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Een proef met overgangszorg na ontslag voor patiënten met chronische leverziekte (TLC)

3 november 2026 bijgewerkt door: Eric Orman, Indiana University

Een gerandomiseerde studie van overgangszorg na ontslag voor patiënten met chronische leverziekte

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

1000

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

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

Studie Contact Back-up

  • Naam: Regina Weber, BS
  • Telefoonnummer: 317-278-3584
  • E-mail: reginaw@iu.edu

Studie Locaties

  • Verenigde Staten
    • Illinois
      • Chicago, Illinois, Verenigde Staten, 60637
    • Indiana
      • Indianapolis, Indiana, Verenigde Staten, 46202
        • Werving
        • Indiana University Division of Gastroenterolgy and Hepatology
        • Contact:
          • Regina Weber, BS, RRT
          • Telefoonnummer: 317-278-3584
          • E-mail: reginaw@iu.edu
        • Contact:
        • Hoofdonderzoeker:
          • Eric Orman, MD
    • Michigan
      • Ann Arbor, Michigan, Verenigde Staten, 48109
        • Werving
        • University of Michigan
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, Verenigde Staten, 19141
        • Werving
        • Albert Einstein Healthcare Network
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: 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.
Actieve vergelijker: 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.
Ander: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
30-day hospital readmissions for patients hospitalized with complications of advanced liver disease
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of ER visits
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Indiana University

Medewerkers

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

Onderzoekers

  • Hoofdonderzoeker: Eric Orman, MD, Indiana University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 september 2023

Primaire voltooiing (Geschat)

30 juni 2028

Studie voltooiing (Geschat)

30 juni 2028

Studieregistratiedata

Eerst ingediend

18 januari 2023

Eerst ingediend dat voldeed aan de QC-criteria

8 februari 2023

Eerst geplaatst (Werkelijk)

17 februari 2023

Updates van studierecords

Laatste update geplaatst (Werkelijk)

6 november 2026

Laatste update ingediend die voldeed aan QC-criteria

3 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • TLC
  • R01DK132390 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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