- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01024166
Patient-Reported Outcomes-Based Palliative and Hospice Care Practice: A Usability Study
A Usability Study of Patient-Reported Outcomes (PRO)-Based Palliative and Hospice Care Practice: Integrating PROs and Decision Support Into an Electronic Record
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The Patient-Reported Outcomes (PRO) Computer System:
The PRO computer system used in this study has been designed to help doctors and nurses check the symptoms and overall health status of patients with cancer by reviewing the computer entries of patients and caregivers. The system has also been designed to help doctors and nurses make decisions about how to care for patients based on the computer entries.
Questionnaire and Review Session:
If you agree to take part in this study, you will have an questionnaire and review session at the Palliative Care outpatient clinic. The session will be conducted by a research staff member, but the study chair and/or other study staff members may also attend the session. The questionnaire and review session will have 3 steps, which are described below:
- If you are a patient receiving palliative care, you will use the PRO computer system to complete 2 questionnaires about any symptoms you may be experiencing and your overall health. If you are a caregiver for someone who is receiving palliative care, you will use the PRO computer system to complete 2 questionnaires about any symptoms that the patient you are caring for may be experiencing and their overall health. The study staff will instruct you on how to use the PRO computer system.
- If you are a physician or nurse, you will use the PRO computer system to complete 4 questionnaires about the symptoms and overall health of patients who are receiving palliative care. The study staff will instruct you on how to use the PRO computer system.
- You will then look at the results of the questionnaires you have completed, which will be shown to you in both number and graph form. You will also be shown other features and potential uses of the PRO computer system.
- Last, you will be asked about how easily you were able to use the computer system. You will also be asked about any changes you think could make the program easier to use.
The questionnaire and review session should take about 30 minutes to complete.
Study Data:
Your responses to the questionnaires will be destroyed after the questionnaire and review session. The responses you give when asked about the use of the PRO computer system will be kept after the questionnaire and review session. Only the study staff will have access to your responses. However, your responses will be coded with a study ID number, not by your name. Your saved responses will be stored in password-protected files that are available only to the study staff for 3 years.
Length of Study:
Your participation in this study will be over after you complete the questionnaire and review session.
This is an investigational study.
Up to 9 patients and 9 caregivers will take part in this study. All will be enrolled at M. D. Anderson.
Up to 9 physicians and nurses (4-5 of each) will take part in this study. All will be enrolled at M. D. Anderson.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Texas
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Houston, Texas, Estados Unidos, 77030
- UT MD Anderson Cancer Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- All patient/caregiver participants will be adults 21 years of age or older.
- Participants will be palliative care cancer patients and/or their designated caregivers.
- Participating patients should be receiving palliative care at the MD Anderson Cancer Center as an inpatient or have attended at least one outpatient appointment; participating caregivers should have provided care to their patient during an inpatient stay or have attended at least one outpatient appointment with their patient.
- Physicians and nurses who are experts in palliative care will be eligible for study participation. For this study's purposes, a physician or nurse with a minimum of four years of experience working in a palliative care setting will be considered an expert in palliative care.
Exclusion Criteria:
- Patients or caregivers who are not able to report on symptom status using the electronic measurement system.
- Patient, caregivers, physicians, or nurses who do not agree to sign the study's informed consent documents.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
Patient
Patient computer system use questionnaire
|
Use PRO computer system to complete 2 questionnaires about any symptoms patient may be experiencing and their overall health, 30 minutes to complete.
Review session about use of computer system and suggested changes.
Otros nombres:
Use PRO computer system to complete 4 questionnaires about symptoms their overall health of patients, 30 minutes to complete.
Review session about use of computer system and suggested changes.
Otros nombres:
|
Caregiver
Caregiver computer system use questionnaire
|
Use PRO computer system to complete 2 questionnaires about any symptoms patient may be experiencing and their overall health, 30 minutes to complete.
Review session about use of computer system and suggested changes.
Otros nombres:
Use PRO computer system to complete 4 questionnaires about symptoms their overall health of patients, 30 minutes to complete.
Review session about use of computer system and suggested changes.
Otros nombres:
|
Healthcare Provider
Physician and Nurse computer system use questionnaire
|
Use PRO computer system to complete 2 questionnaires about any symptoms patient may be experiencing and their overall health, 30 minutes to complete.
Review session about use of computer system and suggested changes.
Otros nombres:
Use PRO computer system to complete 4 questionnaires about symptoms their overall health of patients, 30 minutes to complete.
Review session about use of computer system and suggested changes.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Evaluation of System Usability of the Prototype Solution (Questionnaire Responses)
Periodo de tiempo: Single assessment point
|
Single assessment point
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Michael A. Kallen, PhD, UT MD Anderson Cancer Center
Publicaciones y enlaces útiles
Enlaces Útiles
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
- 2009-0776
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. .
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