Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000493943
Ethics application status
Approved
Date submitted
16/03/2011
Date registered
11/05/2011
Date last updated
11/05/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
An Evaluation of the World Health Organization Trauma Care Checklist
Scientific title
Evaluation of Health Care Worker Behavior Change in response to a Trauma Care Checklist Programme intervention Before and After study
Secondary ID [1] 259724 0
Nil
Universal Trial Number (UTN)
U1111-1119-7239
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Resuscitation of severely injured patients by health care workers in the emergency room 261302 0
Condition category
Condition code
Public Health 265604 265604 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Trauma Care Checklist to be used by the health care worker during the first one hour of resuscitation for severely injured patients who present to the emergency room. The purpose of the checklist is to help remind healthcare workers of certain key items in the initial resuscitation that should be completed for all severely injured patients. Health care workers will be assessed for a period of time before checklist implementation and after checklist implementation based on a stepped wedge intervention design.
Intervention code [1] 264148 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 262258 0
Adherence to items on the checklist by health care workers as measured by observation and chart review.
Timepoint [1] 262258 0
During the resuscitation of severely injured patients health care workers will be observed both before and after checklist implementation. The before period for each site will be between 4 and 6 months and the after period will be between 6 and 8 months.
Primary outcome [2] 262259 0
morbidity of patients being treated by health care workers will be measured by chart review at the time of patient discharge.
Timepoint [2] 262259 0
morbidity of patients being treated by health care workers will be measured by chart review at the time of patient discharge both before and after checklist implementation. The before period for each site will be between 4 and 6 months and the after period will be between 6 and 8 months.
Secondary outcome [1] 273666 0
mortality of patients being treated by health care workers measured by chart review at time time of patient discharge.
Timepoint [1] 273666 0
mortality of patients being treated by health care workers measured by chart review at time time of patient discharge both before and after checklist implementation. The before period for each site will be between 4 and 6 months and the after period will be between 6 and 8 months.

Eligibility
Key inclusion criteria
Health care workers treating severely injured patients during the first hour of their admission to the emergency room
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Health care workers who do not wish to participate in the study

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)
This is a pre/post quality improvement study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
There is no randomization of health care workers.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 3284 0
Viet Nam
State/province [1] 3284 0
Country [2] 3285 0
Canada
State/province [2] 3285 0
Country [3] 3286 0
Colombia
State/province [3] 3286 0
Country [4] 3287 0
Cameroon
State/province [4] 3287 0
Country [5] 3288 0
Rwanda
State/province [5] 3288 0
Country [6] 3289 0
India
State/province [6] 3289 0
Country [7] 3290 0
Thailand
State/province [7] 3290 0

Funding & Sponsors
Funding source category [1] 264611 0
Charities/Societies/Foundations
Name [1] 264611 0
Second Assist
Country [1] 264611 0
United States of America
Funding source category [2] 265039 0
Charities/Societies/Foundations
Name [2] 265039 0
AO Foundation
Country [2] 265039 0
Switzerland
Primary sponsor type
Other
Name
World Health Organization
Address
Avenue Appia 20
1211 Geneva 27
Country
Switzerland
Secondary sponsor category [1] 263749 0
None
Name [1] 263749 0
Address [1] 263749 0
Country [1] 263749 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260609 0
World Health Organization
Ethics committee address [1] 260609 0
WHO Ethics Review Committee
Avenue Apia 20
CH-1211 Geneva 27
Ethics committee country [1] 260609 0
Switzerland
Date submitted for ethics approval [1] 260609 0
Approval date [1] 260609 0
12/02/2010
Ethics approval number [1] 260609 0
RPC380

Summary
Brief summary
The purpose of this study is to evaluate if using a checklist immediately after the resuscitation of severely injured patients in order to ensure that certain elements have not been forgotten improves care for those patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32305 0
Address 32305 0
Country 32305 0
Phone 32305 0
Fax 32305 0
Email 32305 0
Contact person for public queries
Name 15552 0
Angela Lashoher
Address 15552 0
World Health Organization
Avenue Appia 20
1211 Geneva 27
Country 15552 0
Switzerland
Phone 15552 0
+41 22 791 12 70
Fax 15552 0
Email 15552 0
lashohera@who.int
Contact person for scientific queries
Name 6480 0
Angela Lashoher
Address 6480 0
World Health Organization
Avenue Appia 20
1211 Geneva 27
Country 6480 0
Switzerland
Phone 6480 0
+41 22 791 12 70
Fax 6480 0
Email 6480 0
lashohera@who.int

No information has been provided regarding IPD availability


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
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