The effect of the designed transitional care plan from the Open Heart Intensive Care Unit to the general ward in patients undergoing coronary artery bypass graft surgery
Determine the effect of designed transitional care plan from OH-ICU to general ward in patients under Coronary artery BYPASS graft surgery
Design
The non-randomized clinical trial, with the control group, on 62 patients
Settings and conduct
The research environment is OH-ICU and cardiac surgery wards of Imam Khomeini hospitals in Tehran. First, the patients in the control group are sampled by the convenience sampling method and then the participants of the intervention group are selected and receive the transfer care program. Questionnaires related to expected outcomes are completed before and after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: all patients undergoing CABG surgery who are candidates for transfer from the OH-ICU to the general ward at least two days after surgery; level of consciousness 15; no chronic progressive disease or acute unpredicted complications of the surgery; no history of diagnosed psychological disorders.
Exclusion criteria: reluctance to continue participating in the study during the intervention; death of the patient; the occurrence of an unpredictable accident that interferes with the implementation of the program.
Intervention groups
The intervention group receives a transitional care plan that includes designed measures to transfer the patient from the physician's decision to transfer the patient from the OH-ICU until discharge from the general ward (5-7 days). This program is implemented with the cooperation of the patient, trained nurses, the treating physician, and the patient's companion (friend, spouse, or relatives). The researcher monitors the patient and the implementation of the program during the intervention and records how the program is implemented in the registration forms.
Main outcome variables
Anxiety; relocation stress syndrome; patient satisfaction; family satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100531004062N2
Registration date:2021-08-02, 1400/05/11
Registration timing:prospective
Last update:2021-08-02, 1400/05/11
Update count:0
Registration date
2021-08-02, 1400/05/11
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
-
Email address
khoshkesht@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-01-21, 1400/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the designed transitional care plan from the Open Heart Intensive Care Unit to the general ward in patients undergoing coronary artery bypass graft surgery
Public title
The effect of the designed transitional care plan from the Open Heart Intensive Care Unit to the general ward in patients undergoing coronary artery bypass graft surgery
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
All patients undergoing Coronary artery bypass graft(CABG) surgery who are candidates for transfer from the Open Heart Intensive Care Unit (OH-ICU) to the general ward at least two days after surgery as directed by the physician
Level of consciousness 15 according to Glasgow Coma Scale (GCS)
No chronic progressive disease or acute unpredicted complications of surgery
No history of diagnosed psychological disorders
Exclusion criteria:
Reluctance to continue participating in the study during the intervention
Death of the patient
The occurrence of an unpredictable accident that interferes with the implementation of the program
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This study is part of a mixed-method study that aims to design, implement and evaluation of the transitional care plan from OH-ICU to general ward; The result of the doctoral dissertation of Nursing, Tehran University of Medical Sciences, School of Nursing and Midwifery, Number: 961199997. In order to design a transitional care program, while examining the concept of transitional care from the perspective of stakeholders (patients, patient companions, physician, and nurse responsible for patient transfer), the needs of patients undergoing CABG surgery eligible for transfer to the general ward have been identified (qualitative study). The program takes into account the preferences and needs of patients and stakeholders, using the best available evidence (systematic review of literature, guidelines, protocols, programs, and models of transitional care over the past 10 years), and the opinions of the Experts panel (Focus group) to be designed. Finally, the transitional care program was designed and developed in four dimensions: 1- Transfer expectation 2- Support, gradual reduction of dependence and increase of independence 3- Communication and strengthening of Care triangle 4- continuity of Integrated and need-based care.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Joint institutional research ethics Committee of School of Nursing and Midwifery & Rehabilitat
Street address
Nosrat St., Tohid Sq., School of Nursing & Midwifery, Tehran University of Medical Sciences, Tehra, Iran
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2019-05-19, 1398/02/29
Ethics committee reference number
IR.TUMS.FNM.REC.1398.020
Health conditions studied
1
Description of health condition studied
Transitional care program for patients undergoing coronary artery bypass graft surgery from the open heart intensive care unit to the general ward
ICD-10 code
I25.7
ICD-10 code description
Atherosclerosis of coronary artery bypass graft(s) and coronary artery of transplanted heart with angina pectoris
Primary outcomes
1
Description
Patients Satisfaction
Timepoint
After the intervention
Method of measurement
Patients Satisfaction Instrument
2
Description
Family Satisfaction
Timepoint
After the intervention
Method of measurement
Family Satisfaction Questionnaire
3
Description
Anxiety
Timepoint
Before and after the intervention
Method of measurement
Speilberger State – Trait Anxiety Inventory (STAI-Y)
4
Description
Relocation Stress Syndrome
Timepoint
After the intervention
Method of measurement
Relocation Stress Syndrome Scale
5
Description
Total Comfort Score
Timepoint
Before and after the intervention
Method of measurement
Visual Analog Scale to Total Comfort
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: after the necessary explanations to the research samples and obtaining informed consent, before transferring the patient from the open heart surgery-intensive care unit, questionnaires related to the expected outcomes (anxiety and perceived social support) are completed. Patients then have a transitional care program that includes measures designed to transfer the patient from the physician's decision to transfer the patient from the open heart surgery-intensive care unit to discharge from the general ward, which is designed to maintain the continuity of the integrated care while transferring the patient. It is performed in a multidisciplinary manner and with the cooperation of the patient, the patient care nurses from the open heart intensive care unit and general care, and the physician with the participation of the patient companions (friend, spouse, or relatives). Interventions are performed by trained nurses to implement this program in the intensive care unit and the general ward. The researcher monitors and tracks the patient and the implementation of the program during the course and records how the program is implemented in the registration forms of the transitional care program. On the day of the patient's discharge, questionnaires related to the expected outcomes (perceived anxiety and social support, patient satisfaction, and family satisfaction) are completed.
Category
N/A
2
Description
Control group: after the necessary explanations to the research samples and obtaining informed consent, before transferring the patient from the open heart surgery-intensive care unit of , questionnaires related to the expected outcomes (anxiety and perceived social support) are completed. Patients then receive routine care during the transfer to the general ward until the day of discharge. The researcher follows the patient throughout the course to be excluded from the study if they meet the exclusion criteria.On the day of the patient's discharge, questionnaires related to the expected outcomes (perceived anxiety and social support, patient satisfaction and family satisfaction) arecompleted.
No. 226, Central Building of TUMS, Ghods St., Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Sahar Khoshkesht
Position
PhD. Candidate
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing & Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
khoshkesht@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masoumeh Zakerimoghadam
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing & Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
zakerimo@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sahar Khoshkesht
Position
PhD. candidate
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing & Midwifery, Tehran University of Medical Sciences, Nosrat St., Tohid Sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
khoshkesht@razi.tums.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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data file, participants' details, information about the outcomes, and the study protocol with the designed program will be published as an articles
When the data will become available and for how long
6 months after publishing the results
To whom data/document is available
For researchers working in academic institutions with the approval of supervisors and advisors
Under which criteria data/document could be used
Only for use of the designed program with cited to the source
From where data/document is obtainable
The main researcher, Ms. Sahar Khoshkasht
What processes are involved for a request to access data/document
Send email to supervisors Dr. Masoumeh ZakeriMoghadam and Dr. Shahrzad Ghiyasvandian