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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.
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
Secondary ID [1] 312507 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
mental health 334371 0
emergency medicine 334372 0
Condition category
Condition code
Emergency medicine 331012 331012 0 0
Other emergency care
Public Health 331103 331103 0 0
Health service research

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 329025 0
Treatment: Other
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.
Control group
Active

Outcomes
Primary outcome [1] 338792 0
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)
Timepoint [1] 338792 0
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)
Secondary outcome [1] 437480 0
(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
Timepoint [1] 437480 0
retrospective review at the conclusion of the study.
Secondary outcome [2] 437481 0
Time to prescribing of first doses of medications for treatment or chemical restraint
Timepoint [2] 437481 0
From time of arrival until first medication ordered.
Secondary outcome [3] 437482 0
(composite outcome). Proportion of patients who are administered additional doses of medications for treatment or chemical restraint within 60 minutes
Timepoint [3] 437482 0
From time of arrival in ED until 60 minutes post. (retrospective data collection after conclusion of the study)
Secondary outcome [4] 437483 0
Proportion of patients charted medications by the EM pharmacist in a BOC call
Timepoint [4] 437483 0
retrospective data collection at the conclusion of the study
Secondary outcome [5] 437484 0
Medications charted by EM pharmacist in a BOC call
Timepoint [5] 437484 0
From arrival in ED until discharge from ED
Secondary outcome [6] 437485 0
Proportion of patients requiring mechanical restraint
Timepoint [6] 437485 0
From arrival in ED until discharge from ED. (retrospective data collection at the conclusion of the study)
Secondary outcome [7] 437486 0
Proportion of patients requiring care within a resuscitation cubicle
Timepoint [7] 437486 0
retrospective review at the conclusion of the study
Secondary outcome [8] 437487 0
ED length of stay
Timepoint [8] 437487 0
From arrival in ED until discharge
Secondary outcome [9] 437488 0
Initial Broset Score on arrival and subsequent Broset scores while in the ED as a violence prediction score.
Timepoint [9] 437488 0
From ED arrival until discharge from ED. Broset scores will be assessed every 30 minutes from ED arrival until discharge from ED.
Secondary outcome [10] 437725 0
Time to administration of first doses of medications for treatment or chemical restraint
Timepoint [10] 437725 0
Time from arrival until time first medication signed electronically on electronic medicartion chart

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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Online computer generated, Single sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2024
Actual
Date of last participant enrolment
Anticipated
3/01/2025
Actual
Date of last data collection
Anticipated
3/02/2025
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316931 0
Hospital
Name [1] 316931 0
Alfred Health
Country [1] 316931 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
Country
Australia
Secondary sponsor category [1] 319172 0
None
Name [1] 319172 0
Address [1] 319172 0
Country [1] 319172 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315681 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 315681 0
https://www.alfredhealth.org.au/research/ethics-research-governance
Ethics committee country [1] 315681 0
Australia
Date submitted for ethics approval [1] 315681 0
31/07/2024
Approval date [1] 315681 0
Ethics approval number [1] 315681 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135490 0
Dr Cristina Roman
Address 135490 0
The Alfred Hospital, 55 Commercial RD, Melbourne, Vic, 3004
Country 135490 0
Australia
Phone 135490 0
+61 3 9076 3405
Fax 135490 0
Email 135490 0
[email protected]
Contact person for public queries
Name 135491 0
Cristina Roman
Address 135491 0
The Alfred Hospital, 55 Commercial RD, Melbourne, Vic, 3004
Country 135491 0
Australia
Phone 135491 0
+61 3 9076 3405
Fax 135491 0
Email 135491 0
[email protected]
Contact person for scientific queries
Name 135492 0
Cristina Roman
Address 135492 0
The Alfred Hospital, 55 Commercial RD, Melbourne, Vic, 3004
Country 135492 0
Australia
Phone 135492 0
+61 3 9076 3405
Fax 135492 0
Email 135492 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23989Study protocol    388108-(Uploaded-20-07-2024-22-20-26)-Pharma-BOC proposal V2.docx



Results publications and other study-related documents

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