- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03656224
Survey of Post-Acute Inpatient Rehabilitation Safety Concerns in Participants With Cancer
Survey of Post-Acute Inpatient Rehabilitation Safety Concerns in the Cancer Population
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
PRIMARY OBJECTIVES:
I. Assess patients' perceptions regarding safety after acute inpatient rehabilitation at discharge and after approximately one month from discharge date.
SECONDARY OBJECTIVES:
I. Assess patient's perception of factors impacting continuity of care at discharge and after approximately one month from discharge date.
II. Determine the frequency of reported falls and the circumstance surrounding reported falls during hospitalization and within approximately one month from discharge date.
III. Determine the frequency of reported near falls and the circumstance surrounding reported near falls within approximately one month from discharge date.
IV. Identify demographic and clinical characteristics associated with feeling safe and unsafe.
OUTLINE:
Participants complete surveys over 15 minutes at 1-2 days before discharge and at 1 month after discharge.
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:
- All patients who are discharged from the acute cancer inpatient rehabilitation unit to personal residence (house, apartment, condominium, hotel, assisted living, etc.)
- Patients who provide informed consent
- English-speaking participants
Exclusion Criteria:
- Patients discharged to another hospital or health facility (Skilled Nursing Facility [SNF], Long Term Acute Care Hospital [LTACH], inpatient hospice, etc.)
- Patients with moderate to severe cognitive deficits as determined by speech language pathologist and/or rehabilitation physician
- Patients who were re-hospitalized at any time during study period (since completion of first survey in the hospital and discharged from the hospital until approximately one month after discharge
- Patients who were readmitted to acute inpatient rehabilitation service and previously completed both surveys
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
Observational (survey)
Participants complete surveys over 15 minutes at 1-2 days before discharge and at 1 month after discharge.
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Estudios complementarios
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Patients' perceptions regarding safety after acute inpatient rehabilitation
Periodo de tiempo: 1 month after discharge
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Will be assessed by Patient Continuity of Care Checklist and Perceptions Regarding Safety after Rehabilitation.
At the end of study, patients' demographics and clinical characteristics will be summarized for all the patients who participated in the study by standard descriptive statistics such as mean, standard deviation, median, and range for continuous variables and frequency and proportion for categorical variables.
The association between these characteristics and feeling safe will be evaluated by Wilcoxon rank sum test and chi-square (or Fisher's exact) test for continuous and categorical variables, respectively.
The proportion of patients who claim they feel safe at each time will be estimated and reported along with the 95% Clopper-Pearson exact confidence interval.
McNemar's test will be applied to evaluate whether the status of feeling safe has changed from the time of discharge to one month afterwards.
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1 month after discharge
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Frequency of experiencing falls and/or near falls
Periodo de tiempo: 1 month after discharge
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Will be calculated and reported along with a 95% confidence interval.
Furthermore, circumstances surrounding reported falls collected by question 19 and 20 in the survey will be summarized by descriptive statistics.
Answers about other aspects of safety concerns collected by the questionnaire will be reported by descriptive statistics.
To further investigate the association of sociodemographic and disease characteristics of patients with their perception of safety logistic regression models may be applied.
Answers to "Patient Continuity of Care Checklist" questionnaire will be summarized and subscale scores will be calculated.
Subscale scores will be compared between patients with different safety perception by applying Wilcoxon rank sum test.
All tests will be performed two-sided and at 5% nominal significance level unless otherwise stated.
Other statistical approaches may be utilized when appropriate.
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1 month after discharge
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jegy Tennison, 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 (Actual)
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
- 2018-0104 (Otro identificador: M D Anderson Cancer Center)
- NCI-2018-01749 (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.
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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