Protocol summary

Summary
The aim of the study is to evaluate the impact of educational intervention on adherence to guidelines for antibiotic prophylaxis before surgeries in Alejalil hospital in Aq-Qala city. This is a quasi-experimental study and single-blinded. Criteria for assessing the performance of surgeons is medical records of their patients. 125 surgical records during the month before the intervention and 125 other surgical records after the intervention will selected proportionally of surgical performed by each physician. Information including indications, type of antibiotic, dose, time of administration of first dose and route of antibiotic administration based on patient records will collected, then the result of prescribed prophylactic antibiotic will compared with Ministry of Health guidelines for antibiotic prophylaxis in surgery. The participants included Surgeons who had at least 6 months work experience in Alejalil hospital. The intervention consisted of holding the 1 training session for one hour by clinical governance and infection control experts with 7 surgeons, increase awareness and sensitizing surgeons and nurses through sending abstract of Managed care instructions # 8 in table to the surgical wards, invite surgeons through letter to compliance antibiotic prophylaxis standards. Intervention for 2 months (October to December 2014) will be performed. After the intervention, practice of surgeons about prescribing of antibiotic prophylaxis compared with before the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014080618704N1
Registration date: 2014-09-09, 1393/06/18
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-09-09, 1393/06/18
Registrant information
Name
Narges Rafiei
Name of organization / entity
Golestan University of Medical Sciences, Aq-Qala Health Center
Country
Iran (Islamic Republic of)
Phone
+98 17 3452 5915
Email address
narges.rafiei@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Golestan University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2014-11-22, 1393/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of the Educational Intervention on Adherence to Guidelines for Antibiotic Prophylaxis before Surgeries
Public title
The effect of education on Prescribing antibiotic prophylaxis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Surgeons who had at least 6 months work experience in Alejalil hospital.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 250
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee, Golestan University of Medical Sciences
Street address
No 1, Shastkola St, Hirkan Blv, Gorgan
City
Gorgan
Postal code
4934174515
Approval date
2013-03-05, 1391/12/15
Ethics committee reference number
911215190

Health conditions studied

1

Description of health condition studied
Infection
ICD-10 code
A49.9
ICD-10 code description
Bacteraemia NOS

Primary outcomes

1

Description
Performance
Timepoint
Before the experiment, 2 months after the intervention.
Method of measurement
Antibiotic prophylaxis Checklist

Secondary outcomes

empty

Intervention groups

1

Description
The intervention consisted of holding the 1 training session for one hour by clinical governance and infection control experts with 7 surgeons, increase awareness and sensitizing surgeons and nurses through sending abstract of Managed care instructions # 8 in table to the surgical wards, invite surgeons through letter to compliance antibiotic prophylaxis standards.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Alejalil Hospital
Full name of responsible person
Fatemeh Koochaki
Street address
No 17, Bandar Torkman Rd, Aq-Qala
City
Aq-Qala

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Golestan University of Medical Sciences
Full name of responsible person
Masood Khoshnia
Street address
No 1, Shastkola St, Hirkan Blv, Gorgan
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Golestan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Aq-Qala Health Center
Full name of responsible person
Narges Rafiei
Position
Responsible for Research
Other areas of specialty/work
Street address
No 25, Emam Khomeyni Ave, Aq-Qala
City
Aq-Qala
Postal code
4931743959
Phone
+98 17 3452 5915
Fax
+98 17 3452 3000
Email
narges.rafiei@goums.ac.ir; narges.rafiei@gmail.com
Web page address
http://www.goums.ac.ir/index.php?slc_lang=fa&sid=35

Person responsible for scientific inquiries

Contact
Name of organization / entity
Golestan University of Medical Sciences Aghala Health Center
Full name of responsible person
Narges Rafiei
Position
Responsible for Research
Other areas of specialty/work
Street address
No 25, Emam Khomeyni Ave, Aq-Qala
City
Aq-Qala
Postal code
4931743959
Phone
+98 17 3452 5915
Fax
+98 17 3452 3000
Email
narges.rafiei@goums.ac.ir; narges.rafie@gmail.com
Web page address
http://www.goums.ac.ir/index.php?slc_lang=fa&sid=35

Person responsible for updating data

Contact
Name of organization / entity
Golestan University of Medical Sciences Aghala Health Center
Full name of responsible person
Narges Rafiei
Position
Responsible for Research
Other areas of specialty/work
Street address
No 25, Emam Khomeyni Ave, Aq-Qala
City
Aq-Qala
Postal code
4931743959
Phone
+98 17 3452 5915
Fax
+98 17 3452 3000
Email
narges.rafiei@goums.ac.ir; narges.rafiei@gmail.com
Web page address
http://www.goums.ac.ir/index.php?slc_lang=fa&sid=35

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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