ANZCTR - Registration

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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 information initially 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]

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

Condition category

Condition code

Public Health

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]

Behaviour

Intervention code [2]

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]

Total number of standard drinks in the past week assessed by a 7-day retrospective diary.

Timepoint [1]

6 months after randomisation.

Primary outcome [2]

AUDIT score with a reference period of the past six months.

Timepoint [2]

6 months after randomisation.

Secondary outcome [1]

Total number of standard drinks in the past week assessed by a 7-day retrospective diary.

Timepoint [1]

12 months after randomisation.

Secondary outcome [2]

AUDIT score with a reference period of the past six months.

Timepoint [2]

12 months after randomisation.

Secondary outcome [3]

Number of drinking days in the past week assessed by a 7-day retrospective diary.

Timepoint [3]

6 and 12 months after randomisation.

Secondary outcome [4]

Number of standard drinks per drinking day in the past week assessed by a 7-day retrospective diary.

Timepoint [4]

6 and 12 months after randomisation.

Secondary outcome [5]

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]

6 and 12 months after randomisation.

Secondary outcome [6]

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]

6 and 12 months after randomisation.

Secondary outcome [7]

Number of inpatient, outpatient and Emergency Department presentations as assessed by data linkage with medical records.

Timepoint [7]

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?

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]

2305

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

GPO Box 1421
CANBERRA ACT 2601

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Hunter New England Human Research Ethics Committee

Ethics committee address [1]

Locked Bag No.1
NEW LAMBTON NSW 2305

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

03/08/2012

Ethics approval number [1]

12/05/16/4.04

Ethics committee name [2]

The University of Newcastle Human Research Ethics Committee

Ethics committee address [2]

Research Integrity Unit
HA148, Hunter Building
The University of Newcastle
CALLAGHAN NSW 2308

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

07/08/2012

Ethics approval number [2]

H-2012-0272

Summary

Brief summary

Since alcohol consumption is linked to more than 60 different medical conditions and is the most common preventable risk factor associated with injuries in Australia, interventions that can reduce these harms are needed. This study is designed to determine whether a computer-based brief alcohol intervention reduces hazardous drinking among hospital outpatients. If effective, the intervention could be implemented nationally as part of routine service delivery.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Kypros Kypri

Address

HMRI Room 4104
University Drive
Callaghan, NSW 2308

Country

Australia

Phone

+61 02 4042 0536

Fax

[email protected]

Contact person for public queries

Name

Prof Associate Professor Kypros Kypri

Address

Level 4 west
HMRI Building
CALLAGHAN NSW 2308

Country

Australia

Phone

+61,2,40420536

Fax

+61,2,40420044

[email protected]

Contact person for scientific queries

Name

Prof Associate Professor Kypros Kypri

Address

Level 4 west
HMRI Building
CALLAGHAN NSW 2308

Country

Australia

Phone

+61,2,40420536

Fax

+61,2,40420044

[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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Date of publication: 01/10/2018 Citation: Natal... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Effect of telephone follow-up on retention and balance in an alcohol intervention trial.	2015	https://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.

Trial Review

Documents added manually

Documents added automatically