Protocol summary

Summary
Objective: Investigation of the effect of ICU liaison nursing service on ICU discharged patients' physical and psychological status in rajaee hospital Study design: Interventional or randomized clinical trial Method Study population: Inclusion criteria: Ability to communicate either verbally or non-verbally; The first admission in ICU; Having been hospitalized in ICU for at least 72 hours; Not having the history of critical physical diseases and known psychological disorders before being hospitalized in ICU. Exclusion criteria: Being transferred to another hospital; Being transferred to the ward on Friday or between 8 P.M. and 8 A.M. Sample size: Based on the previous studies, a 208-subject sample size (104 subjects in each group) was determined for the study. Intervention: According to the studies conducted on the issue, ICU liaison nurses act in 4 fields including training and supporting the wards nurses regarding the patients’ care requirements, creating relationship between the ward and ICU and preparing the two units for the transfer process, training and physically and emotionally supporting the patients, and training and supporting the patients’ families. Time of the intervention: From the moment the patient was transferred to the ward. In this way, ICU liaison nurse interventions will be performed in the intervention group and the results will be compared to the control group in definite intervals.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013053013523N1
Registration date: 2013-08-26, 1392/06/04
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-08-26, 1392/06/04
Registrant information
Name
Tahereh Ghahramani
Name of organization / entity
Shiraz University of Medical Sciences - Fatemeh Nursing and Midwifery College
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4254
Email address
ghahramant@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2013-12-22, 1392/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Impacts of Liaison Nurse Services on ICU Discharged Patients' Physical and Psychological Status in Rajaee Hospital – Shiraz - 2013
Public title
The Impacts of Liaison Nurse Services on ICU Discharged Patients' Physical and Psychological Status
Purpose
Supportive
Inclusion/Exclusion criteria
The inclusion criteria of the study: Age above 18 years; willingness to take part in the study; Ability to communicate either verbally or non-verbally; The first admission in ICU; Having been in ICU for at least 72 hours; Not having the history of critical physical diseases and known psychological disorders before being hospitalized in ICU. The exclusion criteria of the study: Unwillingness to cooperate or disruption of the patient’s cooperation for any reason; Being transferred to another hospital; Being transferred to the ward on Friday or between 8 P.M. and 8 A.M.
Age
From 18 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 208
Randomization (investigator's opinion)
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
Shiraz Univesity of Medical Sciences
Street address
Shiraz Univesity of Medical Sciences, Zand st, Shiraz
City
Shiraz
Postal code
13119–71936
Approval date
2013-04-21, 1392/02/01
Ethics committee reference number
CT-92-6525

Health conditions studied

1

Description of health condition studied
circulatory and respiratory status
ICD-10 code
R00-R09
ICD-10 code description
Symptoms and signs involving the circulatory and respiratory systems

Primary outcomes

1

Description
Physical status
Timepoint
Time of transfer and 24 and 72 hours after being transferred to the ward.
Method of measurement
According to MEWS(Modified early warning score)- Measurment of vital sign- Document return ( readmission ) to icu - Document death and etc .

2

Description
Psychological status
Timepoint
Time of transfer and 24 and 72 hours after being transferred to the ward.
Method of measurement
Hospital Anxiety and Depression Scale ( HADS )

Secondary outcomes

1

Description
Return ( readmission ) to icu
Timepoint
24 and 72 hours after being transferred to the ward.
Method of measurement
Return ( readmission ) to icu and not return

Intervention groups

1

Description
In this study, the patients in the intervention group are visited by the ICU liaison nurse at least once a day, the necessary interventions will be performed, and their physical as well as mental status will be recorded. Based on the studies conducted on the issue, an ICU liaison nurse acts in 4 fields as follows: 1. Training the ward nurses regarding the patients’ care requirements and supporting them. In this regard, The nurse will be informed about the process of patient care in ICU The patient’s body systems, such as the respiratory, cardiovascular, nervous, and gastrointestinal systems, will be reviewed by the responsible nurse, the nurse will be trained regarding the patient’s needs in the ward, and the essential points will be put in the patient’s kardex in form of a pamphlet. The medicines that will be given to the patient in the ward will be reviewed with the responsible nurse. The liaison nurse’s phone number will be given to the ward nurses to contact her/him if necessary. 2. Creating relationship between the ward and ICU and preparing the two units for the transfer process: Informing the ICU nurses about the ward facilities Encouraging the ICU nurses to give complete and clear reports about the patients to the responsible nurses of the ward Preparing appropriate room, bed, and facilities in the ward for the patients discharged from ICU before and after they are transferred to the ward Trying to inform the ward personnel regarding the patients’ transfer and status at least 2-3 hours before the transfer. Also, attempts should be made to avoid patient transfer at inconvenient hours. 3. Training and physically and psychologically supporting the patients: Obtaining the patients’ reports of psychical and mental status during ICU stay and reviewing their records at the beginning of the intervention Explaining the reason for transfer, the facilities, and the number of ward personnel to the patients Physically and emotionally supporting the patients since they are informed about being discharged ICU liaison nurse visiting the patients every day, assessing their physical and mental status, and providing them with the necessary care Training the patients to care about themselves both physically and mentally 4. Training and supporting the patients’ families: Providing the patient’s family with the information about his/her transfer to the ward as well as the ward facilities Explaining the patient’s present status and improvement process to his/her family Training the families regarding supporting the patients in the ward to decrease both the patients’ and the families’ stress
Category
Other

2

Description
On the other hand, the control group patients are transferred to the ward with no interventions. Then, their physical and mental status will be investigated and recorded at the time of transfer and 24 and 72 hours after being transferred to the ward.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Rajaee Martyr Hospital
Full name of responsible person
Marzieh Momennasab ( PHD of Nursing - assistant professor)
Street address
Rajaee Martyr Hospital, Chamran Blvd, Shiraz, Farse
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Hatam
Street address
Seventh floor of Shiraz university of medical sciences and health services, Zandblvd
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Marzieh Momennasab
Position
PHD- assistant professor
Other areas of specialty/work
Street address
Fatemeh Nursing and Midwifery College
City
Shiraz
Postal code
13119–71936
Phone
+98 71 1727 7445
Fax
+98 71 1647 4252
Email
momennasab@sums.ac.ir - mnasab48@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Marzieh Momennasab
Position
PhD
Other areas of specialty/work
Street address
Fatemeh Nursing and Midwifery College
City
Shiraz
Postal code
13119–71936
Phone
+98 71 1727 7445
Fax
+98 71 1647 4252
Email
mnasab48@yahoo.com - momennasab@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Tahereh Ghahramani
Position
Bachelor of Arts in Nursing
Other areas of specialty/work
Street address
Fatemeh Nursing and Midwifery College
City
Shiraz
Postal code
13119–71936
Phone
+98 71 1627 4689
Fax
+98 71 1647 4252
Email
ghahramant@sums.ac.ir - ghahramani.tahereh@yahoo.com
Web page address

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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