The Liver Care Trial: screening for liver disease in individuals attending treatment for alcohol use disorder—study protocol for a randomized controlled study – BioMed Central

Clinical Trial Protocol Report: Advancing Health and Well-being through Liver Disease Screening

Introduction: Aligning with Sustainable Development Goal 3

This report outlines the methodology for a clinical trial designed to improve health outcomes for individuals undergoing treatment for alcohol use disorder. The study directly supports the United Nations’ Sustainable Development Goal 3 (Good Health and Well-being) by focusing on the prevention and treatment of substance abuse (Target 3.5) and reducing premature mortality from non-communicable diseases like alcohol-related liver disease (Target 3.4). By providing enhanced screening and care to a vulnerable population, the trial also addresses SDG 10 (Reduced Inequalities).

Methodology and Procedures

Comparator Group Protocol

The control group receives the standard of care, which contributes to establishing a baseline for health improvements in line with SDG 3. This protocol includes:

• Standard care provided at the alcohol treatment centre.
• Routine blood sampling, including the FIB-4 fibrosis index.

Notably, the provision of FIB-4 testing to the control group represents a more comprehensive service than is typically implemented in general practice in Denmark, thereby contributing to SDG 10 by reducing a potential health disparity for this cohort.

Intervention Protocol

The intervention is a multi-component strategy aimed at promoting health and well-being (SDG 3) through early detection and motivational counseling. The intervention consists of:

1. Transient elastography using FibroScan© to assess liver stiffness.
2. Clinical examination of weight, height, and waist circumference.
3. Routine blood sampling.
4. Delivery of results in the spirit of motivational interviewing, supported by informational leaflets on alcohol-related diseases and the benefits of reducing consumption.

The FibroScan© procedure is a safe, non-invasive tool for early detection of liver fibrosis. Participants receive immediate feedback, which is framed to motivate positive health behavior changes. If FibroScan© is not feasible, the FIB-4 score will be used as an alternative.

Criteria for Intervention Modification

In alignment with ethical healthcare practices central to SDG 3, participants may withdraw consent at any time. Furthermore, if screening results from either FibroScan© (>8.0 kPa) or the FIB-4 index (≥1.30) suggest liver fibrosis, or if blood samples show other abnormalities, the participant will be offered a routine assessment at the hospital, ensuring a pathway to continued care.

Adherence and Concomitant Care

To ensure trial integrity and support participant well-being, proactive strategies are in place. Researchers will contact participants to schedule appointments promptly. Participants are permitted to receive other relevant medical care during the trial, including examinations for liver disease, ensuring that trial participation does not impede access to necessary healthcare, a core principle of universal health coverage under SDG 3.

Post-Trial Care Provisions

Commitment to long-term health (SDG 3) is ensured through provisions for post-trial care. Participants will continue to receive standard care at Novavi centres. Those referred to the hospital department for further investigation will proceed with their diagnostic and treatment pathway after the trial concludes.

Trial Outcomes and Measurement of Progress Towards SDG 3

Primary Outcome

The primary outcome directly measures progress towards SDG Target 3.5 (strengthen the prevention and treatment of substance abuse). It is defined as:

• Alcohol abstinence or light consumption (≤ 10 units/week) during the last 30 days, assessed at the 6-month follow-up.

Secondary Outcomes

Secondary outcomes provide a holistic assessment of improvements in health and well-being (SDG 3):

• Reduction in heavy drinking days.
• Changes in perceived alcohol problems (AUDIT C score).
• Motivation to reduce alcohol consumption.
• Health-related quality of life (SF-12 v2).
• Stress management (PSS).
• Comparison of outcomes between individuals with positive versus negative screen results within the intervention group.
• Assessment of crossover (control group participants receiving liver evaluation outside the study).

Participant Timeline and Recruitment

Trial Timeline

The trial involves an enrolment visit for baseline assessment and randomization, followed by the intervention or standard care. A follow-up assessment is conducted via a phone interview at 6 months to evaluate outcomes related to health and well-being (SDG 3).

