Protocol summary

Summary
(1) Objectives: In many countries liaison nurse has been considered to improve the quality of nursing care in patients discharged from the intensive care unit and fix the gap between ICU and the medical-Surgical wards. This study determines the effect of the liaison nurse's role on recovery index in patients that discharge from the intensive care unit. (2) Design: 80 patients discharged from the intensive care unit on the Medical - Surgical wards. (3) Setting and conduct: a clinical trial for patients in selected hospitals in Tehran for six months in 2013-2014 as sampling. (4) Participants including major eligibility criteria: Inclusion criteria: age between 18 and 50 years, stable hemodynamic conditions. Exclusion criteria: patients in cardiopulmonary arrest and resuscitation, sudden change in hemodynamics (5) Interventions: Nursing care is provided by ICU liaison nurses for ICU discharge patients on the medical-Surgical wards. (6) main outcome measures (variables): index patient, including vital signs, level of consciousness, length of stay, readmission, and patient satisfaction

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201306239219N4
Registration date: 2014-08-29, 1393/06/07
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-08-29, 1393/06/07
Registrant information
Name
Marzieh Pazokian
Name of organization / entity
Baqiyatallah Faculty of Nursing
Country
Iran (Islamic Republic of)
Phone
+98 21 3319 5038
Email address
h_pazokian@iust.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Nursing Faculty of Baqiyatallah University of Medical Sciences
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2014-06-21, 1393/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial to assess the effect of the liaison nurse on recovery process for patients after ICU discharge in comparison with routine nursing care in the general wards in the Armed Forces Hospital in Tehran
Public title
The impact of liaison nurse on the quality of nursing care
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria 1. Patients are in the age range of 18-85 years 2. Absence of dysrhythmias Exclusion criteria 1. Cardiopulmonary arrest and resuscitation 2. Sudden change and unstable in hemodynamics status
Age
From 18 years old to 85 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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
Nursing Faculty of Medical Sciences Baqiyatallah, Araj Square, Aghdasieh, Tehran
City
Tehran
Postal code
Approval date
2013-09-29, 1392/07/07
Ethics committee reference number
6434/3/340/س

Health conditions studied

1

Description of health condition studied
The effect of the nursing care on recovery index
ICD-10 code
XXI, Z50,
ICD-10 code description
Factors influencing health status and contact with health services, Care involving use of rehabilitation procedures, Care involving use of other rehabilitation procedures

Primary outcomes

1

Description
ICU Readmission
Timepoint
Three days after admission, discharge time
Method of measurement
Patient Satisfaction Instrument, Modified Early Warning Score

2

Description
Length of Hospital Stay
Timepoint
Three days after admission, discharge time
Method of measurement
Patient Satisfaction Instrument, Modified Early Warning Score

Secondary outcomes

1

Description
Patient satisfaction with nursing care
Timepoint
Three days after admission + discharge time
Method of measurement
Patient Satisfaction Instrument, Modified Early Warning Score

2

Description
Additional cost of treatment
Timepoint
Three days after admission, discharge time
Method of measurement
Patient Satisfaction Instrument, Modified Early Warning Score

Intervention groups

1

Description
Intervention Group 1: monitoring vital signs, education about the daily movement and activity and nutrition from liaison nurse
Category
Prevention

2

Description
Group 2: received usual nursing care from general wards staff
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiyatallah University
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Nursing Faculty of Baqiyatallah University of Medical Sciences
Full name of responsible person
malihe moayed
Street address
Nursing Faculty of Medical Sciences Baqiyatallah, Araj Square, Aghdasieh
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Nursing Faculty of Baqiyatallah 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
Vice chancellor for research, Nursing Faculty of Baqiyatallah University of Medical Sciences
Full name of responsible person
malihe moayed
Position
Director of Nursing Faculty of Baqiyatallah University of Medical Sciences
Other areas of specialty/work
Street address
Nursing Faculty of Medical Sciences Baqiyatallah, Araj Square, Aghdasieh
City
Tehran
Postal code
Phone
+98 21 2228 9941
Fax
Email
nresearch92@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nursing Faculty of Baqiyatallah University of Medical Sciences
Full name of responsible person
Marzieh Pazokian
Position
Teacher
Other areas of specialty/work
Street address
Nursing Faculty of Medical Sciences Baqiyatallah, Araj Square, Aghdasieh
City
Tehran
Postal code
Phone
+98 21 3351 2169
Fax
Email
mpazokian@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Nursing Faculty of Baqiyatallah University of Medical Sciences
Full name of responsible person
Zeinab Tabanejad
Position
MSc in critical care Nursing
Other areas of specialty/work
Street address
Nursing Faculty of Medical Sciences Baqiyatallah, Araj Square, Aghdasieh
City
Tehran
Postal code
Phone
+98 21 3351 2521
Fax
Email
ztabanejad@yahoo.com; goleyass18@gmail.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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