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Trial registered on ANZCTR


Registration number
ACTRN12612000905864
Ethics application status
Approved
Date submitted
22/08/2012
Date registered
24/08/2012
Date last updated
27/09/2019
Date data sharing statement initially provided
27/09/2019
Date results provided
27/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Hospital Outpatients Alcohol Project: A Randomised Controlled Trial
Scientific title
Are hospital outpatients who receive electronic alcohol screening and brief intervention more likely than hospital outpatients who receive electronic alcohol screening only to reduce their alcohol consumption 6 and 12 months post recruitment?
Secondary ID [1] 281077 0
Nil
Universal Trial Number (UTN)
U1111-1133-7426
Trial acronym
HOAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hazardous drinking 287227 0
Condition category
Condition code
Public Health 287551 287551 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention comprises 5-10 minutes of electronic motivational assessment and personalised feedback on alcohol consumption via an iPad. Specifically, participants in the intervention group complete: the 10-item Alcohol Use Disorders Identification Test (AUDIT); questions concerning the largest number of standard drinks consumed on one occasion in the last four weeks, the duration of the drinking episode in hours, and body weight for the purpose of estimating their blood alcohol concentration; and the 10-item Leeds Dependence Questionnaire (LDQ).

On completion of the above, participants in the intervention group will receive personalised feedback comprising the following:
(i) the patient’s AUDIT score and guidance on its meaning;
(ii) an estimated blood alcohol concentration (BAC) for their heaviest episode in the previous month with information on the behavioural and physiological sequelae of various BACs, and traffic crash relative risk;
(iii) estimates of spending per month;
(iv) a bar graph comparing episodic consumption with medical recommendations, and that of adults of the same age and gender;
(v) a bar graph comparing weekly consumption with medical recommendations, and with adults of the same age and gender;
(vi) an LDQ score with an explanation of the associated health risk and information about how to reduce that risk.

Further web pages will be presented as options, offering facts about alcohol, tips for reducing the risk of alcohol-related harm, and information as to where medical help and counselling support could be found.

Participants will be contacted for follow up 6 and 12 months later.
Intervention code [1] 285533 0
Behaviour
Intervention code [2] 285541 0
Prevention
Comparator / control treatment
Control group only completes the first 3 items of the AUDIT, known as the AUDIT Consumption subscale (AUDIT-C). Subjects in the control group will not receive personalised feedback. Participants in the control group will be contacted for follow up 6 and 12 months post randomisation.
Control group
Active

Outcomes
Primary outcome [1] 287801 0
Total number of standard drinks in the past week assessed by a 7-day retrospective diary.
Timepoint [1] 287801 0
6 months after randomisation.
Primary outcome [2] 287802 0
AUDIT score with a reference period of the past six months.
Timepoint [2] 287802 0
6 months after randomisation.
Secondary outcome [1] 298856 0
Total number of standard drinks in the past week assessed by a 7-day retrospective diary.
Timepoint [1] 298856 0
12 months after randomisation.
Secondary outcome [2] 298857 0
AUDIT score with a reference period of the past six months.
Timepoint [2] 298857 0
12 months after randomisation.
Secondary outcome [3] 298858 0
Number of drinking days in the past week assessed by a 7-day retrospective diary.
Timepoint [3] 298858 0
6 and 12 months after randomisation.
Secondary outcome [4] 298859 0
Number of standard drinks per drinking day in the past week assessed by a 7-day retrospective diary.
Timepoint [4] 298859 0
6 and 12 months after randomisation.
Secondary outcome [5] 298860 0
The proportion who exceed 2009 NHMRC recommended upper limits for risk of acute harm (no more than four drinks per occasion) in the past week assessed by a 7-day retrospective diary.
Timepoint [5] 298860 0
6 and 12 months after randomisation.
Secondary outcome [6] 298861 0
The proportion who exceed 2009 NHMRC recommended upper limits for risk of chronic harm (no more than 14 drinks per week) in the past week assessed by a 7-day retrospective diary.
Timepoint [6] 298861 0
6 and 12 months after randomisation.
Secondary outcome [7] 298862 0
Number of inpatient, outpatient and Emergency Department presentations as assessed by data linkage with medical records.
Timepoint [7] 298862 0
12 months after randomisation.

