Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000371897
Ethics application status
Approved
Date submitted
21/01/2021
Date registered
31/03/2021
Date last updated
2/03/2022
Date data sharing statement initially provided
31/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The Primary Trauma Care Course Impact on Healthcare worker expertise and Patient Outcome in Vietnam
Scientific title
The Primary Trauma Care Training Course Impact on Healthcare worker expertise and Patient Outcome in Vietnam
Secondary ID [1] 302835 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Road Trauma 319806 0
Condition category
Condition code
Injuries and Accidents 317737 317737 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Our intervention is a trauma training course. The course is a combination of a serial lecture and skill station (scenario). Three trauma experts from Hanoi Medical University will run the course. They are also Primary Trauma Care-PTC instructors with more than 10 years of experience. There are 2 parts in PTC course
Part 1 (theory part):There are 11 trauma lectures which last from 30 to 1 hour. These lectures including: airway management, breathing, circulation, chest injuries, abdominal and limb injuries, head and spinal injuries, trauma in children and pregnancy, burn, secondary survey, disaster management will cover wide range of life-threatening cases.
Part 2 (practice part) with seven trauma skill stations which are basic/advance airway, cervical spine and log-roll, chest drains, analgesia, transportation, paediatric trauma, neurological assessment. Each station will last no more than 20 minutes.
All materials such as: lectures, power point slides or scenarios can be downloaded freely at: https://www.primarytraumacare.org/get-involved/download-resources/
In order to avoid to impair hospital activities and keep the number of class in small size. We will divide participant in each hospital into 3 classes, each class will be run in 2 days (follow PTC standard program). One last day will be spent for post-course evaluation. Consequently, it will take one week in each hospital. All healthcare worker in emergency department in 2 provincial hospitals will be invited and the course will be run in the lecture hall of each hospital.
To evaluate the course, we use a Multiple Choice Question (MCQ) test and clinical checklist. The former is used for knowledge assessment and the latter for skill evaluation. The pre-test will be introduced before the first lesson while the post-test will be done immediately after the course finished. All assessment tool will be also available at https://www.primarytraumacare.org/get-involved/download-resources/
We also use the interview questionnaire to interview some key people in each hospital for qualitative assessment of how the trauma system change by our course.
Finally, We also measure the mortality and morbidity of the patient before and after the intervention (within 6 months each) for secondary outcome.
Intervention code [1] 319114 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326083 0
Health workers' knowledge by comparing the result of MCQ test post vs pre-course. The MCQ test is 20 questions which are designed by international PTC instructors and available at Primary Trauma Care Foundation website.

Timepoint [1] 326083 0
baseline (pre-intervention) and immediately post-intervention.
Primary outcome [2] 326084 0
Health workers' skill by comparing the result of prepared checklist pre vs post-course. The clinical checklist are designed and updated annually by international PTC instructors and available at Primary Trauma Care Foundation website.
Timepoint [2] 326084 0
baseline (pre-intervention) and immediately post-intervention.
Primary outcome [3] 326962 0
Health workers' level of confident by comparing the result of confident matrix pre vs post-course. The confident matrix are designed by international PTC instructors and also available at Primary Trauma Care Foundation website.
Timepoint [3] 326962 0
pre-course and immediately post-course
Secondary outcome [1] 390081 0
Patient morbidity will be assessed by using hospital medical records (at 24 hours) and phone call (at 1 months)
Timepoint [1] 390081 0
24 hours and 1 months post trauma
Secondary outcome [2] 392158 0
Patient mortality will be assessed by using hospital medical records (at 24 hours) and phone call (at 1 months)
Timepoint [2] 392158 0
24 hours and 1 month post trauma
Secondary outcome [3] 393314 0
Trauma system change by comparing the result of key members' interview questionnaire. The interview questionnaire had been designed and reviewed by instructor team of Primary Trauma Care Foundation.
Timepoint [3] 393314 0
pre-course vs 1 month, 6 months and 1 year post-course

Eligibility
Key inclusion criteria
All Emergency Department staff in Ninhbinh and Thanhhoa hospital
All alive consenting road trauma patients presenting to participating hospitals emergency departments (including patients under 18 year-old)
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Patients who are:
-Dead on arrival
-Patient with minor injuries without any primary care
-Patient or family members refuse consent.
Staff refuse to joint the project

Study design
Purpose of the study
Educational / counselling / training
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
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2021
Actual
10/07/2021
Date of last participant enrolment
Anticipated
31/08/2022
Actual
Date of last data collection
Anticipated
30/09/2022
Actual
Sample size
Target
98
Accrual to date
92
Final
Recruitment outside Australia
Country [1] 23347 0
Viet Nam
State/province [1] 23347 0
Ha noi
Country [2] 23348 0
Viet Nam
State/province [2] 23348 0
Thanh Hoa
Country [3] 23349 0
Viet Nam
State/province [3] 23349 0
Ninh Binh

Funding & Sponsors
Funding source category [1] 307258 0
University
Name [1] 307258 0
University of Tasmania
Country [1] 307258 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Elphinstone Group
Address
83 Terra Nova Drive
Wynyard Tasmania Australia 7325
PO Box 717, Wynyard TAS 7325
Country
Australia
Secondary sponsor category [1] 308673 0
None
Name [1] 308673 0
Address [1] 308673 0
Country [1] 308673 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307352 0
Tasmania Health and Medical Human Research Ethics Committee (HMHREC)
Ethics committee address [1] 307352 0
301 Sandy Bay Road, Sandy Bay TAS 7005
Ethics committee country [1] 307352 0
Australia
Date submitted for ethics approval [1] 307352 0
05/02/2021
Approval date [1] 307352 0
17/06/2021
Ethics approval number [1] 307352 0
23982

Summary
Brief summary
In pre-intervention phase which lasts 6 months, we will investigate the fact and feature of all trauma care system in 2 local hospitals (Ninhbinh and Thanhhoa provincial hospital) which are including level of healthcare worker expertise, patient morbidity and mortality. After that in each hospital we will run a one week PTC training course in intervention phase. Finally, in post-intervention phase, we re- investigate all mentioned features and compare it with corresponding information in pre-intervention phase to answer the question : Can PTC improve participant's expertise and patient's outcome?
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 106938 0
Prof Mark Nelson
Address 106938 0
Menzies Institute for Medical Research | University of Tasmania Chair of General Practice
School of Medicine | University of Tasmania 17 Liverpool St Hobart TAS 7000
AUSTRALIA
Country 106938 0
Australia
Phone 106938 0
+61 3 6226 4734
Fax 106938 0
Email 106938 0
[email protected]
Contact person for public queries
Name 106939 0
Prof Mark Nelson
Address 106939 0
Menzies Institute for Medical Research | University of Tasmania Chair of General Practice
School of Medicine | University of Tasmania 17 Liverpool St Hobart TAS 7000
AUSTRALIA
Country 106939 0
Australia
Phone 106939 0
+61 3 6226 4734
Fax 106939 0
Email 106939 0
[email protected]
Contact person for scientific queries
Name 106940 0
Dr Nguyen Ba Tuan
Address 106940 0
Hanoi Medical University
Number 1, Ton That Tung street, Dong Da District, Ha Noi, Viet Nam
Country 106940 0
Viet Nam
Phone 106940 0
+84 936568824
Fax 106940 0
Email 106940 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
10122Study protocol    380970-(Uploaded-21-01-2021-15-17-57)-Study-related document.docx
10123Informed consent form    380970-(Uploaded-25-12-2020-19-30-39)-Study-related document.docx
10124Informed consent form    380970-(Uploaded-25-12-2020-19-31-05)-Study-related document.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.