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Trial registered on ANZCTR
Registration number
ACTRN12624000942550p
Ethics application status
Submitted, not yet approved
Date submitted
12/07/2024
Date registered
5/08/2024
Date last updated
5/08/2024
Date data sharing statement initially provided
5/08/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Addition of Pharmacists in Behaviours Of Concern response teams in the emergency department.
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Scientific title
Pharmacists in behaviours of concern (Pharma-BOC1): A randomised controlled trial of the addition of emergency medicine pharmacists in Behaviours Of Concern response teams and the effect on subsequent behavioural episodes
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Secondary ID [1]
312507
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nil known
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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:
mental health
334371
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emergency medicine
334372
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Condition category
Condition code
Emergency medicine
331012
331012
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0
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Other emergency care
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Public Health
331103
331103
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0
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Health service research
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Addition of the Emergency Medicine (EM) pharmacist to behaviour of concern (BOC) response teams in the emergency department. This will be a randomised controlled trial comparing having an Emergency Medicine pharmacist versus standard care looking at enrolling 25 patients in each arm over a 6 month period. All patients being received after a “Behaviour of Concern” (BOC) call, initially assessed in the BOC room will be elligible for inclusion in the study if presenting during EM pharmacist working hours (7am-9pm Monday to Friday). Specific responsibilities of the EM pharmacist in the team will be to facilitate medication decision making after consultation with the medical team leader on previous allergies, known past medical history and current medications; prescribe and draw up medications where required for administration by a nurse, and obtain an accurate and efficient medication history on patient arrival, where possible. A medication treatment plan will be prescribed using both regular and as required medications. The use of chemical restraint will be minimised according to local guidelines and in accordance with the Mental Health and Wellbeing Act 2022. The EM pharmacist will also expedite prescribing and administration of other medications including home medications, nicotine replacement therapy, opioid agonist treatment and alcohol related withdrawal. Prescribing of medications by the EM pharmacist will occur prior to medication administration, directly into electronic medical records, utilising the Partnered Pharmacist Medication charting model (PPMC) previously evaluated.
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Intervention code [1]
329025
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Treatment: Other
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Comparator / control treatment
The Behaviour of Concern (BOC) notification calls in the emergency department is where multidisciplinary teams respond to patients with, or who have the potential for aggressive behaviour. These BOC calls do not currently involve pharmacists.
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Control group
Active
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Outcomes
Primary outcome [1]
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The primary outcome will be defined as the proportion of patients that have a subsequent Code Grey and/or Code Black during ED length of stay after initial Behaviour of Concern call. (A composite outcome)
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Assessment method [1]
338792
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Nominal, binary data assessed via electronic medical records
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Timepoint [1]
338792
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Assessed from time of arrival in ED when first behaviour of concern call occurs until discharge from ED. (retrospective data collection at the conclusion of the study)
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Secondary outcome [1]
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(Composite outcome).Treatment with medications according to locally established guidelines will be defined as the proportion of patients who are compliant with all the following criteria:
-Selection of medication
-Dose of medication
-Route of medication
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Assessment method [1]
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Retrospective review of electronic medical records and comparing to local ED guidelines by a senior trial pharmacist.
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Timepoint [1]
437480
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retrospective review at the conclusion of the study.
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Secondary outcome [2]
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Time to prescribing of first doses of medications for treatment or chemical restraint
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Assessment method [2]
437481
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Using electronic medical records
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Timepoint [2]
437481
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From time of arrival until first medication ordered.
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Secondary outcome [3]
437482
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(composite outcome). Proportion of patients who are administered additional doses of medications for treatment or chemical restraint within 60 minutes
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Assessment method [3]
437482
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Using electronic medical records
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Timepoint [3]
437482
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From time of arrival in ED until 60 minutes post. (retrospective data collection after conclusion of the study)
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Secondary outcome [4]
437483
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Proportion of patients charted medications by the EM pharmacist in a BOC call
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Assessment method [4]
437483
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Using electronic medical records as nominal data
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Timepoint [4]
437483
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retrospective data collection at the conclusion of the study
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Secondary outcome [5]
437484
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Medications charted by EM pharmacist in a BOC call
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Assessment method [5]
437484
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Using electronic medical records
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Timepoint [5]
437484
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From arrival in ED until discharge from ED
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Secondary outcome [6]
437485
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Proportion of patients requiring mechanical restraint
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Assessment method [6]
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Using electronic medical records as nominal data.
