Effectiveness of Teleconsultation in Referring a Patient With Early Myocardial Infarction From Peripheral Hospital to Cardiac Centre in Hail, Saudi Arabia (Telehealth)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Telemedicine
• Intervention / Treatment: Other: Application of teleconsultation for a patient with a provisional diagnosis of myocardial infarction at the district hospital

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 440
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fakhralddin Elfakki, Researcher at MOC; Phone Number: +966530855161; Email: abbasfakhraddin@gmail.com
• Study Contact Backup: Name: Marwa Mahdy, Family Physician; Phone Number: +966508258235; Email: maroo_79@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Application of teleconsultation using WhatsApp to refer patient with with myocardial infarction; 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; Using teleconsultation for a patient with a provisional diagnosis of myocardial infarction during referral from the district hospital to the cardiac centre
No Intervention: Routine care and handling of a patient with mycardial infarction at peripheral hospital; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The New Model of Care, Hail Health Cluster
• Collaborators: Health Holding Company, Hail Health Cluster, Saudi Arabia
• Investigators: Study Chair: Khalil Alshammari, VIP Chief MO, Hail Health Cluster; Principal Investigator: Fakhralddin Elfakki, Researcher at MOC, New Model of Care, Hail Health Cluser; Study Director: Meshari Aljamani, MOC Lead, New Model of Care, Hail Health Cluster

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: December 15, 2022
• First Posted (Actual): December 16, 2022

Study Record Updates

• Last Update Posted (Actual): December 16, 2022
• Last Update Submitted That Met QC Criteria: December 15, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: telemedicine
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: Model of Care

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No