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
Official title: Enhancing Strategic Management of Acute Reperfusion and Therapies in Acute Myocardial Infarction Using a Novel Smartphone APPlication (SMART-AMI APP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
STEMI
Keywords: Mixed-methods
Promote Efficient Delivery of Health Care Resources
Technology
Health Care Delivery
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Hamilton Health Sciences Corporation
name: Centre for Evidence-Based Implementation
First posted: 2022-03-22
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Usability
timeFrame: 12 months
measure: Acceptability
timeFrame: 12 months
measure: Functionality
timeFrame: 12 months
Secondary outcomes:
measure: Implementation
timeFrame: 12 months
measure: Timing of Care Intervals
timeFrame: 12 months
measure: False Positive Activation Rates
timeFrame: 12 months
measure: STEMI Activations via App
timeFrame: 12 months
Other outcomes:
Locations:
city: Brantford
country: Canada
facility: Brantford General Hospital
state: Ontario
city: Burlington
country: Canada
facility: Joseph Brant Hospital
state: Ontario
city: Dunnville
country: Canada
facility: Haldimand War Memorial Hospital
state: Ontario
city: Fort Erie
country: Canada
facility: Fort Erie Urgent Care Center
state: Ontario
city: Grimsby
country: Canada
facility: West Lincoln Memorial Hospital
state: Ontario
city: Hagersville
country: Canada
facility: West Haldimand General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Urgent Care Center
state: Ontario
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Hospital
state: Ontario
city: Hamilton
country: Canada
facility: Main Street West UCC
state: Ontario
city: Hamilton
country: Canada
facility: Juravinski Hospital
state: Ontario
city: Niagara Falls
country: Canada
facility: Greater Niagara General Hospital
state: Ontario
city: Paris
country: Canada
facility: Willett Urgent Care Centre
state: Ontario
city: Port Colborne
country: Canada
facility: Port Colborne Urgent Care Center
state: Ontario
city: Simcoe
country: Canada
facility: Norfolk General Hospital
state: Ontario
city: St. Catharines
country: Canada
facility: St. Catharines General Hospital
state: Ontario
city: Welland
country: Canada
facility: Welland County General Hospital
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences Corporation
name: Madhu K Natarajan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hamilton Health Sciences Corporation
name: Mathew Mercuri, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ottawa Heart Institute Research Corporation
name: Hassan K Mir, MD
role: PRINCIPAL_INVESTIGATOR
References: