Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
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
Query!
Scientific title
Evaluation of Health Care Worker Behavior Change in response to a Trauma Care Checklist Programme intervention Before and After study
Query!
Secondary ID [1]
259724
0
Nil
Query!
Universal Trial Number (UTN)
U1111-1119-7239
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Resuscitation of severely injured patients by health care workers in the emergency room
261302
0
Query!
Condition category
Condition code
Public Health
265604
265604
0
0
Query!
Health promotion/education
Query!
Intervention/exposure
Study type
Interventional
Query!
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.
Query!
Intervention code [1]
264148
0
Behaviour
Query!
Comparator / control treatment
No control group
Query!
Control group
Uncontrolled
Query!
Outcomes
Primary outcome [1]
262258
0
Adherence to items on the checklist by health care workers as measured by observation and chart review.
Query!
Assessment method [1]
262258
0
Query!
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.
Query!
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.
Query!
Assessment method [2]
262259
0
Query!
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.
Query!
Secondary outcome [1]
273666
0
mortality of patients being treated by health care workers measured by chart review at time time of patient discharge.
Query!
Assessment method [1]
273666
0
Query!
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.
Query!
Eligibility
Key inclusion criteria
Health care workers treating severely injured patients during the first hour of their admission to the emergency room
Query!
Minimum age
No limit
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
Health care workers who do not wish to participate in the study
Query!
Study design
Purpose of the study
Educational / counselling / training
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is a pre/post quality improvement study.
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
There is no randomization of health care workers.
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Single group
Query!
Other design features
Query!
Phase
Not Applicable
Query!
Type of endpoint/s
Efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Recruiting
Query!
Date of first participant enrolment
Anticipated
12/10/2010
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
3200
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
3284
0
Viet Nam
Query!
State/province [1]
3284
0
Query!
Country [2]
3285
0
Canada
Query!
State/province [2]
3285
0
Query!
Country [3]
3286
0
Colombia
Query!
State/province [3]
3286
0
Query!
Country [4]
3287
0
Cameroon
Query!
State/province [4]
3287
0
Query!
Country [5]
3288
0
Rwanda
Query!
State/province [5]
3288
0
Query!
Country [6]
3289
0
India
Query!
State/province [6]
3289
0
Query!
Country [7]
3290
0
Thailand
Query!
State/province [7]
3290
0
Query!
Funding & Sponsors
Funding source category [1]
264611
0
Charities/Societies/Foundations
Query!
Name [1]
264611
0
Second Assist
Query!
Address [1]
264611
0
Second Assist
1700 Sawtelle Blvd PH13
Los Angeles, CA 90025
Query!
Country [1]
264611
0
United States of America
Query!
Funding source category [2]
265039
0
Charities/Societies/Foundations
Query!
Name [2]
265039
0
AO Foundation
Query!
Address [2]
265039
0
AO Foundation
Clavadelerstrasse 8
7270 Davos
Switzerland
Query!
Country [2]
265039
0
Switzerland
Query!
Primary sponsor type
Other
Query!
Name
World Health Organization
Query!
Address
Avenue Appia 20
1211 Geneva 27
Query!
Country
Switzerland
Query!
Secondary sponsor category [1]
263749
0
None
Query!
Name [1]
263749
0
Query!
Address [1]
263749
0
Query!
Country [1]
263749
0
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
260609
0
World Health Organization
Query!
Ethics committee address [1]
260609
0
WHO Ethics Review Committee
Avenue Apia 20
CH-1211 Geneva 27
Query!
Ethics committee country [1]
260609
0
Switzerland
Query!
Date submitted for ethics approval [1]
260609
0
Query!
Approval date [1]
260609
0
12/02/2010
Query!
Ethics approval number [1]
260609
0
RPC380
Query!
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.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
32305
0
Query!
Address
32305
0
Query!
Country
32305
0
Query!
Phone
32305
0
Query!
Fax
32305
0
Query!
Email
32305
0
Query!
Contact person for public queries
Name
15552
0
Angela Lashoher
Query!
Address
15552
0
World Health Organization
Avenue Appia 20
1211 Geneva 27
Query!
Country
15552
0
Switzerland
Query!
Phone
15552
0
+41 22 791 12 70
Query!
Fax
15552
0
Query!
Email
15552
0
[email protected]
Query!
Contact person for scientific queries
Name
6480
0
Angela Lashoher
Query!
Address
6480
0
World Health Organization
Avenue Appia 20
1211 Geneva 27
Query!
Country
6480
0
Switzerland
Query!
Phone
6480
0
+41 22 791 12 70
Query!
Fax
6480
0
Query!
Email
6480
0
[email protected]
Query!
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
No additional documents have been identified.
Download to PDF