Medical Communication Center, enabling direct visualization of the patient's clinical condition during the remote assessment. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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To determine whether the use of video-assisted medical triage improves the quality of medical decision-making during the regulation of adult patients contacting Emergency Medical Communication Center with acute dyspnea
Periodo de tiempo: 28 days
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To determine whether the use of video-assisted medical triage, based on real-time transmission from the caller's smartphone camera, improves the quality of medical decision-making during the regulation of adult patients contacting Emergency Medical Communication Center with acute dyspnea as their primary complaint by reducing the proportion of under-triage and over-triage. Definitions: Under-triage is defined as the assignment of a level of response that is insufficient for the patient's actual clinical needs. Over-triage is defined as the assignment of a level of response that exceeds the patient's actual clinical needs. |
28 days
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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To compare patients managed with and without video-assisted medical triage with respect to the proportion of patients experiencing under-triage
Periodo de tiempo: 28 days
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28 days
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To compare patients managed with and without video-assisted medical triage with respect to the proportion of patients experiencing over-triage
Periodo de tiempo: 28 days
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28 days
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To compare patients managed with and without video-assisted medical triage with respect to the proportion of patients requiring advanced respiratory support (defined as any oxygenation or ventilatory support beyond conventional oxygen therapy)
Periodo de tiempo: 3 hours, 24 hours, 28 days
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3 hours, 24 hours, 28 days
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To compare patients managed with and without video-assisted medical triage with respect to the proportion of patients admitted to an intensive care unit
Periodo de tiempo: 24 hours
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24 hours
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To compare patients managed with and without video-assisted medical triage with respect to the proportion of patients experiencing cardiac arrest
Periodo de tiempo: 3 hours, 24 hours, 28 days
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3 hours, 24 hours, 28 days
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To compare patients managed with and without video-assisted medical triage with respect to all-cause mortality
Periodo de tiempo: 3 hours, 24 hours, 28 days
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3 hours, 24 hours, 28 days
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To compare patients managed with and without video-assisted medical triage with respect to the total duration of the medical regulation process
Periodo de tiempo: Immediately after the procedure
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Immediately after the procedure
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Medical economic impact: cost-effectiveness study (difference in costs divided by the difference in effectiveness: cost/serious complication avoided)
Periodo de tiempo: 28 days
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28 days
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026-A00879-42
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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