- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05998330
LiverPAL: En randomiserad prövning av palliativ vård på slutenvård för patienter med avancerad leversjukdom (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.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Massachusetts
-
Boston, Massachusetts, Förenta staterna, 02114
- Massachusetts General Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Usual Hepatology Care
Usual hepatology care |
|
|
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Patient Quality of Life (Functional Assessment of Chronic Illness Therapy - Palliative Care, FACIT-Pal) up t0 4 weeks
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Patient FACIT-Pal Score longitudinally between study arms
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Nneka Ufere, MD MSCE, Massachusetts General Hospital
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2023P001894
- 80736 (Annat bidrag/finansieringsnummer: Robert Wood Johnson Foundation)
- 242379 (Annat bidrag/finansieringsnummer: Cambia Health Foundation)
- 243432 (Annat bidrag/finansieringsnummer: American Association for the Study of Liver Diseases)
- 236965 (Annat bidrag/finansieringsnummer: Massachusetts General Hospital Executive Committee on Researrch)
Läkemedels- och apparatinformation, studiedokument
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