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Trial registered on ANZCTR


Registration number
ACTRN12617001254381p
Ethics application status
Submitted, not yet approved
Date submitted
11/08/2017
Date registered
28/08/2017
Date last updated
28/08/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study to assess the feasibility of hospital alcohol screening and brief intervention with referral to general practice
Scientific title
Pilot study to assess the feasibility of hospital alcohol screening and brief intervention with referral to general practice for adult participants admitted to an emergency department short stay unit
Secondary ID [1] 292420 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
at-risk alcohol use 304013 0
Addiction 304014 0
Condition category
Condition code
Public Health 303343 303343 0 0
Other public health
Public Health 303344 303344 0 0
Health service research
Mental Health 303711 303711 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Alcohol screening and brief intervention (where indicated) will be introduced as standard practice in the target ward. Participants will be randomised to receive either discharge information being sent to their General practitioner or treatment as usual.
Patients will be screened with the 3 item alcohol use disorders identification test (AUDIT-C). Men scoring 5-8 and women scoring 4-7 will receive a brief intervention on their alcohol use. Men scoring 9 or more and women scoring 8 or more will also be referred to the hospital alcohol and drug team.. After checking eligibility criteria (see below) patients will be invited to participate in the randomised trial which consists of alcohol related information being sent to their GP or not. The expected duration of recruitment is 6 months.
GP referral - this consists of 2 parts. First a summary of the project plus list of local alcohol and other drug services & specialist GP resources. and second a hospital 'discharge' letter outlining the alcohol screening result and the intervention provided in hospital and any additional alcohol related indictors. The GP is invited, "based on this information, and your knowledge of the individual’s medical history, please provide any further intervention that you consider necessary. If you decide that more extensive intervention would be beneficial, we include a flyer on specialist alcohol services in the community".

We also plan two sub-studies. Firstly, validation of self-reports of contact with GPs will be conducted in three groups. From the GP referral arm of the study we will randomly select from those who: 1) report no GP contact (estimate n=10), 2) report GP contact from the moderate risk participants (n=20) and, 3) report GP contact in the high risk group (n=10). At three months we will contact the nominated GP to confirm if the patient has been seen in the interim period and if any information or treatment was provided and obtain GP feedback on the referral process. This is included in the main HREC application but is not an outcome measure for the study.
Secondly, feasibility will be tested at Rockingham General Hospital emergency department, where alcohol screening and brief intervention will be introduced without additional research support. A clinical audit will be used to document the proportion of patients screened and receiving appropriate brief intervention. This clinical audit process does not require HREC approval.
Intervention code [1] 298592 0
Early detection / Screening
Intervention code [2] 298593 0
Behaviour
Comparator / control treatment
Alcohol screening and brief intervention (where indicated) will be introduced as standard practice in the target ward. Those in the treatment as usual group will receive no additional care other than that indicated by the screening process. In particular, details of the alcohol results and alcohol related brief intervention or referral to hospital AOD team will not be included.

It should be noted that the trial does not change standard clinical practice at the hospital so GPs may receive information such as results of liver function tests that could indicate at risk alcohol use.
Control group
Active

