Elastography-based Brief Alcohol Intervention in Hospitalized Individuals (PREDILECTION)
Proactive Liver Disease Assessment and Brief Intervention Among Hospitalized People With Harmful Alcohol Consumption: An Investigator-initiated, Pragmatic, Parallel-group, Open-label, 2-arm Randomized Controlled Trial to Investigate the Efficacy of Proactive Elastography-based Brief Alcohol Intervention Compared With Usual Care in Hospitalized Adult Participants at Risk of Alcohol-related Liver Disease
Aperçu de l'étude
Statut
Intervention / Traitement
Description détaillée
Harmful alcohol consumption constitutes a major contributor to global morbidity, being associated with many diseases and injury outcomes; it is the leading cause of liver cirrhosis and represents a significant cause of hospital admissions. Alcohol-related liver disease (ALD) is characterized by slow progression from a healthy liver to steatohepatitis, progressive fibrosis, cirrhosis, and life-threatening liver decompensation. The risk of progression is related to the volume and pattern of drinking. Because disease progression is usually asymptomatic with subtle biochemical or imaging abnormalities, liver disease may remain undiagnosed for decades and often present with end-stage complications at a point where survival is poor. At all stages of ALD, substantial reversibility and improved prognosis can be achieved if alcohol intake is stopped or reduced.
Brief alcohol intervention (BAI) is a time-limited structured motivational intervention targeting harmful alcohol use. Meta-analyses have shown that BAI can lead to modest but clinically meaningful reductions in alcohol intake, alcohol-related harm and mortality in primary care and hospital settings.
Elastography is an ultrasound-based technique that provides liver stiffness measurements (LSM) as a surrogate marker of liver fibrosis and portal hypertension. A unique feature of elastography is that it provides immediate disease staging following a quick bedside examination with ample opportunities for biofeedback, tailored BAI, and linkage to further hepatology and addiction care as needed. There is increasing evidence that such personalized healthcare communications involving biofeedback based on markers of liver injury may have more impact on drinking behavior than BAI alone.
There is an unmet need for interventions to promote case-finding, timely liver fibrosis detection, and reduction of alcohol-related harms among people at risk of ALD. Hospitalization presents a unique opportunity for intervention, as patients may be more receptive to behavioral change during acute illness. Hospital admission may therefore represent a 'teachable moment' that may enhance intervention impact.
This study will investigate the efficacy of proactive elastography-based liver disease assessment and structured counseling according to BAI principles in emergency hospitalized individuals at risk of ALD. The hypothesis is that proactive assessment of liver health during hospitalization may motivate reductions in alcohol use and thereby prevent disease complications and recurrent admissions more effectively than usual care.
This is a Norweigan multicenter study that will include patients at risk of ALD admitted for inpatient care for any reason. Approximately 500 patients will be included from 8 hospitals over a period of 18 months. Patients will be screened for harmful alcohol use (AUDIT-C) and for liver fibrosis (FIB-4) during admission/hospitalization, and will be assigned 1:1 to recieve elastography-based BAI in addition to usual care, or usual care alone, according to standard clinical practice.
Elastography-based BAI will be delivered during hospitalization. After discharge, patients will be followed up with study visits after 3, 6 and 12 months. Assessment during follow-up includes questionnaires on health related quality of life, alcohol consumption and effects of alcohol, clinical investigation, and blood test including the alcohol biomarker PEth. Long-term follow up are registry data extraction after 2, 5 and 10 years.
