Ignite Creation Date:
2024-05-06 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05720247
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-02-09
First Post:
2022-09-30
Brief Title:
Brief Intervention and Fibroscan for Harmful Drinkers Presenting to the Emergency Department
Sponsor:
Nottingham University Hospitals NHS Trust
Organization:
Nottingham University Hospitals NHS Trust
Study Overview
Official Title:
Brief Intervention and Fibroscan for Harmful Drinkers Presenting to the Emergency Department
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IBAFiRST
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 35 billion per year This equates to 36 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None