Determining the impact of web-based patient safety training to nursing managers on patient safety culture in nursing staff
Design
two arm parallel group semi-experimental study with 2 control and intervention group of 100 head nurses (each 50)
selecting hospitals (Imam Khomeini in one group, Sina and Shariati in another group) through simple dice sampling method
selecting head nurses through available sampling method
selecting nursing staff (nurses and nursing assistants) through Table of random sampling
Settings and conduct
Interview with Head nurses and nursing staff of Imam Khomeini, Shariati and Sinai hospitals and inviting them. After obtaining Informed consent, links of classes and questionnaire will be sent to.
CCU, ICU, Dialysis and other wards like internal medicine, surgery, etc., are included in the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Having a management position at least 6 months and not participating in a similar management course for head nurses
having at least a nursing bachelor's degree, having a certificate of nursing assistant, access to a smartphone or computer, willingness to participate in the study.
Exclusion criteria: Changing the management post.
Intervention groups
Intervention group: educational content with weekly updates during 6 sessions of 30-40 minutes is presented only to head nurses of the intervention group during 6-12 weeks. The platform is in the educational system of the university. The pre-test before the first session and the post-test 2 and 6 weeks later will be taken from all participants.
Control group: They do not receive any training, they only do the pre-test and post-test at the beginning and end of the training period of the intervention group.
Main outcome variables
Age؛ gender؛ education level؛ working experience in hospital؛ time and duration of having management position؛ patient safety education. patient safety culture
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170827035918N3
Registration date:2023-12-09, 1402/09/18
Registration timing:prospective
Last update:2023-12-09, 1402/09/18
Update count:0
Registration date
2023-12-09, 1402/09/18
Registrant information
Name
zahra sajedi monfared
Name of organization / entity
Tehran University of Medical sciences/ Students\' Scientific Research Center (SSRC)
Country
Iran (Islamic Republic of)
Phone
+98 21889891614
Email address
zahrasajedi75@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-12-22, 1402/10/01
Expected recruitment end date
2024-04-20, 1403/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Impact of web-based patient safety training to nursing managers on patient safety culture in nurses
Public title
Impact of web-based patient safety training to nursing managers on patient safety culture in nurses
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Head nurses: having the management position for at least 6 months, having at least a bachelor's degree, not participating in a similar management course, access to a smartphone or computer, willingness to participate in the study
Nursing staff/nurses: Having at least a bachelor's degree for nurses, including the title of nurse in their employment order, working as a nurse in hospital wards, access to a smartphone or computer, willingness to participate in the study
Nursing staff/nursing assistants: Having a certificate of nursing assistant, including the title of nursing assistant in their employment order, working as a nursing assistant in hospital wards, access to a smartphone or computer, willingness to participate in the study
Exclusion criteria:
Changing the management post
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
selecting hospitals (Imam Khomeini in one group, Sina and Shariati in another group) through simple dice sampling method
selecting nursing staff (nurses and nursing assistants) through Table of random sampling
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Nursing and Midwifery & Rehabilitation - Tehran University o
Street address
Tehran University of Medical Sciences, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2023-11-18, 1402/08/27
Ethics committee reference number
IR.TUMS.FNM.REC.1402.163
Health conditions studied
1
Description of health condition studied
No diseases
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Patient safety culture
Timepoint
Before intervention. 2 and 6 weeks after intervention
Method of measurement
Hospital Survey on Patient Safety Culture
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Individuals who join the intervention group receive the following training. The content is a combination of relevant sections on patient safety in nursing and management textbooks, patient safety culture questionnaires, clinical guidelines provided by the World Health Organization, and the literature review. The training includes patient safety and its culture, communication and feedback regarding errors, organizational learning, teamwork, error reporting, risk assessment and management, drug adverse effects and interactions, infection control, nursing leadership and safety leadership, and managerial support for patient safety. The training is presented to the head nurses intervention group only in six 30-40 minute sessions over a period of 6-12 weeks through media. The electronic content is prepared under the supervision of the research team and will be controlled by nursing management group of the nursing and midwifery faculty members as well as the virtual education group of the university. The potential platform is in the university's educational system. Each individual has their own password and access code. After logging into their personal page, each person have access to the content of the session they need. The educational content cannot be downloaded and individuals have online access to it. The educational content of each session is updated weekly. A message is sent each week as reminder and motivation. Individuals are given two weeks to study the content of each session. It should be noted that the content of the next session is only accessible only if they answer the questions at the end of each session. Head nurses can this opportunity to ask their question. Pre-test is taken before starting the first session, and post-test is taken two weeks and six weeks after providing the training from all participants (head nurses and nursing staff).
Category
N/A
2
Description
Control group: people who allocate to control group receives no training. They are just asked to do pre and post tests at the beginning and end of training in intervention group,
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
zahra sajedimonfared
Street address
Shariati Hospital, Jalal Al Ahmad Three Roads, North Kargar St, Tehran, Tehran Province
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
shariatihosp@tums.ac.ir
2
Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
zahra sajedimonfared
Street address
Tehran Province, Tehran, at the end of Keshavarz Boulevard, Imam Khomeini Hospital Complex
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 0000
Email
imamhospital@tums.ac.ir
3
Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Zahra Sajedimonfared
Street address
Sina Hospital, Hassan Abad Square, Imam Khomeini Street, Tehran, Tehran Province
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Email
hosp_sina@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbarisari
Street address
Keshavarz Blvd, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1473138714
Phone
+98 912 437 0416
Email
zahrasajedi75@gmail.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
Zahra Sajedimonfared
Position
Master student of Nursing Management
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 1079, Hakim buildings, Bahonar Street, Ashrafi Esfahani highway, Hakim Gharb highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1473138714
Phone
+98 21 6692 7171
Email
zahrasajedi75@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Nahid Dehghan Nayeri
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mirkhani St. (East Nusrat), Tohid Square, School of Nursing and Midwifery, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
nahid.nayeri@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Sajedi Monfared
Position
Master student of Nursing Management
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 1079, Hakim buildings, Bahonar Street, Ashrafi Esfahani highway, Hakim Gharb highway, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1473138714
Phone
+98 21 4612 4823
Email
zahrasajedi75@gmail.com
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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals.
When the data will become available and for how long
Start access after printing the results
To whom data/document is available
No limitation.
Under which criteria data/document could be used
The data can be used to plan empowerment programs for nurses and nursing managers.