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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
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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
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Secondary ID [1]
292420
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
at-risk alcohol use
304013
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Addiction
304014
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Condition category
Condition code
Public Health
303343
303343
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0
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Other public health
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Public Health
303344
303344
0
0
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Health service research
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Mental Health
303711
303711
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0
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Addiction
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
298592
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Early detection / Screening
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Intervention code [2]
298593
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Behaviour
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Feasibility - proportion of eligible participants screened
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Assessment method [1]
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Timepoint [1]
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Commencement date to end of recruitment
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Primary outcome [2]
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Feasibility - proportion of eligible participants receiving indicated intervention
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Assessment method [2]
303080
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Timepoint [2]
303080
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Commencement date to end of recruitment
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Secondary outcome [1]
336848
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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.
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Assessment method [1]
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Timepoint [1]
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Six months pre and post enrolment in the study
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Secondary outcome [2]
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Change in alcohol use disorders identification test (consumption) (AUDIT C)
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Assessment method [2]
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Timepoint [2]
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Baseline, 1 and 3 months
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Secondary outcome [3]
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Change in weekly alcohol consumption assessed with a seven day drinking diary
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Assessment method [3]
336850
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Timepoint [3]
336850
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Baseline, 1 and 3 months
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Secondary outcome [4]
336851
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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
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Assessment method [4]
336851
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Timepoint [4]
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12 months pre and post enrolment
NB Additional funding and further HREC approvals will be sought for this outcome
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Secondary outcome [5]
336852
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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
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Assessment method [5]
336852
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Timepoint [5]
336852
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12 months pre and post enrolment
NB Additional funding and further HREC approvals will be sought for this outcome
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Secondary outcome [6]
336853
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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
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Assessment method [6]
336853
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Timepoint [6]
336853
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5 years pre and post enrolment
NB Additional funding and further HREC approvals will be sought for this outcome
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Secondary outcome [7]
336854
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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
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Assessment method [7]
336854
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Timepoint [7]
336854
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5 years pre and post enrolment
NB Additional funding will and further HREC approvals be sought for this outcome
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Secondary outcome [8]
337356
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Difference in the proportion of intervention and control group self-reporting contact with general practitioner where alcohol use was discussed
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Assessment method [8]
337356
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Timepoint [8]
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Baseline 1 and 3 months
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Secondary outcome [9]
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(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.
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Assessment method [9]
337845
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Timepoint [9]
337845
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Baseline to 3 months
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Secondary outcome [10]
337846
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(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)
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Assessment method [10]
337846
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Timepoint [10]
337846
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Baseline to 1 month
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Secondary outcome [11]
337847
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(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)
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Assessment method [11]
337847
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Timepoint [11]
337847
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Baseline to 1 month
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Secondary outcome [12]
337854
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(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?)
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Assessment method [12]
337854
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Timepoint [12]
337854
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Baseline to 3 months
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Secondary outcome [13]
337855
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(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
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Assessment method [13]
337855
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Timepoint [13]
337855
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Baseline 1 and 3 months
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Secondary outcome [14]
337856
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(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
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Assessment method [14]
337856
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Timepoint [14]
337856
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Baseline 1 and 3 months
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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).
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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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.
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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).
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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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.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
4/09/2017
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Actual
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Date of last participant enrolment
Anticipated
5/02/2018
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Actual
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Date of last data collection
Anticipated
5/02/2023
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Actual
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Sample size
Target
582
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
8526
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Fiona Stanley Hospital - Murdoch
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Recruitment postcode(s) [1]
16620
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6150 - Murdoch
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Funding & Sponsors
Funding source category [1]
296974
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Charities/Societies/Foundations
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Name [1]
296974
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WA Primary Health Alliance
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Address [1]
296974
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2-5, 7 Tanunda Drive, Rivervale WA 6103
P.O Box 591, Belmont WA 6984
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Country [1]
296974
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Australia
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Primary sponsor type
Hospital
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Name
Fiona Stanley Hospital
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Address
Administration Building, Fiona Stanley Hospital
14 Barry Marshall Parade, MURDOCH WA 6150
Locked Bag 100, PALMYRA DC WA 6961
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Country
Australia
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Secondary sponsor category [1]
295978
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None
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Name [1]
295978
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Address [1]
295978
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Country [1]
295978
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Other collaborator category [1]
279638
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University
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Name [1]
279638
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Nationa Drug Research Institute, Curtin University
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Address [1]
279638
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Kent Street, Bentley, Perth
Western Australia, 6102
GPO Box U1987, Perth
Western Australia, 6845
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Country [1]
279638
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Australia
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
298177
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South Metropolitan Health Service
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Ethics committee address [1]
298177
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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
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Ethics committee country [1]
298177
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Australia
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Date submitted for ethics approval [1]
298177
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28/07/2016
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Approval date [1]
298177
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Ethics approval number [1]
298177
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Ethics committee name [2]
298389
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Curtin University
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Ethics committee address [2]
298389
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Kent Street, Bentley, Perth
Western Australia, 6102
GPO Box U1987, Perth
Western Australia, 6845
(NB This will be reciprocal approval application)
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Ethics committee country [2]
298389
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Australia
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Date submitted for ethics approval [2]
298389
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24/08/2017
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Approval date [2]
298389
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Ethics approval number [2]
298389
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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
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
76226
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Dr Simon Hazeldine
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Address
76226
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Department of Gastroenterology
Fiona Stanley Hospital
102 - 118 Murdoch Drive, Murdoch WA 6150
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Country
76226
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Australia
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Phone
76226
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+618615 23802
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Fax
76226
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+61861521172
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Email
76226
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[email protected]
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Contact person for public queries
Name
76227
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Dr Simon Hazeldine
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Address
76227
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Department of Gastroenterology
Fiona Stanley Hospital
102 - 118 Murdoch Drive, Murdoch WA 6150
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Country
76227
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Australia
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Phone
76227
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+618615 23802
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Fax
76227
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+61861521172
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Email
76227
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[email protected]
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Contact person for scientific queries
Name
76228
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Dr Robert Tait
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Address
76228
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National Drug Research Institute,
7 Parker Place, Building 609 level 2, Technology Park, Bentley, WA 6102
GPO Box U1987, Perth WA 6845
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Country
76228
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Australia
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Phone
76228
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+61892661610
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Fax
76228
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+6192661611
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Email
76228
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[email protected]
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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
Source
Title
Year of Publication
DOI
Embase
Critical Role of General Practitioners in Preventing Readmission Following Emergency Department Alcohol Screening and Brief Intervention Management of Alcohol-Related Problems.
2021
https://dx.doi.org/10.1177/21501327211027437
N.B. These documents automatically identified may not have been verified by the study sponsor.
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