Protocol summary

Study aim
The study aims to: Phase one: 1. To assess the emergency nurse’s knowledge and skill on trauma triage in public hospitals of the West Bank of Palestine. Phase two: 2. To determine and compare the differences of the emergency nurses’ knowledge and skill at pre, post, and 12 weeks follow-up within and between the experimental and control groups of intervention.
Design
This study will have two phases; phase one is a Cross-sectional study, and phase two is a double-blinded randomized control trial (RCT). The study includes one group of experimental and one control group.
Settings and conduct
Dr. Sajed Faisal Ghawadra will be helped during the intervention and doing the lottery method to avoid the bias and control the confounder. Thus, the hospital, participants, researcher, and trainer (Dr. Belal H. Rawajbeh) are blinded.
Participants/Inclusion and exclusion criteria
Emergency nurses will participate in this study.
Intervention groups
The program materials will use articles and a tenth edition of the ATLS book. ATLS needs two days (8 am to 4 pm). The program will be prepared and presented by an emergency physician/ specialist, and a qualified person to give ATLS intervention. The control group will receive two days a needle stick injury lecture by Dr. Belal H. Rawajbeh.
Main outcome variables
The main outcomes: 1. Assessment of the level of emergency nurses' knowledge and skills on trauma triage as define low, moderate, and high. 2. Determine and compare the differences mean of the emergency nurses’ knowledge and skill at pre, post, and 3 months follow-up within and between the experimental and control groups of intervention. Thus, it will be there is significant differences or no significant differences within and between groups. 3. It will measure the develop, implement, and evaluate the content of a trauma triage educational intervention on knowledge and skill.

General information

Reason for update
Acronym
ATLS (Advance Trauma Life Support)
IRCT registration information
IRCT registration number: IRCT20200626047926N1
Registration date: 2020-06-28, 1399/04/08
Registration timing: prospective

Last update: 2020-06-28, 1399/04/08
Update count: 0
Registration date
2020-06-28, 1399/04/08
Registrant information
Name
Khalaf Awwad
Name of organization / entity
Universiti Putra Malaysia (UPM)
Country
Malaysia
Phone
+60 3-8947 2396
Email address
gs55200@student.upm.edu.my
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-01, 1399/07/10
Expected recruitment end date
2021-09-30, 1400/07/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of a Trauma Triage Educational Intervention on Knowledge and Skill among Emergency Nurses in Public Hospitals in the West Bank, Palestine
Public title
Effect of Trauma triage program among emergency nurses
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Nurses in the emergency department with fully employed in the selected for the experimental and control hospitals with at least one year working experience in the emergency department. It also will be included those who are available for the research study and those who do not on leave or retire during this study. Emergency nurses in Public hospital affiliated to the Palestinian Ministry of Health. Emergency nurses who are less than 60 years old. Emergency nurses who had not trained on trauma triage.
Exclusion criteria:
Jerusalem hospitals in the West Bank will be excluded with reason unsafe city in phases one and two of this study. The hospitals have moderate or high knowledge and skills in phase one will be excluded in phase two of this study.
Age
To 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 114
Randomization (investigator's opinion)
Randomized
Randomization description
The first box will consist of each selected hospital in small pieces of paper that are covered, while the second box will consist of either experimental or control groups also written in small pieces of paper and covered. Next, randomly will draw from the first box to determine the hospital and likewise from the second box to determine whether it be experimental or control group by lottery method. Then randomly will draw the second paper from the first box to determine the hospital while for the second box it will automatically be the remaining paper to determine whether it be experimental or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Dr. Sajed Faisal Ghawadra will be helped during the intervention and doing the lottery method to avoid the bias and control the confounder. Thus, the hospital, participants, researcher, and trainer (Dr. Belal H. Rawajbeh) are blinded. This study will be recorded the intervention and lottery method by videos and share them with the researchers at the end of data analysis to make sure the program and lottery method were done in the right way. In this study, the trial will be a double-blind trial, and therefore, the hospital, participants, researcher, and trainer are blinded. They will not aware of the random allocation or the hypothesis that is tested until the intervention will finish. The study design, measurements, and population.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee for Research involving Human Subjects, (JKEUPM) at Universiti Putra Malaysia (UPM)
Street address
serdang hosital street, serdang, kl
City
Kuala Lumpur
Postal code
43300
Approval date
2020-05-20, 1399/02/31
Ethics committee reference number
JKEUPM-2020-088