The primary objective is to demonstrate whether elastography-based BAI is superior to usual care in reducing hospital admissions for any reason within 2 years. Key secondary objectives are to demonstrate whether elastography-based BAI is superior to usual care in reduce harmful alcohol consumption as measured by PEth, AUDIT and weekly alcohol units. The study also aims to evaluate cost-effectiveness of the intervention, health-related quality of life, self-reported alcohol effects, prognostic serum biomarkers, candidate genetic polymorphisms, and metabolomics.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Håvard Midgard, Professor
- Numéro de téléphone: +47 908 30 071
- E-mail: havardmi@gmail.com
Sauvegarde des contacts de l'étude
- Nom: Caroline Rootwelt
- Numéro de téléphone: +47 928 37 796
- E-mail: carroo@ous-hf.no
Lieux d'étude
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Bergen, Norvège
- Haraldsplass Deaconess Hospital
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Contact:
- Mette N Vesterhus
- E-mail: mette.vesterhus@uib.no
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Drammen, Norvège
- Vestre Viken Bærum Hospital
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Contact:
- Annette J Ingram
- E-mail: annette.julia.ingram@vestreviken.no
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Levanger, Norvège
- Sykehuset Nord-Trøndelag Levanger
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Contact:
- Eivind Ness-Jensen
- E-mail: eivind.ness-jensen@ntnu.no
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Lillehammer, Norvège
- Sykehuset Innlandet Lillehammer
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Contact:
- Gunnbjørg Hjeltnes
- E-mail: gunnbjorg.hjeltnes@sykehuset-innlandet.no
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Lørenskog, Norvège
- Akershus University Hospital
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Contact:
- Kristin K Jørgensen
- E-mail: Kristin.kaasen.jorgensen@outlook.com
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Oslo, Norvège
- Oslo University Hospital
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Contact:
- Midgard Håvard, Professor
- Numéro de téléphone: +47 908 30 071
- E-mail: havardmi@gmail.com
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Oslo, Norvège
- Diakonhjemmet Hospital
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Contact:
- Raziye Boyar
- E-mail: raziye.boyar@diakonsyk.no
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Oslo, Norvège
- Lovisenberg Diaconal Hospital
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Contact:
- Guro Tengesdal
- E-mail: guro.tengesdal@lds.no
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Emergency hospitalized for any reason in any participating centre
- Adults 18 years or older
- Harmful alcohol use, defined as AUDIT-C ≥6 (for men) or AUDIT-C ≥5 (for women)
- Moderate to high risk of liver fibrosis, defined as FIB-4 >1.3
- Signed informed consent
Exclusion Criteria:
Decompensated liver disease that impedes intervention delivery, defined as one or more of the following:
- Moderate or severe ascites
- Overt hepatic encephalopathy (West Haven grade ≥2)
- Acute-on-chronic liver failure requiring admission to intensive care unit
- Acute hepatitis of any aetiology, defined as ALT or AST >5 x upper limit of normal (ULN)
- Unable to participate for any reason in the opinion of the investigator
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Aucune intervention: Usual care
Participants randomized to the usual care arm will recieve standard clinical care as provided during routine hospital practice for inpatients with signs of harmful alcohol use.
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Comparateur actif: Elastography-based brief alcohol intervention
Participants randomized to the elastography-based brief alcohol intervention groupe, will, in addition to usual care, recieve liver stifness measurements (LSM) and brief alcohol intervention.
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Participants randomized to elastography-based BAI will receive elastography assessment during first hospitalization.
Elastography is a widely validated ultrasound-based technique that measures liver stiffness as a surrogate marker of liver fibrosis.
The BAI will be delivered according to the FRAMES model, a structured, evidence-based framework for brief motivational interventions targeting harmful alcohol use.
The intervention is patient-centered, non-confrontational, and based on principles of motivational interviewing.
Both the elastography and the BAI will last approximately 10-15 minutes and will be delivered by trained study personnel directly following elastography assessment.
At 3 months, participants will receive BAI by telephone.
Follow-up reinforcement of elastography-based BAI will subsequently be provided during scheduled visits at 6 and 12 months.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Number of all-cause emergency hospitalizations
Délai: 24 months after randomization.
