The effect of education to high-risk patients, their families and pre-hospital emergency personnel about strokes on patients’ timely referral to the hospital
Determining the effect of training high-risk patients, families and pre-hospital emergency personnel regarding strokes on timely patient referral to the hospital
Design
The clinical trial has intervention and control groups, in a blinded, randomized form, which was used for randomization by lottery and in a random manner.
Settings and conduct
In the selected cluster, based on the files in the comprehensive health service center, all high-risk patients and at least one member of their family will undergo educational intervention.
In the case of EMS personnel, the whole number method will also be used.
Participants/Inclusion and exclusion criteria
Entry criteria for high-risk patients and families
- Having a record of blood pressure, diabetes or hyperlipidemia in comprehensive health service centers in the city of Shahindej and the villages affiliated to the selected center
- Willingness to participate in study and training sessions
- Access to a smart mobile phone to join the WhatsApp group to continue and repeat the training
- In the case of family members, preferably the person who spends the most hours with the patient will be selected
Intervention groups
According to the clustering, a random cluster will be selected as an intervention group under the educational program, and the other clusters will play the role of the control group.
Main outcome variables
Timely referral of patients, number of calls to EMS, time interval from observing symptoms to calling EMS, time from the onset of symptoms until the patient arrives at the hospital (STD)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230706058688N1
Registration date:2023-08-04, 1402/05/13
Registration timing:prospective
Last update:2023-08-04, 1402/05/13
Update count:0
Registration date
2023-08-04, 1402/05/13
Registrant information
Name
Naseh Soltani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 4633 2449
Email address
nasehsoltani400@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-06, 1402/05/15
Expected recruitment end date
2023-12-21, 1402/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education to high-risk patients, their families and pre-hospital emergency personnel about strokes on patients’ timely referral to the hospital
Public title
Investigating the impact of education on high-risk patients, their families and pre-hospital emergency personnel
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having a record of blood pressure, diabetes or hyperlipidemia in comprehensive health service centers in the city of Shahindej and the affiliated villages of the selected center
Willingness to participate in study and training session
Access to a smart mobile phone to join the WhatsApp group to continue and repeat the training
In the case of family members, the person who spends the most time with the patient will be chosen
Being 30 years old or older
Exclusion criteria:
Not having a file as a high-risk patient (hypertension, diabetes, hyperlipidemia)
Age
From 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Data analyser
Sample size
Target sample size:
1000
Randomization (investigator's opinion)
Randomized
Randomization description
A cluster sampling method will be used in which one of four urban centers and nearby rural centers will be randomly selected as the intervention group and other centers will be included as the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The intervention group (including high-risk patients and their families in the selected cluster which is selected randomly out of 4 centers in Shahindej city) and the main researcher will know the center which is trained about the timely referral of suspected stroke patients to the hospital. But the data recorders (pre-hospital emergency personnel and emergency ward personnel of Shahin Dej Hospital) are unaware of whether the referred patients are in the intervention group or the control group, and the analyzers also do not know the grouping of the patients.
Placebo
Not used
Assignment
Parallel
Other design features
Community-based randomized trial
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Working Group / Ethics Committee in Research Faculty of Nursing and Midwifery and Faculty of Rehabil
Street address
9, Shahriar Ave., Shahindej Town
City
Shahindej
Province
West Azarbaijan
Postal code
5981719164
Approval date
2023-07-09, 1402/04/18
Ethics committee reference number
IR.TUMS.FNM.REC.1402.067
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
G46.4
ICD-10 code description
Cerebellar stroke syndrome
Primary outcomes
1
Description
Fast identification and diagnosis
Timepoint
The necessary time periods are about 6 months after the intervention to analyze the obtained data
Method of measurement
The desired variable is quick identification and diagnosis, which will be expressed in minutes from the available documentation
Secondary outcomes
1
Description
timely referal to the hospital,
Timepoint
After the educational intervention, the data will be gathered and analyzed up to 6 months later
Method of measurement
According to the data extracted from the available documents, the time will be calculated in minutes
2
Description
going to hospital by EMS service
Timepoint
After the educational intervention, the data will be gathered and analyzed up to 6 months later
Method of measurement
The ratio of patients admitted with suspected stroke to the hospital through EMS to the total number of patients admitted with suspected stroke
Intervention groups
1
Description
Intervention group: In the case of high-risk patients, the intervention is in the form of educational sessions and using slides in the simple and native language of the region as far as the audience can understand, as well as the use of educational animations in humorous language. Highlighting and answering possible questions will be done to complete the educational process.
Category
Other
2
Description
Intervention group: In the case of pre-hospital emergency personnel, the intervention is in the form of retraining regarding the quick and accurate diagnosis of suspected stroke cases, for this purpose, in addition to the FAST tool, the BEFAST tool and the Iranian IRPSS tool aim to improve diagnosis, inform the hospital and announce the code. Stroke will be used to improve the correct and quick referral of the suspected patient and the time from the onset of symptoms to the transfer of the patient to the hospital. The training of pre-hospital emergency personnel will be done face-to-face and in groups in two two-hour interactive sessions using real scenarios. Then, the important points of the training sessions will be reviewed by sending short reminder messages in the WhatsApp group of medical emergencies, and the personnel will share their experience of using new tools with the aim of solving possible ambiguities.
Category
Early detection
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasi hospital
Full name of responsible person
Naseh Soltani
Street address
No. 9, Shahriar Ave., Shahindej Town
City
Shahindej
Province
West Azarbaijan
Postal code
5981719164
Phone
+98 44 4633 2449
Fax
+98 44 4633 4816
Email
nasehsoltani@yahoo.com
2
Recruitment center
Name of recruitment center
Medical emergency center
Full name of responsible person
Naseh Soltani
Street address
No. 9, Shahriar Ave., Shahindej Town
City
Shahindej
Province
West Azarbaijan
Postal code
5981719164
Phone
+98 44 4633 2449
Fax
+98 44 4633 4816
Email
nasehsoltani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mehrnaz Geranmayeh
Street address
No. 9, Shahriar Ave., Shahindej Town
City
Shahindej
Province
West Azarbaijan
Postal code
5981719164
Phone
+98 21 8670 5503
Email
nasehsoltani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Naeh Soltani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 9, Shahriar Ave.,Shahindej Town
City
Shahindej
Province
West Azarbaijan
Postal code
5981719164
Phone
+98 44 4633 2449
Fax
+98 44 4633 4816
Email
nasehsoltani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Naseh Soltani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 9, Shahriar Ave., Shahindej Town
City
Shahindej
Province
West Azarbaijan
Postal code
5981719164
Phone
+98 44 4633 2449
Fax
+98 44 4633 4816
Email
nasehsoltani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Naseh Soltani
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 9, Shahriar Ave., Shahindej Town
City
Shahindej
Province
West Azarbaijan
Postal code
5981719164
Phone
+98 44 4633 2449
Fax
+98 44 4633 1846
Email
nasehsoltani@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
After consultation with the professors and according to the rules of the faculty and ethics committee
When the data will become available and for how long
After consultation with the professors and according to the rules of the faculty and ethics committee
To whom data/document is available
After consultation with the professors and according to the rules of the faculty and ethics committee
Under which criteria data/document could be used
After consultation with the professors and according to the rules of the faculty and ethics committee
From where data/document is obtainable
After consultation with the professors and according to the rules of the faculty and ethics committee
What processes are involved for a request to access data/document
After consultation with the professors and according to the rules of the faculty and ethics committee