Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000338864
Ethics application status
Approved
Date submitted
6/01/2021
Date registered
25/03/2021
Date last updated
25/03/2021
Date data sharing statement initially provided
25/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Time to analgesia with early involvement of the Emergency Medicine pharmacist in trauma callouts: a randomised trial (Study Protocol)
Scientific title
Time to analgesia with early involvement of the Emergency Medicine pharmacist in trauma callouts: a randomised trial (Study Protocol)
Secondary ID [1] 300166 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Trauma 321215 0
Condition category
Condition code
Emergency medicine 313999 313999 0 0
Resuscitation
Public Health 318590 318590 0 0
Health service research
Emergency medicine 318591 318591 0 0
Other emergency care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Early Emergency Medicine Pharmacist involvement in trauma callouts. In the intervention arm the EM pharmacist will attend a trauma call pre-arrival or on arrival of the patient at bedside in the emergency department. The will be involved in the initial assessment of the patient and assist with appropriate medication ordering and administration, with a focus on early analgesic administration within 30 minutes of patient arrival in the emergency department.
This intervention is estimated to take between 20-30 minutes.
To monitor adherence the scribe in the trauma callout will have a standardised form to complete for both standard care and intervention arms which will be provided to the principle investigator. The research team will be monitoring progress through the regular auditing of medical records for patients recruited.
Intervention code [1] 316444 0
Treatment: Other
Comparator / control treatment
Emergency Medicine Pharmacist involvement in trauma callouts as deemed required by clinicians involved in the patients care (nurse, doctor or pharmacist referral). Standard care does NOT include pharmacist involvement on arrival or pre-arrival trauma callouts. The pharmacist will review patients if required usually after the first hour of arrival into the ED. The comparator treatment arm has a shorter duration as the pharmacist would not routinely be involved in the initial analgesic ordering and drawing up of medication for administration.
The same strategies will be used to monitor adherence to the control arm as to the intervention arm.
Control group
Active

Outcomes
Primary outcome [1] 326110 0
Time to first dose analgesia determined as time first dose of analgesia is signed for on the medication record.
Timepoint [1] 326110 0
Time from ED registration to first dose of analgesia
Secondary outcome [1] 390171 0
Time to verbal request of analgesia as documented by data collector
Timepoint [1] 390171 0
Time from patient ED registration to verbal request of first analgesia in the ED by an emergency clinician (physician or registrar) assessed at one timepoint only in the ED.
Secondary outcome [2] 391903 0
Time to sedation and analgesia for intubated patients as signed for on the medication records
Timepoint [2] 391903 0
Time from patient ED registration to first sign off of analgesia and sedation most intubation in the ED assessed at one timepoint only in the ED
Secondary outcome [3] 391904 0
Pain scores on arrival, at 30 mins and 60 mins post arrival in ED as documented in the electronic medical records
Timepoint [3] 391904 0
Time from ED registration to first pain score documentation, documentation at 30 mins and 60 mins post arrival in the ED
Secondary outcome [4] 391905 0
Compliance with local and or national antimicrobial/tetanus vaccine prophylaxis determined retrospectively from the electronic medical records.
Timepoint [4] 391905 0
Assessed for duration of management in the ED
Secondary outcome [5] 391908 0
Drugs and doses used for; sedation, analgesia and RSI, raised ICP in TBI, seizure prophylaxis, reversal of anticoagulation and haemostasis assessed from retrospective review of electronic medical records
Timepoint [5] 391908 0
Assessed for the duration of time medications ordered and administered in the ED.
Secondary outcome [6] 391909 0
Activation of massive transfusion protocol assessed from retrospective review of electronic medical records
Timepoint [6] 391909 0
assessed for the duration of time patient is present in the ED

Eligibility
Key inclusion criteria
All patients presenting to The Alfred Emergency and Trauma Centre meeting trauma callout criteria.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients presenting outside of pharmacist working hours (Monday-Friday 7am-9pm).

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomisation using computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A local retrospective audit of 28 major trauma patients in 2014 revealed 67% of patients had first doses of analgesia within 30 minutes of arrival.
We will test for a change in proportion of patients getting analgesia within 30 minutes from 67% to 95% using alpha of 0.05 and 80% power. This will require a sample size of 37 patients in each arm. To account for potential loss to follow up and early deaths we will aim to recruit 40 patients in each arm. Once the target sample size is reached data collection will cease.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/04/2021
Actual
Date of last participant enrolment
Anticipated
2/04/2022
Actual
Date of last data collection
Anticipated
9/04/2022
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18274 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 32343 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 304606 0
Hospital
Name [1] 304606 0
Alfred Health- Melbourne
Country [1] 304606 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health- Melbourne
Address
Commercial Rd, Melbourne, Vic, 3001
Country
Australia
Secondary sponsor category [1] 304898 0
University
Name [1] 304898 0
Monash University
Address [1] 304898 0
381 Royal Parade, Parkville, Vic, 3052
Country [1] 304898 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305027 0
Alfred Hospital Research and Ethics Committee
Ethics committee address [1] 305027 0
Ethics committee country [1] 305027 0
Australia
Date submitted for ethics approval [1] 305027 0
08/01/2020
Approval date [1] 305027 0
31/01/2020
Ethics approval number [1] 305027 0
AH 7/20

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

Contacts
Principal investigator
Name 99018 0
Ms Cristina Roman
Address 99018 0
Alfred Hospital
Commercial Rd, Melbourne, Victoria, 3001
Country 99018 0
Australia
Phone 99018 0
+61 39076 2061
Fax 99018 0
Email 99018 0
[email protected]
Contact person for public queries
Name 99019 0
Cristina Roman
Address 99019 0
Alfred Hospital
Commercial Rd, Melbourne, Victoria, 3001
Country 99019 0
Australia
Phone 99019 0
+61 39076 2061
Fax 99019 0
Email 99019 0
[email protected]
Contact person for scientific queries
Name 99020 0
Cristina Roman
Address 99020 0
Alfred Hospital
Commercial Rd, Melbourne, Victoria, 3001
Country 99020 0
Australia
Phone 99020 0
+61 39076 2061
Fax 99020 0
Email 99020 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
All participant data will be made re-identifiable. Data will only be available to investigators conducting data collection and analysis.


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.