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The effect of Transitional Care Pathway on HealthCare Seeking Behaviors, Treatment Adherence, and Care Transition in patients with Acute Coronary Syndrome

Protocol summary

Study aim
Determining the effect of transitional care pathway on health care seeking behaviors, treatment adherence and care transition in patients with acute coronary syndrome.
Design
Clinical trial with control group, with parallel groups, blinding of analyst and allocator, randomized, on 70 patients. Closed-envelope randomization.
Settings and conduct
This randomized controlled clinical trial will be conducted on 70 patients with acute coronary syndrome hospitalized in Imam Reza Hospital in Mashhad, who meet the criteria for entering the research and will be included in the study through available sampling. The participants in the research will be randomly assigned to one of the two control or intervention groups. Patients in the control group will receive standard care, but in the intervention group, in addition to the usual interventions, interventions related to the transitional care pathway will be implemented. Questionnaires related to health care-seeking behaviors, and treatment adherence at the beginning of hospitalization and one month later, and the care transition measure one week after discharge, will be completed by phone and online. Finally, the data will be analyzed by statistical tests. In this study, blinding of the analyst and allocator is done.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age more than 18 Consent to participate in the study Hospitalization with diagnosis of acute coronary syndrome The ability to communicate verbally Exclusion criteria: Unstable clinical condition of the patient
Intervention groups
In the intervention group, in addition to routine care, patients will also receive the transitional care pathway interventions. In the control group, in addition to routine care, participants will receive standard care designed based on Tuna et al.
Main outcome variables
Health care seeking behaviors; Treatment Adherence; Care transition Measure

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220130053882N2
Registration date: 2023-08-09, 1402/05/18
Registration timing: registered_while_recruiting

Last update: 2023-08-09, 1402/05/18
Update count: 0
Registration date
2023-08-09, 1402/05/18
Registrant information
Name
AmirReza JamshidBeigi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 918 846 0124
Email address
amir.h.r.j@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-06, 1402/05/15
Expected recruitment end date
2023-11-06, 1402/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Transitional Care Pathway on HealthCare Seeking Behaviors, Treatment Adherence, and Care Transition in patients with Acute Coronary Syndrome
Public title
Investigating the effect of transitional care pathway on the outcomes of patients with acute coronary syndrome
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age more than 18 years Consent to participate in the study Hospitalization with diagnosis of acute coronary syndrome (diagnosis confirmed by doctor) Ability to communicate verbally
Exclusion criteria:
Instability of the patient's clinical condition
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
In order to prevent the dissemination of information, the method of randomization is time block method. In this way, sampling in the intervention and control groups will be done in the middle of the week. In this way, the first group will be randomly selected by lottery, then the patients who meet the criteria for entering the study will be included in the intervention or control group in the middle of the week. Randomization is such that first a random sequence will be generated for 8 weeks by Randomizer.org and this sequence will be kept in a sealed envelope. At the beginning of each week, the door of the envelope is opened and based on the code in the envelope, all the patients of that week are assigned to the intervention or control group.
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
Research Ethics Committees of School of Nursing & Midwifery, Mashhad University of Medical Sciences
Street address
Faculty of Nursing and Midwifery, Doctor's Crossroad, Ibn Sina Street, Mashhad University of Medical Sciences , Khorasan Razavi, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9176943314
Approval date
2023-07-11, 1402/04/20
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.058

Health conditions studied

1

Description of health condition studied
Angina pectoris
ICD-10 code
I20
ICD-10 code description
Angina pectoris

2

Description of health condition studied
Acute myocardial infarction
ICD-10 code
I21
ICD-10 code description
ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction

Primary outcomes

1

Description
Questionnaire score of health care seeking behaviors
Timepoint
At the time of hospitalization and one month later
Method of measurement
A researcher-made questionnaire of health care seeking behaviors

2

Description
Questionnaire score of treatment adherence
Timepoint
At the time of hospitalization and one month later
Method of measurement
Ziyai et al. treatment adherence questionnaire

3

Description
Questionnaire score of Care Transition
Timepoint
one week after discharge
Method of measurement
Care Transition Measure (CTM-15)

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention group, patients will receive interventions related to the transitional care pathway in addition to routine care after the need for assessment performed by the "Cardiac Disease Need Assessment Form". Interventions of transitional care pathway, which includes care interventions and education, and based on the review of reliable sources and the use of experts' opinions, will begin from the time of admission (emergency/CCU) for the patient after the illness, and according to the time of patient care, during hospitalization (emergency/CCU/I/post-angio). after discharge (telephone or online follow-up at home) will continue. The care and content of this program is provided by the researcher and through oral explanation and presentation of pamphlets, and includes things that use patient hospitalization (such as pain relief, rhythm and hemodynamic monitoring, introduction of the care team, ward and hospital, assessment of patient needs, etc.), treatment of diseases, activity, etc.), discharge time (such as self-care training and monitoring of complications, recognition of danger signs, bathing, prayer, smoking, rest, activity, tests, periodic check-ups, care of devices (such as ICD), coordination with cardiac rehabilitation program, etc.) After discharge, home care is done by phone or online (such as patient status, answering questions, checking side effects, medication side effects, taking medications, observing activity level and diet, rehabilitation status, monitoring ACS side effects, etc.). The frequency of follow-up of patients at home will be once a week by phone and online, and during this period, patients can ask their questions to the researcher. At the time of discharge, the patient will be asked how to communicate online and the communication received (Soroush, Eeta, Gap, Telegram, WhatsApp, etc.).
Category
N/A

2

Description
Control group: Among the control group, the participants will receive standard care designed based on Tuna et al. research in addition to routine care, which includes planned discharge training as well as a manual prepared by the researcher. In the educational program planned for this group, the definition of heart attack, symptoms, treatment goals and risk factors are presented. The training program also contains information about the importance of exercise and nutrition. The training is simple and understandable and the patient is allowed to ask his questions.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza hospital
Full name of responsible person
Amirreza Jamshidbeigi
Street address
Imam Reaz hospital, Ibn Sina Blvd, Mashhad, Razavi Khorasan Province, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
٩١٣٧٩١٣٣١۶
Phone
+98 51 3854 3031
Fax
Email
emamreza@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Qayour
Street address
University St., Mashhad, Razavi Khorasan Province, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
١٣٩۴۴ ٩١٣٨٨
Phone
+98 51 3841 2081
Email
ghayourm@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
Amirreza Jamshidbeigi
Position
MSc. Medical Surgical Nursing student ,Student Research Committee, Faculty of Nursing and Midwifery,
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 96, Fakouri 85, Rezashahr
City
Mashhad
Province
Razavi Khorasan
Postal code
9176943314
Phone
+98 918 846 0124
Fax
Email
jamshidar4001@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amirreza Jamshidbeigi
Position
MSc. Medical Surgical Nursing student ,Student Research Committee, Faculty of Nursing and Midwifery,
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 96, Fakouri 85, Rezashahr
City
Mashhad
Province
Razavi Khorasan
Postal code
9176943314
Phone
+98 918 846 0124
Fax
Email
jamshidar4001@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amirreza Jamshidbeigi
Position
MSc. Medical Surgical Nursing student ,Student Research Committee, Faculty of Nursing and Midwifery,
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 96, Fakouri 85, Rezashahr
City
Mashhad
Province
Razavi Khorasan
Postal code
9176943314
Phone
+98 918 846 0124
Fax
Email
jamshidar4001@mums.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
There is no further information
Study Protocol
No - There is not 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
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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