Eligibility
Key inclusion criteria
Patients attending the Ambulatory Care Centre will be eligible for inclusion if they are 18 years of age or older, live in the Hunter New England Local Health District, provide informed consent, and screen positive for hazardous drinking.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who cannot read English, unable to self-administer the e-SBI instrument via the iPad, or are moving to an unknown address during the next 12 months (ie., will be lost to follow-up) will not be recruited.

Following screening, participants will be excluded if they:
(i) have not consumed any alcohol in the past 12 months;
(ii) report they are currently receiving treatment for their drinking;
(iii) do not screen positive for hazardous drinking in the past 12 months (AUDIT-C <5);
(iv) may be dependent on alcohol (AUDIT-C >9).

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Research assistants located in one (South Block) of the waiting areas in the Ambulatory Care Centre (ACC) will be trained in the application of a study protocol stipulating they should invite the next patient leaving the reception desk (awaiting a medical consultation) to participate in the study, obtain informed consent, and log the participant onto an iPad. When the participant has finished with the iPad, the research assistant will return to the reception desk to recruit the next patient. In the event that there are no patients leaving the reception desk (for a period of 5 minutes), research assistants will invite patients occupying particular seats in rotation around the waiting area (clockwise and then anticlockwise).

As randomisation after screening will be effected by computer, research staff will not be aware of participants’ group allocations. Participants will be blind to the true nature of the study also as they will be asked to consent to participate in a series of surveys rather than a trial.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation.
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
Completed
Date of first participant enrolment
Anticipated
27/08/2012
Actual
28/08/2012
Date of last participant enrolment
Anticipated
Actual
21/12/2012
Date of last data collection
Anticipated
Actual
9/01/2014
Sample size
Target
771
Accrual to date
Final
837
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 5605 0
2305

Funding & Sponsors
Funding source category [1] 285862 0
Government body
Name [1] 285862 0
National Health and Medical Research Council
Country [1] 285862 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Kypros Kypri
Address
Level 4 West
HMRI Building
The University of Newcastle
CALLAGHAN NSW 2308
Country
Australia
Secondary sponsor category [1] 284683 0
None
Name [1] 284683 0
Address [1] 284683 0
Country [1] 284683 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287890 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 287890 0
Ethics committee country [1] 287890 0
Australia
Date submitted for ethics approval [1] 287890 0
Approval date [1] 287890 0
03/08/2012
Ethics approval number [1] 287890 0
12/05/16/4.04
Ethics committee name [2] 287891 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 287891 0
Ethics committee country [2] 287891 0
Australia
Date submitted for ethics approval [2] 287891 0
Approval date [2] 287891 0
07/08/2012
Ethics approval number [2] 287891 0
H-2012-0272

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

Contacts
Principal investigator
Name 34607 0
Prof Kypros Kypri
Address 34607 0
HMRI Room 4104
University Drive
Callaghan, NSW 2308
Country 34607 0
Australia
Phone 34607 0
+61 02 4042 0536
Fax 34607 0
Email 34607 0
[email protected]
Contact person for public queries
Name 17854 0
Associate Professor Kypros Kypri
Address 17854 0
Level 4 west
HMRI Building
CALLAGHAN NSW 2308
Country 17854 0
Australia
Phone 17854 0
+61,2,40420536
Fax 17854 0
+61,2,40420044
Email 17854 0
[email protected]
Contact person for scientific queries
Name 8782 0
Associate Professor Kypros Kypri
Address 8782 0
Level 4 west
HMRI Building
CALLAGHAN NSW 2308
Country 8782 0
Australia
Phone 8782 0
+61,2,40420536
Fax 8782 0
+61,2,40420044
Email 8782 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
participant data underlying published results
When will data be available (start and end dates)?
Perpetuity
Available to whom?
Open access
Available for what types of analyses?
not specified
How or where can data be obtained?
NOVA open access repository (University of Newcastle)


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
SourceTitleYear of PublicationDOI
EmbaseEffect of telephone follow-up on retention and balance in an alcohol intervention trial.2015https://dx.doi.org/10.1016/j.pmedr.2015.08.016
N.B. These documents automatically identified may not have been verified by the study sponsor.