Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000335998
Ethics application status
Approved
Date submitted
30/03/2011
Date registered
31/03/2011
Date last updated
1/04/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised control trial of brief intervention for harmful alcohol use to reduce alcohol consumption in trauma patients
Scientific title
Brief intervention in trauma patients to reduce alcohol consumption
Secondary ID [1] 259886 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
alcohol abuse 265481 0
trauma 265482 0
Condition category
Condition code
Injuries and Accidents 265632 265632 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief intervention for alcohol use is a validated tool for discussing alcohol use and its potential adverse effects to patients with risky alcohol drinking behaviours. It consists of a brief discussion of alcohol related harms based on a standard proforma and is administered face to face with the patient using one of two trained study investigators. Brief intervention takes no more than 10 minutes to administer per patient. An information booklet and drinking diary is also provided to the patient.

The aim is to reduce levels of harmful drinking in patients admitted to hospital due to injuries and have evidence of harmful alcohol consumption based on the AUDIT (Alcohol Use Disorders Identifiation Test) screening tool.

Eligible patients randomised to the study arm will all receive brief intervention in addition to standard clinical care
Intervention code [1] 264308 0
Behaviour
Comparator / control treatment
Eligible patients randomised to control group will receive standard clinical care. This involves clinical care for the injury and its complications as well as routine case management. If a clinical indication for referral to Drug and Alcohol is indicated, this will be completed independently if the trial group allocation.
Control group
Active

Outcomes
Primary outcome [1] 262420 0
Self reported number of standard drinks on average drinking session

This will be assessed using a telephone follow up of patients. A standard survey form will be completed by the study investigators
Timepoint [1] 262420 0
3 months follow up
Secondary outcome [1] 273741 0
Alcohol Use Disorders Identification Test (AUDIT) score. The AUDIT score categorises patients who are at risk of harmful alcohol use. A score of >8 means a patient has harmful alcohol consumtion levels.

This will be assessed over the telephone with trained study investigators
Timepoint [1] 273741 0
3 months
Secondary outcome [2] 273742 0
Percentage of patients in at risk drinking group (AUDIT score 8 or more)
Timepoint [2] 273742 0
3 months
Secondary outcome [3] 273743 0
Representations or another injury event.

This outcome will also be self reported at the time of follow up telephone interview. A standard follow up preforma will be used
Timepoint [3] 273743 0
3 months

Eligibility
Key inclusion criteria
Adult patients admitted under the trauma service at Royal Prince Alfred Hospital
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non English speaking (requiring translator to communicate)
Cognitive impairment
Severe head injury or severe injury precluding brief intervention

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible patients are identified during routine hospital ward rounds by the trauma clinical nurse consultant and informed about the study. A study investigator then approaches patient and tells them about the study. Writeen consent is then obtained. A screening tool (AUDIT - Alcohol Use Disorders Identification Test) is then used to screen patients for at risk drinking. If the screening tool scores 8 or more then the patient is randomised. Randomisation involves opening a prefilled sealed envelope which contains group assignment. These envelopes are kept in a locked research cabinet.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer based random number generator was used to determine randomisation sequence. Group allocations were then placed in a numbered and sealed envelope.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 264771 0
Self funded/Unfunded
Name [1] 264771 0
Country [1] 264771 0
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital Trauma Department
Address
Level 10E
Missenden Road
Camperdown, NSW 2050
Country
Australia
Secondary sponsor category [1] 263886 0
None
Name [1] 263886 0
Address [1] 263886 0
Country [1] 263886 0
Other collaborator category [1] 251908 0
Other Collaborative groups
Name [1] 251908 0
The George Institute for Global Health
Address [1] 251908 0
George St
Sydney NSW 2000
Country [1] 251908 0
Australia
Other collaborator category [2] 251909 0
University
Name [2] 251909 0
Sydney University
Address [2] 251909 0
Central Clinical School
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country [2] 251909 0
Australia
Other collaborator category [3] 251910 0
Hospital
Name [3] 251910 0
Drug and Alcohol Services
Address [3] 251910 0
Royal Prince Alfred Hospital
Missenden Road
Camperdown, NSW 2050
Country [3] 251910 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 266749 0
Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 266749 0
Ethics committee country [1] 266749 0
Australia
Date submitted for ethics approval [1] 266749 0
Approval date [1] 266749 0
18/11/2010
Ethics approval number [1] 266749 0
HREC/10/RPAH/493

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32413 0
Address 32413 0
Country 32413 0
Phone 32413 0
Fax 32413 0
Email 32413 0
Contact person for public queries
Name 15660 0
Dr Michael Dinh
Address 15660 0
Emergency Department
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 15660 0
Australia
Phone 15660 0
+61 2 9515 6386
Fax 15660 0
+61 2 95155099
Email 15660 0
[email protected]
Contact person for scientific queries
Name 6588 0
Dr Michael Dinh
Address 6588 0
Emergency Department
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050
Country 6588 0
Australia
Phone 6588 0
+61 2 9515 6386
Fax 6588 0
+61 2 95155099
Email 6588 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.