Determining the impact of virtual and face-to-face alarm management education on knowledge and ventilator alarm fatigue
Design
A randomized clinical trial, first phase, with three parallel groups, single blind, simple randomized with 45 nurses in each group.
Settings and conduct
The intensive care unit (ICU) of selected hospitals will be affiliated to Shahid Beheshti University of Medical Sciences. The in-person education group received the content of the educational program in the form of training in the department in groups of 5 to 10 people, and the virtual group includes sending the educational video through the messenger channel to the participants
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Have at least a bachelor's degree in nursing.
Have at least one year of clinical work experience in the department of ICU
have not completed a educational course related to mechanical ventilation alarm management in the past year.
exclusion criteria:
Leave the intensive care unit before completing the study for any reason.
Not viewing the training program and not providing feedback to the researcher more than a training video
Intervention groups
The intervention includes in-person education group (A) and virtual training group (B) and the third group is the control group. In the virtual training group, samples will be members on the platform of a mass messaging channel, and the content of the training program will be sent every week for two weeks, with a time of 15 to 20 minutes, in the field of ventilator alarm management, and at the end of each week, about the content of the participation Feedback will be taken from the participants and it will be provided in face-to-face training through face-to-face training on ventilator management in 3 sessions of 30 to 45 minutes in groups of 5-10 people.
Main outcome variables
Ventilator alarm knowledge and ventilator alert fatigue
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240707062353N1
Registration date:2024-07-31, 1403/05/10
Registration timing:prospective
Last update:2024-07-31, 1403/05/10
Update count:0
Registration date
2024-07-31, 1403/05/10
Registrant information
Name
fateme rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8865 5366
Email address
rahimifrahimi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-21, 1403/06/31
Expected recruitment end date
2024-12-19, 1403/09/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effectiveness of virtual and face-to-face alarm management education on knowledge and ventilator alarm fatigue
Public title
A comparative study of the effectiveness of virtual and face-to-face alarm management training on knowledge and ventilator alarm fatigue
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Have at least a bachelor's degree in nursing.
have at least one year of clinical work experience in the internal special care or surgery department except cardiac surgery
They have not completed a training course related to mechanical ventilation alarm management in the past year.
Exclusion criteria:
Leave the intensive care unit before the end of the study for any reason.
have not completed the questionnaires completely.
Not viewing the training program and not providing feedback to the researcher more than a training video.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
135
Randomization (investigator's opinion)
Randomized
Randomization description
At first, the list of educational hospitals with ICU General was extracted and then three hospitals were selected by simple randomization method and then one hospital for face-to-face education, one virtual education hospital and one control group hospital will be randomly selected. and sampling will continue simultaneously in three hospitals. In order to prevent contamination of the samples, it is not possible to select the samples by block or stratified sampling method.
Blinding (investigator's opinion)
Single blinded
Blinding description
Data were collected by research assistants, and the person evaluating the outcomes was not aware of the allocation of the samples to the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Number 13/1, Shahid Beheshti College of Nursing and Midwifery, in front of Shahid Rajaee Heart Hospital intersection of Ayat allah Hashemi Rafsanjani Highway, Vali Asr Street, Tehran
City
Tehran
Province
Tehran
Postal code
1996835119
Approval date
2024-06-24, 1403/04/04
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1403.060
Health conditions studied
1
Description of health condition studied
Life-threatening disorders
ICD-10 code
R68.89
ICD-10 code description
Other general symptoms and signs
Primary outcomes
1
Description
Knowledge of ventilator alarm management
Timepoint
Before and 6 weeks after the intervention
Method of measurement
The checklist is the knowledge of ventilator alarm management and it contains 20 questions and the total score of the checklist is 0 to 20 and in front of each question there is a yes/no/don't know answer item. The correct item has one point and the item I don't know and the wrong item has zero points. A higher score is a sign of better knowledge to manage ventilator alarms.
2
Description
Alarm fatigue
Timepoint
Before and 6 weeks after the intervention
Method of measurement
Alarm Fatigue questionnaires includes 13 items on a five-point Likert scale including (never = zero, rarely = 1, sometimes = 2, often = 3, always = 4). . Statements 1 and 9 have reverse scoring (never=-4, rarely=-3, sometimes=-2, often=-1 and always=zero). The total scores range from 8 to 44. A higher score indicates a higher level of warning fatigue. A score of 8-20 indicates low fatigue, 21-32 indicates moderate fatigue, and 33-44 indicates severe fatigue.
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: in-person education through the provision of face-to-face education in the field and training on ventilator alarm management for three sessions of 30 to 45 minutes in groups of 5-10 people / the second intervention group: virtual training in the messaging channel and Sending three educational videos in simulator format (15-25 minutes) during two weeks, two videos/control group: not receiving training
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Loqman Hakim Hospital
Full name of responsible person
Neda Sanaie
Street address
Lashgar intersection of Makhsos street, Tehran
City
Tehran
Province
Tehran
Postal code
1333635445
Phone
+98 21 5541 9005
Email
loghman.hospital@sbmu.ac.ir
2
Recruitment center
Name of recruitment center
Imam Hossein Hospital
Full name of responsible person
neda sanaie
Street address
Imam Hossein Medical Research Training Center, Shahid Madani St ,Tehran
City
tehran
Province
Tehran
Postal code
3187889091
Phone
+98 21 8864 4549
Fax
Email
info@sbmu.ac.ir
3
Recruitment center
Name of recruitment center
Shahid Modares Hospital
Full name of responsible person
neda sanaie
Street address
Saadat Abad intersection, Yadgar Imam highway (RA), Tehran
City
Tehran
Province
Tehran
Postal code
2288310908
Phone
+98 21 2351 5000
Email
pr_modarres@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
3rd floor ,Faculty of Medicine ,next to Taleghani Hospital ,Evin ,Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717434
Phone
+98 21 2243 9951
Email
nedasanaie@ymail.com
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
Neda Sanaie
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery ,Hashemi Rafsanjani intersection, Valiasr Street, Tehran
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
nedasanaie@ymail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Neda Sanaie
Position
Faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Hashemi Rafsanjani intersection, Valiasr Street, Tehran
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8865 5366
Email
nedasanaie@ymail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Neda Sanaie
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Beheshti College of Nursing and Midwifery, in front of Shahid Rajaee Heart Hospital intersection of Ayat allah Hashemi Rafsanjani Highway, Vali Asr Street, Tehran
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
0218865536670
Fax
+98 21 8865 5363
Email
nedasanaie@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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is 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
Not applicable
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
No decision has been made yet
When the data will become available and for how long
No decision has been made yet
To whom data/document is available
researchers
Under which criteria data/document could be used
No decision has been made yet
From where data/document is obtainable
Send an email request to the project supervisor nedasanaie@ymail.com
What processes are involved for a request to access data/document
Send an email request to the project supervisor nedasanaie@ymail.com