1.01.05
2024:05:17 12:35:38.456
heart attack
495219
10599
1
1
1
NCT05654389
Model of Care
The New Model of Care, Hail Health Cluster
OTHER_GOV
Effectiveness of Teleconsultation in Referring a Patient With Early Myocardial Infarction From Peripheral Hospital to Cardiac Centre in Hail, Saudi Arabia
Effectiveness of a New Pathway of Referring a Patient With Early Myocardial Infarction From Peripheral Hospital to Cardiac Centre in Hail, Saudi Arabia: A Randomized Clustered Trial
Telehealth
December 2022
Not yet recruiting
No
January 2023
Anticipated
June 2023
Anticipated
July 2023
Anticipated
December 7, 2022
December 15, 2022
December 16, 2022
Actual
December 27, 2022
December 28, 2022
Actual
Sponsor
The New Model of Care, Hail Health Cluster
OTHER_GOV
Health Holding Company, Hail Health Cluster, Saudi Arabia
UNKNOWN
No
No
No
The goal of this pragmatic trial is to test the benefit of using a teleconsultation for referring a patient with a heart attack at an early stage from the suburban hospital to the heart centre. A teleconsultation with an expert cardiologist will be conducted by the physician at a suburban hospital. The main questions it aims to answer are:
To what extent does the use of a teleconsultation for a patient with a heart attack work well in lowering the proportion of deaths among patients with heart attacks who will be referred from suburban hospitals to the heart centre? To what extent does the use of a teleconsultation for a patient with a heart attack work well in raising the proportion of stable cases with heart attacks who will be referred from suburban hospitals to the heart centre? Participants will be asked to participate in a teleconsultation referral pathway from the suburban hospital to the heart centre.
Researchers will compare the change in the proportion of death rate and survivors or stable cases in the intervention versus the control group during referral from suburban hospital to heart centre.
Making use of telehealth and smart applications will positively improve the quality of the provided health service at suburban hospitals where there is a limited number of specialized doctors.
The economic burden of myocardial infarction is the highest in Saudi Arabia. This burden is mainly due to the associated costs of medical interventions and the length of hospital stay.
It is advisable that the health system in Saudi Arabia deploy appropriate measures for the prevention and early detection of myocardial infarction among diabetic patients. Otherwise, the economic burden of cardiovascular diseases is expected to shoot up.
A practical approach for referring patients with Myocardial Infarction (MI) is the modified meta-plan methodology for refereeing a patient from primary care to a cardiology clinic. This approach is recommended as an additional practical pathway for a patient with cardiovascular disease in primary care.
A concentrated value assessment model (CVAM) for determining percutaneous coronary intervention (PCI) levels is suggested to predict MI using accumulated sessions of ECG observation.
Patients at high risk of future myocardial infarction could be identified by every optician at the eye clinic using retinal images and demographic data,
Research Questions:
To what extent does the use of a teleconsultation intervention is effective in reducing the proportion of deaths among patients with myocardial infarction who will be referred from peripheral hospital to the cardiac centre? To what extent does the use of teleconsultation is effective in increasing the proportion of stable cases with myocardial infarction who will be referred from the peripheral hospital to the cardiac centre?
General objective:
To estimate the effectiveness of using a teleconsultation for patients with myocardial infarction at peripheral hospitals in reducing the proportion of deaths and increasing the proportion of stable cases among referral cases.
Specific Objectives:
Aim 1: To compare the proportion of death among cases with myocardial infarction who will be referred from a peripheral hospital to the cardiac centre in the intervention versus the control group (routine care).
Aim 2: To compare the proportion of stable cases of myocardial infarction who will be referred from the peripheral hospital to the cardiac centre in the intervention versus the control group (routine care).
Aim 3: To compare the proportion of cases who developed co-morbidities such as heart failure in the intervention versus the control group (routine care).
Literature Review:
A positive protective effect of antidepressant use to protect against developing myocardial infarction as primary care intervention is evident.
Research Design and Methods:
This is a six months clustered randomized trial that will recruit patients with provisional a diagnosis of myocardial infarction at a governmental peripheral hospital in Hail city.
