- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07820852
Clinical Governance of Home Care and 30-Day Stability (CG-HOME-DSS4)
Clinical Governance of Home Care and 30-Day Home Stability: A Prospective Observational Study in the Health and Social Care District No. 4 of Barletta
This prospective observational study evaluates the organization, quality, and outcomes of home care provided by the Health and Social Care District No. 4 of Barletta, Azienda Sanitaria Locale BT, Italy. It includes patients receiving integrated home care, scheduled general practitioner home visits, or temporary home care during the study period.
The study will assess timeliness of care activation, care characteristics, and 30-day home stability. Home stability is defined as the absence of emergency department visits and unplanned hospital admissions within 30 days. The collected data will be used to identify organizational and clinical factors associated with outcomes and to support quality-improvement activities in community-based care.
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
This single-center prospective observational study is part of a clinical governance program for home care services in the Health and Social Care District No. 4 of Barletta, Azienda Sanitaria Locale BT, Italy. The study concerns three community-based care pathways: integrated home care (ADI), scheduled general practitioner home care (ADP), and temporary home care (ADT).
Eligible care episodes activated during the study period will be identified through routinely collected health service data. No experimental treatment or additional clinical procedure will be assigned by the study. Patients will continue to receive care according to standard clinical practice and their individualized care plans.
The primary outcome is home stability at 30 days, defined as the absence of emergency department visits and unplanned hospital admissions during the 30 days following activation of home care. Additional variables will include the type and intensity of home care, time from request to activation, emergency department visits without admission, unplanned hospital admissions, interruptions or reactivations of care, and selected organizational indicators.
Data will be obtained from the regional health information systems and the administrative and clinical information sources available to the participating district. The analysis will describe the study population, care processes, and 30-day outcomes and will explore differences across care pathways and levels of care complexity. Findings will support multidisciplinary audit and quality-improvement actions aimed at strengthening continuity, appropriateness, and safety of home-based care.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Ilaria Alicino, MD
- Número de teléfono: +39 0883 577810
- Correo electrónico: dss4@aslbat.it
Ubicaciones de estudio
-
-
Barletta-Andria-Trani
-
Barletta, Barletta-Andria-Trani, Italia, 76121
- Health and Social Care District No. 4 of Barletta, Azienda Sanitaria Locale BT
-
Contacto:
- Ilaria Alicino, MD
- Número de teléfono: 0883-577810
- Correo electrónico: dss4@aslbat.it
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Age 18 years or older.
- Resident of, or receiving primary care within, Health and Social Care District No. 4 of Barletta.
- Activation of an Integrated Home Care (ADI), Scheduled General Practitioner Home Care (ADP), or Temporary Home Care (ADT) episode during the study enrollment period.
- Availability of the administrative and clinical data required to assess care processes and 30-day outcomes.
Exclusion Criteria:
- Age younger than 18 years.
- Home care episode initiated outside the study enrollment period.
- Records that cannot be reliably linked across the data sources required for 30-day follow-up.
- Duplicate records relating to the same participant and the same home care episode.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Integrated Home Care (ADI)
Standard multidisciplinary integrated home care provided according to an individualized care plan.
|
Standard scheduled home care provided by the participant's general practitioner.
|
|
Scheduled GP Home Care (ADP)
Participants receiving scheduled home visits from their general practitioner.
|
Standard scheduled home care provided by the participant's general practitioner.
|
|
Temporary Home Care (ADT)
Participants receiving temporary home care because they are temporarily unable to attend an outpatient healthcare setting.
|
Standard temporary home care provided to participants who are temporarily unable to attend an outpatient healthcare setting.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
30-Day Home Stability
Periodo de tiempo: From home care activation through 30 days
|
Percentage of participants with no emergency department visit and no unplanned hospital admission within 30 days after activation of home care.
|
From home care activation through 30 days
|
|
30-Day Home Stability
Periodo de tiempo: From home care activation through 30 days
|
Percentage of participants with no emergency department visit and no unplanned hospital admission within 30 days after activation of home care.
The numerator is the number of participants without either event, and the denominator is the total number of participants evaluable at 30 days.
|
From home care activation through 30 days
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Emergency Department Visits Within 30 Days
Periodo de tiempo: From home care activation through 30 days
|
Percentage of participants with at.gmail least one emergency department visit, without subsequent hospital admission, within 30 days after activation of home care.
|
From home care activation through 30 days
|
|
Unplanned Hospital Admissions Within 30 Days
Periodo de tiempo: From home care activation through 30 days
|
Percentage of participants with at least one unplanned hospital admission within 30 days after activation of home care.
|
From home care activation through 30 days
|
|
Time to Home Care Activation
Periodo de tiempo: From home care request to home care activation, assessed up to 30 days
|
Number of days between the documented request for home care and the activation of the home care episode.
|
From home care request to home care activation, assessed up to 30 days
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Domenico Spinazzola, Azienda Sanitaria Locale BT
- Silla de estudio: Ilaria Alicino, MD, Azienda Sanitaria Locale BT
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
Palabras clave
Términos MeSH relevantes adicionales
- Efectos fisiológicos de las drogas
- Hormonas, sustitutos hormonales y antagonistas hormonales
- Antagonistas hormonales
- Compuestos heterocíclicos
- Compuestos heterocíclicos, 2 anillos
- Compuestos heterocíclicos, anillo fusionado
- Ácidos nucleicos, nucleótidos y nucleósidos
- Acciones farmacológicas
- Acciones y usos químicos
- Purinas
- Ribonucleótidos
- Nucleótidos
- Nucleótidos de adenina
- Nucleótidos de purina
- Antagonistas de andrógenos
- Difosfato de Adenosina
Otros números de identificación del estudio
- ASLBT-DSS4-ADI-2026
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. .