Health conditions studied

1

Description of health condition studied
Trauma
ICD-10 code
G89.11
ICD-10 code description
Acute pain due to trauma

Primary outcomes

1

Description
Determine and compare the mean of differences in the emergency nurses’ knowledge and skill at pre, post, and 3 months follow-up within and between the experimental and control groups of intervention.
Timepoint
This study will measure the variables at pre, post, and 12 weeks follow-up of intervention.
Method of measurement
Repeated measures ANOVA will measure the comparison of differences in means of the emergency nurses’ knowledge and skill scores between and within the experimental and control groups at pre, post, and 3 months follow-up of intervention.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group will receive 2 days of ATLS. It will measure at pre, post, and 12 weeks follow-up of intervention.
Category
Prevention

2

Description
Control group: the control group will receive 2 days of needle stick injury lectures. It will measure at pre, post, and 12 weeks follow-up of intervention.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Palestinian Ministry of Health (government hospitals)
Full name of responsible person
Khalaf Abdelfattah Mohd Awwad
Street address
Os street, one south
City
Kuala Lumpur
Postal code
43300
Phone
+60 3-8947 2396
Email
gs55200@student.upm.edu.my

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Universiti Putra Malaysia
Full name of responsible person
Ng Yee Guan
Street address
serdang hosital street, serdang, kl
City
Kuala Lumpur
Postal code
43300
Phone
+60 3-8947 2396
Fax
+60 3-8947 2395
Email
shah86zam@upm.edu.my
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Universiti Putra Malaysia
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Foreign
Category of foreign source of funding
UN agencies and international organizations
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
University Putra Malaysia
Full name of responsible person
Khalaf Abdelfattah Mohd Awwad
Position
PhDc
Latest degree
Master
Other areas of specialty/work
emergency department at hospitals
Street address
serdang hosital street, serdang, kl
City
Jenin
Province
Jenin
Postal code
43300
Phone
+60 3-8947 2395
Email
gs55200@student.upm.edu.my

Person responsible for scientific inquiries

Contact
Name of organization / entity
Universiti Putra Malaysia
Full name of responsible person
Khalaf Abdelfattah Moh Awwad
Position
student
Latest degree
Master
Other areas of specialty/work
Emergency Medicine
Street address
serdang hosital street, serdang, kl
City
Kuala Lumpur
Province
serdang
Postal code
43300
Phone
+60 3-8947 2395
Email
gs55200@student.upm.edu.my

Person responsible for updating data

Contact
Name of organization / entity
Universiti Putra Malaysia
Full name of responsible person
Khalaf Abdelfattah Mohd Awwad
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Emergency Medicine
Street address
serdang hosital street, serdang, kl
City
Kuala Lumpur
Province
serdang
Postal code
43300
Phone
+60 3-8947 2395
Email
gs55200@student.upm.edu.my

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The information obtained from this study will allow you to know your existing level of knowledge and skills in trauma triage. For those selected to participate in the second phase of the study, you will be able to upgrade and improve your knowledge and skills via the intervention program.
When the data will become available and for how long
It will start on1st of October 2020 - 30 of September 2021
To whom data/document is available
The information of this study will be available for a researcher who seeks emergency field
Under which criteria data/document could be used
SPSS, Chi-square, repeated measure ANOVA. the supervisors will review the data individually.
From where data/document is obtainable
online journals, UPM Library.
What processes are involved for a request to access data/document
The questionnaire will be kept for a maximum period of one year until the end of the analysis and discussion of the results, and it will be placed in a sealed envelope inside a locked cabinet. Further, the soft copy and data will be stored in a computer with a username and password and accessible only by the main researcher and my supervisor. Confidentiality will be maintained by assigning a code instead of the name. After the lapse of one year.
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