- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07756554
Clinical Assessment and Treatment in the Nursing Home as an Alternative to Hospital Admission
Home-Based Assessment and Treatment by Municipal Acute Care Teams Combined With Remote Senior Physician Consultation as an Alternative to Hospital Admission for Nursing Home Residents: A Multicenter Randomized Controlled Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background and Rationale:
Nursing home residents represent one of the most vulnerable populations in the healthcare system. Most residents are older adults with multiple chronic conditions, frailty, reduced functional capacity, and a high risk of adverse outcomes associated with hospitalization. Hospital admissions may lead to complications such as delirium, hospital-acquired infections, functional decline, and reduced quality of life.
In Denmark, all nursing home residents are registered with a general practitioner, who is responsible for addressing medical issues requiring physician assessment during regular office hours (Monday through Friday 08:00-16:00). During out-of-hours periods, nursing home staff often have limited access to medical assessment and decision support. Municipal acute care teams, staffed by experienced nurses, possess substantial clinical competencies; however, access to physician consultation is often limited during evenings, weekends, and public holidays. Consequently, nursing home residents may be referred to an emergency department or admitted to hospital in situations where clinical assessment and treatment within the nursing home could potentially represent a safe and appropriate alternative.
This study evaluates a new cross-sector care model developed through collaboration between municipalities, municipal acute care teams and hospitals in the Capital Region of Denmark. The model combines home-based clinical assessment by municipal acute care teams with remote consultations with senior physicians from the emergency or geriatrics department. The overall aim is to improve access to timely clinical decision-making, provide treatment in familiar surroundings whenever appropriate, and reduce potentially avoidable hospital admissions.
Study Design:
This is a multicenter, cluster-randomized, unblinded quality-improvement study conducted among nursing homes in the Capital Region of Denmark. Nursing homes are randomized to either the intervention pathway or usual care.
The intervention is implemented during out-of-hours periods, defined as weekdays between 16:00 and 22:00 and weekends and public holidays between 08:00 and 22:00. During these periods, participating intervention nursing homes follow the study pathway, whereas control nursing homes continue standard practice. During regular office hours (Monday through Friday 08:00-16:00) both groups contact the general practitioner as usual, and during nights (22:00-08:00), both groups contact the regional medical helpline, 1813.
Before contacting external healthcare services, nursing home staff in both groups always perform an initial assessment including measurement of vital signs and evaluation of the resident's clinical condition. Residents with immediately life-threatening conditions continue to be managed through standard emergency medical services (112).
The study includes an initial run-in period (1 February-1 September 2026) to optimize implementation of the intervention. Following the run-in period, a new cluster randomization with an increased number of intervention nursing homes will be performed before the start of the main data collection.
Intervention (Home-Based Care Program):
Nursing homes randomized to the intervention arm will, whenever a resident requires urgent clinical assessment during out-of-hours periods, call the municipal acute care team directly instead of the regional medical helpline (1813). The acute care team may manage and conclude the case directly by phone, or they may conduct an on-site comprehensive clinical assessment first. When physician input is required, the acute care team consults a senior physician from the emergency or geriatrics department by telephone or video conference.
Following this remote consultation, a treatment and/or observation plan is established. Possible outcomes of include:
- Management and discharge at the nursing home with advice and minor interventions.
- Follow-up by the resident's general practitioner on the next working day.
- Home-based treatment under hospital responsibility with planned follow-up from the municipal acute care team (Hospital-at-Home, HaH).
- Subacute outpatient assessment at the hospital.
- Assessment by a mobile physician service.
- Acute hospital admission when clinically indicated.
Control Group:
Nursing homes in the control group will follow standard care when a resident experiences acute illness or clinical deterioration during out-of-hours periods, that is, call the regional medical helpline, 1813.
Data Collection and Analysis:
Data on the primary outcomes will be collected by physicians employed at Copenhagen University Hospital - Herlev and Gentofte. Data on disposition following the initial assessment will be recorded by nurses from the municipal acute care teams and subsequently collected by the study physicians. Statistical analyses will be performed by the study physicians in collaboration with a biostatistician from the University of Copenhagen. The study findings will be submitted for publication in peer-reviewed scientific journals.
Sample Size and Run-in Period:
This is a pragmatic quality-improvement study. All municipalities in the Capital Region of Denmark, with the exception of Bornholm, have been invited to participate, and all nursing homes within participating municipalities are eligible for inclusion. Consequently, the final sample size will depend on the number of participating municipalities and nursing homes during the study period. Although the study is ongoing, data collection for the main analyses has not yet commenced. A statistical power calculation based on the expected sample size will therefore be performed before initiation of the primary data collection to estimate the study's power to detect clinically relevant differences in the primary outcomes.
An initial run-in period was conducted from 1 February to 1 September 2026 to evaluate and optimize implementation of the intervention. Following this period, a new cluster randomization with an increased number of intervention nursing homes will be performed before commencement of the main study period.
