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Trial registered on ANZCTR


Registration number
ACTRN12612000919819
Ethics application status
Approved
Date submitted
28/08/2012
Date registered
28/08/2012
Date last updated
6/09/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot randomised controlled trial of electronic screening and brief intervention (e-SBI) to increase uptake of referral for specialist care among hospital outpatients with possible alcohol dependence
Scientific title
Among hospital outpatients who screen positive for possible alcohol dependence, are those randomly assigned to receive electronic screening and brief intervention (e-SBI) more likely than those assigned to screening alone to accept or attend an outpatient appointment for further assessment?
Secondary ID [1] 281106 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alcohol dependence 287265 0
Condition category
Condition code
Public Health 287590 287590 0 0
Health promotion/education
Mental Health 287597 287597 0 0
Addiction

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.
Intervention code [1] 285557 0
Behaviour
Intervention code [2] 285558 0
Early detection / Screening
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.
Control group
Active

Outcomes
Primary outcome [1] 287850 0
Proportion who accept an appointment at the Drug and Alcohol Outpatient Clinic.
Timepoint [1] 287850 0
At baseline.
Primary outcome [2] 287853 0
Proportion who attend the appointment at the Drug and Alcohol Outpatient Clinic.
Timepoint [2] 287853 0
6 months post randomisation.
Secondary outcome [1] 298935 0
Total number of standard drinks in the past week assessed by a 7-day retrospective diary.
Timepoint [1] 298935 0
6 and 12 months post randomisation.
Secondary outcome [2] 298937 0
AUDIT score with a reference period of the past 6 months.
Timepoint [2] 298937 0
6 and 12 months post randomisation.
Secondary outcome [3] 298938 0
Number of drinking days in the past week assessed by a 7-day retrospective diary.
Timepoint [3] 298938 0
6 and 12 months post randomisation.
Secondary outcome [4] 298939 0
Number of standard drinks per drinking day in the past week assessed by a 7-day retrospective diary.
Timepoint [4] 298939 0
6 and 12 months post randomisation.
Secondary outcome [5] 298940 0
The proportion who exceed 2009 NHMRC recommended upper limits for risk of acute harm (no more than 4 drinks per occasion) in the past week assessed by a 7-day retrospective diary.
Timepoint [5] 298940 0
6 and 12 months post randomisation.
Secondary outcome [6] 298941 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] 298941 0
6 and 12 months post randomisation.
Secondary outcome [7] 298944 0
Self-reported use of services to reduce drinking.
Timepoint [7] 298944 0
6 and 12 months post 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 possible alcohol dependence indicated by an AUDIT-C score > 9.
Minimum age
18 Years
Maximum age
No limit
Gender
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 an 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 possible alcohol dependence (AUDIT-C <10);

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

Funding & Sponsors
Funding source category [1] 285891 0
Government body
Name [1] 285891 0
National Health and Medical Research Council
Address [1] 285891 0
GPO Box 1421
CANBERRA ACT 2601
Country [1] 285891 0
Australia
Primary sponsor type
Individual
Name
Associate Professor Kypros Kypri
Address
Level 4 West
HMRI Bldg
CALLAGHAN NSW 2308
Country
Australia
Secondary sponsor category [1] 284714 0
None
Name [1] 284714 0
Address [1] 284714 0
Country [1] 284714 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287919 0
Hunter New England Human Research Ethics Committee
Ethics committee address [1] 287919 0
Locked Bag No.1
NEW LAMBTON NSW 2305
Ethics committee country [1] 287919 0
Australia
Date submitted for ethics approval [1] 287919 0
Approval date [1] 287919 0
03/08/2012
Ethics approval number [1] 287919 0
12/05/16/4.04
Ethics committee name [2] 287920 0
The University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 287920 0
Research Integrity Unit
HA148, Hunter Building
The University of Newcastle
CALLAGHAN NSW 2308
Ethics committee country [2] 287920 0
Australia
Date submitted for ethics approval [2] 287920 0
Approval date [2] 287920 0
07/08/2012
Ethics approval number [2] 287920 0
H-2012-0272

Summary
Brief summary
There is little evidence on how to care for patients with alcohol dependence who are not seeking treatment for their drinking. Research has shown that only a small proportion of such patients take up a referral for specialist care. This pilot study, utilising the NHMRC funded "Hospital Outpatients Alcohol Project" framework, will determine the feasibility of conducting a large trial designed to establish whether e-SBI can increase uptake of specialist care in this group of patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34628 0
Address 34628 0
Country 34628 0
Phone 34628 0
Fax 34628 0
Email 34628 0
Contact person for public queries
Name 17875 0
Associate Professor Kypros Kypri
Address 17875 0
Level 4 West
HMRI Bldg
CALLAGHAN NSW 2308
Country 17875 0
Australia
Phone 17875 0
+61,2,40420536
Fax 17875 0
+61,2,40420044
Email 17875 0
Kypros.Kypri@newcastle.edu.au
Contact person for scientific queries
Name 8803 0
Associate Professor Kypros Kypri
Address 8803 0
Level 4 West
HMRI Bldg
CALLAGHAN NSW 2308
Country 8803 0
Australia
Phone 8803 0
+61,2,40420536
Fax 8803 0
+61,2,40420044
Email 8803 0
Kypros.Kypri@newcastle.edu.au

No information has been provided regarding IPD availability
Summary results
No Results