Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000109000
Ethics application status
Approved
Date submitted
29/01/2010
Date registered
2/02/2010
Date last updated
11/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Mailed feedback for at-risk drinkers presenting to rural emergency departments
Scientific title
A randomised control trial evaluating the effects of mailed feedback on alcohol consumption and related problems in risky drinking patients of rural emergency departments
Secondary ID [1] 1362 0
None
Universal Trial Number (UTN)
U1111-1113-5177
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol consumption 256713 0
Alcohol-related problems 256714 0
Repeat emergency department presentations 256715 0
Condition category
Condition code
Public Health 256872 256872 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention comprises screening for alcohol problems followed by written personalised feedback regarding alcohol consumption delivered to participants in the mail. Emergency Department (ED) staff invite eligible patients to participate in a phone survey regarding their alcohol consumption. The principal investigator contacts consenting patients and administers the screening questionnaire, which consists of the Alcohol Use Disorders Identification Test (AUDIT). The written personalised feedback presents the participant's responses on the AUDIT items relative to normative data from residents of the same rural communities. This feedback is mailed to participants on a single occasion approximately 1 week after he/she completes the screening questionnaire.
Intervention code [1] 255943 0
Other interventions
Comparator / control treatment
The control group receives screening for alcohol problems with mailed feedback delayed until follow-up is completed
Control group
Active

Outcomes
Primary outcome [1] 257738 0
Quantity/frequency of alcohol consumption. This will be assessed in a phone administered questionnaire, and calculated from the first two items of the AUDIT.
Timepoint [1] 257738 0
6 weeks & 6 months post screening
Primary outcome [2] 257739 0
Frequency of heavy drinking. This will be assessed in a phone administered questionnaire, and calculated from the third item of the AUDIT.
Timepoint [2] 257739 0
6 weeks & 6 months post screening
Primary outcome [3] 257740 0
Alcohol-related injuries. This will be assessed in a phone administered questionnaire, and calculated from 9th item of the AUDIT.
Timepoint [3] 257740 0
6 weeks & 6 months post screening
Primary outcome [4] 257741 0
Repeat emergency department presentations. This will be assessed in a phone administered questionnaire, in which patients will be asked how many times they visited an emergency department for treatment over the follow-up period.
Timepoint [4] 257741 0
6 months post screening
Secondary outcome [1] 263108 0
Nil
Timepoint [1] 263108 0
Nil

Eligibility
Key inclusion criteria
Patients aged 14 years and older who present to one of 5 emergency departments in rural NSW, who screen at-risk for alcohol problems (8 or more on the Alcohol Use Disorders Identification Test).
Minimum age
14 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No mailing address in Australia

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)
Patients who score 'at-risk' according to the screener are immediately invited to participate in follow-up interviews. Allocation to intervention/control is performed later by the holder of the allocation schedule who is at the central administration site ie allocation is concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A blocked randomisation sequence was generated using Stata Statistical Software. Randomisation was stratified by hospital and gender.
Masking / blinding
Blinded (masking 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
Active, not recruiting
Date of first participant enrolment
Anticipated
5/03/2009
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)
Recruitment postcode(s) [1] 2516 0
2460
Recruitment postcode(s) [2] 2517 0
2680
Recruitment postcode(s) [3] 2518 0
2380
Recruitment postcode(s) [4] 2519 0
2360
Recruitment postcode(s) [5] 2520 0
2440

Funding & Sponsors
Funding source category [1] 256438 0
Charities/Societies/Foundations
Name [1] 256438 0
Alcohol Education and Rehabilitation Foundation Ltd
Country [1] 256438 0
Australia
Primary sponsor type
University
Name
University of New South Wales, National Drug and Alcohol Research Centre
Address
National Drug and Alcohol Research Centre
University of New South Wales
Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 255739 0
None
Name [1] 255739 0
Address [1] 255739 0
Country [1] 255739 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258492 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 258492 0
Ethics committee country [1] 258492 0
Australia
Date submitted for ethics approval [1] 258492 0
Approval date [1] 258492 0
06/11/2008
Ethics approval number [1] 258492 0
08/10/15/4.01
Ethics committee name [2] 258493 0
NSW Population & Health Services Research Ethics Committee
Ethics committee address [2] 258493 0
Ethics committee country [2] 258493 0
Australia
Date submitted for ethics approval [2] 258493 0
Approval date [2] 258493 0
02/12/2008
Ethics approval number [2] 258493 0
08/CIPHS/12
Ethics committee name [3] 258494 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [3] 258494 0
Ethics committee country [3] 258494 0
Australia
Date submitted for ethics approval [3] 258494 0
Approval date [3] 258494 0
17/12/2008
Ethics approval number [3] 258494 0
HREC 08373

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

Contacts
Principal investigator
Name 30789 0
Address 30789 0
Country 30789 0
Phone 30789 0
Fax 30789 0
Email 30789 0
Contact person for public queries
Name 14036 0
Alys Havard
Address 14036 0
National Drug and Alcohol Research Centre
University of New South Wales
Sydney NSW 2052
Country 14036 0
Australia
Phone 14036 0
+61293850254
Fax 14036 0
+61293850222
Email 14036 0
[email protected]
Contact person for scientific queries
Name 4964 0
Alys Havard
Address 4964 0
National Drug and Alcohol Research Centre
University of New South Wales
Sydney NSW 2052
Country 4964 0
Australia
Phone 4964 0
+6193850254
Fax 4964 0
Email 4964 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.