The effect of telenursing on newborn readmission rate after discharge from NICU
Design
Randomized Controlled Clinical Trials
Settings and conduct
The research environment was the NICU units of selected hospitals of Qazvin University of Medical Sciences including Kowsar and Qods hospitals. In the intervention group, training was provided through telenursing every 6 days and in 5 stages. The control group only received the ordinary care. One month after the infant’s being discharged from the hospital; both groups were surveyed regarding readmission through calling them. Data were collected using Mothers and Infants Demographic Characteristics Form and Mothers' Awareness Assessment checklist.
Participants/Inclusion and exclusion criteria
Mothers are included in the study who:
1. Their infant was admitted to one of the NICU units of the selected hospitals of Qazvin University of Medical Sciences for the first time.
2. They were willing to participate in this study.
3. They had no hearing or speech problems.
4- They spoke Persian (had Persian dialect).
5- Being Single baby
Exclusion criteria:
1- Baby's death
2. Permanent transfer of the baby (transfer for more than one shift) to another center
3. No telephone access (more than 3 consecutive times)
Intervention groups
The sample size was 288 cases (144 in the intervention group and 144 in the control group). According to the number of beds in the NICU, 110 patients from Kowsar hospital and 34 from the Qods hospital were included in each of the intervention and control groups.
Main outcome variables
Number of newborn readmission
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161024030474N3
Registration date:2020-03-25, 1399/01/06
Registration timing:retrospective
Last update:2020-03-25, 1399/01/06
Update count:0
Registration date
2020-03-25, 1399/01/06
Registrant information
Name
Azam Shirinabadi Farahani
Name of organization / entity
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21886553668
Email address
farahani1381@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2015-09-22, 1394/06/31
Actual recruitment start date
2015-04-21, 1394/02/01
Actual recruitment end date
2015-09-22, 1394/06/31
Trial completion date
2015-09-22, 1394/06/31
Scientific title
Investigation of telenursing in readmission post of discharch in neonate intensive care unit in hospitals, Qazvin University of Medical sciences
Public title
The effect of telenursing on the rate of newborn readmission
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers are included in the study: Their infants were first admitted to the neonatal intensive care unit of the selected hospitals of Qazvin University of Medical Sciences.
They were willing to participate in this study.
They had no hearing and speech problems
They spoke Persian (had Persian dialect).
Being single baby
Exclusion criteria:
Infant death
Permanent transfer of infant (transfer for more than one shift) to another center
No telephone access (more than 3 consecutive times)
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
288
Actual sample size reached:
288
Randomization (investigator's opinion)
Randomized
Randomization description
144 cases in the intervention group and 144 in the control group were randomly assigned.
Thus, A cards indicated the intervention group and B cards indicated the control group.
When the first preterm infant entered the intensive care unit in each of the two hospitals, one of the cards was randomly selected and the intervention or control group was identified.
The mother of the next preterm infant was in a group other than her previous group.
This work continued one by one until the sampling was completed and the expected sample size was reached.
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 Shahid Beheshti University of Medical Sciences
Street address
School of Nursing and Midwifery, Next to Ayatollah Rafsanjani's crossroads,Valiasr Street,Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2015-09-28, 1394/07/06
Ethics committee reference number
SBMU2.REC.1394.105
Health conditions studied
1
Description of health condition studied
Newborn readmission
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Newborn Readmission
Timepoint
One month after discharge, mothers of both groups were contacted to determine if the infants had readmitted and to obtain information on the frequency of readmissions.
Method of measurement
Telephone call and questions from the mother about readmission
Secondary outcomes
empty
Intervention groups
1
Description
The mothers in the intervention group were contacted within 2-3 days after their infants’ discharge, and then every 6 days and 5 times. Training material was presented during 5 sessions, as follows: 1-Breastfeeding techniques and diet. 2- Changing the infant’s position, and its rest and sleep patterns. 3- Skin and perineal care.4- Medications, medicine complications.5- Dressing care (if any), infection control procedures, and the next visit to the doctor’s. In each session, mothers were questioned on the material discussed during the previous session, first, and their level of awareness was examined by the “Mother’s Awareness Assessment Checklist”, which included 22 phrase on the infant’s general health at home. Then the mothers' questions were answered, and after the elimination of any ambiguity, training was done according to the educational package.
Kowsar Educational / Medical Center,Kowsar Alley ,Shahid Taleghani Street,Qazvin
City
Qazvin
Province
Qazvin
Postal code
13176- 34156
Phone
+98 28 3323 6374
Fax
+98 28 3323 6378
Email
hoskosar@qums.ac.ir
Web page address
http://hoskosar.qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Shahid Beheshti University of Medical Sciences - Next to Taleghani Hospital - Shahid Abbas Aerebi St. (Parvaneh) - Yemen Street - Shahid Chamran Highway-Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9780
Fax
+98 21 2243 9780
Email
farahani1381@sbmu.ac.ir
Web page address
http://sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Azam Shirinabadi Farahani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid School of Nursing and Midwifery, Next to Ayatollah Rafsanjani's crossroads,Valiasr Street,Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8820 2518
Email
farahani1381@sbmu.ac.ir
Web page address
http://nm.sbmu.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azam Shirinabadi Farahani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Next to Ayatollah Rafsanjani's crossroads,Valiasr Street,Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
Email
farahani1381@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azam Shirinabadi Farahani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Next to Ayatollah Rafsanjani's crossroads,Valiasr Street,Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Fax
+98 21 8820 2518
Email
farahani1381@sbmu.ac.ir
Web page address
http://nm.sbmu.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information on the main outcome (Newborn Readmission) can be shared
When the data will become available and for how long
Immediately after the publication of the article
To whom data/document is available
Care providers for infants (Mothers-Nurses-Physicians)
Under which criteria data/document could be used
Just to reduce the newborn readmission
From where data/document is obtainable
farahani1381@sbmu.ac.ir
What processes are involved for a request to access data/document