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| Name | Class |
|---|---|
| Canadian VIGOUR Centre | OTHER |
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This is a prospective, multicenter, cluster randomised trial which will assess the feasibility and acceptability of AI-assisted point of care echocardiography on HF detection and downstream care processes for patients with suspected HF discharged from the Emergency Department.
Heart failure remains underdiagnosed in frontline care settings, in part due to limited access to timely echocardiography. Recent advances in artificial intelligence (AI)-assisted echocardiography may facilitate scalable bedside screening through automated image acquisition support and interpretation.
This is a prospective, multicenter, cluster randomised trial which will assess the feasibility and acceptability of routine implementation of AI-assisted point of care echocardiography on HF detection and downstream processes of care for patients with suspected HF being discharged from the Emergency Department.
This study will be carried out at 2 participating Emergency Departments (EDs) in Alberta, Canada. Each ED site will alternate monthly between Intervention (AI-assisted echocardiography) and Control (Usual Care) periods.
During intervention periods, patients with suspected HF will undergo AI-assisted echocardiography using a handheld point of care EchoNous Kosmos device by the treating ED physician. The US2.ai algorithm will generate an AI-automated echo report. During control periods, patients will be managed according to usual care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | During each month-long Intervention period, an AI-assisted POCUS tool will be available for ED physicians use, at their discretion, to assess left ventricular ejection fraction (LVEF) and diastolic function in patients presenting to the ED with suspected HF. The AI-automated echocardiogram report may be used in the referral pathway to the HF clinic if deemed clinically appropriate. |
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| Control Period (Usual Care) | No Intervention | During each month-long Control period, the ED physicians will manage patients as close to "true" usual care as possible. There is no "placebo" arm. No actions will be undertaken to impede or prohibit care in the usual care arm. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI-assisted point-of-care ultrasound (POCUS) | Device | ED physicians at both sites will be provided with 1 session of in person training in the use of the AI-assisted POCUS device within 4 weeks of randomization including,
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of AI Assisted Point of Care Echocardiography Implementation | Proportion of eligible patients successfully undergoing AI assisted echo assessment at the point of care. | During the enrollment period. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnosis of heart failure (HF) within 90 days | At 90 days. | |
| Downstream health care resource utilization at 90 days and 1 year (e.g. rates of requests for echocardiography, cardiology referral, primary care appointments, HF hospitalization). | At 90 days and 1 year. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Project Lead | Contact | 1-800-707-9098 | aa2i2@ualberta.ca |
| Name | Affiliation | Role |
|---|---|---|
| Safia Chatur, MD | Massachusetts General Hospital/Harvard Medical School and University of Alberta | Principal Investigator |
| Justin Ezekowitz, MD | University of Alberta | Principal Investigator |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
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This study utilizes a time-sequential randomization structure, alternating monthly between control (standard care) and intervention (AI Assisted Echocardiography) periods. Patients will be consecutively enrolled based on their presentation during the assigned period, with no crossover within a given time block.
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| Proportion of patients with HF receiving GDMT within 90 days | At 90 days. |
| Difference in ratio of the incidence of diagnoses of HF via hospital admission-based versus community-based pathways | At 90 days. |
| Uptake and utilization: differential rates of uptake and utilization of AI Assisted echocardiography in the emergency department | During the enrollment period. |
| Determinants of uptake and utilization of AI assisted echocardiography in the emergency department (clinician questionnaire) | During the enrollment period. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |