- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05290389
A Smartphone APPlication for the Transmission of ECGs in the Management of Patients Presenting With Suspected Heart Attacks in the Hamilton, Niagara, Haldimand, and Brant Area
Enhancing Strategic Management of Acute Reperfusion and Therapies in Acute Myocardial Infarction Using a Novel Smartphone APPlication (SMART-AMI APP)
The delivery of timely and appropriate care is crucial for patients with heart attacks. Blocked arteries need immediate intervention to restore blood flow. However, the intervention to open the artery is only available in large, regional hospitals. There are only 18 such hospitals across Ontario. Patients with heart attacks in smaller hospitals, where the majority of patients present, require transfer for specialized services. The smartphone application being evaluated in this study is meant to help with communication between doctors to arrange transfer of such patients.
The current model for communication is based on fax machines or non-secure text messages. Additionally, these are not easily accessible for most physicians, so decisions to transfer patients may be based on incomplete information. Unnecessary transfer, treatments, and procedures expose patients and healthcare providers to undue risk.
Smartphone technology is well integrated into clinical practice and widely accessible. The proposed solution being tested is secure and leverages the accessibility of smartphones. Emergency physicians can use this to quickly, securely, and accurately transmit information ensuring faster and appropriate decision making for transfers.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A multi-centre, mixed methods observational study focused on Emergency Department physicians who care for patients presenting to a regional partner hospital in the Hamilton, Niagara, Haldimand, Brant Local Health Integration Network (Canada) with suspected ST-segment Elevation Myocardial Infarction (STEMI). There are approximately 700 STEMI patients per year transferred and treated in the Hamilton General Hospital Cardiac Catheterization Lab. As this study is expected to run over the course of one year, it is anticipated that aggregate patient level data on approximately 700 STEMI patients in the STEMI database will be reviewed.
The study will use a pre-post design to evaluate the implementation and use of a clinical intervention, the SMART AMI App. The study will use quantitative registry data already being collected via the ongoing SMART-AMI project (e.g., STEMI database), utilization of data collected from the SMART AMI App, and quantitative and qualitative survey data from participating physicians. As the intervention in this study is a change in process to improve communication between Emergency Department physicians and Interventional Cardiologists, the study does not directly involve patients and individual patient consent will not be required. No new patient data will be collected for the purposes of this study.
Descriptive quantitative analysis and thematic qualitative analysis of survey results will be conducted. Descriptive and inferential statistics will be used for quantitative data derived from patient charts/registry and physician surveys. Continuous variables will be described using mean ± standard deviation. An interrupted time series analysis will be used to compare trends on time-based quality of care indicators. Categorical variables, such as false activation, will be described as frequencies and compared using a Fisher exact test or chi-square test.
Funding for this study was provided by the Hamilton Academic Health Sciences Organization (HAHSO) #HAH-21-015.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ontario
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Brantford, Ontario, Canada, N3R 1G9
- Brantford General Hospital
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Burlington, Ontario, Canada, L7S 0A2
- Joseph Brant Hospital
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Dunnville, Ontario, Canada, N1A 2P7
- Haldimand War Memorial Hospital
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Fort Erie, Ontario, Canada, L2A 1Z2
- Fort Erie Urgent Care Center
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Grimsby, Ontario, Canada, L3M 1P3
- West Lincoln Memorial Hospital
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Hagersville, Ontario, Canada, N0A 1H0
- West Haldimand General Hospital
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Hamilton, Ontario, Canada, L8L 2X2
- Hamilton General Hospital
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Hamilton, Ontario, Canada, L8N 4A6
- St. Joseph's Hospital
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Hamilton, Ontario, Canada, L8V 1C3
- Juravinski Hospital
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Hamilton, Ontario, Canada, L8G 5E4
- St. Joseph's Urgent Care Center
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Hamilton, Ontario, Canada, L8S 1A4
- Main Street West UCC
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Niagara Falls, Ontario, Canada, L2E 6X2
- Greater Niagara General Hospital
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Paris, Ontario, Canada, N3L 2M7
- Willett Urgent Care Centre
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Port Colborne, Ontario, Canada, L3K 2N7
- Port Colborne Urgent Care Center
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Simcoe, Ontario, Canada, N3Y 1T7
- Norfolk General Hospital
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St. Catharines, Ontario, Canada, L2S 0A9
- St. Catharines General Hospital
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Welland, Ontario, Canada, L3B 4W6
- Welland County General Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Physicians:
Emergency Medicine physicians working at the partner emergency departments and urgent care centres that refer STEMI patients to the cardiac catheterization lab at Hamilton General Hospital.
