- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02686411
Evaluation of Satisfaction With Quality of Care on the Palliative Care Unit
A Prospective Evaluation of Satisfaction With Quality of Care on the Palliative Care Unit
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
PRIMARY OBJECTIVE:
I. To determine the change of satisfaction with quality of care after an experience on the palliative care unit (PCU) for both patients and caregivers, as determined by the global rating survey.
SECONDARY OBJECTIVES:
I. To determine the change of the quality of care as determined by patients and caregivers utilizing validated assessment tools and a global rating survey assessing different aspects of care after PCU.
II. To determine domains of care that are strongly or poorly provided by the PCU, as reported by patient and caregiver opinions on quality of care.
III. To determine which demographic features (i.e. cancer diagnosis; time since diagnosis; reason for transfer to the PCU; gender; caregiver ethnic group; comfort with the idea of transfer to the PCU; Memorial Delirium Assessment Scale [MDAS], Edmonton Symptom Assessment Scale [ESAS], and distress thermometer) may correlate with patient and caregiver satisfaction with PCU care measured by global survey and with the family satisfaction with end-of-life care.
OUTLINE:
Patients and caregivers complete surveys over 5-10 minutes before and after care in the PCU.
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
- M D 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:
- Patients and/or patients' caregivers who have completed at least 2 weekdays on an in-patient service together with the assistance of the palliative care consult services (PCCS), and who then are transitioned to the care of the PCU team along with an admission order to that effect
- A caregiver (if participating) must have been present with the patient during 2 weekdays on the inpatient service and present for at least 2 weekdays of care on the PCU
- Both patient and caregiver participation is optional but both must be 18 years of age or older
- A caregiver will be defined by the patient as "the person most involved with their care". However, if the patient lacks capacity, the caregiver will be decided via discussion with individuals indicated in the patient's Medical Power of Attorney or the Texas rule of law if this is not present
- Both patient and caregiver (if participating) must understand, read and speak English
- Both patient (if actively participating) and caregiver (if participating) must sign an informed consent form
Exclusion Criteria:
- Patients or caregivers with physical limitations (visual or motor impairment) causing inability to read, complete or sign the consent form and surveys after considering appropriate aid and assistance
- Patients or caregivers who the research staff, bedside nurse, or palliative care physician or mid-level provider deems unable to participate due to poor cognitive capacity or acute physical distress
- Caregivers who are not able to attend the patient for at least 2 weekdays while on the PCU
- Patients who are imminently dying as determined by the palliative physician (or designated advanced practice provider [APP]/fellow)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
Observational (survey)
Patients and caregivers complete surveys over 5-10 minutes before and after care in the PCU.
|
Encuesta completa
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Relative satisfaction rate
Periodo de tiempo: through study completion, an average of 1 year
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Defined as the percentage of patients that answered "Better" and "Much Better" to the first question in the global rating on "overall care".
The relative satisfaction rate after palliative care unit (PCU) care in patients or caregivers will be estimated with 95% confidence interval.
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through study completion, an average of 1 year
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Patient Global Survey/Caregiver Global Survey
Periodo de tiempo: through study completion, an average of 1 year
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Assessed by Edmonton Symptom Assessment Scale (ESAS), Memorial Delirium Assessment Scale (MDAS) distress thermometer will be summarized by descriptive analysis and/or tabulation.
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through study completion, an average of 1 year
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Distress thermometer
Periodo de tiempo: through study completion, an average of 1 year
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Measured by Family Satisfaction with end-of-life care will be summarized descriptively for each time point and may be compared within patients and within caregivers before and after the PCU by Wilcoxon signed-rank test, when the outcome is on Likert ordinal scales with 3, 5 levels or even 10 levels and the differences in the scales can be considered as continuous variables.
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through study completion, an average of 1 year
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Patients' and caregivers' opinions on quality of care
Periodo de tiempo: through study completion, an average of 1 year
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Measured by Family Satisfaction with end-of-life care will be summarized descriptively for each time point and may be compared within patients and within caregivers before and after the PCU by Wilcoxon signed-rank test, when the outcome is on Likert ordinal scales with 3, 5 levels or even 10 levels and the differences in the scales can be considered as continuous variables.
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through study completion, an average of 1 year
|
Colaboradores e Investigadores
Patrocinador
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2015-1074 (Otro identificador: M D Anderson Cancer Center)
- NCI-2020-11433 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
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.
producto fabricado y exportado desde los EE. UU.
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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