Protocol summary

Study aim
The effect of Hospital Readmissions Reduction Program on knowledge, self-care behaviors, 30-day readmission rate on heart failure patients
Design
Clinical trial with control group, with parallel groups, without blinding, randomized
Settings and conduct
Imam Reza Hospital (a.s.) and heart departments and post CCU, CCU process: 1.Redesigning the referral process: the existing hospital method by the research researcher, patients and their families are referred by the nurses of the special care department of the heart, and other departments with a referral form to the nursing clinic of the hospital. 2.Education to the patient and family: Trainings will be conducted by nurses in health education nursing clinic. The trainings will be provided to these patients in two 30-minute sessions individually with their families. In order to prepare these nurses, a two-hour training session will be held with an emphasis on the educational needs of heart failure patients and the introduction of educational content in this regard. 3.Follow-up : Follow-up will be done by phone within 30 days after discharge.
Participants/Inclusion and exclusion criteria
Inclusion Patients with heart failure confirmed by their doctor . The age of patients should be between 18 years and older. Having complete consent that is verbal and written. Patients who go home after discharge. Exit : Patients who are in critical condition and are hospitalized in special departments. The patient's unwillingness to continue the study. Patients who do not go home after discharge.
Intervention groups
a program that has three components: referral process design, patient and family education, and post-discharge follow-up, which will be done in coordination with the hospital's inpatient departments and health education nursing clinics.
Main outcome variables
knowledge ،behaviors self care,30-day readmission rate of heart failure patients

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230717058816N1
Registration date: 2023-12-26, 1402/10/05
Registration timing: retrospective

Last update: 2023-12-26, 1402/10/05
Update count: 0
Registration date
2023-12-26, 1402/10/05
Registrant information
Name
solmaz Ghebleh Govidaragh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 936 612 8805
Email address
gheblehgs2@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-23, 1402/09/02
Expected recruitment end date
2023-12-11, 1402/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Hospital Readmissions Reduction Program on knowledge, self-care behaviors, 30-day readmission rate on heart failure patients
Public title
the effect of hospital readmission reduction program on heart failure patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with heart failure confirmed by their doctor. The age of patients should be between 18 years and older Having complete consent that is oral and written patients who go home after discharge.
Exclusion criteria:
Patients who are in critical condition and are hospitalized in special departments. The patient's unwillingness to continue the study. patients who do not go home after discharge
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 76
Randomization (investigator's opinion)
Not randomized
Randomization description
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, Mashhad University of Nursing and Midwifery
Street address
east gate of Ferdowsi University of Mashhad، Azadi Square، university campus, educational complex of Shahid Dr. Kharazmi ،Khorasan Razavi, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2023-08-15, 1402/05/24
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.093

Health conditions studied

1

Description of health condition studied
Heart failur
ICD-10 code
I50
ICD-10 code description
Heart failure

Primary outcomes

1

Description
Self-care behaviors
Timepoint
Self-care behaviors will be measured before the intervention and one month after the intervention.
Method of measurement
How to measure the self-care variable will be measured with Rachel et al.'s self-care questionnaire.

Secondary outcomes

1

Description
Knowledge
Timepoint
At the beginning of the study, the knowledge variable will be measured and one month after the study, the knowledge of patients with heart failure will be measured.
Method of measurement
The method of measuring the knowledge of heart failure patients is with the Dutch knowledge questionnaire, and the knowledge of the patients will be measured before the intervention and one month later.

2

Description
30-day readmission rate of patients
Timepoint
The 30-day readmission rate of patients will be measured one month after the intervention.
Method of measurement
The method of measuring the rate of re-hospitalization is that one month after the intervention, it will be done by asking the patients and companions if they were hospitalized in Imam Reza Hospital or any other medical hospital and it will be measured quantitatively.

Intervention groups

1

Description
Intervention group: Education to the patient and family: At first, a needs assessment of the patients about the disease and the required educational materials will be done. The training of patients in the intervention group and their families during hospitalization and before discharge will be individual and together with their families .which will focus on learning patients about diet, daily weighing, medications, permitted and unauthorized activities, and smoking cessation. Trainings will be conducted by nurses working in health education nursing clinic. The trainings will be provided to these patients in two 30-minute sessions individually with their families. In order to prepare these nurses, a two-hour training session will be held with an emphasis on the educational needs of heart failure patients and the introduction of educational content in this regard. The educational contents of the patients including educational pamphlets (at least 4 pamphlets) and an educational video will be prepared by the researcher and will be provided to the patients. At the end, the guide form for monitoring the symptoms of the disease by the patient will be presented to the patient and the family.
Category
Lifestyle

2

Description
Control group: In this research, the control group will receive the usual training of the department, which includes the training codes in the training sheet about heart failure disease, which has been in the hospital before.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam reza hospital
Full name of responsible person
Solmaz Ghebleh
Street address
Ibn Sina Street, Imam Reza (AS) Hospital Square, Imam Reza (AS) Educational Research and Treatment Center, Razavi Khorasan
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3854 3031
Email
gheblehgs2@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Vice President of University Research
Street address
east gate of Ferdowsi University of Mashhad، Azadi Square، university campus, educational complex of Shahid Dr. Kharazmi ،Khorasan Razavi, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Fax
+98 51 3859 7313
Email
nms.pr@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Solmaz Ghebleh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
East gate of Ferdowsi University of Mashhad ،Azadi Square، university campus, educational complex of Shahid Dr. Kharazmi ،university campus, educational complex of Shahid Dr. Kharazmi، Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
098 51 38591511-3
Fax
+98 51 3859 7313
Email
nms.pr@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
HeshmatiNabavi Fatemeh
Position
University professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
East gate of Ferdowsi University of Mashhad ،Azadi Square، university campus, educational complex of Shahid Dr. Kharazmi ،university campus, educational complex of Shahid Dr. Kharazmi، Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
098 51 38591511-3
Email
heshmatinf@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Solmaz Ghebleh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
East gate of Ferdowsi University of Mashhad ،Azadi Square، university campus, educational complex of Shahid Dr. Kharazmi ،university campus, educational complex of Shahid Dr. Kharazmi، Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
098 51 38591511-3
Fax
Email
nms.pr@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
In the next steps, a decision will be made with the research team about the release of data and its details
When the data will become available and for how long
In the next steps, a decision will be made with the research team about the release of data and its details
To whom data/document is available
In the next steps, a decision will be made with the research team about the release of data and its details
Under which criteria data/document could be used
In the next steps, a decision will be made with the research team about the release of data and its details
From where data/document is obtainable
In the next steps, a decision will be made with the research team about the release of data and its details
What processes are involved for a request to access data/document
In the next steps, a decision will be made with the research team about the release of data and its details
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