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The effect of structured education and post-discharge follow-up on the incidence of early complications and mortality after open heart surgery

Protocol summary

Study aim
The effect of structured education and post-discharge follow-up on the incidence of early complications and mortality after open heart surgery
Design
The researcher referred to the research environment (Razi Hospital of Birjand) 100 patients admitted to the ICU of open heart surgery, by non-random and available sampling Will choose. After obtaining informed consent and explaining the research objectives to the research units, these individuals will be randomly divided into two groups of intervention time (structured training and follow-up after discharge) and control (routine training).
Settings and conduct
research environment (Razi Hospital of Birjand) Intervention group (structured training and follow-up after discharge) and control (routine training)
Participants/Inclusion and exclusion criteria
age over 18 years, no history of heart surgery, no history of stroke, no history of complications related to complications, literacy, lack of speech and hearing problems, the possibility of making phone calls, not being part of the health team And not receiving additional training will be.
Intervention groups
Educational content, based on the average number of days of hospitalization of these patients will be provided from admission to discharge. After the patient's discharge, a telephone call (with a maximum time of 15 minutes) will be made to follow up. The condition of the patients will be followed up to 3 months after discharge.
Main outcome variables
Common and important side effects such as disorders of the central nervous system, cardiovascular system, gastrointestinal, renal, pulmonary, hematologic, infectious, readmission and mortality cases will be investigated.Absolute and relative frequency of these complications will be determined and recorded.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180903040938N2
Registration date: 2021-01-17, 1399/10/28
Registration timing: registered_while_recruiting

Last update: 2021-01-17, 1399/10/28
Update count: 0
Registration date
2021-01-17, 1399/10/28
Registrant information
Name
Fahimeh Nikraftar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3859 1511
Email address
nikraftarf961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-12-21, 1399/10/01
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of structured education and post-discharge follow-up on the incidence of early complications and mortality after open heart surgery
Public title
The effect of structured education and post-discharge follow-up on the incidence of early complications and mortality after open heart surgery
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years Literacy Ability to make phone calls
Exclusion criteria:
receive additional training speech and hearing problems Being a member of a health team history of heart surgery history of stroke history of disease-related complications
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Random time block: In order to prevent patients from contacting each other and exchanging information between them, a random sequence of two-week time blocks will be randomly determined through SPSS software. The sequence is kept in a sealed envelope and when opened every two weeks, it is determined which intervention should be performed.
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 Birjand University of Medical Sciences
Street address
ghaffari street
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Approval date
2020-10-12, 1399/07/21
Ethics committee reference number
IR.BUMS.REC.1399.314

Health conditions studied

1

Description of health condition studied
open heart surgery
ICD-10 code
I23.8
ICD-10 code description
Other current complications following acute myocardial infarction

Primary outcomes

1

Description
Incidence of complications and mortality
Timepoint
At the beginning of the study and 3 months after the intervention
Method of measurement
Complication checklist

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Educational content prepared from reputable sources such as Clinical key, Medline plus and nursing consult after approval by experts in this field (nurses and physicians working in open heart surgery) based on the average number of days of hospitalization of these patients in the ward with the titles of initial admission Ward, general rules of the ward, how to wash hands properly, introduction of staff and how to use the nurse summons, the nature of the disease and the cause of hospitalization, methods of diagnosis and treatment of the disease, preparations before open heart surgery, postoperative care Open heart surgery, physical activity, diet, constipation prevention, on-site care, medication regimen and on-the-go training will be provided in each shift from admission to discharge. The presentation method includes lectures, showing pictures and related videos and presenting a pamphlet containing a summary of the content presented in each shift, and after the training, the patient and his caregiver will understand the training provided with open-ended questions. Also, before presenting each training, the patient's understanding of the training provided in the previous shift will be measured by asking questions and will be reviewed if necessary. After the patient's discharge, a telephone call (with a maximum time of 15 minutes) will be made to follow up on the patient's condition, remind them of the issues mentioned at the time of admission and answer possible questions on a specific day and according to the previously coordinated time with patients / their caregivers. Also, the contact number of the department will be provided to them to answer the questions. The condition of the patients will be followed up (telephone-doctor's visit) up to 3 months after discharge.
Category
Rehabilitation

2

Description
Control group: Get routine care in the ward
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Fahimeh Nikraftar
Street address
Ghaffari street, Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3238 1210
Email
Nikraftarf1992@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Toba Kazemi
Street address
ghaffari street, Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3238 1200
Email
drtooba.kazemi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Fahimeh Nikraftar
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
ghaffari street, Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3238 1210
Email
Nikraftarf1992@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Fahimeh Nikraftar
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Ghaffari street, Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3238 1210
Email
Nikraftarf1992@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Fahimeh Nikraftar
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
ghaffari street, Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۵۷۷
Phone
+98 56 3238 1210
Email
Nikraftarf1992@gmailcom

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Participants' information will be kept confidential and the results will be presented without mentioning the names of the individuals.
When the data will become available and for how long
After printing the results
To whom data/document is available
Everyone
Under which criteria data/document could be used
By respecting literary rights and trust
From where data/document is obtainable
Birjand University of Medical Sciences
What processes are involved for a request to access data/document
After reviewing the application, within a maximum of one week
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