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临床试验/NCT05290389
NCT05290389已完成不适用

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

McMaster University17 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2022年4月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
260
试验地点
17
主要终点
Usability

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 未提供

结局指标

主要结局

Usability

时间窗: 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.

Acceptability

时间窗: 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.

Functionality

时间窗: 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.

次要结局

  • STEMI Activations via App(12 months)
  • Implementation(12 months)
  • Timing of Care Intervals(12 months)
  • False Positive Activation Rates(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (17)

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