- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04496713
Pilot Study of Video and Telephone Primary Care Visits
Pilot Study - Randomized Controlled Trial of Video and Telephone Primary Care Visits
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Maryland
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Baltimore, Maryland, Estados Unidos, 21287
- Johns Hopkins Outpatient Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Adult patients scheduled for telephone-based visits who are doing so because of a lack of ability to conduct a video visit (i.e. no tablet/laptop; no access to internet) who live in Baltimore City
Exclusion Criteria:
- Patients with significant visual or hearing impairment
- Patients that have legal guardians or who are marked as lacking healthcare decision-making capacity
- Patients that have not selected English as their preferred language
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: Telemedicine - Phone
Patients will continue with their telephone-based telemedicine visit as scheduled.
There will be no change to their care.
Patients will receive a survey by mail about the visit.
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Experimental: Telemedicine - Audio/Video
Patients will be given an internet-connected tablet to have their upcoming visit with their physician by audio/video.
A survey can be completed on the tablet.
The devices will be sent back to the research time after their single use.
|
An internet-connected tablet provided to patient for upcoming visit with physician by audio/video which can also be used to complete a survey.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Provider rating as assessed by the Consumer Assessment of Healthcare Providers and Systems question on provider rating
Periodo de tiempo: Within 2 weeks of the study visit
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Provider rating will be assessed with the Consumer Assessment of Healthcare Providers and Systems question on provider rating of 0-10; 0 being worst provider possible and 10 being best provider possible.
|
Within 2 weeks of the study visit
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Satisfaction with telemedicine visit for patient as assessed by a Likert scale
Periodo de tiempo: Within 2 weeks of the study visit
|
Satisfaction with telemedicine visit for patient will be assessed with Likert-scale questions related to satisfaction. Satisfaction (1=strongly disagree to 5=strongly agree).
Overall score 3 to 15 with higher scores signifying better satisfaction. |
Within 2 weeks of the study visit
|
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Satisfaction with telemedicine visit for provider as assessed by a Likert scale
Periodo de tiempo: Within 2 weeks of the study visit
|
Satisfaction with telemedicine visit for provider will be assessed with Likert-scale questions related to satisfaction. [1=Strongly Disagree. 5=Strongly Agree].
Overall score 2 to 10 with higher scores signifying better satisfaction. |
Within 2 weeks of the study visit
|
|
Efficacy of telemedicine visit for provider as assessed by a Likert scale
Periodo de tiempo: Within 2 weeks of the study visit
|
Efficacy of telemedicine visit for provider will be assessed with Likert-scale questions related to efficacy. [1=Strongly Disagree. 5=Strongly Agree]. b. I was able to understand the patient's explanation of their medical problems well enough. c. In general, this telemedicine visit was effective in improving this patient's medical care d. An in-person visit would likely have provided additional clinically-relevant information e. An in-person visit would likely have led to a change in management |
Within 2 weeks of the study visit
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Provider communication as assessed by yes/no question
Periodo de tiempo: Within 2 weeks of the study visit
|
The ability of a provider to communicate will be assessed by patients with the yes/no question of a modified version of the Consumer Assessment of Healthcare Providers and Systems questionnaire related to communication. Did this provider explain things in a way that was easy to understand? Yes/No |
Within 2 weeks of the study visit
|
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Provider listening as assessed by yes/no question
Periodo de tiempo: Within 2 weeks of the study visit
|
Provider listening will be assessed by patients with the yes/no question of a modified version of the Consumer Assessment of Healthcare Providers and Systems questionnaire related to listening. Did this provider listen carefully to you? Yes/No |
Within 2 weeks of the study visit
|
|
Provider respect as assessed by yes/no question
Periodo de tiempo: Within 2 weeks of the study visit
|
Provider respect will be assessed by patients with the yes/no question of a modified version of the Consumer Assessment of Healthcare Providers and Systems questionnaire relating to respect. Did this provider show respect for what you had to say? Yes/No |
Within 2 weeks of the study visit
|
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Provider time spent as assessed by yes/no question
Periodo de tiempo: Within 2 weeks of the study visit
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Provider time spent will be assessed by patients with the yes/no question of a modified version of the Consumer Assessment of Healthcare Providers and Systems questionnaire relating to time spent during the clinical encounter. Did this provider spend enough time with you? Yes/No |
Within 2 weeks of the study visit
|
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Patient health rating as assessed by a likert scale
Periodo de tiempo: Within 2 weeks of the study visit
|
Patient health will be assessed with Likert-scale questions related to patient health. In general, how would you rate your overall health?
In general, how would you rate your overall mental or emotional health?
Overall score 2 to 10 with lower scores signifying better health. |
Within 2 weeks of the study visit
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jeremy A Epstein, MD, Johns Hopkins University
- Investigador principal: Casey Overby Taylor, PhD, Johns Hopkins University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Otros números de identificación del estudio
- IRB00257994
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
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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