To determine the impact of transitional care upon the rate of readmission in patients after Coronary Artery Bypass Graft
Design
Randomized control trial containing two groups of 40 people (intervention and control)
Settings and conduct
Samples are selected in ICU-OH wards. During first week after discharge, in intervention group,each night, patient completes a checklist and sends its picture via internet messager. In case of a new problem or any need to further explanation patient can call researcher.
On the other hand,researcher calls patient in case of suspicious conditions to give some advice. In serious cases, researcher recommends patient to return the initial or nearest hospital. Researcher does two sessions of home visit ; first session in first week after discharge and the second one two weeks after that. The patient will be assessed according to the assessment form each session. In addition, researcher observes implementing instructions by patient and recommends referral to surgeon or other specialists if needed.
Ultimately, readmission rate and other complications are compared between groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria consists of: Being in high risk group according to '30-days readmission score', living in Tehran/suburbs in first month after discharge, Having and being able to use mobile and internet messaging(patient/ his or her care giver), Not having vital organ complicated diseases and not having mental disease.
Exclusion criteria consists of unwillingness to continue participating in research,Leaving Tehran/suburbs in first month after surgery,Hospital stay more than 10 days after surgery and patients death.
Intervention groups
Intervention group receive transitional care after discharge.though, control group receive only usual cares of hospital discharge program.
Main outcome variables
Readmission rate, complications of surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180408039238N1
Registration date:2018-09-10, 1397/06/19
Registration timing:retrospective
Last update:2018-09-10, 1397/06/19
Update count:0
Registration date
2018-09-10, 1397/06/19
Registrant information
Name
mehrnaz khishvand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3656 4998
Email address
m-khishvand@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-08-23, 1397/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The impact of transitional care upon the rate of readmission in patients after Coronary Artery Bypass Graft
Public title
The impact of transitional care upon the rate of readmission in patients after Coronary Artery Bypass Graft
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Being in high risk group according to "30-days readmission score", containing: Diabetes mellitus, haematocrit less than 35 before surgery, Using On-pump technique for surgery, Serum glycemic index of 200 and more.
Habitation in Tehran our suburbs in first month after discharge to ease the access to patients for home visits.
Having access to a mobile phone and being able to use mobile and using telegram(patient or his or her home care person) for educational relation and tele- Health
Not having vital organs complicated diseases(motor disfunction, rhumatoid artheritis, CVA,... )
Not having mental diseases(Schisophrenia. psychosis, major depression,...)
Exclusion criteria:
Unwillingness of patient to continue participating in research .
Leaving Tehran and suburbs in less than one month after discharge; because this impedes home visits.
Hospital stay more than 10 days after CABG surgery leads to omitting the patient from samples.
Patients death during first month after surgery.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Random blocking
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 faculty of Nursing and Midwifery of Tehran University of Medical Sciences
Street address
Faculty of Nursing and Midwifery , Dr. Mirkhani St (Nosrat St) ,Towhid sq,Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2018-01-31, 1396/11/11
Ethics committee reference number
IR.TUMS.FNM.REC.1396.4398
Health conditions studied
1
Description of health condition studied
Coronary Artery Bypass Graft Surgery
ICD-10 code
T82.9
ICD-10 code description
Unspecified complication of cardiac and vascular prosthetic device, implant and graft
Primary outcomes
1
Description
Readmission rate after discharge from hospital following Coronary artery bypass graft surgery
Timepoint
At the end of 30th day after discharge from hospital, readmission rate in groups (intervention and control) is measured.
Method of measurement
Asking patient and studying patient's case
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In intervention group, patient or his/her home caregiver is trained by researcher about how to keep connection with researcher from home and help tele-nursing. Instructions consists of how to measure body temperature, pulse rate, respiratory rate, blood pressure, efficient using of incentive spirometry, stair workout, walking, appropriate position (sleeping, sitting and during activities), using medications, assessing and caring sternal or limb incision, measuring weight, warning signs and what to do if those occur, wearing sternal support, suitable diet precautions when taking a bath, praying and during travel. Patient/ home caregiver sends to researcher ,by internet messaging, a report from patient's condition(using the report form designed by researcher) each night in first week after discharge. It is said to patient that she/he can contact researcher by phone call or voice message in case of a new problem or needing to ask question. In case of not sending reports regularly, researcher reminds patient/caregiver by phone call. Researcher contacts patient/home caregiver in case of suspicious conditions and gives some advice or in serious cases recommends patient to return to the initial hospital or first hospital near his/her home. . Researcher does two sessions of home visit ;one in first week after discharge and second session two weeks after first session. In each session, general assessment of patient's state is done, researcher observes implementing instructions by patient and recommends referral to surgeon or other specialists if needed. Patient is recommended to return initial hospital or other hospital in case of occurrence of warning signs between home visit sessions and every other time needed.
Category
Prevention
2
Description
Control group: This group will receive rutine care in hospital and after discharge follow ups. Ultimately, researcher will measure 30 day readmission rate in this group and will compare two groups.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Saeed Reza Mehrpour
Street address
Shariati Hospital, On the corner of Jalal Al Ahmad and Kargar st, Tehran
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
shariatihosp@tums.ac.ir
2
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Khosro Sadegh Neiat
Street address
Imam Khomeini Hospital, Gharib st, At the end of Keshavarz blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 8823 0231
Email
Imamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Faculty of nursing and midwifery of Tehran university of medical sciences
Full name of responsible person
Alireza Nikbakht Nasr Abadi
Street address
Room 48, Tehran School of Nursing & Midwifery, Tohid Sq.,Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
Nikbakht@tums.ac.ir
Grant name
Not determined yet
Grant code / Reference number
هنوز مشخص نیست
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Faculty of nursing and midwifery of Tehran university of medical sciences
Proportion provided by this source
50
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
Tehran University of Medical Sciences
Full name of responsible person
Mehrnaz Khishvand
Position
Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery,West Nosrat st,Towhid sq, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
+98 21 6990 4252
Email
M-khishvand@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Khatere Seylani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, West Nosrat st, Towhid sq, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
seylanikh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mehrnaz Khishvand
Position
Student of Master of Science
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and midwifery, West Nosrat st, Towhid sq, Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Email
m-khishvand@razi.tums.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
we have not decided about this topic yet.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
If we decided to share data file, it will be done unanimously both for demographic data and main outcome.
When the data will become available and for how long
It will be available from 2019
To whom data/document is available
Just will be available for academic staff.
Under which criteria data/document could be used
For secondary analysis, conducting comparative studies or met-analysis.
From where data/document is obtainable
They should send request for access to data to this Email Address:
M-khishvand@razi.tums.ac.ir
What processes are involved for a request to access data/document
In case of eligibility to have access to data, data file will be sent within 10 days.