A comparative study on the effect of using the modified World Health Organization trauma cares checklist and standard World Health Organization trauma cares checklist on morbidity and mortality among traumatic patients
The effectiveness of modified World Health Organization's checklist on mortality/ Morbidity of Traumatic patients
Design
First, the patients will be evaluated according to the demographic and numerical scale of the pain and the severity of the trauma. The patients were then randomly assigned into three groups: (1) routine without using the checklist (control group), (2). In accordance with the WHO checklist (intervention group A) and (3). The modified checklist (the second intervention group). Patients are assessed for pain intensity, severity of injury, mortality/ morbidity and complications for one month after entering the study. The results will compare at the end.
Settings and conduct
This study is done in patients referring to the trauma center of Taleghani Hospital of Kermanshah University of Medical Sciences. Double blind is done for all patients and who analyzes the data.
Participants/Inclusion and exclusion criteria
Criteria for entering the study:
1) Traumatic patients aged 18 to 60 years and GCS greater than or equal to 10
2) The existence of a specific field of life threatening organs based on the judgment of the therapist
3) Patients who need trauma team services
Exit criteria:
1- Pregnancy
2. Unwillingness to participate in the study
3. Patients with a history of chronic psychiatric, pulmonary, renal disease or chemotherapy patients.
4. Drug addiction
Intervention groups
Control group: Patients treated routinely without using the checklist.
First intervention group: They are treated with the WHO checklist.
Second intervention group: Treated by the modified WHO checklist
Main outcome variables
Mortality rate;
Type and number of complications following trauma;
Duration of hospitalization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20081007001310N12
Registration date:2018-09-15, 1397/06/24
Registration timing:retrospective
Last update:2018-09-15, 1397/06/24
Update count:0
Registration date
2018-09-15, 1397/06/24
Registrant information
Name
Alireza Ahmadi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 3428 2670
Email address
info-jivr@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-06, 1396/12/15
Expected recruitment end date
2018-09-06, 1397/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study on the effect of using the modified World Health Organization trauma cares checklist and standard World Health Organization trauma cares checklist on morbidity and mortality among traumatic patients
Public title
The effect of World Health Organization modified checklist on the complications and mortality rate of trauma patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
GCS equal to or greater than 10
The existence of a specific life threatening event for organs, based on the judgment of the therapist
Patients need trauma team services
Exclusion criteria:
Pregnancy
Unwillingness to participate in the study
Patients with a history of chronic psychiatric, pulmonary, renal disease or chemotherapy
drug addiction
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
180
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization: simple randomization;
Unit of randomization: patients;
Tools used for randomization: random allocation software
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, all participants, the main researcher, data collection and outcome assessors, the Data Safety and Monitoring Board's safety and data monitoring committee, and those who prepare the draft of article are blind. However, health personnel and doctors who are responsible for providing services to patients in the Emergency Department are not blind. But doctors and nurses in after emergency wards are blind in the hospital.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
By referring to patients' documents files in hospital and telephone contacts with patients or visiting patients place of residence.
2
Description
severity of complications of patients
Timepoint
Three months after entering the study
Method of measurement
The Injury Severity Score (ISS)
3
Description
duration of hospitalization
Timepoint
Three months after entering the study
Method of measurement
World Health Organization Trauma Care Checklist
Secondary outcomes
1
Description
Patient Satisfaction
Timepoint
Three days after hospitalization
Method of measurement
Visual Analogue Scale
Intervention groups
1
Description
Intervention group 1 (standard). care services are based on the standard WHO Trauma Care Checklist. This checklist contains several intervention items such as airway control, blood coagulation control, hemothorax, examination, and so on. In this traumatic patients group, the services in the emergency department are provided according to this checklist.
Category
Treatment - Other
2
Description
Intervention Group (2): receives medical treatment based on WHO modified checklist with focusing on pain management (intervention items are as follows: airway intervention control, internal hemorrhage control and hemothorax diagnosis, etc)
Category
Treatment - Other
3
Description
Control Group: receives routine medical treatment without using checklist