Protocol summary

Study aim
the effect of the role of the nurse liaison of the LNICU Intensive Care Unit on the patient's outcomes following transfer from the cardiac surgery department
Design
Clinical trial with control and control groups, one-way blind, sampling was performed by available patients.
Settings and conduct
Research in Jamaran Heart Hospital is performed on patients with cardiac surgery that can be transferred to the ward.
Participants/Inclusion and exclusion criteria
Ability to understand and speak Persian Transfer to the public sector according to the routine of the department and not as an emergency (transfer after 48 hours) The first experience of open heart surgery Age over 18 years Lack of disease or disability such as Alzheimer's, severe depression, hallucinations and pathological delusions The patient should be aware of the place, time and person. Lack of willingness to continue working on the study Transfer from the intensive care unit to cardiac surgery to other intensive care units The occurrence of any unforeseen events that lead to the patient's return, such as (rhythm rhythm or hemodynamic abnormalities)
Intervention groups
Accompanying and supporting the patient and preparing the patient for transfer from the intensive care unit to the general ward Educate the patient to increase self-care، patient delivery based on the ISBAR form and provide a complete report of medical history, treatment process, Required care, important points and follow-ups required by the patient to the ward staff, monitoring and ensuring the implementation of required care programs during the patient's hospitalization
Main outcome variables
Intensive care unit nurse, pleural effusion, pericardial effusion, atelectasis, readmission, length of hospital stay, patient satisfaction, hospital anxiety and depression

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20191225045890N1
Registration date: 2021-02-19, 1399/12/01
Registration timing: retrospective

Last update: 2021-02-19, 1399/12/01
Update count: 0
Registration date
2021-02-19, 1399/12/01
Registrant information
Name
ّFatemeh Keyvanlou shahrestanaki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7779 7446
Email address
fkeyvanlou@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-10, 1399/05/20
Expected recruitment end date
2020-11-20, 1399/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the Intensive care unit liaison nurse's role on patient's outcomes following transition from cardiovascular surgery intensive care unit (ICU - CVS)
Public title
The effect of the Intensive care unit liaison nurse's role on patient's outcomes following transition from cardiovascular surgery intensive care unit (ICU - CVS)
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to understand and speak Persian Transfer to the ward according to the routine section Over 18 years of age Lack of disease or disability Be aware of place and time and person.
Exclusion criteria:
Lack of cooperation in the study Transfer from the intensive care unit to cardiac surgery to other intensive care units The occurrence of any unforeseen events that lead to the patient's return, such as (َdis Rhythmi or hemodynamic abnormalities)
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Baqiyatallah University of medical sciences
Street address
No. 7/Nirou havaei St.8/26
City
tehran
Province
Tehran
Postal code
1749663837
Approval date
2020-03-16, 1398/12/26
Ethics committee reference number
IR.BMSU.BAQ.REC.1398.053

Health conditions studied

1

Description of health condition studied
role liaison nurse
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Hospital Anxiety and Depression
Timepoint
When transferring a patient from the intensive care unit and when discharging from the hospital
Method of measurement
Use of Hospital Anxiety Depression scale Questionnaire

2

Description
Patient satisfaction
Timepoint
When transferring the patient from the intensive care unit to the general ward and when discharging the patient from the hospital
Method of measurement
Using a standard questionnaire of patient satisfaction Instrument

3

Description
Duration of hospitalization
Timepoint
From the initial hospitalization of the patient in the intensive care unit until the end of discharge from the hospital
Method of measurement
the number of days of hospitalization

4

Description
Readmission
Timepoint
Within 14 days after discharge from the hospital
Method of measurement
Telephone contact with the patient and hospital admission

5

Description
Blood retention syndrome (pericardial and pleural effusion)
Timepoint
Before transferring the patient from the intensive care unit to the general ward and the day before the patient is discharged
Method of measurement
With chest x-ray and echocardiography

6

Description
Atelectasis
Timepoint
Before transferring the patient from the intensive care unit to the general ward and the day before the patient is discharged
Method of measurement
With chest x-ray and echocardiography

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: First, an explanatory study will be conducted to explain and formulate the role of the liaison nurse in the intensive care unit. To perform intensive care both in the intensive care unit and appropriately and as needed for patients in the internal medicine and surgery wards, ability to communicate with the patient and having educational skills, familiar with the goals of the project and how to perform the role and the importance of the role) Transfer of the patient from the intensive care unit to the general ward will begin and continue until the end of the discharge from the ward
Category
Prevention

2

Description
Control group: The control group receives routine care and training
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Jamaran Heart Hospital
Full name of responsible person
Zohre Vafadar
Street address
Tajrish Square - Shahid Ba Honar St. (Niavaran) Jamaran St. - Jamaran Sq. - Shahid Hassani Kia
City
tehran
Province
Tehran
Postal code
1977916773
Phone
+98 21 2303 4888
Fax
+98 21 2613 0812
Email
RM_283@hotmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Seyed Tayeb Moradian
Street address
Vanak Square - Mulla Sadra St. - Sheikh Baha'i St. South - Shahid Nosrati Alley - Baqiyatallah University of Medical Sciences
City
tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 5480
Email
fkeyvanlou@bmsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
School of Nursing, Baqiyatallah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
fatemeh keyvanlou shahrestanaki
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
nirou havaei 8/26 Street . No. 7
City
tehran
Province
Tehran
Postal code
1749663837
Phone
+98 21 7740 7679
Email
fkeyvanlou@bmsu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
fatemeh keyvanlou shahrestanki
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
nirou havaei 8/26 Street . No. 7
City
tehran
Province
Tehran
Postal code
1749663837
Phone
+98 21 7740 7679
Email
fkeyvanlou@bmsu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
fatemeh keyvanlou shahrestanki
Position
steudent
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
nirou havaei 8/26 Street . No. 7
City
tehran
Province
Tehran
Postal code
1749663837
Phone
+98 21 7740 7679
Email
fkeyvanlou@bmsu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The data is kept completely confidential by the research team
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Raw data is not made available to anyone and is confidential and is at the disposal of the research team. The statistical analysis map will be made available to the public in the research design booklet and part of it will be published through articles in scientific journals.
When the data will become available and for how long
After defending the research project and publishing booklets and articles
To whom data/document is available
The data is published only in the form of statistical findings in booklets and articles and its use is open to the public
Under which criteria data/document could be used
The data can only be used in the form of research project findings and for the use of findings in clinical settings
From where data/document is obtainable
The research team and the library of the university and the scientific journal in which the article was published
What processes are involved for a request to access data/document
Raw data will not be made available to anyone and will be confidential and available to the research team, but the findings of statistical tests will be made available to applicants.
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