- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Texas
-
Houston, Texas, Estados Unidos, 77030
- University of Texas MD Anderson Cancer Center
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
Outros nomes:
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.
Outros nomes:
|
|
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.
Outros nomes:
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.
Outros nomes:
|
|
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.
Outros nomes:
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.
Outros nomes:
|
|
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.
Outros nomes:
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.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Participant's Rating of Physician's Compassion
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Participant's Rating of Physician Communication Skills
Prazo: 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
Prazo: 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
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2016-0494
- NCI-2017-00621 (Identificador de registro: NCI CTRP)
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