Brief Intervention and Fibroscan for Harmful Drinkers Presenting to the Emergency Department

NCT05720247 | Unknown

• 1 other identifier: 19AE001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators plan to assess the feasibility of a randomised controlled trial of an innovative screening (Identification), Brief Intervention, Fibroscan and Self-Referral for Specialist Treatment (IBAFiRST) programme for high risk drinkers in the Emergency Department (ED). IBAFiRST extends existing screening and advice given to people with potential alcohol use disorders (AUD) in ED. Currently patients who drink heavily have brief advice and are asked to refer themselves to community specialist alcohol treatment services (ATS) after leaving ED. A Fibroscan is a safe, quick and reliable ultrasound test to see if there are signs of "stiffening" of the liver which can indicate early liver damage. It is recommended as a non-invasive test by the National Institute for Health and Care Excellence (NICE) but is not known to be used within EDs in the UK. The investigators wish to test whether giving the patients the results of this scan will make them more likely to self-refer to ATS. Currently take up rates of ATS are low in this population and too few people are seeking treatment to help them reduce their alcohol intake. Because so little is known about self-referral in ED the investigators are completing a feasibility study before seeking funding for a large scale randomised trial.

Conditions

Alcohol Use Disorder (AUD)

Keywords

Emergency Department; Fibroscan; Brief Intervention; Screening, Brief Intervention, referral to Treatment (SBIRT)

Outcome Measures

Primary Outcomes (1)

• Self-referral to community alcohol treatment services

  independently confirmed record of self-referral

  6 months

Secondary Outcomes (4)

• Alcohol use disorders identification test consumption (AUDIT C)

  Baseline, 1, 3 and 6 months

• Drinks consumed in previous 7 days

  Baseline, 1, 3 and 6 months

• Days drinking alcohol in the previous 7 days

  Baseline, 1, 3 and 6 months

• Attendance at an Emergency Department

  Baseline, 1, 3 and 6 months

Study Arms (2)

Fibroscan

EXPERIMENTAL

Screening and brief intervention with additional Fibroscan procedure and sharing of results with patient

Diagnostic Test: Fibroscan; Behavioral: Brief Intervention

Standard Care

ACTIVE COMPARATOR

Screening and brief intervention without Fibroscan

Behavioral: Brief Intervention

Interventions

Fibroscan DIAGNOSTIC_TEST

Fibroscan is a safe and effective test using ultrasound to measure liver elasticity and can detect early signs of liver disease even before a patient shows symptoms.

Fibroscan

Brief Intervention BEHAVIORAL

Short counselling session to discuss drinking behavior, risks to health and available sources of treatment and support.

Fibroscan; Standard Care

Eligibility Criteria

• Age: 18 Years - 64 Years
• Gender Eligibility Details: As expressed by the patient
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Has capacity to give informed consent
• Have no urgent or life-threatening illness or injury
• Have not eaten a larger meal within 3 hours of trial enrollment
• Answer "yes" to a single item alcohol screening question (standard care)
• Score of 11 or 12 on the Audit-C alcohol screening tool

You may not qualify if:

• They are unable or unwilling to undertake single-question screening (standard care)
• They are living in postcodes outside of the catchment areas for Nottingham City or Nottingham County community alcohol treatment services
• They have an urgent or life-threatening illness or injury

Sponsors & Collaborators

• Nottingham University Hospitals NHS Trust: lead

Study Sites (1)

Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Alcoholism; Emergencies

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Research collecting outcome data is blinded to the study allocation
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised Controlled Trial

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: February 9, 2023
• Study Start: February 24, 2021
• Primary Completion: August 24, 2022
• Study Completion: September 23, 2023
• Last Updated: February 9, 2023

Record last verified: 2023-02

Locations

GB (1)