- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02957565
Patient Perception of Physician's Compassion, Communication Skills, and Professionalism During an Outpatient Palliative Care Visit
Patient Perception of Physician's Compassion, Communication Skills, and Professionalism During an Outpatient Palliative Care Visit: A Randomized Controlled Trial
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
If you agree to take part in this study, during an already-scheduled office visit, you will complete 5 questionnaires about your symptoms, your physical and emotional health, and your trust in the medical profession. These questionnaires should take about 17 minutes to complete.
Study Groups:
After you have completed the first 5 questionnaires, you will be randomly assigned (as in the roll of the dice) to 1 of 4 groups.
Each group will watch 2 short videos that show actors playing doctor and patient roles, discussing different cancer-related symptom treatment options. Each video is about 4 minutes long and will discuss the same content, but setting of each video will be different.
After watching the first video, you will complete 3 questionnaires about your opinions of the doctor's behavior. These questionnaires should take about 5 minutes to complete.
After you watch the second video, you will complete the same 3 questionnaires. You will also complete 2 additional questionnaires about which doctor you would rather have as your doctor and why, and your opinion about the setting of the examination room in the video. It should take about 8 minutes to complete these questionnaires.
Length of Study:
It should take about 38 minutes to watch both videos and to complete all questionnaires. Your participation on this study will be over after you have completed the last questionnaire.
Other Information:
You must attend the study visit alone. Your family members should not be in the room with you while you are participating in the study. You may request to have family members remain in the room, but they must remain silent so that they do not influence your opinions.
This is an investigational study.
Up to 120 participants will be enrolled in this study. All will take part at MD Anderson.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Texas
-
Houston, Texas, Estados Unidos, 77030
- University of Texas MD Anderson Cancer Center
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Patients with the diagnosis of advanced cancer defined as locally advanced, recurrent or metastatic disease.
- Outpatients (either new referrals or follow ups) seen in the Supportive Care Clinic.
- Age >/= 18 years old
- English speaking
- Patients with normal cognitive status (Memorial Delirium Assessment Scale (MDAS) </=6/30) who are able to understand the nature and purpose of the study and have the ability to complete the consent process.
Exclusion Criteria:
1) Patients who are experiencing severe symptom distress, including severe emotional distress and cognitive dysfunction, which may interfere with study participation. This will be determined by the principle investigator and/or attending physician who is caring for the patient during that visit.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Video 1: No EHR - Physician A
Participant completes 5 questionnaires during an already-scheduled office visit. Participant then watches 2 short videos. After the first video, participant completes 3 questionnaires. After viewing the second video, participant completes 5 questionnaires. |
Participant completes 5 questionnaires during an already-scheduled office visit.
Questionnaires ask about symptoms, physical and emotional health, and trust in the medical profession.
These questionnaires should take about 17 minutes to complete.
Otros nombres:
Participant watches 2 short videos that show actors playing doctor and patient roles, discussing different cancer-related symptom treatment options.
Each video is about 4 minutes long and discusses the same content, but setting of each video is different.
After viewing first video, participant completes assessment questionnaire to evaluate their opinion of the physicians behavior. These questionnaires should take about 5 minutes to complete. After viewing second video, participant completes the same 3 assessment questionnaires. Participant also completes 2 additional questionnaires asking which physician participant would prefer as a primary physician and the satisfaction with health information technology use in their care.
Otros nombres:
|
|
Experimental: Video 1: No EHR - Physician B
Participant completes 5 questionnaires during an already-scheduled office visit. Participant then watches 2 short videos. After the first video, participant completes 3 questionnaires. After viewing the second video, participant completes 5 questionnaires. |
Participant completes 5 questionnaires during an already-scheduled office visit.
Questionnaires ask about symptoms, physical and emotional health, and trust in the medical profession.
These questionnaires should take about 17 minutes to complete.
Otros nombres:
Participant watches 2 short videos that show actors playing doctor and patient roles, discussing different cancer-related symptom treatment options.
Each video is about 4 minutes long and discusses the same content, but setting of each video is different.
After viewing first video, participant completes assessment questionnaire to evaluate their opinion of the physicians behavior. These questionnaires should take about 5 minutes to complete. After viewing second video, participant completes the same 3 assessment questionnaires. Participant also completes 2 additional questionnaires asking which physician participant would prefer as a primary physician and the satisfaction with health information technology use in their care.
Otros nombres:
|
|
Experimental: Video 2: With EHR - Physician A
Participant completes 5 questionnaires during an already-scheduled office visit. Participant then watches 2 short videos. After the first video, participant completes 3 questionnaires. After viewing the second video, participant completes 5 questionnaires. |
Participant completes 5 questionnaires during an already-scheduled office visit.
Questionnaires ask about symptoms, physical and emotional health, and trust in the medical profession.
These questionnaires should take about 17 minutes to complete.
Otros nombres:
Participant watches 2 short videos that show actors playing doctor and patient roles, discussing different cancer-related symptom treatment options.
Each video is about 4 minutes long and discusses the same content, but setting of each video is different.
After viewing first video, participant completes assessment questionnaire to evaluate their opinion of the physicians behavior. These questionnaires should take about 5 minutes to complete. After viewing second video, participant completes the same 3 assessment questionnaires. Participant also completes 2 additional questionnaires asking which physician participant would prefer as a primary physician and the satisfaction with health information technology use in their care.
Otros nombres:
|
|
Experimental: Video 2: With EHR - Physician B
Participant completes 5 questionnaires during an already-scheduled office visit. Participant then watches 2 short videos. After the first video, participant completes 3 questionnaires. After viewing the second video, participant completes 5 questionnaires. |
Participant completes 5 questionnaires during an already-scheduled office visit.
Questionnaires ask about symptoms, physical and emotional health, and trust in the medical profession.
These questionnaires should take about 17 minutes to complete.
Otros nombres:
Participant watches 2 short videos that show actors playing doctor and patient roles, discussing different cancer-related symptom treatment options.
Each video is about 4 minutes long and discusses the same content, but setting of each video is different.
After viewing first video, participant completes assessment questionnaire to evaluate their opinion of the physicians behavior. These questionnaires should take about 5 minutes to complete. After viewing second video, participant completes the same 3 assessment questionnaires. Participant also completes 2 additional questionnaires asking which physician participant would prefer as a primary physician and the satisfaction with health information technology use in their care.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Participant's Rating of Physician's Compassion
Periodo de tiempo: 1 day
|
Participant's rating of physician's compassion assessed by using a 5-item tool consisting of five 0-10 numerical rating scales assessing five dimensions: warm-cold, pleasant-unpleasant, compassionate distant, sensitive insensitive, caring-uncaring.
The sum of the five scales gives a final score representing physician's compassion with a 0 to 50 scale.
|
1 day
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Participant's Rating of Physician Communication Skills
Periodo de tiempo: 1 day
|
Participant's rating of physician communication skills assessed by using a 14-item tool consisting of 1 to 4 numerical rating scales assessing communication skills.
The sum of these 14 scales gives a final score representing physician's communication skills with a 14 to 70 scale.
|
1 day
|
|
Participant's Rating of Physician's Professionalism
Periodo de tiempo: 1 day
|
Participant's rating of physician's professionalism assessed by using a 4-item tool assessing politeness, listening, explaining the condition and treatment to the participant and participant's involvement in treatment decisions.
Participant rates from poor to very good.
|
1 day
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ali Haider, MBBS, M.D. Anderson Cancer Center
Publicaciones y enlaces útiles
Enlaces Útiles
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 (Estimar)
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
- 2016-0494
- NCI-2017-00621 (Identificador de registro: NCI CTRP)
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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