Elastography-based Brief Alcohol Intervention in Hospitalized Individuals

NCT07637539 | Not Yet Recruiting

• 1 other identifier: REK#963066
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Alcohol Use Disorder; Alcoholic Liver Disease (ALD)

Keywords

alcohol; brief intervention; brief alcohol intervention; elastography; liver fibrosis; alcohol use disorder; alcoholic liver disease; ALD; BAI; proactive liver disease assessment

Outcome Measures

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).

  24 months after randomization.

Secondary Outcomes (21)

• Change in phosphatidylethanol (PEth)

  Baseline, 6 and 12 months after randomization.

• Reduction in phosphatidylethanol (PEth)

  Baseline and 12 months after randomization.

• Change in The Alcohol Use Disorders Identification Test (AUDIT) score

  Baseline, 6 and 12 months after randomization.

• Reduction in The Alcohol Use Disorders Identification Test (AUDIT) score

  Baseline and 12 months after randomization.

• Change in weekly alcohol units

  Baseline, 6 and 12 months after randomization.

Other Outcomes (7)

• Predictive value of the Enhanced Liver Fibrosis (ELF) score for liver-related events

  24, 60 and 120 months after randomization.

• Predictive value of baseline level of heat shock protein 47 and subsequent liver-related events

  24, 60 and 120 months after randomization.

• Relative change in Enhanced Liver Fibrosis (ELF) score from baseline to 12 months

  Baseline, 6 and 12 months after randomization.

Study Arms (2)

Usual care

NO INTERVENTION

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.

Elastography-based brief alcohol intervention

ACTIVE COMPARATOR

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.

Behavioral: Elastography-based brief alcohol intervention

Interventions

Elastography-based brief alcohol intervention BEHAVIORAL

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.

Elastography-based brief alcohol intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (8)

Haraldsplass Deaconess Hospital

Bergen, Norway

Location

Vestre Viken Bærum Hospital

Drammen, Norway

Location

Sykehuset Nord-Trøndelag Levanger

Levanger, Norway

Location

Sykehuset Innlandet Lillehammer

Lillehammer, Norway

Location

Akershus University Hospital

Lørenskog, Norway

Location

Diakonhjemmet Hospital

Oslo, Norway

Location

Lovisenberg Diaconal Hospital

Oslo, Norway

Location

Oslo University Hospital

Oslo, Norway

Location

MeSH Terms

Conditions

Liver Diseases, Alcoholic; Alcoholism; Liver Cirrhosis

Interventions

Ethanol; Methods

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Investigative Techniques

Study Officials

• Mette Vesterhus

  Haraldsplass Deaconess Hospital, Bergen, Norway

  PRINCIPAL INVESTIGATOR

• Håvard Midgard

  Oslo University Hospital, Oslo, Norway

  STUDY CHAIR

Central Study Contacts

Håvard Midgard, Professor

CONTACT

+47 908 30 071; havardmi@gmail.com

Caroline Rootwelt

CONTACT

+47 928 37 796; carroo@ous-hf.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The study statistician will, to the best ability, perform the analysis as if the study was blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Senior Consultant

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: June 9, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): May 15, 2030
• Study Completion (Estimated): May 15, 2038
• Last Updated: June 9, 2026

Record last verified: 2026-06

Locations

NO (8)