- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT06396897
Modelo de atención hospitalaria en casa para la cirrosis (H@H)
El modelo de atención Hospital @ Home: una novedosa solución sanitaria para el tratamiento de la cirrosis descompensada
The purpose of this study is to work with patients diagnosed with end-stage liver disease to understand their perspectives on the Health at Home (H@H) Program, including desired outcomes and expectations, perceived barriers, and drivers. H@H is an emerging model of home-based care, designed to extend traditional, inpatient hospital care which may address these needs. Through H@H, acute medical care services as well as ancillary care such as rehabilitation therapy can be delivered in the home. The study is divided into three phases: Phase 1 occurs while the participant is an inpatient. Phase 2 is when the actual H@H program takes place as part of the participant's clinical care. The study team will not be involved in the Phase 2 - H@H program as it will be conducted by the clinical staff. Phase 3, at which point the participant enters a rehabilitation phase to transition the patient to self-management, involves a research jam session with the participant and caregiver to assess the value of the program.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Hospital at Home (H@H) as an emerging model of care is designed as an extension for traditional inpatient hospital care. Patients experiencing certain medical conditions normally requiring admission to an inpatient hospital can instead consent to receive acute care treatment in their homes. Prior studies have shown success of this model through demonstration of clinical and economic efficacy and feasibility, as well as greater satisfaction with care for patients, their family members and their providers. Since November 2020, Centers for Medicare and Medicaid Services has provided a waiver for H@H services. Similarly in 2020, Indiana University Health (IUH) introduced the Hospital at Home (H@H) Program for its beneficiaries to increase hospital capacity during the Public Health Emergency. Through this program, primary medical management services as well as ancillary services such as Occupational Therapy, Physical Therapy, and diagnostic testing can be delivered in the home. This model has been successful used at IUH to management patients with moderate COVID-19 infection, common infectious diseases, and decompensated heart failure.
In the realm of liver disease, acute decompensations of chronic liver disease often require hospitalizations for acute management. In certain clinical scenarios, while the initial 24-48 hour period may require the intensive management offered in an acute care hospital, the remaining hospital days represent less acute and/or intense needs such as continued administration of IV medications, monitoring for safe transition to oral medications and/or daily lab monitoring for period of time. We hypothesize that services through the IUH H@H program can offer equally safe and effective for these clinical scenarios while improving patient satisfaction, reducing care-giver burden, being cost-saving and improving access to acute care hospital services to other patients. We also hypothesize that completing the acute care management in the home setting will lead to more effective transition to chronic management as measured by subsequent 30-day readmissions and 30-day emergency room visits leading to reduced overall cost of health care. As a next step in expansion, the IUH H@H team is partnering with the PI and IUH Hepatology team to manage select patients with chronic liver disease (CLD). The overall goal of this proposal is to assess whether IUH's H@H program represents a novel care delivery model in cirrhosis that is safe, improves patient and caregiver experience as well as reduces HCU in the high-risk, CLD population.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Regia Weber
- Número de teléfono: 317-278-3584
- Correo electrónico: reginaw@iu.edu
Copia de seguridad de contactos de estudio
- Nombre: Archita Desai, MD
- Número de teléfono: (317) 278-1664
- Correo electrónico: desaiar@iu.edu
Ubicaciones de estudio
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Reclutamiento
- IU School of Medicine
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Contacto:
- Miranda Stovall
- Número de teléfono: (317) 278-2401
- Correo electrónico: mirstova@iu.edu
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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:
- Enrolled into IUH's H@H program
- At least 18 years of age
- Chronic liver disease/cirrhosis based on characteristic clinical, laboratory, and imaging findings
- English speaking
- Able to provide consent
- Caregiver able to be present during the acute phase of care (first 48 hours post-hospital discharge)
- Able to perform activities of daily living independently
- Lives within IU Health Home service area
Exclusion Criteria:
- Unable to complete study questionnaires due to neurocognitive disease, legal blindness or hearing loss
- Transplant of organ other than liver
- Pregnant
- Incarcerated
- New hemodialysis
- Blood pressure < 90/60, Pulse > 120, O2 > 6L or >2L above baseline
- HIV+/CD4 count < 200
- Receiving hospice services
- Concurrent enrollment in a related research study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: Decompensated Cirrhotics
Phase 1:
Phase 2: • completion of the Hospital at Home (H@H) program as part of clinical care. In brief, the Hospital at Home program (H@H) is an innovative care delivery method that aims to provide hospital-level care at home and facilitate the transition care from the hospital to the home. Phase 3:
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Structure of Care in IUH H@H Program: The IUH H@H program allows patients to be cared for at home using home remote monitoring devices, travel laboratory services and both in-person and virtual rounding by the health care team. The team includes registered nurses (RN), advanced practice provider (APP, nurse practitioner and physician assistants) and hospitalist physician. Care at home is divided into 4 consecutive phases after initial hospitalization: (1) evaluation/planning, (2) acute, (3) recovery, and (4) rehabilitation. All patients are sent home with a RPM tablet used to obtain vital signs, send messages between patient and RN, & perform video visits. The device is Bluetooth enabled and does not require WiFi or a phone line. All data obtained is automatically pulled into the electronic medical record. The RN uses a device which enables remote physical exams, i.e., obtain heart, lung and bowel sounds, pictures (wounds, lines, etc.) for review by APP/MD. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Number of participants enrolled into program
Periodo de tiempo: Phase 1 Baseline
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Phase 1 Baseline
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Reason for enrollment failure
Periodo de tiempo: Phase 1 Baseline
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Phase 1 Baseline
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of participants with follow-up consultations during Phase 2
Periodo de tiempo: During H@H program and up to and including 90 days after program completion
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During H@H program and up to and including 90 days after program completion
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Number of participants with services utilized in the home during Phase 2
Periodo de tiempo: During H@H program and up to and including 90 days after program completion
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During H@H program and up to and including 90 days after program completion
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Number of participants with ED visits
Periodo de tiempo: During H@H program and up to and including 90 days after program completion
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ED visits, including repeat visits, will be tracked |
During H@H program and up to and including 90 days after program completion
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Number of participants with rehospitalization
Periodo de tiempo: During H@H program and up to and including 90 days after program completion
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During H@H program and up to and including 90 days after program completion
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Number of participants with a liver transplant
Periodo de tiempo: 30 and 90 days after H@H program completion
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30 and 90 days after H@H program completion
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Number of participants with hospice enrollment
Periodo de tiempo: 30 and 90 days after H@H program completion
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30 and 90 days after H@H program completion
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Rate of Mortality
Periodo de tiempo: up to 90 days after H@H program completion
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up to 90 days after H@H program completion
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PSQ 18
Periodo de tiempo: at 2 weeks after H@H program completion
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Patient Satisfaction Questionnaire |
at 2 weeks after H@H program completion
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Telemedicine Questionnaire
Periodo de tiempo: at 2 weeks after H@H program completion
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at 2 weeks after H@H program completion
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ZBI-12
Periodo de tiempo: at 2 weeks after H@H program completion
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Zarit Burden Interview Questionnaire |
at 2 weeks after H@H program completion
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Promis 29+2
Periodo de tiempo: up to 90 days after H@H program completion
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change in health related quality of life |
up to 90 days after H@H program completion
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Colaboradores e Investigadores
Patrocinador
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
Otros números de identificación del estudio
- 21905
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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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