Extended Brief Interventions (EBI) for alcohol-dependent patients in an acute care setting
| ISRCTN | ISRCTN78062794 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78062794 |
| ClinicalTrials.gov (NCT) | NCT01060397 |
| Protocol serial number | PB-PG-0408-15077 |
| Sponsor | Southport and Ormskirk NHS Hospital Trust (UK) |
| Funder | Research for Patient Benefit Programme (ref: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
Plain English summary of protocol
Not provided at time of registration
Contact information
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
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre randomised controlled trial with single-blinded independent follow up |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
1. Alcohol Use Disorders Identification Test (AUDIT) |
| Key secondary outcome measure(s) |
1. Measure of Dependence (Leeds Dependency Questionnaire). |
| Completion date | 01/11/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
L69 3GL
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2016 | Yes | No | |
| Protocol article | protocol | 04/07/2011 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
14/11/2018: Publication reference added.
