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Trial registered on ANZCTR


Registration number
ACTRN12625000092493
Ethics application status
Approved
Date submitted
20/11/2024
Date registered
28/01/2025
Date last updated
28/01/2025
Date data sharing statement initially provided
28/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of emergency medicine pharmacists on medication safety for critically ill patients in the resuscitation area of an emergency department
Scientific title
The impact of emergency medicine pharmacists on medication safety for critically ill patients in the resuscitation area of an emergency department
Secondary ID [1] 313391 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medication error 335759 0
Resuscitation 336460 0
Condition category
Condition code
Emergency medicine 332315 332315 0 0
Resuscitation
Public Health 332512 332512 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients triaged to the resuscitation area of the emergency department (ED) will either have a pharmacist present during the resuscitation event or not. Patients triaged to a resuscitation bay in the Princess Alexandra Hospital (PAH) ED during the resuscitation pharmacist’s allocated working hours will fall into the intervention group. The intervention pharmacist was a senior pharmacist who attended the resuscitation area with the ED resuscitation team in response to an eligible patient presentation to assist with medication related activities during the critical care event.
The pharmacist will use local, national and international therapeutic and other medication guidelines to assist the other members of the resuscitation team with medication management activities
Pharmacist roles and activities could include: medication information provision and advice, administration advice such as dilution and rate of administration, preemptive and timely supply of medication, double-check of medications before administration, documentation of allergies, therapeutic recommendations (e.g. medication choice, dose and administration), documentation of medication history and medication review to identify medication related problems and ensure medications are optimised.
The pharmacist will be at the patients bedside for the duration of the acute resuscitation event or until there presence is required for another patient or their assistance is no longer required for medication related activities for the patient
A retrospective review of the medical record will identify and medication errors and record interventions documented by the pharmacist
Intervention code [1] 329994 0
Treatment: Other
Intervention code [2] 330409 0
Prevention
Comparator / control treatment
Patients triaged to a resuscitation bay outside the pharmacists allocated working hours, will fall into the control group.
Control group
Active

Outcomes
Primary outcome [1] 339937 0
Medication error - composite of all error categories
Timepoint [1] 339937 0
Baseline only. During the patient's resuscitation event management occurring within the emergency department
Secondary outcome [1] 441985 0
Time to medication administration
Timepoint [1] 441985 0
Baseline only. During the patient's resuscitation event management occurring within the emergency department
Secondary outcome [2] 441986 0
Adherence to guidelines
Timepoint [2] 441986 0
Baseline only. During the patient's resuscitation event management occurring within the emergency department
Secondary outcome [3] 441989 0
Accurate documentation on the electronic Medication Administration Record
Timepoint [3] 441989 0
Baseline only. During the patient's resuscitation event management occurring within the emergency department

Eligibility
Key inclusion criteria
Patients presenting to the emergency department and allocated to the resuscitation area who are:
- assigned an Australasian Triage Scale (ATS) category 1 or category 2 for a medical condition
- toxicological related condition or overdose
- patients with suspected sepsis
- requiring an immediate response following an internal ED alarm
- referred to the pharmacist by the ED resuscitation team
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients under 18

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Data will be entered into an ExcelTM spreadsheet. Medication errors will be classified into relevant descriptive categories (likely drug class), and the hospital risk categories of major, minor, and no risk. Categories will be determined by the research team and a sample will be confirmed by a blinded expert panel.

Chi-squared test will be used to confirm statistical significance between medication errors in the control and intervention groups overall, and within the descriptive categories and risk categories. The primary and secondary outcomes will be reported using descriptive statistics including mean time to events, mean event counts in each cohort and outputs from statistical significance tests between the intervention and usual care cohorts.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/03/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/01/2026
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 27347 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 43438 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 317830 0
Charities/Societies/Foundations
Name [1] 317830 0
Princess Alexandra Hospital Research Foundation
Country [1] 317830 0
Australia
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
Country
Australia
Secondary sponsor category [1] 320163 0
None
Name [1] 320163 0
Address [1] 320163 0
Country [1] 320163 0
Other collaborator category [1] 283301 0
University
Name [1] 283301 0
University of Queensland
Address [1] 283301 0
Country [1] 283301 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316517 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 316517 0
Ethics committee country [1] 316517 0
Australia
Date submitted for ethics approval [1] 316517 0
28/05/2019
Approval date [1] 316517 0
04/10/2019
Ethics approval number [1] 316517 0
HREC/2019/QMS/54845 (Oct ver 2)

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138134 0
Ms Elizabeth Currey
Address 138134 0
Princess Alexandra Hospital, 199 Ipswich Rd, Woolloongabba, QLD, 4102
Country 138134 0
Australia
Phone 138134 0
+61 0434871811
Fax 138134 0
Email 138134 0
elizabeth.currey@health.qld.gov.au
Contact person for public queries
Name 138135 0
Elizabeth Currey
Address 138135 0
Princess Alexandra Hospital, 199 Ipswich Rd, Woolloongabba, QLD, 4102
Country 138135 0
Australia
Phone 138135 0
+61 07 3176 7444
Fax 138135 0
Email 138135 0
elizabeth.currey@health.qld.gov.au
Contact person for scientific queries
Name 138136 0
Elizabeth Currey
Address 138136 0
Princess Alexandra Hospital, 199 Ipswich Rd, Woolloongabba, QLD, 4102
Country 138136 0
Australia
Phone 138136 0
+61 0434871811
Fax 138136 0
Email 138136 0
elizabeth.currey@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data will be published/may be provided with ethics approval only by request.
Patient data: sex, age, presenting complaint, co-morbidities, time to medication administration, medication adherence to guidelines, medication harm events and length of stay.
Clinician data: profession
When will data be available (start and end dates)?
Data will be available to the investigator team upon completion of data collection (estimated December 2025). Data will be publicly available immediately following publication, with no end date determined.
Available to whom?
Individual participant data (IPD) for this trial will not be publicly available. De-identified data will be published. Further de-identified data, underlying published results only, may be provided with ethics approval only by request.
Available for what types of analyses?
Data will be available on request for only data underlying published results to achieve the aims in the approved proposal.
How or where can data be obtained?
Access is subject to approvals by Principal Investigator and the Metro South Human Research Committee via contacting the Principal Investigator Elizabeth Currey, Princess Alexandra Hospital Pharmacy Department, Ph. 3176 2478, Email: elizabeth.currey@health.qld.gov.au


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
No additional documents have been identified.