- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03951090
Geriatric Assessment Reporting in Real Time (GARRT) in Non-electively Hospitalized Older Cancer Patients
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study evaluates the impact of geriatric assessment reporting in real-time (GARRT) on key hospital based outcomes in non-electively hospitalized older (> 70 years) adults with cancer. Participants will be randomly assigned to the GARRT group, or the control group. All participants will fill out user friendly questionnaire called the geriatric assessment. The results of the geriatric assessment will be given to the physicians of participants in the GARRT group in real-time. The physicians of participants in the control group will not receive real time results.
This study will compare the referral rates of participants in each group to determine if providing real-time results of the geriatric assessment impact referral rates.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599
- UNC Lineberger Comprehensive Cancer Center
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Age 70 years or older.
- English speaking.
- Admitted to UNC Hospitals non-electively within 72 hours.
- Biopsy proven solid tumor or myeloma or lymphoma.
- Newly diagnosed cancer patients for whom active cancer directed therapy is planned within the next six months or patients on active cancer directed therapy either currently or within the previous 6 months.
- Signed written IRB-approved informed consent.
Exclusion Criteria:
- Patients meeting any of the following exclusion criteria at baseline will be excluded from study participation. Patients with a life expectancy <6 weeks
- Patients who are <48 hours post-surgery.
- Patients who are admitted to an intensive care setting.
- Patients with acute myeloma lymphoma (AML) or other high grade hematologic malignancies.
- Patients undergoing bone marrow transplant or admitted to the bone marrow transplant unit.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: GARRT Arm
Participants in this arm complete an brief geriatric assessment, and the results of these assessments are given to providers with recommendations to address deficits identified by the geriatric assessment
|
Providers will receive results of the brief geriatric assessment with recommendations for address deficits identified through the results of the brief geriatric assessment
|
Comparador activo: Control Arm
Providers of participants of this group will not receive the results of the brief geriatric assessments.
These participants will receive standard of care treatment
|
Providers will not receive results of the brief geriatric assessment.
Participants will receive standard of care treatment
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Referral rate for GA-identified deficits in intervention and control groups
Periodo de tiempo: 2 years
|
Number of participants with at least one referral for a GA-idenfied deficit
|
2 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Referral to Physical and Occupational therapy
Periodo de tiempo: 2 years
|
Number of times physical and occupation therapy referral was given in Intervention and Control group
|
2 years
|
Referral to Geriatic Consultation
Periodo de tiempo: 2 years
|
Number of times a Geriatric Consultation referral was given in Intervention and Control group
|
2 years
|
Referral to Clinical Pharmacist
Periodo de tiempo: 2 years
|
Number of times Clinical Pharmacist referral was given in Intervention and Control group
|
2 years
|
Referral to Nutritionist
Periodo de tiempo: 2 years
|
Number of times Nutritionist referral was given in Intervention and Control group
|
2 years
|
Referral to psyhcosocial support team
Periodo de tiempo: 2 years
|
Number of times psychosocial support referral was given in Intervention and Control group
|
2 years
|
Physician Reported New information
Periodo de tiempo: 2 years
|
Number of times physicians answer "yes" to the questions "did report provide new information about patient deficits that would warrant a referral"
|
2 years
|
Physician Reported Satisfaction
Periodo de tiempo: 2 years
|
Number of times physician indicate "yes" report was helpful when asked "Is this report useful"
|
2 years
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Trevor Jolly, MBBS, UNC Lineberger Comprehensive Cancer Center
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
- LCCC 1538
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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