Heart Failure
Conditions
Keywords
Heart Failure (HF), Emergency Department (ED), Point of Care Ultrasound, AI-assisted echocardiography
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAI-assisted point-of-care ultrasound (POCUS)
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, * Device set up * Demo of patient exam with POCUS device (to be used within its CE/Health Canada marked intended purpose or where deemed clinically appropriate by the treating physician). * Generation of AI-automated echocardiogram report for LVEF and diastolic dysfunction.
Sponsors
University of Alberta
Canadian VIGOUR Centre
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult patients age ≥18 years presenting to the ED; 2. with signs or symptoms of HF as per the treating physician and 3. elevated natriuretic peptides (NT-proBNP\>125pg/mL or BNP\>50pg/mL); drawn as part of standard of care of evaluation in the ED, OR age≥ 40 years and ≥1 HF risk factor: * Established diagnosis of type 2 diabetes * Coronary artery disease (prior documented type 1 myocardial infarction or coronary artery bypass grafting or percutaneous coronary intervention or documented stenosis of an epicardial coronary artery (\>50% left main or \>70% left anterior descending, circumflex or right coronary artery) * Previous ischemic or embolic stroke * Peripheral artery disease (previous surgical or percutaneous revascularization or a documented stenosis greater than 50% of a major peripheral arterial vessel). * Regular loop diuretic use
Exclusion criteria
1. prior documented diagnosis of HF; 2. any patient receiving renal replacement therapy; 3. any patient receiving comfort or palliative care; 4. pregnant or nursing patients; 5. patients planned for admission 6. Investigator/treating physician discretion: any patient not suitable for participation for other reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of AI Assisted Point of Care Echocardiography Implementation | During the enrollment period. | Proportion of eligible patients successfully undergoing AI assisted echo assessment at the point of care. |
Secondary
| Measure | 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. |
| 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. |
Contacts
CONTACTClinical Trials Project Lead
PRINCIPAL_INVESTIGATORSafia Chatur, MD
Massachusetts General Hospital/Harvard Medical School and University of Alberta
PRINCIPAL_INVESTIGATORJustin Ezekowitz, MD
University of Alberta
Outcome results
None listed