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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 试验地点
- 8
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
The study statistician will, to the best ability, perform the analysis as if the study was blinded.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究者
Håvard Midgard
Professor and Senior Consultant
Oslo University Hospital