Description
Inclusion Criteria:
Emergency Medicine physicians at hospitals and urgent care centres located in the Hamilton, Niagara and Brant Local Health area:
- Brantford General Hospital
- Fort Erie Urgent Care Center
- Greater Niagara General Hospital
- Haldimand War Memorial Hospital
- Hamilton General Hospital
- Joseph Brant Hospital
- Juravinski Hospital
- Main Street West UCC
- Norfolk General Hospital
- Port Colborne Urgent Care Center
- St. Catharines General Hospital
- St. Joseph's Hospital
- St. Joseph's Urgent Care Center
- Welland County General Hospital
- West Haldimand General Hospital
- West Lincoln Memorial Hospital
- Willett Urgent Care Centre
Exclusion Criteria:
- N/A
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Physicians
All Emergency Medicine physicians and Interventional Cardiologists involved in STEMI care in the Hamilton Niagara Haldimand Brant Local Health area will be eligible for participation in this study.
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SMART AMI allows real-time sharing and review of patient history and ECG between Emergency Department physicians and Interventional Cardiologists to allow for immediate decision-making regarding the need for percutaneous coronary intervention. Participant physicians will use a smartphone application to communicate, transmit the ECG, and activate the STEMI team. This application enables calling and transmission of up to three images of ECGs, which can be reviewed immediately by the Interventional Cardiologist when communicating with the referring physician. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Usability
Time Frame: 12 months
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The first primary outcome is usability of the App for Emergency Medicine physicians.
This will be measured using electronic surveys and focus groups to identify barriers and facilitators faced when using the App.
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12 months
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Acceptability
Time Frame: 12 months
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The second primary outcome is acceptability of the App for Emergency Medicine physicians.
This will be measured using the mHealth App Usability Questionnaire.
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12 months
|
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Functionality
Time Frame: 12 months
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The third primary outcome will measure functionality of the App for Emergency Medicine physicians.
Through electronic surveys, barriers and facilitators faced when using the App will be assessed.
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Implementation
Time Frame: 12 months
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The secondary outcome will measure implementation of the App.
This will be acquired by the number of Emergency Medicine physicians who signed up for the App and used the App.
This measurement will be acquired from Google Data Analytics.
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12 months
|
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Timing of Care Intervals
Time Frame: 12 months
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Further secondary outcomes include measuring effectiveness of the App through timing of care intervals.
This outcome will be acquired from a consecutive sample of patients from the regional STEMI registry.
As these data are already collected as part of the ongoing SMART AMI program, no new patient data will need to be collected for the purpose of this study.
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12 months
|
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False Positive Activation Rates
Time Frame: 12 months
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Effectiveness of the App will be further measured by false positive STEMI activation rates.
This outcome will be acquired from a consecutive sample of patients from the regional STEMI registry.
As these data are already collected as part of the ongoing SMART AMI program, no new patient data will need to be collected for the purpose of this study.
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12 months
|
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STEMI Activations via App
Time Frame: 12 months
|
Effectiveness will also be measured by the rate of STEMI activations that utilized the App.
This outcome will be acquired from a consecutive sample of patients from the regional STEMI registry.
As these data are already collected as part of the ongoing SMART AMI program, no new patient data will need to be collected for the purpose of this study.
|
12 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Madhu K Natarajan, MD, Hamilton Health Sciences Corporation
- Principal Investigator: Mathew Mercuri, PhD, Hamilton Health Sciences Corporation
- Principal Investigator: Hassan K Mir, MD, Ottawa Heart Institute Research Corporation
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HAH-21-015
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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