Alcohol Use Disorder (AUD)IBAFiRSTNCT05720247
Brief Intervention and Fibroscan for Harmful Drinkers Presenting to the Emergency Department
A study testing Fibroscan and Brief Intervention in people with Alcohol Use Disorder (AUD), run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Alcohol Use Disorder (AUD)
- What is being tested?
- Fibroscan and Brief Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Feb 2021to 23 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- They are unable or unwilling to undertake single-question screening (standard care)
- They refuse or lack capacity to give informed consent to trial inclusion
- 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
- Their treating clinician thinks there is any other reason that they would not benefit from trial inclusion
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Nottingham University Hospitals NHS Trust
Nottingham, Nottinghamshire, NG7 2UH
About this study
Official title: Brief Intervention and Fibroscan for Harmful Drinkers Presenting to the Emergency Department.
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.
Read the detailed description
Alcohol Use Disorder (AUD) poses a significant burden to individuals, the population and the health and social care system in the United Kingdom (UK). Chronic liver disease is now the third most common cause of death and costs the National Health Service (NHS) an estimated £3.5 billion per year. This equates to 3.6% of the total NHS budget. The only effective way to reduce the risk of liver damage for people at high risk is to abstain from drinking alcohol. Alcohol services can successfully help people reduce their risk of liver damage by helping them reduce or stop drinking. Many people with AUD use emergency departments and it is NHS policy for them to be screened for harmful drinking and referred for treatment if indicated.
There is currently very little evidence that existing methods to screen for alcohol use disorders and encourage high risk patients to refer themselves to ATS from ED, are effective. Fibroscan is a safe and effective test to look for early signs of liver disease even before a patient shows symptoms. Research into the use of Fibroscan as part of a brief advice intervention for AUDs in ED has not been undertaken before. If effective in increasing treatment uptake the reduction in liver disease from treating more ED attenders could be substantial.
All patients attending the Emergency Department are already asked a single alcohol screening question as part of their normal assessment: "Have you drunk more than 6 units of alcohol on one occasion in the previous month?". Those answering yes are briefly counselled about their alcohol use ( standard brief intervention) and advised to self-refer for community treatment services. During the study these patients will be offered participation in the trial. If they consent the research team will assess their eligibility by using the AUDIT-C questionnaire a widely used set of 6 questions taking approximately 5 minutes to complete. Patients scoring 10 or less will receive a brief intervention and advice on self-referral as usual. Patients scoring 11 or 12 will be eligible to be randomised to a Fibroscan (intervention arm) in addition to brief advice and information (control arm).
All patients will receive the same verbal and printed information about community alcohol treatment services and how to self-refer. Patients will be followed up at 1, 3 and 6 months post randomisation by telephone. A research nurse blinded to the allocation will collect data on their drinking behaviour in the previous week and ask whether they have sought help from alcohol services their General Practitioner (GP) or from other NHS services. In addition the primary outcome measure, engagement in alcohol treatment services at 6 months, will be confirmed by collecting data from the services themselves under a research information sharing agreement. This activity is explained clearly in the information and consent processes for patients given the sensitivity of the information. Study data will be analysed using descriptive statistics and cross-tabulations. This will provide the detailed information necessary to assess the success of the feasibility trial and to inform a power calculation for a full-scale randomised trial of the effect of the Fibroscan intervention in ED.
- Conditions
- Alcohol Use Disorder (AUD)
- Being tested
- Fibroscan, Brief Intervention
- Keywords
- Emergency Department, Fibroscan, Brief Intervention, Screening, Brief Intervention, referral to Treatment (SBIRT)
- Medical subject headings
- Alcoholism, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibroscanDiagnostic 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.
Brief InterventionBehavioural
Short counselling session to discuss drinking behavior, risks to health and available sources of treatment and support.
| Study group | Role | What they receive |
|---|---|---|
| Fibroscan | Experimental | Screening and brief intervention with additional Fibroscan procedure and sharing of results with patient Receives: Diagnostic Test: Fibroscan; Behavioral: Brief Intervention |
| Standard Care | Active comparator | Screening and brief intervention without Fibroscan Receives: Behavioral: Brief Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-referral to community alcohol treatment services
independently confirmed record of self-referral
Measured: 6 months
Secondary outcomes (4)
Alcohol use disorders identification test consumption (AUDIT C)
standardised alcohol risk score
Measured: Baseline, 1, 3 and 6 months
Drinks consumed in previous 7 days
Number of drinks consumed
Measured: Baseline, 1, 3 and 6 months
Days drinking alcohol in the previous 7 days
Days on which any alcohol was consumed
Measured: Baseline, 1, 3 and 6 months
Attendance at an Emergency Department
ED attendance since previous study event
Measured: Baseline, 1, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start24 Feb 2021
- Primary completion24 Aug 2022
- Study completion23 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use Disorder (AUD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nottingham University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720247
- Sponsor's protocol ID
- 19AE001
- Acronym
- IBAFiRST
- Status last verified
- Feb 2023
- First submitted
- 30 Sep 2022
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Intervention and Fibroscan for Harmful Drinkers Presenting to the Emergency Department.
