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ISRCTN
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ISRCTN78062794
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ClinicalTrials.gov identifier
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NCT01060397
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Public title
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Extended Brief Interventions (EBI) for alcohol-dependent patients in an acute care setting.
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Scientific title
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A randomised controlled trial of extended brief interventions for alcohol-dependent patients in an acute care setting.
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Acronym
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ADPAC
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Serial number at source
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PB-PG-0408-15077
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Study hypothesis
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Extended Brief Interventions (EBI) delivered to alcohol-dependent patients in a hospital setting by an Alcohol Specialist Nurse (ASN) will be effective in reducing overall alcohol consumption and improving on the standard measures of alcohol dependence.
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Lay summary
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Ethics approval
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North West 2 Research Ethics Committee - Liverpool Central. Identifier: 09/H1005/61
Favourable opinion on 23rd September 2009.
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Study design
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Single centre randomised controlled trial with single blinded independent follow up
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Alcohol dependence
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Participants - inclusion criteria
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Patients with a score equal to or greater than 16 on the Alcohol Use Disorder Identification Test (AUDIT) screening tool.
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Participants - exclusion criteria
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1. Patient’s known to be intravenous drug abusers
2. Patients unable to give informed consent
3. Patients whose medical co-morbidity requires frequent or long term hospital admission
4. Patients known to be pregnant
5. Patient's presently recruited to any other research trial
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Anticipated start date
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01/11/2009
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Anticipated end date
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01/11/2012
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use contact details below to request a patient information sheet.
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Target number of participants
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260
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Interventions
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Consecutive alcohol-related attendances will be screened for alcohol dependence. Eligible patients who consent will be randomised to either the treatment arm or normal clinical care. Randomisation will be carried out using computer-generated sequentially-numbered sealed envelopes.
Treatment: The EBI utilised by the ASN will follow the FRAMES approach (6 point approach - Feedback, Responsibility, Advice, Menu of Options, Empathy, Self-efficacy). Four to six interventions (20 minutes duration each) will be delivered by an ASN within a twelve-week period. Measures will be recorded at recruitment, 12 weeks and 6 months.
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Primary outcome measure(s)
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1. Alcohol Use Disorders Identification Test (AUDIT)
2. Severity of Alcohol dependence (SADQ)
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Secondary outcome measure(s)
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1. Measure of Dependence (Leeds Dependency Questionnaire).
2. Quantity and frequency of alcohol consumption in UK units per drinking day.
3. Readiness to Change Questionnaire (RTCQ).
4, Number of ED attendances 6 months pre and 6 months post treatment/control.
5. Hospital length of stay sum days in hospital 6 months and 6 months post treatment/control.
6. Number of hospital admissions 6 months pre and 6 months post treatment/control.
7. Length of stay for initial treatment in days.
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Sources of funding
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National Institute of Health Research (NIHR) Research for Patient Benefit (UK) (ref:PB-PG-0408-15077)
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Trial website
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Publications
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Contact name
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Prof
Munir
Pirmohamed
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Address
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Deputy Director
MRC Centre for Drug Safety Science
Department of Pharmacology
The University of Liverpool
Ashton Street
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City/town
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Liverpool
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Zip/Postcode
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L69 3GL
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Country
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United Kingdom
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Email
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munirp@liv.ac.uk
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Sponsor
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Southport and Ormskirk NHS Hospital Trust (UK)
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Address
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R&D Manager
Southport and Ormskirk Hospitals NHS Trust
Room 119
LRC
Ormskirk Hospital
Wigan Road
Ormskirk
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City/town
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Southport
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Zip/Postcode
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L39 2AZ
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Country
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United Kingdom
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Email
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beverley.harrison@southportandormskirk.nhs.uk
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Date applied
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04/02/2010
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Last edited
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16/03/2010
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Date ISRCTN assigned
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16/03/2010
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