Contact information
Type
Scientific
Primary contact
Prof Munir Pirmohamed
ORCID ID
Contact details
MRC Centre for Drug Safety Science
Department of Pharmacology
The University of Liverpool
Ashton Street
Liverpool
L69 3GL
United Kingdom
-
munirp@liv.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT01060397
Protocol/serial number
PB-PG-0408-15077
Study information
Scientific title
A randomised controlled trial of extended brief interventions for alcohol-dependent patients in an acute care setting
Acronym
ADPAC
Study hypothesis
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.
Ethics approval
North West 2 Research Ethics Committee - Liverpool Central, 23/09/2009, ref: 09/H1005/61
Study design
Single-centre randomised controlled trial with single-blinded independent follow up
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet.
Condition
Alcohol dependence
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Alcohol Use Disorders Identification Test (AUDIT)
2. Severity of Alcohol dependence (SADQ)
Secondary outcome measures
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.
Overall trial start date
01/11/2009
Overall trial end date
01/11/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients with a score equal to or greater than 16 on the Alcohol Use Disorder Identification Test (AUDIT) screening tool.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
260
Participant exclusion criteria
1. Patients 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
Recruitment start date
01/11/2009
Recruitment end date
01/11/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The University of Liverpool
Liverpool
L69 3GL
United Kingdom
Sponsor information
Organisation
Southport and Ormskirk NHS Hospital Trust (UK)
Sponsor details
Room 119
LRC
Ormskirk Hospital
Wigan Road
Ormskirk
Southport
L39 2AZ
United Kingdom
-
beverley.harrison@southportandormskirk.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Research for Patient Benefit Programme (ref:PB-PG-0408-15077)
Alternative name(s)
NIHR Research for Patient Benefit Programme, RfPB
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21726445
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27151969