- ClinicalTrials.gov ID
- NCT05720247
- Acronym / sponsor ID
- IBAFiRST / 19AE001
- Conditions
- Alcohol Use Disorder (AUD)
- Keywords
- Emergency Department, Fibroscan, Brief Intervention, Screening, Brief Intervention, referral to Treatment (SBIRT)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Nottingham University Hospitals NHS TrustUniversity, hospital or other
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 24 Aug 2022 (actual)
- Study completion
- 23 Sep 2023 (estimated)
- First posted
- 9 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Alcohol Use Disorder (AUD) poses a significant burden to individuals, the population and the health and social care system in the United Kingdom (UK). Chronic liver disease is now the third most common cause of death and costs the National Health Service (NHS) an estimated £3.5 billion per year. This equates to 3.6% of the total NHS budget. The only effective way to reduce the risk of liver damage for people at high risk is to abstain from drinking alcohol. Alcohol services can successfully help people reduce their risk of liver damage by helping them reduce or stop drinking. Many people with AUD use emergency departments and it is NHS policy for them to be screened for harmful drinking and referred for treatment if indicated.
There is currently very little evidence that existing methods to screen for alcohol use disorders and encourage high risk patients to refer themselves to ATS from ED, are effective. Fibroscan is a safe and effective test to look for early signs of liver disease even before a patient shows symptoms. Research into the use of Fibroscan as part of a brief advice intervention for AUDs in ED has not been undertaken before. If effective in increasing treatment uptake the reduction in liver disease from treating more ED attenders could be substantial.
All patients attending the Emergency Department are already asked a single alcohol screening question as part of their normal assessment: "Have you drunk more than 6 units of alcohol on one occasion in the previous month?". Those answering yes are briefly counselled about their alcohol use ( standard brief intervention) and advised to self-refer for community treatment services. During the study these patients will be offered participation in the trial. If they consent the research team will assess their eligibility by using the AUDIT-C questionnaire a widely used set of 6 questions taking approximately 5 minutes to complete. Patients scoring 10 or less will receive a brief intervention and advice on self-referral as usual. Patients scoring 11 or 12 will be eligible to be randomised to a Fibroscan (intervention arm) in addition to brief advice and information (control arm).
All patients will receive the same verbal and printed information about community alcohol treatment services and how to self-refer. Patients will be followed up at 1, 3 and 6 months post randomisation by telephone. A research nurse blinded to the allocation will collect data on their drinking behaviour in the previous week and ask whether they have sought help from alcohol services their General Practitioner (GP) or from other NHS services. In addition the primary outcome measure, engagement in alcohol treatment services at 6 months, will be confirmed by collecting data from the services themselves under a research information sharing agreement. This activity is explained clearly in the information and consent processes for patients given the sensitivity of the information. Study data will be analysed using descriptive statistics and cross-tabulations. This will provide the detailed information necessary to assess the success of the feasibility trial and to inform a power calculation for a full-scale randomised trial of the effect of the Fibroscan intervention in ED.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Fibroscan | Experimental | Diagnostic Test: Fibroscan, Behavioral: Brief InterventionScreening and brief intervention with additional Fibroscan procedure and sharing of results with patient |
| Standard Care | Active comparator | Behavioral: Brief InterventionScreening and brief intervention without Fibroscan |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- They are unable or unwilling to undertake single-question screening (standard care)
- They refuse or lack capacity to give informed consent to trial inclusion
- 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
- Their treating clinician thinks there is any other reason that they would not benefit from trial inclusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FibroscanFibroscan 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. | Diagnostic test | Fibroscan |
| Brief InterventionShort counselling session to discuss drinking behavior, risks to health and available sources of treatment and support. | Behavioural | Fibroscan, Standard Care |
Primary outcome
Self-referral to community alcohol treatment services
Time frame: 6 months
independently confirmed record of self-referral
4 secondary outcomes
Alcohol use disorders identification test consumption (AUDIT C)
Time frame: Baseline, 1, 3 and 6 months
Drinks consumed in previous 7 days
Time frame: Baseline, 1, 3 and 6 months
Days drinking alcohol in the previous 7 days
Time frame: Baseline, 1, 3 and 6 months
Attendance at an Emergency Department
Time frame: Baseline, 1, 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fibroscan and Brief Intervention in people with Alcohol Use Disorder (AUD), run by Nottingham University Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-referral to community alcohol treatment services (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.