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Próba opieki przejściowej po wypisaniu ze szpitala dla pacjentów z przewlekłą chorobą wątroby (TLC)

3 listopada 2026 zaktualizowane przez: Eric Orman, Indiana University

Randomizowana próba opieki przejściowej po wypisaniu ze szpitala dla pacjentów z przewlekłą chorobą wątroby

Patients with complications of advanced liver disease often have difficulties after hospital discharge that result in early hospital readmission. Poor outcomes for these patients during this transitional time could be improved through the use of innovative transitional care models. This proposal aims to examine the effect of a transitional care model, The Transitional Liver Clinic (TLC), in reducing hospital re-admissions, improving quality of life, and improving patient experience.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

This study is a stepped-wedge randomized trial of 1,000 patients with advanced liver disease at four high-volume centers over 45 months (250 participants/site; <6 participants/site/month) to evaluate the efficacy of the Transitional Liver Clinic (TLC) compared to control.

In the stepped-wedge design, all sites provide usual care (control) during the initial 9-month enrollment interval. At each subsequent 9-month interval, one site is randomized via a computer-generated randomization scheme to crossover to implement the TLC, which will continue through the final interval where all sites will have implemented the TLC.

All sites enroll for the entire 45 months and thus contribute patients to both the control and TLC groups. There are an equal number of TLC and control intervals; thus approximately 500 patients will be in each group. Participant follow-up will occur by telephone at 30 and 90 days after discharge.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

1000

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: Jake McCarty, BS
  • Numer telefonu: 317-278-6305
  • E-mail: jacmccar@iu.edu

Kopia zapasowa kontaktu do badania

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

Lokalizacje studiów

  • Stany Zjednoczone
    • Illinois
      • Chicago, Illinois, Stany Zjednoczone, 60637
    • Indiana
      • Indianapolis, Indiana, Stany Zjednoczone, 46202
        • Rekrutacyjny
        • Indiana University Division of Gastroenterolgy and Hepatology
        • Kontakt:
          • Regina Weber, BS, RRT
          • Numer telefonu: 317-278-3584
          • E-mail: reginaw@iu.edu
        • Kontakt:
        • Główny śledczy:
          • Eric Orman, MD
    • Michigan
      • Ann Arbor, Michigan, Stany Zjednoczone, 48109
        • Rekrutacyjny
        • University of Michigan
        • Kontakt:
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stany Zjednoczone, 19141
        • Rekrutacyjny
        • Albert Einstein Healthcare Network
        • 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:

  1. Male or female age ≥18

  2. Diagnosis of advanced liver disease, defined as either (must meet either a or b)

    1. cirrhosis based on (either i or ii):

      • biopsy
      • characteristic clinical, laboratory, and imaging findings

    2. acute alcoholic hepatitis, defined by NIAAA Alcoholic Hepatitis Consortia, as

      • onset of jaundice (serum bilirubin >3.0 mg/dL) in prior 8 weeks
      • consumption of >40 (female) or 60 (male) g alcohol/day for ≥6 months, with <60 days abstinence before jaundice onset,
      • AST>50 IU/L, AST/ALT>1.5, and both values <400 IU/L
      • liver biopsy confirmation in patients with confounding factors

  3. Has at least one of the following complications due to advanced liver disease occurring during hospitalization:

    1. ascites requiring diuretics or paracentesis
    2. hepatic encephalopathy requiring lactulose or rifaximin
    3. gastrointestinal bleeding due to portal hypertension
    4. jaundice

  4. Has planned discharge alive to home or a facility within 72 hours of informed consent

  5. Able and willing to provide informed consent

Exclusion Criteria:

  1. discharge under hospice
  2. listed for liver transplant with MELD-Na ≥ 35
  3. unable or unwilling to participate in post-discharge follow-up either in-person or virtually
  4. unable to speak or understand English and/or Spanish
  5. low hearing or communicative ability (examiner rated) that would interfere with interventions and outcome assessments
  6. lack of access to a telephone
  7. incarcerated
  8. concurrent enrollment in an interventional 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: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie krzyżowe
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Brak interwencji: Control group

Patients in the usual care arm will receive standard follow-up care from their usual providers based on recommendations made by inpatient providers at the time of discharge from the hospital.
Aktywny komparator: Transitional Liver Clinic (TLC)

Enrolled patients discharged during the experimental TLC intervention implementation period will receive a phone call from TLC staff within 2 business days of discharge followed by an in-person or video telehealth clinic visit with a hepatology APP within 14 days of discharge. TLC staff will provide additional care based on individual patient needs during the 30-day transitional period.
Inny: Transitional Liver Clinic (TLC)

Participants in this intervention receive additional attention from their Hepatology providers in terms of an additional call/telemedicine visit and more specific/additional attention from their Hepatology APP (advanced practice provider) based on individual patient needs

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
30-day hospital readmissions for patients hospitalized with complications of advanced liver disease
Ramy czasowe: 30 days after discharge of initial hospitalization at which the participant was enrolled in the study.

