Extended Brief Interventions (EBI) for alcohol-dependent patients in an acute care setting

ISRCTN ISRCTN78062794
DOI https://doi.org/10.1186/ISRCTN78062794
ClinicalTrials.gov number NCT01060397
Secondary identifying numbers PB-PG-0408-15077
Submission date
04/02/2010
Registration date
16/03/2010
Last edited
14/11/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Munir Pirmohamed
Scientific

MRC Centre for Drug Safety Science
Department of Pharmacology
The University of Liverpool
Ashton Street
Liverpool
L69 3GL
United Kingdom

Email munirp@liv.ac.uk

Study information

Study designSingle-centre randomised controlled trial with single-blinded independent follow up
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet.
Scientific titleA randomised controlled trial of extended brief interventions for alcohol-dependent patients in an acute care setting
Study acronymADPAC
Study objectivesExtended 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(s)North West 2 Research Ethics Committee - Liverpool Central, 23/09/2009, ref: 09/H1005/61
Health condition(s) or problem(s) studiedAlcohol dependence
InterventionConsecutive 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 typeOther
Primary outcome measure1. Alcohol Use Disorders Identification Test (AUDIT)
2. Severity of Alcohol dependence (SADQ)
Secondary outcome measures1. 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 study start date01/11/2009
Completion date01/11/2012

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants260
Key inclusion criteriaPatients with a score equal to or greater than 16 on the Alcohol Use Disorder Identification Test (AUDIT) screening tool.
Key exclusion criteria1. 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
Date of first enrolment01/11/2009
Date of final enrolment01/11/2012

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

The University of Liverpool
Liverpool
L69 3GL
United Kingdom

Sponsor information

Southport and Ormskirk NHS Hospital Trust (UK)
Hospital/treatment centre

Room 119
LRC
Ormskirk Hospital
Wigan Road
Ormskirk
Southport
L39 2AZ
England
United Kingdom

Email beverley.harrison@southportandormskirk.nhs.uk
ROR logo "ROR" https://ror.org/0586bt104

Funders

Funder type

Government

Research for Patient Benefit Programme (ref:PB-PG-0408-15077)
Government organisation / National government
Alternative name(s)
NIHR Research for Patient Benefit Programme, RfPB
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 04/07/2011 Yes No
Results article results 01/09/2016 Yes No

Editorial Notes

14/11/2018: Publication reference added.