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

Sponsor
McMaster University (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05290389
Collaborator
Hamilton Health Sciences Corporation (Other), Centre for Evidence-Based Implementation (Other)
184
17
12
10.8
0.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: SMART AMI APPLICATION

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
184 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Enhancing Strategic Management of Acute Reperfusion and Therapies in Acute Myocardial Infarction Using a Novel Smartphone APPlication (SMART-AMI APP)
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Usability [12 months]

    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.

  2. Acceptability [12 months]

    The second primary outcome is acceptability of the App for Emergency Medicine physicians. This will be measured using the mHealth App Usability Questionnaire.

  3. Functionality [12 months]

    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.

Secondary Outcome Measures

  1. Implementation [12 months]

    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.

  2. Timing of Care Intervals [12 months]

    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.

  3. False Positive Activation Rates [12 months]

    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.

  4. STEMI Activations via App [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Brantford General Hospital Brantford Ontario Canada N3R 1G9
2 Joseph Brant Hospital Burlington Ontario Canada L7S 0A2
3 Haldimand War Memorial Hospital Dunnville Ontario Canada N1A 2P7
4 Fort Erie Urgent Care Center Fort Erie Ontario Canada L2A 1Z2
5 West Lincoln Memorial Hospital Grimsby Ontario Canada L3M 1P3
6 West Haldimand General Hospital Hagersville Ontario Canada N0A 1H0
7 St. Joseph's Urgent Care Center Hamilton Ontario Canada L8G 5E4
8 Hamilton General Hospital Hamilton Ontario Canada L8L 2X2
9 St. Joseph's Hospital Hamilton Ontario Canada L8N 4A6
10 Main Street West UCC Hamilton Ontario Canada L8S 1A4
11 Juravinski Hospital Hamilton Ontario Canada L8V 1C3
12 Greater Niagara General Hospital Niagara Falls Ontario Canada L2E 6X2
13 Willett Urgent Care Centre Paris Ontario Canada N3L 2M7
14 Port Colborne Urgent Care Center Port Colborne Ontario Canada L3K 2N7
15 Norfolk General Hospital Simcoe Ontario Canada N3Y 1T7
16 St. Catharines General Hospital St. Catharines Ontario Canada L2S 0A9
17 Welland County General Hospital Welland Ontario Canada L3B 4W6

Sponsors and Collaborators

  • McMaster University
  • Hamilton Health Sciences Corporation
  • Centre for Evidence-Based Implementation

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
McMaster University
ClinicalTrials.gov Identifier:
NCT05290389
Other Study ID Numbers:
  • HAH-21-015
First Posted:
Mar 22, 2022
Last Update Posted:
Mar 22, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by McMaster University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 22, 2022