Brief Intervention and Fibroscan for Harmful Drinkers Presenting to the Emergency Department (IBAFiRST)
Brief Intervention and Fibroscan for Harmful Drinkers Presenting to the Emergency Department.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
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 Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nottinghamshire
-
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
- Nottingham University Hospitals NHS Trust
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
EXPERIMENTAL: Fibroscan
Screening and brief intervention with additional Fibroscan procedure and sharing of results with patient
|
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.
Short counselling session to discuss drinking behavior, risks to health and available sources of treatment and support.
|
|
ACTIVE_COMPARATOR: Standard Care
Screening and brief intervention without Fibroscan
|
Short counselling session to discuss drinking behavior, risks to health and available sources of treatment and support.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-referral to community alcohol treatment services
Time Frame: 6 months
|
independently confirmed record of self-referral
|
6 months
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Alcohol use disorders identification test consumption (AUDIT C)
Time Frame: Baseline, 1, 3 and 6 months
|
standardised alcohol risk score
|
Baseline, 1, 3 and 6 months
|
|
Drinks consumed in previous 7 days
Time Frame: Baseline, 1, 3 and 6 months
|
Number of drinks consumed
|
Baseline, 1, 3 and 6 months
|
|
Days drinking alcohol in the previous 7 days
Time Frame: Baseline, 1, 3 and 6 months
|
Days on which any alcohol was consumed
|
Baseline, 1, 3 and 6 months
|
|
Attendance at an Emergency Department
Time Frame: Baseline, 1, 3 and 6 months
|
ED attendance since previous study event
|
Baseline, 1, 3 and 6 months
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Study Start
Primary Completion (ACTUAL)
Primary Completion
Study Completion (ANTICIPATED)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
First Posted
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 19AE001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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