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What is the effect of elastography-based BAI on new all-cause emergency hospital admissions in hospitalized patients at risk of ALD receiving elastography-based BAI compared with usual care, regardless of adherence to study intervention and while at risk of an emergency hospitalization? The primary outcome will be measured as any emergency inpatient emergency admission within 24 months after randomization, as registred in The Norwegian Patient Registry (NPR). |
24 months after randomization.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Change in phosphatidylethanol (PEth)
Délai: Baseline, 6 and 12 months after randomization.
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What is the effect of elastography-based BAI on alcohol consumption as measured by PEth?
This will be measured as change in PETh from baseline to 12 months.
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Baseline, 6 and 12 months after randomization.
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Reduction in phosphatidylethanol (PEth)
Délai: Baseline and 12 months after randomization.
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What is the effect of elastography-based BAI on alcohol consumption as measured by PEth?
This will be measured as whether or not PEth at 12 months is <0.30
μmol/L.
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Baseline and 12 months after randomization.
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Change in The Alcohol Use Disorders Identification Test (AUDIT) score
Délai: Baseline, 6 and 12 months after randomization.
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What is the effect of elastography-based BAI on alcohol-related symptoms and risk as measured by AUDIT score?
This outcome will be defined as the change in AUDIT score (range 0-40) from baseline to 12 months.
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Baseline, 6 and 12 months after randomization.
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Reduction in The Alcohol Use Disorders Identification Test (AUDIT) score
Délai: Baseline and 12 months after randomization.
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What is the effect of elastography-based BAI on alcohol-related symptoms and risk?
This outcome will be defined as whether or not AUDIT score at 12 months is <8 points.
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Baseline and 12 months after randomization.
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Change in weekly alcohol units
Délai: Baseline, 6 and 12 months after randomization.
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What is the effect of elastography-based BAI on weekly alcohol consumption?
This will be assessed as change in weekly alcohol intake (units per week) over the past month from baseline to 12 months, measured using the Timeline Follow-Back questionnaire (TLFB-28).
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Baseline, 6 and 12 months after randomization.
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Change in proportion of drinking days
Délai: Baseline, 6 and 12 months after randomization.
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What is the effect of elastography-based BAI on the proportion of drinking days?
The outcome will be defined as the change in the proportion of drinking days from baseline to 12 months, measured using the Timeline Follow-Back questionnaire (TLFB-28).
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Baseline, 6 and 12 months after randomization.
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Change in proportion of heavy drinking days
Délai: Baseline, 6 and 12 months after randomization.
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What is the effect of elastography-based BAI on change in proportion of heavy drinking days (≥5 units per day for men and ≥4 units per day for women) from baseline to 12 months?
This will be measured using the Timeline Follow-Back questionnaire (TLFB-28).
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Baseline, 6 and 12 months after randomization.
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Achieving stringent alcohol reduction
Délai: Baseline, 6 and 12 months after randomization.
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What is the effect of elastography-based BAI on achieving stringent alcohol reduction?
This will be measured as whether or not AUDIT score is <8 points at 12 months AND at least 2-point AUDIT reduction at 12 months AND any reduction in PEth from baseline to 12 months.
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Baseline, 6 and 12 months after randomization.
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Change in health-related quality of life EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Délai: Baseline, 6 and 12 months after randomization.
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What is the effect of elastography-based BAI on health-related quality of life?
The outcome will be defined as the change in EQ-5D-5L index score (range 0-1) from baseline to 12 months.
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Baseline, 6 and 12 months after randomization.
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Improvement in health-related quality of life measured by EuroQol 5-Dimension 5-Level (EQ-5D-5L)
Délai: Baseline, 6 and 12 months after randomization
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What is the effect of elastography-based BAI on health-related quality of life?
This will be assessed as whether or not EQ-5D-5L index score has increased by ≥0.05 from baseline to 12 months.
