Satellite-supplementation of Medical Outreach Clinics: a Feasibility Study
8 de mayo de 2014 actualizado por: Bart M. Demaerschalk, Mayo Clinic
Much of the basic general medical care and chronic disease management in rural Honduras comes from groups of volunteers setting up temporary clinics run by volunteers.
These clinics, also known as brigades, or medical missions, are often criticized for their lack of quality and the lack of follow-up, both of which stem, in part, from understaffing with volunteer physicians.
This study is designed to assess if it is feasible, safe, and acceptable to treat patients in short-term mobile medical clinics in rural Honduras using US physicians connected with patients by videoconference.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
144
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Francisco Morazan
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Tegucigalpa, Francisco Morazan, Honduras
- Global Brigades
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Able to give informed consent
- Non-emergent medical complaints
- At least 18 yrs in age
Exclusion Criteria:
- Pregnancy
- Mental Disability
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Telemedicine First
Patients whose first physician visit during the clinic was using videoconference, a form of telemedicine, and whose second physician visit during the clinic was with a physician in-person.
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Patients undergo a detailed history and examination to the degree that is possible using the videoconference program, skype, a digital camera for high-resolution images, and an electronic stethoscope.
A clinic volunteer aids with examination, translation and documentation.
Otros nombres:
Patients undergo a detailed history and examination by an in-person physician.
A clinic volunteer aids with examination, translation and documentation, as needed.
Otros nombres:
|
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Experimental: Telemedicine Second
Patients whose first physician visit during the clinic was with a physician in-person, and whose second physician visit during the clinic was using videoconference, a form of telemedicine.
This is the reverse order of visits of the "Telemedicine fist" arm.
|
Patients undergo a detailed history and examination to the degree that is possible using the videoconference program, skype, a digital camera for high-resolution images, and an electronic stethoscope.
A clinic volunteer aids with examination, translation and documentation.
Otros nombres:
Patients undergo a detailed history and examination by an in-person physician.
A clinic volunteer aids with examination, translation and documentation, as needed.
Otros nombres:
|
|
Comparador activo: Two physician visits
Patients who had two sequential visits with different in-person physicians.
|
Patients undergo a detailed history and examination by an in-person physician.
A clinic volunteer aids with examination, translation and documentation, as needed.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Clinical Diagnoses
Periodo de tiempo: Same Day as clinic visit (less than 6 hours)
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The diagnoses resulting from the two physician visits will be compared and a cohen's kappa statistic will be calculated for diagnoses between the visits.
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Same Day as clinic visit (less than 6 hours)
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Recommended clinical treatments
Periodo de tiempo: Same Day as clinic visit (less than 6 hours)
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After each of a patient's two physician visits, the physician's resulting recommended treatments will be gathered for comparison between the two visits.
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Same Day as clinic visit (less than 6 hours)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Patient opinions of physician interactions
Periodo de tiempo: Immediately following physician interactions (less than 6 hours)
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Patients will receive a survey following each interaction with a doctor.
These surveys cover communication, comfort and satisfaction.
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Immediately following physician interactions (less than 6 hours)
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Physician opinions of patient interactions
Periodo de tiempo: immediately following volunteer activities with the clinic (less than 48 hours)
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doctors will fill out a survey about their patient interactions after they complete their experience volunteering with the clinic.
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immediately following volunteer activities with the clinic (less than 48 hours)
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Volunteer opinions of physician-patient interactions
Periodo de tiempo: immediately following experience with the clinic (Less than 48 hours)
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Volunteers who helped with physician interactions will receive a survey about their experience concerning physician patient communication, volunteer educational value and perceived value of the experience.
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immediately following experience with the clinic (Less than 48 hours)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Cost
Periodo de tiempo: One year (from pilot to completion of study)
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The costs of materials and services required to conduct the patient examinations will be collected to build an economic model and projected cost of scaling up the videoconference interventions.
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One year (from pilot to completion of study)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Bart Demaerschalk, MD/MSc, Mayo Clinic
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de febrero de 2013
Finalización primaria (Actual)
1 de junio de 2013
Finalización del estudio (Actual)
1 de junio de 2013
Fechas de registro del estudio
Enviado por primera vez
20 de marzo de 2013
Primero enviado que cumplió con los criterios de control de calidad
26 de marzo de 2013
Publicado por primera vez (Estimar)
29 de marzo de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
12 de mayo de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
8 de mayo de 2014
Última verificación
1 de mayo de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 13-000132
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .