Determining the effectiveness of transition theory-based training on the discharge readiness of patients undergoing open heart surgery
Design
The clinical trial will be conducted as a quasi-experimental study using a convenience sampling method, with a control group, on 60 patients in two phases.
Settings and conduct
This quasi-experimental study will be conducted in the open heart ICU ward of Baqiyatallah Hospital in two phases using convenience sampling. In the first phase, the development and validation of educational content for open heart surgery patients from 2020 to 2024 will be carried out by reviewing the literature and examining it in a group of experts. In the second phase, patients will be randomly assigned to two control and experimental groups based on the sample size and inclusion and exclusion criteria.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
No history of previous open heart surgery - Age 30 to 75 years - Willingness to participate in the educational session - Literacy - No history of psychological disorders
Intervention groups
Control group: Patients who are candidates for cardiac surgery who are randomly assigned to the control group and receive routine hospital care.
Intervention group: First, written consent to participate in the study will be obtained. Then, one day before surgery (the day of patient preparation for surgery), discharge readiness, anxiety, and treatment compliance questionnaires will be completed. The experimental group will receive discharge readiness training based on Mellis' transition theory in addition to usual care.
Main outcome variables
Increasing readiness for discharge in open heart surgery patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241208063990N1
Registration date:2025-02-14, 1403/11/26
Registration timing:prospective
Last update:2025-02-14, 1403/11/26
Update count:0
Registration date
2025-02-14, 1403/11/26
Registrant information
Name
Ali Bayanati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8755 9886
Email address
reza.asgar57@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-02-19, 1403/12/01
Expected recruitment end date
2025-03-18, 1403/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Educational Intervention Based on Transition Theory on the Readiness for Hospital Discharge in Patients Undergoing Open Heart Surgery
Public title
A study of a new training for preparing cardiac patients before discharge after open heart surgery.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
No history of previous open heart surgery
Age 30 to 75 years
Willingness to participate in an educational session
Literacy
No history of psychological disorders
Exclusion criteria:
History of open heart surgery
Simultaneous participation in another study with similar educational content
Deterioration of the patient's condition and return to the intensive care unit
Age
From 30 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a block randomization method will be used to allocate patients to intervention and control groups. Initially, using random number generator software, blocks of size 4 will be created, consisting of combinations of intervention (I) and control (C) groups (such as IICC, ICIC, CCII). These blocks will be randomly arranged to create the final group allocation list. Each eligible patient entering the study will be assigned to either the intervention or control group in order from this randomized list. To maintain allocation concealment, sealed and numbered envelopes will be used. The person responsible for group allocation will not be involved in outcome assessment to ensure blinding. This method ensures that the number of participants in each group is balanced and minimizes the possibility of predicting group allocations, thereby increasing the internal validity of the study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee of Baqiyatallah Al-Azam Educational and Therapeutic Center
Street address
No. 150, West Brazil Street, Tehran
City
Tehran
Province
Tehran
Postal code
1435814817
Approval date
2024-12-03, 1403/09/13
Ethics committee reference number
IR.BMSU.BAQ.REC.1403.190
Health conditions studied
1
Description of health condition studied
Heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure
Primary outcomes
1
Description
Score obtained using the Readiness for Discharge Scale
Timepoint
Before the intervention and two months after surgery
Method of measurement
Score obtained from the Morisky questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Patients who are candidates for heart surgery at Baqiyatallah Hospital will be randomly selected to participate in the study. They will receive education over five days through in-person sessions, structured step-by-step based on the Transition Theory as follows: Session One (Day before surgery): To assess patient awareness, patients will complete an anxiety questionnaire and a readiness for discharge survey. Session Two (60-minute group session on the second day after surgery): Face-to-face education based on identified educational needs from reviewing literature on patient awareness, engagement, and participation. Education continues until patients demonstrate independence. Session Three (60-minute group session on the third day after surgery): Focuses on patient engagement and participation during the transition period to another ward. Feedback is provided on previously taught lessons, with additional instruction if needed. Patients are encouraged mentally to continue learning as they move wards. Session Four (15-20 minute individual or family interview): Considering critical aspects when preparing patients for home transfer, encouraging adherence to care plans taught earlier, motivating families to create a stress-controlled environment, monitoring medication intake. Session Five (Phone follow-up): Focusing on event aspects by contacting patients and their families two weeks post-discharge to review dietary and medication adherence; completing a medication regimen compliance questionnaire. This structured approach aims to enhance patient recovery through comprehensive support throughout their transition from hospital care back home.
Category
Lifestyle
2
Description
In the control group, patients who are candidates for heart surgery are randomly assigned to the control group and receive routine hospital care.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah Al-Azam Hospital, Tehran
Full name of responsible person
Saeed Hashemi
Street address
Vanak Square, Mulla Sadra Street, Sheikh Bahai Street
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 912 464 3976
Email
hashemisaeed65@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Saeed Hashemi
Street address
Vanak Square, Mulla Sadra Street, Sheikh Bahai Street
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 912 464 3976
Email
hashemisaeed65@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Saeed Hashemi
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Vanak Square, Mulla Sadra Street, Sheikh Bahai Street
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 9800
Email
hashemisaeed65@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Saeed Hashemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Vanak Square, Mulla Sadra Street, Sheikh Bahai Street
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 9800
Email
hashemisaeed65@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Saeed Hashemi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Vanak Square, Mulla Sadra Street, Sheikh Bahai Street
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8755 9800
Email
hashemisaeed65@yahoo.com
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All questionnaire questions, including researcher-made variables and scores of the questionnaires used, are available.
When the data will become available and for how long
Immediately after the article was published
To whom data/document is available
Researchers, professors and students of medical universities and healthcare workers
Under which criteria data/document could be used
The results of this study can be used in medical centers to improve the health of patients and to benefit the educational system.
From where data/document is obtainable
University Library, Published Article
What processes are involved for a request to access data/document
The request is sent via email or other means of communication to the responsible author or colleagues, and then the required information is made available to the applicants.