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

Myocardial Infarction Clinical Trial

Official title:

Enhancing Strategic Management of Acute Reperfusion and Therapies in Acute Myocardial Infarction Using a Novel Smartphone APPlication (SMART-AMI APP)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05290389
• Other study ID #: HAH-21-015
• Status: Completed
• Start date: April 4, 2022
• Est. completion date: November 30, 2023

Study information

• Verified date: November 2023
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: November 30, 2023
• Est. primary completion date: March 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• STEMI

Intervention

Other:
• SMART AMI APPLICATION
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.

Locations

Country	Name	City	State
Canada	Brantford General Hospital	Brantford	Ontario
Canada	Joseph Brant Hospital	Burlington	Ontario
Canada	Haldimand War Memorial Hospital	Dunnville	Ontario
Canada	Fort Erie Urgent Care Center	Fort Erie	Ontario
Canada	West Lincoln Memorial Hospital	Grimsby	Ontario
Canada	West Haldimand General Hospital	Hagersville	Ontario
Canada	Hamilton General Hospital	Hamilton	Ontario
Canada	Juravinski Hospital	Hamilton	Ontario
Canada	Main Street West UCC	Hamilton	Ontario
Canada	St. Joseph's Hospital	Hamilton	Ontario
Canada	St. Joseph's Urgent Care Center	Hamilton	Ontario
Canada	Greater Niagara General Hospital	Niagara Falls	Ontario
Canada	Willett Urgent Care Centre	Paris	Ontario
Canada	Port Colborne Urgent Care Center	Port Colborne	Ontario
Canada	Norfolk General Hospital	Simcoe	Ontario
Canada	St. Catharines General Hospital	St. Catharines	Ontario
Canada	Welland County General Hospital	Welland	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
McMaster University	Centre for Evidence-Based Implementation, Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Usability	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.	12 months
Primary	Acceptability	The second primary outcome is acceptability of the App for Emergency Medicine physicians. This will be measured using the mHealth App Usability Questionnaire.	12 months
Primary	Functionality	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.	12 months
Secondary	Implementation	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.	12 months
Secondary	Timing of Care Intervals	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.	12 months
Secondary	False Positive Activation Rates	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.	12 months
Secondary	STEMI Activations via App	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