Sample Size

A total of 408 individuals will be included (272 intervention, 136 control). This sample size is calculated to detect a significant difference in alcohol consumption outcomes, providing robust evidence to inform future health policies and interventions in line with the evidence-based approach of SDG 3. The 2:1 randomization ratio allows for meaningful subgroup analysis within the intervention arm.

Recruitment Strategy and Partnerships (SDG 17)

Recruitment will be conducted by clinical staff at three specialized alcohol outpatient treatment centres. This collaboration between treatment centres and researchers exemplifies SDG 17 (Partnerships for the Goals), leveraging existing healthcare infrastructure to reach and support a vulnerable population. This partnership is critical for successfully implementing health interventions and achieving the targets of SDG 3 and SDG 10.

Analysis of Sustainable Development Goals in the Article

1. Which SDGs are addressed or connected to the issues highlighted in the article?

• SDG 3: Good Health and Well-being

  The entire article is centered on health, specifically addressing the harmful use of alcohol and its consequences, such as alcohol-related liver disease (ALD). The study described is a clinical trial designed to improve health outcomes for individuals with alcohol use disorder. It focuses on an intervention that includes screening for liver disease and motivational interviewing to encourage reduced alcohol consumption, directly aligning with the goal of ensuring healthy lives and promoting well-being.

2. What specific targets under those SDGs can be identified based on the article’s content?

• Target 3.5: Strengthen the prevention and treatment of substance abuse, including narcotic drug abuse and harmful use of alcohol.

  This target is directly addressed. The study is conducted in “specialized alcohol outpatient treatment centres” and recruits “individuals attending treatment for alcohol use disorder.” The primary goal of the intervention is to achieve “Alcohol abstinence or light consumption (≤ 10 units/week),” which is a clear effort to treat the harmful use of alcohol. The motivational interviewing component is a therapeutic technique aimed at strengthening this treatment.

• Target 3.4: By 2030, reduce by one third premature mortality from non-communicable diseases through prevention and treatment and promote mental health and well-being.

  The article connects to this target by focusing on the prevention and early detection of alcohol-related liver disease, which is a non-communicable disease (NCD). The intervention uses screening tools like “transient elastography using FibroScan©” and the “FIB-4 index” to detect liver fibrosis early. The article notes that participants with signs of liver fibrosis are “offered routine assessment for this at the hospital department,” which constitutes treatment. Furthermore, the study measures secondary outcomes like “health-related quality of life (SF-12 v2) and stress management (PSS),” which directly relate to the promotion of mental health and well-being.

3. Are there any indicators mentioned or implied in the article that can be used to measure progress towards the identified targets?

• Indicator for Target 3.5 (Harmful use of alcohol):

  The article provides specific, measurable indicators related to alcohol consumption. The primary outcome is defined as “Alcohol abstinence or light consumption (≤ 10 units/week) throughout the last 30 days (yes/no).” This is a direct measure of reducing harmful alcohol use. Additionally, a secondary outcome is the number of “heavy drinking days,” which is explicitly defined as “for men as consuming five or more drinks and for women as consuming four or more drinks.” These metrics serve as direct indicators for monitoring the treatment of harmful alcohol use.

• Indicators for Target 3.4 (Prevention and treatment of NCDs and promotion of well-being):

  The article implies indicators for the prevention and treatment of NCDs. The use of screening tools and their results, such as “FibroScan© > 8.0 kPa or FIB-4 ≥ 1.30,” serve as indicators for the early detection of liver fibrosis (an NCD). The number of participants referred for further “routine assessment” at a hospital based on these results can measure access to treatment. For the mental health and well-being component of the target, the article explicitly mentions using standardized questionnaires like “health-related quality of life (SF-12 v2) and stress management (PSS)” as secondary outcomes, which are direct indicators of well-being.

4. Table of SDGs, Targets, and Indicators

Source: trialsjournal.biomedcentral.com