Ethical Considerations:
The study is classified as a quality-improvement initiative and therefore does not require approval from the National Committee on Health Research Ethics. It has been approved by the regional research governance office of the Capital Region of Denmark (P-2026-21209).
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Josephine L Nielsen, MD
- Número de teléfono: +4527156091
- Correo electrónico: josephine.lund.nielsen@regionh.dk
Copia de seguridad de contactos de estudio
- Nombre: Maria N Larsen, MD, PhD
- Número de teléfono: +4540314282
- Correo electrónico: maria.normand.larsen@regionh.dk
Ubicaciones de estudio
-
-
-
Copenhagen, Dinamarca
- Reclutamiento
- Copenhagen University Hospital - Bispebjerg and Frederiksb
-
Herlev, Dinamarca
- Reclutamiento
- University Hospital of Copenhagen Herlev
-
Hillerød, Dinamarca
- Reclutamiento
- Copenhagen University Hospital - North Zealand Hospital
-
Hvidovre, Dinamarca
- Reclutamiento
- University Hospital of Copenhagen Amager and Hvidovre
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Clusters (Nursing Homes):
Inclusion Criteria:
- Nursing homes, defined as long-term care facilities with care personnal available 24/7 for residents with need for continued medical care
- Nursing homes located in the Capital Region of Denmark
- Nursing homes accepting participation and cluster randomization
Exclusion criteria
- Assisted living facilities, intermediate/temporary care units, rehabilitation units, hospices, or other non-nursing-home setting.
- Nursing homes located on the island of Bornholm
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: Cuidado estándar
El grupo de control
|
|
|
Experimental: Home-based assessment and treatment
The intervention group
|
Nursing homes in the intervention group will, if a resident experiences acute illness or clinical deterioration, call the municipal acute care team directly.
They will then do a home-based clinical assessment and, if deemed necessary, consult a senior physician in the hospital emergency or geriatrics department to establish a treatment and observation plan.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time to first event
Periodo de tiempo: From date of randomization until the date of first event, up to 7 months.
|
Time to first event defined as either "acute hospital admission" or "death from any cause", compared between intervention and usual care groups using time-to-event methods, with superiority testing.
|
From date of randomization until the date of first event, up to 7 months.
|
|
All-cause mortality
Periodo de tiempo: From date of randomization until date of death from any cause, up to 7 months
|
Time to death from any cause, compared between intervention and usual care groups using time-to-event methods, with non-inferiority testing.
|
From date of randomization until date of death from any cause, up to 7 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Initial Disposition After Assessment by the Municipal Acute Care Team
Periodo de tiempo: At completion of the index assessment, up to 6 hours.
|
Distribution of contacts according to the immediate disposition following assessment by the municipal acute care team. Disposition categories include:
|
At completion of the index assessment, up to 6 hours.
|
|
Number of emergency contacts (both groups)
Periodo de tiempo: From date of randomization until the end of follow-up, up to 48 weeks.
|
Number of contacts to 1813 or the municipal acute care team, respectively, during follow-up period.
|
From date of randomization until the end of follow-up, up to 48 weeks.
|
|
Total healthcare cost per nursing home resident
Periodo de tiempo: From date of randomization until the end of follow-up, up to 48 weeks.
|
Economic evaluation comparing the intervention and control groups based on the mean total cost per nursing home resident (DKK) during the follow-up period. Multiple resource measures will be collected. These include:
|
From date of randomization until the end of follow-up, up to 48 weeks.
|
|
Proportion of in-hospital deaths
Periodo de tiempo: From date of randomization until date of death from any cause, up to 7 months
|
Proportion of in-hospital deaths out of all deseased nursing home residents in both the intervention and the control group.
|
From date of randomization until date of death from any cause, up to 7 months
|
|
Proportion of end-of-life hospitalizations
Periodo de tiempo: From date of randomization until date of death from any cause, up to 7 months
|
Proportion of end-of-life hospitalizations, defined as hospitalizations during the last month before death, out of total number of deseased nursing home residents.
|
From date of randomization until date of death from any cause, up to 7 months
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Nursing home resident experience (qualitative)
Periodo de tiempo: One month after clinical assessment
|
Evaluation through semi-structured interviews
|
One month after clinical assessment
|
|
Healthcare personal experience (qualitative)
Periodo de tiempo: 6 months after enrollment of nursing home
|
Evaluation through semi-structured interviews
|
6 months after enrollment of nursing home
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Silla de estudio: Kasper K Iversen, MD, Professor, University Hospital of Copenhagen Herlev and Gentofte
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Procesos Patológicos
- Atributos de la enfermedad
- Enfermedades metabólicas
- Manifestaciones neuroconductuales
- Desequilibrio de agua y electrolitos
- Trastornos de la percepción
- Enfermedad progresiva
- Condiciones Patológicas, Signos y Síntomas
- Enfermedades Nutricionales y Metabólicas
- Signos y síntomas
- Deterioro Clínico
- Deshidración
- Infecciones
- Agnosia
- Terapéutica
Otros números de identificación del estudio
- Hospital in the Nursing Home
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. .