LiverPAL : un essai randomisé de soins palliatifs en milieu hospitalier pour les patients atteints d'une maladie hépatique avancée (LiverPAL)
The goal of this clinical trial is to evaluate whether early integration of palliative care in the care of hospitalized patients with advanced liver disease (AdvLD) can improve patients' quality of life, physical symptoms, mood, and serious illness communication. Palliative care is a medical specialty focused on lessening (or "palliating") symptoms and assisting in coping with serious illness.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The main purpose of this study is to compare two types of care - usual hepatology care and usual hepatology care with early involvement of palliative care clinicians to see which is better for improving the experience of hospitalized patients with advanced liver disease (AdvLD).
The investigators aim to find out whether introducing hospitalized patients with AdvLD to the palliative care team that specializes in symptom management can improve the quality of life and physical and psychological symptoms that patients and families experience during their hospitalizations as well as enhance the quality of patients' end of life care.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Massachusetts
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Boston, Massachusetts, États-Unis, 02114
- Massachusetts General Hospital
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Patient Inclusion Criteria:
-
Hospitalized patient with a diagnosis of advanced liver disease, defined as cirrhosis with one of the following (new or ongoing) within the prior six months from date of consent:
- Ascites (requiring diuretics or serial large volume paracenteses)
- Spontaneous bacterial peritonitis
- Hepatic hydrothorax (requiring diuretics)
- Variceal bleed (with one or more occurrences)
- Overt hepatic encephalopathy (requiring medications)
-
Ability to comprehend English
Patient Exclusion Criteria:
- Prior history of liver transplantation
- Have uncontrolled hepatic encephalopathy, cognitive impairment, psychiatric disorder or other comorbid condition which the primary medical, hepatology, and/or transplant surgery teams believes prohibits the ability to provide informed consent
- Current or recent (within 5 years of receiving curative cancer treatment) history of extrahepatic malignancy (excluding non-melanoma skin cancer)
- Presence of hepatocellular carcinoma beyond Milan criteria
- Are already receiving hospice care
- Receive a score of <10 on the Simplified Animal Naming Test
Caregiver Inclusion Criteria
- Adult caregiver (≥ 18 years of age)
- A relative or friend identified by the patient upon whom the patient relies for help and who likely is to be present in-person during hospitalizations or clinic appointments, or willing to participate by phone
- Ability to comprehend English and can complete questionnaires
Caregiver Exclusion Criteria
1. Inability to comprehend English
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: Usual Hepatology Care
Usual hepatology care |
|
|
Expérimental: Usual Hepatology Care with Early Palliative Care
Usual hepatology care with early palliative care |
The intervention include integrating early palliative care with usual hepatology care to evaluate and treat patients' symptoms, enhance their illness and prognostic understanding, support their coping, and coordinate their serious illness, transitional, and end-of-life care. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Patient Quality of Life (Functional Assessment of Chronic Illness Therapy - Palliative Care, FACIT-Pal) up t0 4 weeks
Délai: Up to 4 weeks
|
Compare patient quality of life (FACIT-Pal) scores up to 4 weeks adjusting for baseline quality of life scores between the study arms. Score range 0-184 with higher scores indicating better quality of life. |
Up to 4 weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Patient FACIT-Pal Score longitudinally between study arms
Délai: Up to 6 months
|
Compare patient quality of life (FACIT-Pal) scores longitudinally between the study arms. Score range 0-184 with higher scores indicating better quality of life. |
Up to 6 months
|
|
Patient Symptom Burden (revised Edmonton Symptom Assessment Scale, ESAS-r)
Délai: Up to 6 months
|
Compare patient symptom burden scores (ESAS-r) between the study arms. Score range 0-100 with higher scores indicating higher symptom burden. |
Up to 6 months
|
|
Patient Depression Symptoms (Hospital Anxiety and Depression Scale, HADS-D)
Délai: Up to 6 months
|
Compare patient depression symptoms (HADS-D) between the study arms. Score range 0-21 with higher scores indicating higher depression symptoms. |
Up to 6 months
|
|
Patient Anxiety Symptoms (Hospital Anxiety and Depression Scale, HADS-A)
Délai: Up to 6 months
|
Compare patient anxiety symptoms (HADS-A) between study arms. Score range 0-21 with higher scores indicating higher anxiety symptoms. |
Up to 6 months
|
|
Patient End-of-Life (EOL) Care Communication with Clinicians
Délai: Final assessment prior to patient death or at 6 months
|
"Has [participant] talked with [participant's] doctor about the kind of medical care [participant] would want if [participant] were very sick or near the end of life?" |
Final assessment prior to patient death or at 6 months
|
|
Documentation of Patient End-of-Life (EOL) Care Preferences
Délai: After patient death, up to 60 months
|
Compare documentation of EOL care preferences in the electronic health record between study arms since baseline. |
After patient death, up to 60 months
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Nneka Ufere, MD MSCE, Massachusetts General Hospital
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
- 2023P001894
- 80736 (Autre subvention/numéro de financement: Robert Wood Johnson Foundation)
- 242379 (Autre subvention/numéro de financement: Cambia Health Foundation)
- 243432 (Autre subvention/numéro de financement: American Association for the Study of Liver Diseases)
- 236965 (Autre subvention/numéro de financement: Massachusetts General Hospital Executive Committee on Researrch)
Informations sur les médicaments et les dispositifs, documents d'étude
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