The Effectiveness of Patient Safety Empowerment program with the health care Failure Mode and Effects Analysis approach on the Safety Culture and the Profession commitment of Nurses in critical care units
The present study has been done to determine The Effectiveness of Patient Safety Empowerment program with the health care Failure Mode and Effects Analysis approach on the Safety Culture and the Profession commitment of Nurses in critical care units.
Design
This study is a two-group design, in which 72 nurses of intensive care units were randomly assigned to one of the two experimental groups (36) and control (36).
Settings and conduct
Special sections of Hajar Hospital and Kashani Shahrekord are randomly assigned to one of the two intervention and control groups. Then, according to the number of nurses in each department and the determination of the share of each one for entering the study, the samples are randomly selected. If nursing does not want to participate in the study, it will be out of research and replaced with another person.
Participants/Inclusion and exclusion criteria
Nurses working in critical care units ,nurses Have a bachelor's degree or higher ,Satisfaction of nurses to participate in the study ,Having at least 6 months of work experience in the critical care unit, Lack of previous participation in a curriculum related to Patient Safety Empowerment; Exclusion criteria: Unwillingness to cooperate and discontinue participation in the study, Incomplete completeness of questionnaires by nurses, Failure to attend a Empowerment sessions.
Intervention groups
The intervention group Patient Safety Empowerment program in six sessions, one and a half hours group( six times a month)while The control group does not receive training
Main outcome variables
Patient safety culture, professional commitment
General information
Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number:IRCT20091215002861N15
Registration date:2019-05-10, 1398/02/20
Registration timing:retrospective
Last update:2019-05-10, 1398/02/20
Update count:0
Registration date
2019-05-10, 1398/02/20
Registrant information
Name
Reza Masoodi
Name of organization / entity
Nursing department, Shahrekord University of Medical Science,
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 5654
Email address
masoodi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-03, 1397/11/14
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Patient Safety Empowerment program with the health care Failure Mode and Effects Analysis approach on the Safety Culture and the Profession commitment of Nurses in critical care units
Public title
The Effectiveness of Patient Safety Empowerment program with the health care Failure Mode and Effects Analysis approach on the Safety Culture and the Profession commitment of Nurses in critical care units
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
En Inclusion criteria:Nurses working in critical care units
nurses Have a bachelor's degree or higher
Satisfaction of nurses to participate in the study
Having at least 6 months of work experience in the critical care unit
Lack of previous participation in a curriculum related to Patient Safety Empowerment
Exclusion criteria:
Exclusion criteria: Unwillingness to cooperate and discontinue participation in the study
Incomplete completeness of questionnaires by nurses
Failure to attend a Empowerment sessions
Age
From 22 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Special sections of Hajar Hospital and Kashani Shahrekord are randomly assigned to one of the two intervention and control groups. Then, according to the number of nurses in each department and the determination of the share of each one for entering the study, the samples are randomly selected. If nursing does not want to participate in the study, it will be out of research and replaced with another person.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
There is no particular explanation.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences
Street address
Building No. 2, Headquarters of Shahrekord Universiy of Medical Sciences, Kashani Blvd, Shahrekord, Iran
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814681681
Approval date
2019-02-03, 1397/11/14
Ethics committee reference number
IR.Skums.REC.1397.265
Health conditions studied
1
Description of health condition studied
The Effectiveness of Patient Safety Empowerment Program in critical care units nurses
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Patient Safety
Timepoint
Before the intervention, after intervention and 2 months after
Method of measurement
Patient Safety Culture Questionnaire
Secondary outcomes
1
Description
Profession commitment
Timepoint
Before the intervention, after intervention and 2 months after
Method of measurement
Profession commitment Questionnaire
Intervention groups
1
Description
Intervention group: The intervention group Patient Safety Empowerment program in six sessions, one and a half hours group( six times a month)
Category
Behavior
2
Description
Control group: The control group does not receive training
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
The Hajar Hospital ShahreKord
Full name of responsible person
SedigehLalegani
Street address
Parastar Street, Shahrekord
City
ShahreKord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816854633
Phone
+98 38 3222 0016
Fax
+98 38 3224 3715
Email
Hajar@Skums.ac.ir
Web page address
https://Hajarhp.Skums.ac.ir/
2
Recruitment center
Name of recruitment center
The Kashani Hospital ShahreKord
Full name of responsible person
SedigehLalegani
Street address
Parastar Street, Shahrekord
City
ShahreKord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8816758915
Phone
+98 38 3226 4825
Fax
+98 38 3222 8600
Email
info@Skums.ac.ir
Web page address
https://kashanihp.Skums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr Kamal Solati
Street address
Building No. 2, Headquarters of Shahrekord Universiy of Medical Sciences, Kashani Blvd, Shahrekord, Iran.
City
Shahre-kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0016
Fax
Email
info@skums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Sedigeh Lalegani
Position
Nursing Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing And Midwifery School, Shahrekord University of Medical Sciences, Rahmatieh, Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8818676458
Phone
+98 38 3333 1284
Fax
+98 38 3334 6714
Email
sedigehlalegani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr Reza Masoodi
Position
Assisstant Professor of Shahrekord University of Medical Sciences/Ph.D in Nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery School, Shahrekord University of Medical Sciences, Rahmatieh, Shahrekord
City
Shahre-kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813833435
Phone
+98 38 3333 5652
Fax
+98 38 1334 6714
Email
masoodi1383@yahoo.com
Web page address
https://skums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Sedigeh Lalegani
Position
Nursing Master Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing Department, Nursing and Midwifery College, Rahmatie, Shahrekord
City
Shahre-kord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8814681681
Phone
+98 38 3333 1284
Email
sedigehlalegani@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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