The primary outcome, 30-day hospital readmission, is publicly reported by CMS, and is the benchmark measure in the Hospital Readmissions Reduction Program. It is therefore the most appropriate primary outcome.
30 days after discharge of initial hospitalization at which the participant was enrolled in the study.
Quality of life for patients hospitalized with complications of advanced liver disease via Promis 29+2 survey
Ramy czasowe: 30 days after discharge of initial hospitalization at which the participant was enrolled in the study.

This measure includes 4 items in each of 7 health domains (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference) as well as a single item assessing pain intensity. Each domain is scored using a T-score metric in which 50 corresponds to the average for the US population with a standard deviation of 10, and a higher T-score represents more of the concept being measured. For example, higher fatigue scores indicate more fatigue (worse quality of life), while higher physical function scores represent better physical function (better quality of life).
30 days after discharge of initial hospitalization at which the participant was enrolled in the study.
Quality of life for patients hospitalized with complications of advanced liver disease via Promis 29+2 survey
Ramy czasowe: 90 days after discharge of initial hospitalization at which the participant was enrolled in the study

This measure includes 4 items in each of 7 health domains (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference) as well as a single item assessing pain intensity. Each domain is scored using a T-score metric in which 50 corresponds to the average for the US population with a standard deviation of 10, and a higher T-score represents more of the concept being measured. For example, higher fatigue scores indicate more fatigue (worse quality of life), while higher physical function scores represent better physical function (better quality of life).
90 days after discharge of initial hospitalization at which the participant was enrolled in the study
Patient satisfaction for patients hospitalized with complications of advanced liver disease via the PSQ 18 questionnaire
Ramy czasowe: 30 days after discharge of initial hospitalization at which the participant was enrolled in the study

The PSQ-18 consists of 18 items examining 7 dimensions of satisfaction with medical care: general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, and accessibility and convenience. Each item is scored with a 1 to 5 Likert scale and the individual item scores are averaged, with higher scores reflecting higher satisfaction.
30 days after discharge of initial hospitalization at which the participant was enrolled in the study
Patient satisfaction for patients hospitalized with complications of advanced liver disease via the PSQ 18 questionnaire
Ramy czasowe: 90 days after discharge of initial hospitalization at which the participant was enrolled in the study

The PSQ-18 consists of 18 items examining 7 dimensions of satisfaction with medical care: general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, and accessibility and convenience. Each item is scored with a 1 to 5 Likert scale and the individual item scores are averaged, with higher scores reflecting higher satisfaction.
90 days after discharge of initial hospitalization at which the participant was enrolled in the study

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Number of ER visits
Ramy czasowe: 30 days after discharge of initial hospitalization at which the participant was enrolled in the study and 90 days after discharge of initial hospitalization at which the participant was enrolled in the study

Recognizing the limitations on CMS data, the number of ER visits for each participant will be taken from the medical record and will be measured as a secondary outcome to provide a fuller picture of acute care utilization.
30 days after discharge of initial hospitalization at which the participant was enrolled in the study and 90 days after discharge of initial hospitalization at which the participant was enrolled in the study
90 day mortality
Ramy czasowe: 90 days after discharge of initial hospitalization at which the participant was enrolled in the study.

Recognizing the limitations on CMS data, 90 day mortality will be measured as a secondary outcome to provide a fuller picture of acute care utilization.
90 days after discharge of initial hospitalization at which the participant was enrolled in the study.
Days alive out of the hospital
Ramy czasowe: 90 days after discharge of initial hospitalization at which the participant was enrolled in the study.

Recognizing the limitations on CMS data, number of days alive out of the hospital will be measured as a secondary outcome to provide a fuller picture of acute care utilization.
90 days after discharge of initial hospitalization at which the participant was enrolled in the study.
Hospital readmissions
Ramy czasowe: 30 days after discharge of initial hospitalization at which the participant was enrolled in the study and 90 days after discharge of initial hospitalization at which the participant was enrolled in the study

Participants will self report or data will be obtained from local institutional medical records the number of times, if any, they were admitted to the hospital during their time of participation in this study
30 days after discharge of initial hospitalization at which the participant was enrolled in the study and 90 days after discharge of initial hospitalization at which the participant was enrolled in the study

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Indiana University

Współpracownicy

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Śledczy

  • Główny śledczy: Eric Orman, MD, Indiana University

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)

1 września 2023

Zakończenie podstawowe (Szacowany)

30 czerwca 2028

Ukończenie studiów (Szacowany)

30 czerwca 2028

Daty rejestracji na studia

Pierwszy przesłany

18 stycznia 2023

Pierwszy przesłany, który spełnia kryteria kontroli jakości

8 lutego 2023

Pierwszy wysłany (Rzeczywisty)

17 lutego 2023

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

6 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

3 listopada 2026

Ostatnia weryfikacja

1 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • TLC
  • R01DK132390 (Grant/umowa NIH USA)

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 .

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