- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02204605
Video-based Consensus Opinion for Hand and Upper Extremity Problems
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Before visiting a specialist, patients have assumptions regarding diagnosis, etiology, prognosis, and preferred treatment for their condition. Naturally, some of these assumptions may be inaccurate or incomplete or there may be room for debate and disagreement even among specialists. We are looking for ways to make unexpected and indeterminate aspects of an illness less unsettling for patients. When the hand surgeon's advice doesn't ring true, the patient may lose confidence in that provider. Sometimes the interaction can feel disrespectful and even adversarial. We are curious whether patient's satisfaction with diagnosis, surgeon, and treatment plan would improve if they were able to get an opinion from many surgeons at once. One feasible way to do that would be to show an edited and anonymized video to a set of hand surgeons for their opinions on diagnosis and treatment.
Primary study question:
Among patients with initially puzzling pains, there is no difference in satisfaction with diagnosis between patients that receive a video based consensus opinion and those that receive routine care from a single hand surgeon controlling for psychological factors, demographics, and initial and final diagnosis.
Secondary study questions:
- Among patients with initially puzzling pains, there is no difference in pain intensity and disability one month after the initial visit between patient that receive a consensus diagnosis and those that receive routine care from a single surgeon.
- There is no variation in diagnosis between observers (Observers are hand surgeons viewing the visit video and consulting on the diagnosis).
Tipo de estudio
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Massachusetts General Hospital
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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:
- All patients (>18 years) presenting to Dr. David Ring with painful conditions that are puzzling (A puzzling pain condition is defined as Dr. Ring being puzzled about what is causing the pain. Subject eligibility based on this criterion will be determined by Dr. Ring).
- English fluency and literacy
- Able to provide informed consent
Exclusion Criteria:
- Pregnant Women
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: Control
Visits are not videotaped
|
|
|
Experimental: Videoed Patients
Patients will have their visit videotaped.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Likert Scale for Satisfaction
Periodo de tiempo: At enrollment
|
At enrollment
|
|
Likert Scale for Satisfaction
Periodo de tiempo: 4-6 weeks
|
4-6 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Patient Self-Efficacy Questionnaire (PSEQ-2)
Periodo de tiempo: At enrollment
|
At enrollment
|
|
Patient Self-Efficacy Questionnaire (PSEQ-2)
Periodo de tiempo: 4-6 weeks
|
4-6 weeks
|
|
Patient Health Questionnaire (PHQ-2)
Periodo de tiempo: at enrollment
|
at enrollment
|
|
Patient Health Questionnaire (PHQ-2)
Periodo de tiempo: 4-6 weeks
|
4-6 weeks
|
|
QuickDASH (Disabilities of the Arm, Shoulder, and Hand)
Periodo de tiempo: At enrollment
|
At enrollment
|
|
QuickDASH (Disabilities of the Arm, Shoulder, and Hand)
Periodo de tiempo: 4-6 weeks
|
4-6 weeks
|
|
Numerical Rating Scale for Pain
Periodo de tiempo: at enrollment
|
at enrollment
|
|
Numerical Rating Scale for Pain
Periodo de tiempo: 4-6 weeks
|
4-6 weeks
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
- 2014P000132
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. .