Un essai de soins de transition post-congé pour les patients atteints d'une maladie hépatique chronique (TLC)
Un essai randomisé sur les soins de transition post-congé pour les patients atteints d'une maladie hépatique chronique
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Jake McCarty, BS
- Numéro de téléphone: 317-278-6305
- E-mail: jacmccar@iu.edu
Sauvegarde des contacts de l'étude
- Nom: Regina Weber, BS
- Numéro de téléphone: 317-278-3584
- E-mail: reginaw@iu.edu
Lieux d'étude
-
-
Illinois
-
Chicago, Illinois, États-Unis, 60637
- Recrutement
- University of Chicago
-
Contact:
- Michael Charleton, MD
- Numéro de téléphone: 773-702-1234
- E-mail: mcharlton@medicine.bsd.uchicago.edu
-
-
Indiana
-
Indianapolis, Indiana, États-Unis, 46202
- Recrutement
- Indiana University Division of Gastroenterolgy and Hepatology
-
Contact:
- Regina Weber, BS, RRT
- Numéro de téléphone: 317-278-3584
- E-mail: reginaw@iu.edu
-
Contact:
- Eric Orman, MD
- Numéro de téléphone: 317-278-1630
- E-mail: esorman@iu.edu
-
Chercheur principal:
- Eric Orman, MD
-
-
Michigan
-
Ann Arbor, Michigan, États-Unis, 48109
- Recrutement
- University of Michigan
-
Contact:
- Elliott Tapper, MD
- Numéro de téléphone: 734- 936-9250
- E-mail: etapper@umich.edu
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, États-Unis, 19141
- Recrutement
- Albert Einstein Healthcare Network
-
Contact:
- Victor Navarro, MD
- Numéro de téléphone: 215-456-8242
- E-mail: navarrov@einstein.edu
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
-
Male or female age ≥18
-
Diagnosis of advanced liver disease, defined as either (must meet either a or b)
-
cirrhosis based on (either i or ii):
- biopsy
- characteristic clinical, laboratory, and imaging findings
-
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
-
-
Has at least one of the following complications due to advanced liver disease occurring during hospitalization:
- ascites requiring diuretics or paracentesis
- hepatic encephalopathy requiring lactulose or rifaximin
- gastrointestinal bleeding due to portal hypertension
- jaundice
-
Has planned discharge alive to home or a facility within 72 hours of informed consent
-
Able and willing to provide informed consent
Exclusion Criteria:
- discharge under hospice
- listed for liver transplant with MELD-Na ≥ 35
- unable or unwilling to participate in post-discharge follow-up either in-person or virtually
- unable to speak or understand English and/or Spanish
- low hearing or communicative ability (examiner rated) that would interfere with interventions and outcome assessments
- lack of access to a telephone
- incarcerated
- concurrent enrollment in an interventional research study
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: 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. |
|
|
Comparateur actif: 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. |
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 |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
30-day hospital readmissions for patients hospitalized with complications of advanced liver disease
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of ER visits
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Eric Orman, MD, Indiana University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- TLC
- R01DK132390 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .