Elastography-based Brief Alcohol Intervention in Hospitalized Individuals
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOslo University Hospital
About this trial
Harmful alcohol use is a common cause of hospital admissions and the leading cause of liver cirrhosis. Timely detection of liver disease is crucial to prevent liver disease progression and reduce alcohol-related harms. 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. The study will recruit 500 patients at risk of alcohol-related liver disease who are admitted for inpatient care for any reason. Recruitment will be done at 8 Norwegian hospitals over an 18-month period. Participants will be randomized to liver elastography (liver stiffness measurement) and personalized alcohol counselling, or to usual care. After discharge, participants will be followed with study visits after 3, 6 and 12 months. Assessments during follow-up include self-reported alcohol use, the alcohol biomarker PEth and health-related quality of life. The primary outcome is the number of emergency hospital admissions for any reason within 2 years, collected from the Norwegian Patient Registry. The study has very low risk for the participants, with no invasive procedures or risks associated with the intervention. The potential benefit is considerably greater, with opportunities for improved health, prognosis, and quality of life for a large patient group for whom effective interventions are largely lacking. The study has very low risk for the participants, with no invasive procedures or risks associated with the intervention. The potential benefit is considerably greater, with opportunities for improved health, prognosis, and quality of life for a large patient group for whom effective interventions are largely lacking.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Elastography-based brief alcohol intervention
BehavioralParticipants 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.
Treatment groups
500 Participants
are divided into 2 treatment groupsGroup A: Usual careNo intervention 0 interventions
Group B: Elastography-based brief alcohol interventionActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of all-cause emergency hospitalizations
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).
Time frame
24 months after randomization.Secondary outcomes
1
Change in phosphatidylethanol (PEth)
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.
Time frame
Baseline, 6 and 12 months after randomization.2
Reduction in phosphatidylethanol (PEth)
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.
Time frame
Baseline and 12 months after randomization.3
Change in The Alcohol Use Disorders Identification Test (AUDIT) score
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.
Time frame
Baseline, 6 and 12 months after randomization.4
Reduction in The Alcohol Use Disorders Identification Test (AUDIT) score
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.
Time frame
Baseline and 12 months after randomization.Other outcomes
1
Predictive value of the Enhanced Liver Fibrosis (ELF) score for liver-related events
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).
Time frame
24, 60 and 120 months after randomization.2
Predictive value of baseline level of heat shock protein 47 and subsequent liver-related events
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.
Time frame
24, 60 and 120 months after randomization.3
Relative change in Enhanced Liver Fibrosis (ELF) score from baseline to 12 months
Is there a difference in the relative change in ELF score from baseline to 12 months between the intervention arms?
Time frame
Baseline, 6 and 12 months after randomization.4
Change in liver stiffness measured by transient elastography
Does liver stiffness measurements, measured by transient elastography, change in the intervention arm?
Time frame
Baseline, 6 and 12 months after randomization.Sponsors and contacts
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Source ClinicalTrials.gov
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