Protocol summary

Study aim
The effect of education of using(Identification, Mechanism, Injuries, Signs, Treatment and Trends, Allergies, Medication, Background history, Other information) IMIST-AMBO protocol in delivering patients from pre-hospital staff on patient safety in hospital emergency department Shahid Gholipour Bukan Hospital in 1400
Design
Clinical trial with control group, with parallel group, one-way blind, randomized, on 400 patients. Randomizer software was used for randomization.
Settings and conduct
In this study, emergency medical personnel are trained and the effect of training on how patients are delivered in the emergency department is measured. Among the patients who are delivered by the emergency medical staff of the emergency department of Shahid Gholipour Buokan Hospital. 400 samples are selected by convinient sampling method.
Participants/Inclusion and exclusion criteria
Criteria for inclusion of patients in the study: The patient enters the emergency room by the pre-hospital emergency department Criteria for excluding patients from the study: 1- The patient leaves before 6 hours by completing and signing the personal consent form 2- Death of the patient before 6 hours 3- The need for emergency surgery or momentary transfer to other departments Criteria for including pre-hospital emergency staff and nurses in the study: Have at least six months of work experience in the emergency department or pre-hospital Criteria for excluding pre-hospital emergency staff and nurses from research: Lack of regular attendance at training classes
Intervention groups
Intervention group: Pre-hospital emergency staff who meet the inclusion criteria will be trained in the IMIST-AMBO protocol in two face-to-face sessions.Control group: No educational intervention will be performed on the control group.
Main outcome variables
Improving the patient delivery and patient safety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20211205053284N1
Registration date: 2022-03-26, 1401/01/06
Registration timing: registered_while_recruiting

Last update: 2022-03-26, 1401/01/06
Update count: 0
Registration date
2022-03-26, 1401/01/06
Registrant information
Name
Chiman Ebrahimian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 4625 2160
Email address
chiman.ebrahimian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-21, 1401/01/01
Expected recruitment end date
2022-05-22, 1401/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education of using IMIST-AMBO protocol in delivering patients from pre-hospital staff on patient safety in hospital emergency department
Public title
Education of using IMIST-AMBO protocol in delivering patients from pre-hospital staff on patient safety in hospital emergency department
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The patient enters the emergency room by the pre-hospital emergency department Criteria for admission of pre-hospital emergency staff and nurses to work experience research for at least six months in the emergency department or pre-hospital
Exclusion criteria:
Patient leaves before 6 hours by completing and signing the personal consent form Patient dies before 6 hours Need emergency surgery or immediate transfer to other wards Exclusion criteria for pre-hospital emergency staff and nurses Lack of regular attendance at training classes
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 400
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done in a simple and individual way using Randomizer random allocation software. Emergency medical personnel are listed according to the national code and then divided into group 1 (intervention) and group 2 (control) using random allocation software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Research Schools of Pharmacy, Nursing and Midwifery - Shahid Beheshti University
Street address
In front of Shahid Rajaei Heart Hospital.,Niayesh Intersection.,Valiasr St.,School of Nursing and Midwifery.,Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2021-11-02, 1400/08/11
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1400.201

Health conditions studied

1

Description of health condition studied
Patients transferred by pre-hospital emergency.
ICD-10 code
N98.3
ICD-10 code description
Safety

Primary outcomes

1

Description
Patient safety The meaning of patient safety is the score obtained from the checklist of safety assessment of patients admitted to the emergency room, which measures patient safety in the areas of 1) attention to drugs with similar forms and pronunciation, 2) correct patient identification, 3) communication Effective health workers at the time of patient delivery, 4) Performing the correct procedure in the correct location of the patient's body, 5) Controlling high concentration electrolyte solutions, 6) Ensuring drug accuracy in the delivery of care services, 7) Avoiding incorrect connections of catheters and tubes, 8 ) Measures the immediate use of injection equipment. 9) Improves hand hygiene to prevent infections.
Timepoint
Before intervention and after intervention
Method of measurement
Questionnaire nine WHO patient safety solutions

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Pre-hospital emergency staff Step 1 (before intervention): For all patients (traumatic and non-traumatic) who are delivered to the emergency department by pre-hospital emergency staff and delivered as usual, the safety standards checklist by the researcher is up to six hours (4 to 6 hours). ) Will be completed later. The reason for the period of four to six hours is the stabilization of the patient's condition and the initial stages of care and treatment, which is done faster in some patients and later in others. Also, according to the laws of the Ministry of Health, each patient in the emergency department must be assigned within six hours and a final decision must be made regarding the patient's hospitalization or discharge. Step 2 (Intervention): In this step, all pre-hospital emergency staff of the IMIST-AMBO protocol intervention group will be trained in two face-to-face sessions. The validity of the educational content is confirmed by 4 emergency medicine specialists and nursing faculty members. The training will be presented by the researcher using PowerPoint in person for two hours. It should be noted that the objectives of the research will be explained to all participants and all of them will be informed. Stage 3 (after intervention): In this stage, the safety checklist of patients admitted to the emergency department for all trauma and non-trauma patients who have been transferred to the hospital by pre-hospital emergency staff trained in the IMIST-AMBO protocol, until Six hours (4 to 6 hours) will be completed later. Then the patient's safety in the stage before and after the study will be compared with each other and the results will be prepared for statistical analysis.
Category
Prevention

2

Description
Control group: Pre-hospital emergency staff did not intervene in the control group
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Emergency department of Shahid Gholipour Hospital in Bukan
Full name of responsible person
Chiman Ebrahimian
Street address
Shohada Boulevard.,Shahid Gholipur Hospital.,Bukan
City
Bukan
Province
West Azarbaijan
Postal code
5951678467
Phone
+98 44 4623 0702
Fax
Email
hit.boukan@gmail.com
Web page address
https://bookan.umsu.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahrokh Dolatian
Street address
In front of Shahid Rajaei Heart Hospital.,Niayesh Intersection.,Valiasr St.,School of Nursing and Midwifery.,Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8865 5363
Email
sbnmf@sbmu.ac.ir
Web page address
https://nm.sbmu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Chiman Ebrahimian
Position
Master of Science Emergency Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Amirabad - Keshavarz Boulevard - next to Bisotoun Alley 5
City
Bukan
Province
West Azarbaijan
Postal code
5951112374
Phone
+98 44 4625 2160
Fax
Email
chiman.ebrahimian@sbmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fateme Monjazebi
Position
Assistant Professor of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
Email
fmonjazebi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Chiman Ebrahimian
Position
Master of Science Emergency Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Amirabad - Keshavarz Boulevard - next to Bisotoun Alley 5
City
Buokan
Province
West Azarbaijan
Postal code
5951112374
Phone
+98 44 4625 2160
Fax
Email
chiman.ebrahimian@sbmu.ac.ir

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
Not applicable
Title and more details about the data/document
Safety measured before and after the intervention
When the data will become available and for how long
Access to the study will be after the publication of the article
To whom data/document is available
The data will be available to all medical researchers
Under which criteria data/document could be used
If the principles of research ethics are observed, it will be provided to researchers.
From where data/document is obtainable
Refer to the registration email address in the published article and request.
What processes are involved for a request to access data/document
The article will be provided to the requesting researchers immediately after approval and publication.
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