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Timepoint [6]
437485
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From arrival in ED until discharge from ED. (retrospective data collection at the conclusion of the study)
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Secondary outcome [7]
437486
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Proportion of patients requiring care within a resuscitation cubicle
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Assessment method [7]
437486
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Using electronic medical records as nominal data
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Timepoint [7]
437486
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retrospective review at the conclusion of the study
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Secondary outcome [8]
437487
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ED length of stay
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Assessment method [8]
437487
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using electronic medical records
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Timepoint [8]
437487
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From arrival in ED until discharge
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Secondary outcome [9]
437488
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Initial Broset Score on arrival and subsequent Broset scores while in the ED as a violence prediction score.
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Assessment method [9]
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Electronic medical records to collect Broset score
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Timepoint [9]
437488
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From ED arrival until discharge from ED. Broset scores will be assessed every 30 minutes from ED arrival until discharge from ED.
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Secondary outcome [10]
437725
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Time to administration of first doses of medications for treatment or chemical restraint
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Assessment method [10]
437725
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Electronic medical records
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Timepoint [10]
437725
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Time from arrival until time first medication signed electronically on electronic medicartion chart
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Eligibility
Key inclusion criteria
All patients being received after a “Behaviour of Concern” (BOC) call, initially assessed in the BOC room during EM pharmacist working hours (7am-9pm Monday to Friday).
Caring for patients with behavioural concerns in the Emergency Department (ED) is a common occurrence. Violence and aggression, self-harm, absconding, and assault are often a consequence of patients in acute distress who react unfavourably to a restrictive, unfamiliar and often re-traumatising hospital environment. The causes of aggression are usually multifactorial and include characteristics and severity of mental illness, the rules and limitations of the environment, past experience, waiting times to see clinical staff, comorbidities such as underlying psychiatric illness or are facilitated by exposure to alcohol and other drugs such as methamphetamines. These behaviours pose threats to patients, visitors, and staff who must be protected from harm.
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Minimum age
18
Years
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Maximum age
65
Years
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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
BOC call for patients already in the ED, apart from in the Waiting Room
Patients less than 18 years and greater than 65 years
Patients not requiring medication for treatment or restrictive intervention
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Study design
Purpose of the study
Treatment
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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 will be performed by one of the study investigators via an online single sequence randomisation service with allocations concealed via opaque, sealed, numbered envelopes prior to commencement of the study.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Online computer generated, Single sequence
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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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
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/11/2024
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Actual
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Date of last participant enrolment
Anticipated
3/01/2025
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Actual
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Date of last data collection
Anticipated
3/02/2025
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Actual
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Sample size
Target
50
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
316931
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Hospital
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Name [1]
316931
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Alfred Health
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Address [1]
316931
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Country [1]
316931
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Australia
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Primary sponsor type
Hospital
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Name
Alfred Health
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Address
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Country
Australia
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Secondary sponsor category [1]
319172
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None
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Name [1]
319172
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Address [1]
319172
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Country [1]
319172
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
315681
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Alfred Hospital Ethics Committee
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Ethics committee address [1]
315681
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https://www.alfredhealth.org.au/research/ethics-research-governance
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Ethics committee country [1]
315681
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Australia
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Date submitted for ethics approval [1]
315681
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31/07/2024
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Approval date [1]
315681
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Ethics approval number [1]
315681
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Summary
Brief summary
Caring for patients with behavioural concerns in the Emergency Department (ED) is a common occurrence. The aim of this project is to test the feasibility of the addition of the Emergency pharmacist to a multidisciplinary BOC response team. This will be a pilot un-blinded randomised controlled trial comparing EM pharmacist attendance at BOC calls versus standard care. It is expected that the pharmacist will provide additional resources for adherence to the guidelines, reducing subsequent distress and agitation.
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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
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Dr Cristina Roman
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Address
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The Alfred Hospital, 55 Commercial RD, Melbourne, Vic, 3004
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Country
135490
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Australia
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Phone
135490
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+61 3 9076 3405
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Fax
135490
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Email
135490
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[email protected]
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Contact person for public queries
Name
135491
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Cristina Roman
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Address
135491
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The Alfred Hospital, 55 Commercial RD, Melbourne, Vic, 3004
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Country
135491
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Australia
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Phone
135491
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+61 3 9076 3405
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Fax
135491
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Email
135491
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[email protected]
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Contact person for scientific queries
Name
135492
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Cristina Roman
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Address
135492
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The Alfred Hospital, 55 Commercial RD, Melbourne, Vic, 3004
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Country
135492
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Australia
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Phone
135492
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+61 3 9076 3405
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Fax
135492
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Email
135492
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
23989
Study protocol
388108-(Uploaded-20-07-2024-22-20-26)-Pharma-BOC proposal V2.docx
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF