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Modelo de atención hospitalaria en casa para la cirrosis (H@H)

17 de septiembre de 2026 actualizado por: Archita P. Desai, Indiana University

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

Reclutamiento

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

Intervencionista

Inscripción (Estimado)

30

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

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

    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46202
        • Reclutamiento
        • IU School of Medicine
        • Contacto:
          • Miranda Stovall
          • Número de teléfono: (317) 278-2401
          • Correo electrónico: mirstova@iu.edu

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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
Otro: Decompensated Cirrhotics

Phase 1:

  • two questionnaires to assess patient reported outcomes
  • an open-ended patient interview using a variety of patient-engagement methods to assess program expectations

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:

  • researchers engage virtually to discuss actual experience, outcomes, and challenges. These will be semi-structured interviews about their perspectives on the program, including desired outcomes and expectations and perceived barriers and drivers and will last about two hours.
  • complete four questionnaires relating to quality of life.

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
Number of participants enrolled into program
Periodo de tiempo: Phase 1 Baseline
Phase 1 Baseline
Reason for enrollment failure
Periodo de tiempo: Phase 1 Baseline
Phase 1 Baseline

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
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
During H@H program and up to and including 90 days after program completion
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
During H@H program and up to and including 90 days after program completion
Number of participants with ED visits
Periodo de tiempo: During H@H program and up to and including 90 days after program completion

ED visits, including repeat visits, will be tracked

During H@H program and up to and including 90 days after program completion
Number of participants with rehospitalization
Periodo de tiempo: During H@H program and up to and including 90 days after program completion
During H@H program and up to and including 90 days after program completion
Number of participants with a liver transplant
Periodo de tiempo: 30 and 90 days after H@H program completion
30 and 90 days after H@H program completion
Number of participants with hospice enrollment
Periodo de tiempo: 30 and 90 days after H@H program completion
30 and 90 days after H@H program completion
Rate of Mortality
Periodo de tiempo: up to 90 days after H@H program completion
up to 90 days after H@H program completion
PSQ 18
Periodo de tiempo: at 2 weeks after H@H program completion

Patient Satisfaction Questionnaire

at 2 weeks after H@H program completion
Telemedicine Questionnaire
Periodo de tiempo: at 2 weeks after H@H program completion
at 2 weeks after H@H program completion
ZBI-12
Periodo de tiempo: at 2 weeks after H@H program completion

Zarit Burden Interview Questionnaire

at 2 weeks after H@H program completion
Promis 29+2
Periodo de tiempo: up to 90 days after H@H program completion

change in health related quality of life

up to 90 days after H@H program completion

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

10 de mayo de 2024

Finalización primaria (Estimado)

30 de septiembre de 2028

Finalización del estudio (Estimado)

31 de diciembre de 2028

Fechas de registro del estudio

Enviado por primera vez

30 de abril de 2024

Primero enviado que cumplió con los criterios de control de calidad

30 de abril de 2024

Publicado por primera vez (Actual)

2 de mayo de 2024

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

17 de septiembre de 2026

Última verificación

1 de septiembre de 2026

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)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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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