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Baseline, 6 and 12 months after randomization
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Change in health-related quality of life measured in Euro-Qol Visual Analogue Scale (EQ-VAS)
Délai: Baseline, 6 and 12 months after randomization
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What is the effect of elastography-based BAI on health-related quality of life?
This will be assessed as change in EQ-VAS (0-100) from baseline to 12 months.
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Baseline, 6 and 12 months after randomization
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Change in anxiety and depression measured by EQ-5D-5L anxiety/depression dimension score
Délai: Baseline, 6 and 12 months after randomization.
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What is the effect of elastography-based BAI on reducing anxiety and depression?
This will be measured as change in EQ-5D-5L anxiety/depression dimension score from baseline to 12 months.
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Baseline, 6 and 12 months after randomization.
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Reduction in anxiety and depression measured by EQ-5D-5L anxiety/depression dimension score
Délai: Baseline, 6 and 12 months after randomization.
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What is the effect of elastography-based BAI on reducing anxiety and depression?
This will be measured as whether or not EQ-5D-5L anxiety/depression score is reduced by ≥1 level from baseline to 12 months.
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Baseline, 6 and 12 months after randomization.
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Improving cost-effectiveness
Délai: 24 months after randomization.
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What is the effect of elastography-based BAI on improving cost-effectiveness?
The outcome will be incremental cost-effectiveness ratios (ICERs), estimated using quality-adjusted life years (QALYs) as the measure of health effects from EQ-5D-5L utility scores, and total health care costs derived from health care utilization derived from the Norwegian Patient Registry (number of hospitalizations, bed days, outpatients visit, procedures).
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24 months after randomization.
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Reduction in re-hospitalizations
Délai: 24 months after randomization.
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What is the effect of elastography-based BAI on reducing re-hospitalizations?
The outcome will be measured as whether or not a participant is rehospitalized for any reason at least once within 24 months after randomization.
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24 months after randomization.
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Reduction in liver-related hospitalizations
Délai: 24, 60 and 120 months after randomization.
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What is the effect of elastography-based BAI in reducing liver-related hospitalizations? Three estimands are defined for this endpoint:
The endpoints will be measured as number of liver-related hospitalizations, as registred in The Norwegian Patient Registry (NPR). |
24, 60 and 120 months after randomization.
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Reduction in alcohol-related hospitalizations
Délai: 24, 60 and 120 months after randomization.
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What is the effect of elastography-based BAI in reducing alcohol-related hospitalizations? Three estimands are defined for this endpoint:
The endpoints will be measured as number of alcohol-related hospitalizations, as registred in The Norwegian Patient Registry (NPR). |
24, 60 and 120 months after randomization.
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Reduction in liver-related mortality
Délai: 24, 60 and 12 months after randomization.
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What is the effect of elastography-based BAI in reducing liver-related mortality? Three estimands are defined for this endpoint:
The endpoints will be measured as number of liver-related deaths as registred in The Norwegian Patient Registry (NPR) and Norwegian cause of death registry (CDR). |
24, 60 and 12 months after randomization.
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Reduction in all-cause mortality
Délai: 24, 60 and 120 months after randomization.
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What is the effect of elastography-based BAI in reducing all-cause mortality? Three estimands are defined for this endpoint:
The endpoints will be measured as number of all-cause deaths as registred in The Norwegian Patient Registry (NPR) and Norwegian cause of death registry (CDR). |
24, 60 and 120 months after randomization.
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Reduction in liver related events
Délai: 24, 60 and 120 months after randomization.
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What is the effect of elastography-based BAI on reducing number of liver-related events? Three estimands are defined for this endpoint:
The endpoints will be measured as number of liver related events defined as variceal bleeding, ascites, overt hepatic encephalopathy, severe alcoholic hepatitis, heptaocellular carcinoma, liver transplantation and liver-related death, as registered from inpatient admissions or outpatient consultations in NPR, the Nordic Liver Transplant Registry and the Norwegian Cancer Registry. |
24, 60 and 120 months after randomization.
