search
Back to results

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

Primary Purpose

Alcohol Use Disorder (AUD)

Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Fibroscan
Brief Intervention
Sponsored by
Nottingham University Hospitals NHS Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Alcohol Use Disorder (AUD) focused on measuring Emergency Department, Fibroscan, Brief Intervention, Screening, Brief Intervention, referral to Treatment (SBIRT)

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Nottingham University Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fibroscan

Standard Care

Arm Description

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

Screening and brief intervention without Fibroscan

Outcomes

Primary Outcome Measures

Self-referral to community alcohol treatment services
independently confirmed record of self-referral

Secondary Outcome Measures

Alcohol use disorders identification test consumption (AUDIT C)
standardised alcohol risk score
Drinks consumed in previous 7 days
Number of drinks consumed
Days drinking alcohol in the previous 7 days
Days on which any alcohol was consumed
Attendance at an Emergency Department
ED attendance since previous study event

Full Information

First Posted
September 30, 2022
Last Updated
February 7, 2023
Sponsor
Nottingham University Hospitals NHS Trust
search

1. Study Identification

Unique Protocol Identification Number
NCT05720247
Brief Title
Brief Intervention and Fibroscan for Harmful Drinkers Presenting to the Emergency Department
Acronym
IBAFiRST
Official Title
Brief Intervention and Fibroscan for Harmful Drinkers Presenting to the Emergency Department.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 24, 2021 (Actual)
Primary Completion Date
August 24, 2022 (Actual)
Study Completion Date
September 23, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nottingham University Hospitals NHS Trust

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder (AUD)
Keywords
Emergency Department, Fibroscan, Brief Intervention, Screening, Brief Intervention, referral to Treatment (SBIRT)

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised Controlled Trial
Masking
Outcomes Assessor
Masking Description
Research collecting outcome data is blinded to the study allocation
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fibroscan
Arm Type
Experimental
Arm Description
Screening and brief intervention with additional Fibroscan procedure and sharing of results with patient
Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
Screening and brief intervention without Fibroscan
Intervention Type
Diagnostic Test
Intervention Name(s)
Fibroscan
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Brief Intervention
Intervention Description
Short counselling session to discuss drinking behavior, risks to health and available sources of treatment and support.
Primary Outcome Measure Information:
Title
Self-referral to community alcohol treatment services
Description
independently confirmed record of self-referral
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Alcohol use disorders identification test consumption (AUDIT C)
Description
standardised alcohol risk score
Time Frame
Baseline, 1, 3 and 6 months
Title
Drinks consumed in previous 7 days
Description
Number of drinks consumed
Time Frame
Baseline, 1, 3 and 6 months
Title
Days drinking alcohol in the previous 7 days
Description
Days on which any alcohol was consumed
Time Frame
Baseline, 1, 3 and 6 months
Title
Attendance at an Emergency Department
Description
ED attendance since previous study event
Time Frame
Baseline, 1, 3 and 6 months

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
As expressed by the patient
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
State/Province
Nottinghamshire
ZIP/Postal Code
NG7 2UH
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs