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Szpitalny @domowy model opieki nad marskością wątroby (H@H)

17 września 2026 zaktualizowane przez: Archita P. Desai, Indiana University

Model opieki szpitalno-domowej: nowatorskie rozwiązanie w zakresie opieki zdrowotnej w leczeniu niewyrównanej marskości wątroby

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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

30

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Regia Weber
  • Numer telefonu: 317-278-3584
  • E-mail: reginaw@iu.edu

Kopia zapasowa kontaktu do badania

  • Nazwa: Archita Desai, MD
  • Numer telefonu: (317) 278-1664
  • E-mail: desaiar@iu.edu

Lokalizacje studiów

    • Indiana
      • Indianapolis, Indiana, Stany Zjednoczone, 46202
        • Rekrutacyjny
        • IU School of Medicine
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Badania usług zdrowotnych
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Inny: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Ramy czasowe
Number of participants enrolled into program
Ramy czasowe: Phase 1 Baseline
Phase 1 Baseline
Reason for enrollment failure
Ramy czasowe: Phase 1 Baseline
Phase 1 Baseline

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Number of participants with follow-up consultations during Phase 2
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 30 and 90 days after H@H program completion
30 and 90 days after H@H program completion
Number of participants with hospice enrollment
Ramy czasowe: 30 and 90 days after H@H program completion
30 and 90 days after H@H program completion
Rate of Mortality
Ramy czasowe: up to 90 days after H@H program completion
up to 90 days after H@H program completion
PSQ 18
Ramy czasowe: at 2 weeks after H@H program completion

Patient Satisfaction Questionnaire

at 2 weeks after H@H program completion
Telemedicine Questionnaire
Ramy czasowe: at 2 weeks after H@H program completion
at 2 weeks after H@H program completion
ZBI-12
Ramy czasowe: at 2 weeks after H@H program completion

Zarit Burden Interview Questionnaire

at 2 weeks after H@H program completion
Promis 29+2
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Współpracownicy

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

10 maja 2024

Zakończenie podstawowe (Szacowany)

30 września 2028

Ukończenie studiów (Szacowany)

31 grudnia 2028

Daty rejestracji na studia

Pierwszy przesłany

30 kwietnia 2024

Pierwszy przesłany, który spełnia kryteria kontroli jakości

30 kwietnia 2024

Pierwszy wysłany (Rzeczywisty)

2 maja 2024

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

22 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

17 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • 21905

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .