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
Scientific
MRC Centre for Drug Safety Science
Department of Pharmacology
The University of Liverpool
Ashton Street
Liverpool
L69 3GL
United Kingdom
| munirp@liv.ac.uk |
Study information
| Study design | Single-centre randomised controlled trial with single-blinded independent follow up |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet. |
| Scientific title | A randomised controlled trial of extended brief interventions for alcohol-dependent patients in an acute care setting |
| Study acronym | ADPAC |
| Study objectives | 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(s) | North West 2 Research Ethics Committee - Liverpool Central, 23/09/2009, ref: 09/H1005/61 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/11/2009 |
| Completion date | 01/11/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target number of participants | 260 |
| Key inclusion criteria | Patients with a score equal to or greater than 16 on the Alcohol Use Disorder Identification Test (AUDIT) screening tool. |
| Key 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 |
| Date of first enrolment | 01/11/2009 |
| Date of final enrolment | 01/11/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
The University of Liverpool
Liverpool
L69 3GL
United Kingdom
L69 3GL
United Kingdom
Sponsor information
Southport and Ormskirk NHS Hospital Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Room 119
LRC
Ormskirk Hospital
Wigan Road
Ormskirk
Southport
L39 2AZ
England
United Kingdom
| beverley.harrison@southportandormskirk.nhs.uk | |
"ROR" |
https://ror.org/0586bt104 |
Funders
Funder type
Government
Research for Patient Benefit Programme (ref:PB-PG-0408-15077)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- NIHR Research for Patient Benefit Programme, Research for Patient Benefit (RfPB), The NIHR Research for Patient Benefit (RfPB), RfPB
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | |
| Publication and dissemination plan | Not 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.