Participants (P):
The participants will be adults presented to the physician at the peripheral hospital with symptoms and signs of myocardial infarction. The participants are expected to be adults aged 18 years and above. Children and young adults will be excluded. The aim is to report eligible cases by the physician at the peripheral hospital upon satisfaction with the written criteria for early MI diagnosis. The reporting will continue for six months from the beginning of the trial. Cases in both intervention and control clusters will be notified and reported regularly.
Telemedicine
telemedicine
Interventional
Not Applicable
Randomized
Parallel Assignment
Other
None (Open Label)
440
Anticipated
Application of teleconsultation using WhatsApp to refer patient with with myocardial infarction
Experimental
Application of teleconsultation using WhatsApp for a patient with myocardial infarction with a provisional diagnosis of myocardial infarction during referral from a district hospital to a cardiac centre.
Other: Application of teleconsultation for a patient with a provisional diagnosis of myocardial infarction at the district hospital
Routine care and handling of a patient with mycardial infarction at peripheral hospital
No Intervention
Routine care and consultation received by a patient with a provisional diagnosis of myocardial infarction during referral from the district hospital to the cardiac centre
Other
Application of teleconsultation for a patient with a provisional diagnosis of myocardial infarction at the district hospital
Using teleconsultation for a patient with a provisional diagnosis of myocardial infarction during referral from the district hospital to the cardiac centre
Application of teleconsultation using WhatsApp to refer patient with with myocardial infarction
The proportion of death among patients with myocardial infarction who will be referred from the peripheral hospital to the cardiac centre
The proportion of death among patients with myocardial infarction who will be referred from the peripheral hospital to the cardiac centre in the intervention versus the control group (routine care).
6 month from the start of the study
The proportion of stable cases of myocardial infarction who will be referred from the peripheral hospital to the cardiac centre
The proportion of stable cases of myocardial infarction who will be referred from the peripheral hospital to the cardiac centre in the intervention versus the control group (routine care).
6 month from the start of the study
The proportion of stable cases of myocardial infarction who received Tissue Plasminogen Activator (TBA) before referral
The proportion of stable cases of myocardial infarction who received Tissue Plasminogen Activator (TBA) before referral from the peripheral hospital to the cardiac centre in the intervention group versus the control group (routine care).
6 months after the start of the study
The proportion of stable cases of myocardial infarction who developed co-morbidities
The proportion of stable cases of myocardial infarction who developed co-morbidities such as heart failure in the intervention versus the control group (routine care).
6 months after the start of the study
Inclusion Criteria:
patient aged 18 to 80 with provisional diagnose of MI
Exclusion Criteria:
severely ill patient and patient with other chronic conditions or cancer
Accepts Healthy Volunteers
All
18 Years
60 Years
Adult
Fakhralddin Elfakki, Researcher at MOC
Contact
+966530855161
abbasfakhraddin@gmail.com
Marwa Mahmoud Mahdy, CSoC Lead
Contact
+966508258235
maroo_79@hotmail.com
Khalil Alshammari, VIP Chief MO
Hail Health Cluster
Study Chair
Fakhralddin Elfakki, Researcher at MOC
New Model of Care, Hail Health Cluser
Principal Investigator
Meshari Aljamani, MOC Lead
New Model of Care, Hail Health Cluster
Study Director
No
May 17, 2024
D000009203
Myocardial Infarction
D000007238
Infarction
D000007511
Ischemia
D000010335
Pathologic Processes
D000009336
Necrosis
D000017202
Myocardial Ischemia
D000006331
Heart Diseases
D000002318
Cardiovascular Diseases
D000014652
Vascular Diseases
M12155
Myocardial Infarction
Myocardial Infarction
high
M10282
Infarction
Infarction
high
M10543
Ischemia
low
M12284
Necrosis
low
M6546
Coronary Artery Disease
low
M19506
Myocardial Ischemia
low
M9419
Heart Diseases
low
M17400
Vascular Diseases
low
BC14
Heart and Blood Diseases
BC23
Symptoms and General Pathology
All
All Conditions