Outcomes
Primary outcome [1] 302733 0
Feasibility - proportion of eligible participants screened
Timepoint [1] 302733 0
Commencement date to end of recruitment
Primary outcome [2] 303080 0
Feasibility - proportion of eligible participants receiving indicated intervention
Timepoint [2] 303080 0
Commencement date to end of recruitment
Secondary outcome [1] 336848 0
Change in the rate of hospital events (admissions + emergency department presentations) for the participants (Fiona Stanley Hospital only). Emergency department presentations and hospital admissions will be extracted from the hospital electronic database.
Timepoint [1] 336848 0
Six months pre and post enrolment in the study
Secondary outcome [2] 336849 0
Change in alcohol use disorders identification test (consumption) (AUDIT C)
Timepoint [2] 336849 0
Baseline, 1 and 3 months
Secondary outcome [3] 336850 0
Change in weekly alcohol consumption assessed with a seven day drinking diary
Timepoint [3] 336850 0
Baseline, 1 and 3 months
Secondary outcome [4] 336851 0
Change in the rate of hospital admissions and emergency presentations at all Western Australian hospitals for participants.
These data will be obtained via the WA Data Linkage System which an compile administrative data from all WA hospitals
Timepoint [4] 336851 0
12 months pre and post enrolment
NB Additional funding and further HREC approvals will be sought for this outcome
Secondary outcome [5] 336852 0
Change in the length of stay for admissions at all Western Australian hospitals for participants.
These data will be obtained via the WA Data Linkage System which an compile administrative data from all WA hospitals
Timepoint [5] 336852 0
12 months pre and post enrolment
NB Additional funding and further HREC approvals will be sought for this outcome
Secondary outcome [6] 336853 0
Change in the rate of hospital admissions and emergency presentations at all Western Australian hospitals for participants.
These data will be obtained via the WA Data Linkage System which an compile administrative data from all WA hospitals
Timepoint [6] 336853 0
5 years pre and post enrolment
NB Additional funding and further HREC approvals will be sought for this outcome
Secondary outcome [7] 336854 0
Change in the length of stay for admissions at all Western Australian hospitals for participants.
These data will be obtained via the WA Data Linkage System which an compile administrative data from all WA hospitals
Timepoint [7] 336854 0
5 years pre and post enrolment
NB Additional funding will and further HREC approvals be sought for this outcome
Secondary outcome [8] 337356 0
Difference in the proportion of intervention and control group self-reporting contact with general practitioner where alcohol use was discussed
Timepoint [8] 337356 0
Baseline 1 and 3 months
Secondary outcome [9] 337845 0
(Sub-study with GPs)
Validation of participant self reported GP alcohol related treatment. Concordance (yes/no) did the GP provide any alcohol related information at any visit post baseline.
Timepoint [9] 337845 0
Baseline to 3 months
Secondary outcome [10] 337846 0
(Sub-study Rockingham General Hospital - this will be conducted as a clinical audit not a clinical trial)
Percentage of ED or emergency short stay patients who received alcohol screening (AUDIT-C)
Timepoint [10] 337846 0
Baseline to 1 month
Secondary outcome [11] 337847 0
(Sub-study Rockingham General Hospital - this will be conducted as a clinical audit not a clinical trial)
Percentage of ED or emergency short stay patients who received an alcohol brief intervention
when indicated (see above for AUDIT-C threshold scores)
Timepoint [11] 337847 0
Baseline to 1 month
Secondary outcome [12] 337854 0
(Sub-study GPs)
Qualitative feedback on the referral process via open ended questions (e.g. Please describe how the referral process helped or hindered talking to your patient about alcohol use?: How could the referral process be improved to help you in treating your alcohol use?)
Timepoint [12] 337854 0
Baseline to 3 months
Secondary outcome [13] 337855 0
(Participants scoring above AUDIT -C threshold but without a GP. Not eligible to be randomised to the study but data will inform future implementation of SBIRT)
Change in 7 day drinking
Timepoint [13] 337855 0
Baseline 1 and 3 months
Secondary outcome [14] 337856 0
(Participants scoring above AUDIT -C threshold but without a GP. Not eligible to be randomised to the study but data will inform future implementation of SBIRT)
Change in AUDIT-C score
Timepoint [14] 337856 0
Baseline 1 and 3 months

Eligibility
Key inclusion criteria
All patients admitted to the Fiona Stanley Hospital emergency short stay unit (FSH ESSU) aged 18 years or older, who are currently resident in Western Australia and able to read and understand spoken English are eligible.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inability to give informed consent – i.e. unable to understand written or spoken English or due to the severity of the condition (e.g. injury, acute intoxication).
Those without a GP will still receive screening and brief intervention and will not be randomised to study groups but will receive the same follow-ups as the study participants (estimate 146 out of 728 screening positive).

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)
Randomisation codes will be held in numbered, sealed opaque envelopes. These will be opened at the end of the registration process (e.g. eligibility criteria conformed: and non-opt out confirmed*).
* Due to the minimal nature of the intervention and the screening and brief intervention being incorporated into standard care, the HREC recommended the use of and "opt out' design. That is, participants would be asked if they wanted to opt out of research follow-up.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation codes will be generated using a fully automated system(http://www.graphpad.com/quickcalcs/randomize2/) with one-to-one allocation ratio, stratified by risk (moderate risk (AUDIT-C score males 5-8: females 4-7 ) versus high risk (AUDIT-C score: males 9 or more: females 8 or more).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The study is primarily a feasibility study so will report descriptive data on proportion screened, receiving intervention as indicated, proportion referred to a GP (in the active group) .

The secondary measures (AUDIT-C and standard drinks) provide repeated measures (baseline, 1 month and 3 months) of continuous variables. Due to the correlated data arising from the repeated measures, we will employ a multi-level mixed effects regression model with a random intercept term. This will control for clustering of variance within individuals over the repeated measures. For continuous data, we will use an unstructured correlation matrix with a normal distribution and identity link. Hospital event data (e.g. count or categorical) are likely to require the use of multinomial, Poisson or negative binomial distributions together with their appropriate link functions.