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Time to first liver-related event
Délai: 24, 60 and 120 months after randomization.
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What is the effect of elastography-based BAI on time to first liver-related event?
The endpoint will be measured as time to first liver related event, defined as variceal bleeding, ascites, overt hepatic encephalopathy, severe alcoholic hepatitis, heptaocellular carcinoma, liver transplantation and liver-related death, as registered from inpatient admissions or outpatient consultations in NPR, the Nordic Liver Transplant Registry and the Norwegian Cancer Registry.
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24, 60 and 120 months after randomization.
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
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Predictive value of the Enhanced Liver Fibrosis (ELF) score for liver-related events
Délai: 24, 60 and 120 months after randomization.
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Can baseline ELF score predict subsequent liver-related events?
Liver related events is defined as variceal bleeding, ascites, overt hepatic encephalopathy, severe alcoholic hepatitis, heptaocellular carcinoma, liver transplantation and liver-related death, as registred in The Norwegian Patient Registry (NPR) and Norwegian cause of death registry (CDR).
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24, 60 and 120 months after randomization.
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Predictive value of baseline level of heat shock protein 47 and subsequent liver-related events
Délai: 24, 60 and 120 months after randomization.
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Can baseline levels of heat shock protein 47 predict subsequent liver-related events?
Liver related events is defined as variceal bleeding, ascites, overt hepatic encephalopathy, severe alcoholic hepatitis, heptaocellular carcinoma, liver transplantation and liver-related death.
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24, 60 and 120 months after randomization.
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Relative change in Enhanced Liver Fibrosis (ELF) score from baseline to 12 months
Délai: Baseline, 6 and 12 months after randomization.
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Is there a difference in the relative change in ELF score from baseline to 12 months between the intervention arms?
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Baseline, 6 and 12 months after randomization.
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Change in liver stiffness measured by transient elastography
Délai: Baseline, 6 and 12 months after randomization.
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Does liver stiffness measurements, measured by transient elastography, change in the intervention arm?
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Baseline, 6 and 12 months after randomization.
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Associations between self-rated effects of alcohol and concentration of magnesium, calcium and phosphate
Délai: Baseline, 6 and 12 months after randomization.
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Are there associations between self-reported effects of alcohol, as measured by the Self-Rating of the Effects of Alcohol (SRE) questionnaire, and concentrations of the biochemical markers magnesium, calcium, and phosphate?
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Baseline, 6 and 12 months after randomization.
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Associations between self-rated effects of alochol and liver- and alcohol-related events
Délai: Baseline, 6, 12 and 24 months after randomization.
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Are there associations between self-rated effects of alcohol at baseline, 6, and 12 months, as measured by the Self-Rating of the Effects of Alcohol (SRE) questionnaire, and number of liver- and alcohol-related events within 24 months?
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Baseline, 6, 12 and 24 months after randomization.
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Prevalence of genetic polymorphisms linked to susceptibility and disease progression in alcohol-related liver disease
Délai: Baseline
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What is the prevalence of the following genetic polymorphisms?
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Baseline
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Mette Vesterhus, Haraldsplass Deaconess Hospital, Bergen, Norway
- Chaise d'étude: Håvard Midgard, Oslo University Hospital, Oslo, Norway
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
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
Mots clés
Termes MeSH pertinents supplémentaires
- Les troubles mentaux
- Processus pathologiques
- Maladies du système digestif
- Maladies du foie
- Troubles liés à une substance
- Troubles induits chimiquement
- Troubles liés à l'alcool
- Fibrose
- Troubles induits par l'alcool
- Conditions pathologiques, signes et symptômes
- Alcoolisme
- La cirrhose du foie
- Maladies du foie, alcoolique
- Produits chimiques organiques
- Techniques d'investigation
- Alcools
- Éthanol
- Méthodes
Autres numéros d'identification d'étude
- REK#963066
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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