Condition category
Mental and Behavioural Disorders
Date applied
04/02/2010
Date assigned
16/03/2010
Last edited
26/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Munir Pirmohamed

ORCID ID

Contact details

Deputy Director
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 measures

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

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

R&D Manager
Southport and Ormskirk Hospitals NHS Trust
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

National Institute of Health Research (NIHR) Research for Patient Benefit (UK) (ref:PB-PG-0408-15077)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21726445

Publication citations

Additional files

Editorial Notes