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)
WA
Recruitment hospital [1] 8526 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 16620 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 296974 0
Charities/Societies/Foundations
Name [1] 296974 0
WA Primary Health Alliance
Address [1] 296974 0
2-5, 7 Tanunda Drive, Rivervale WA 6103

P.O Box 591, Belmont WA 6984
Country [1] 296974 0
Australia
Primary sponsor type
Hospital
Name
Fiona Stanley Hospital
Address
Administration Building, Fiona Stanley Hospital
14 Barry Marshall Parade, MURDOCH WA 6150

Locked Bag 100, PALMYRA DC WA 6961
Country
Australia
Secondary sponsor category [1] 295978 0
None
Name [1] 295978 0
Address [1] 295978 0
Country [1] 295978 0
Other collaborator category [1] 279638 0
University
Name [1] 279638 0
Nationa Drug Research Institute, Curtin University
Address [1] 279638 0
Kent Street, Bentley, Perth
Western Australia, 6102

GPO Box U1987, Perth
Western Australia, 6845
Country [1] 279638 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 298177 0
South Metropolitan Health Service
Ethics committee address [1] 298177 0
SMHS Research Ethics and Governance Unit
Level 3 | Southern Research Facility (Perkins building)
11 Robin Warren Drive, Murdoch WA 6150

Locked Bag 100 Palmyra DC, WA, 6961
Ethics committee country [1] 298177 0
Australia
Date submitted for ethics approval [1] 298177 0
28/07/2016
Approval date [1] 298177 0
Ethics approval number [1] 298177 0
Ethics committee name [2] 298389 0
Curtin University
Ethics committee address [2] 298389 0
Kent Street, Bentley, Perth
Western Australia, 6102
GPO Box U1987, Perth
Western Australia, 6845
(NB This will be reciprocal approval application)
Ethics committee country [2] 298389 0
Australia
Date submitted for ethics approval [2] 298389 0
24/08/2017
Approval date [2] 298389 0
Ethics approval number [2] 298389 0

Summary
Brief summary
Background: Both ‘at-risk’ and clinical levels (abuse/dependence) of alcohol use are major causes of morbidity and mortality in Australia and are involved in many hospital presentations. However, few hospitals have instigated routine screening and brief interventions with referral to treatment (SBIRT), an approach that has been widely recommended. Objectives: To investigate the effectiveness of SBI with referral to general practicians (GP) in an Australian setting. Design: Eligible participants will be randomised to either 1) SBI with referral to their GP, or 2) SBI with no GP referral. Outcomes: Primary outcomes relate to measures of feasibility and implementation. The secondary outcomes related to changes in alcohol use and the tertiary outcomes will assess change is the use of hospital services. (Additional time and funds are required to evaluate tertiary outcomes via the WA Data Linkage System.) Participants: All people aged 18 or older entering the Fiona Stanley Hospital emergency short stay unit (ESSU) are eligible for screening (with the AUDIT-C). Those classified as ‘at-risk’ with receive a BI. Those classified as high-risk will receive a BI plus intervention by the hospital alcohol and other drug team. Those who consent will then be randomised. Sample size: Target sample per group 291. (Note we estimate that 146 will not have a GP and thus cannot be randomised). Follow-up: Telephone interviews will be conducted at 1 and 3 months to collect information on change in alcohol consumption and attendance at a GP for alcohol related treatment. At 6 months, data on FSH events (ED and admissions) will be extracted from the hospital databases including Bossnet, EDIS, Webpas. Analysis: The main analyses are descriptive. However, we will use multi-level mixed effect models to assess the interaction term of study group (GP referral vs no referral) by time (6 months pre vs 6 months post) for change in rate of presentations.
We also plan two sub-studies. Firstly, validation of self-reports of contact with GPs will be conducted in three groups. From the GP referral arm of the study we will randomly select from those who: 1) report no GP contact (estimate n=10), 2) report GP contact from the moderate risk participants (n=20) and, 3) report GP contact in the high risk group (n=10). At three months we will contact the nominated GP to confirm if the patient has been seen in the interim period and if any information or treatment was provided and obtain GP feedback on the referral process. This is included in the main HREC application but is not an outcome measure for the study.
Secondly, feasibility will be tested at Rockingham General Hospital emergency department, where alcohol screening and brief intervention will be introduced without additional research support. A clinical audit will be used to document the proportion of patients screened and receiving appropriate brief intervention. This clinical audit process does not require HREC approva
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76226 0
Dr Simon Hazeldine
Address 76226 0
Department of Gastroenterology
Fiona Stanley Hospital
102 - 118 Murdoch Drive, Murdoch WA 6150

Country 76226 0
Australia
Phone 76226 0
+618615 23802
Fax 76226 0
+61861521172
Email 76226 0
simon.hazeldine@health.wa.gov.au
Contact person for public queries
Name 76227 0
Dr Simon Hazeldine
Address 76227 0
Department of Gastroenterology
Fiona Stanley Hospital
102 - 118 Murdoch Drive, Murdoch WA 6150
Country 76227 0
Australia
Phone 76227 0
+618615 23802
Fax 76227 0
+61861521172
Email 76227 0
simon.hazeldine@health.wa.gov.au
Contact person for scientific queries
Name 76228 0
Dr Robert Tait
Address 76228 0
National Drug Research Institute,
7 Parker Place, Building 609 level 2, Technology Park, Bentley, WA 6102

GPO Box U1987, Perth WA 6845
Country 76228 0
Australia
Phone 76228 0
+61892661610
Fax 76228 0
+6192661611
Email 76228 0
robert.tait@curtin.edu.au

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