Accelerating Access and Improving Imaging in Heart Failure Care (A2I2HF) Pilot Study
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Clinical Trials Project Lead
- Telefonnummer: 1-800-707-9098
- E-mail: aa2i2@ualberta.ca
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Adult patients age ≥18 years presenting to the ED;
- with signs or symptoms of HF as per the treating physician and
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:
- prior documented diagnosis of HF;
- any patient receiving renal replacement therapy;
- any patient receiving comfort or palliative care;
- pregnant or nursing patients;
- patients planned for admission
- Investigator/treating physician discretion: any patient not suitable for participation for other reasons
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Intervention
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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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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Ingen indgriben: Control Period (Usual Care)
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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Feasibility of AI Assisted Point of Care Echocardiography Implementation
Tidsramme: During the enrollment period.
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Proportion of eligible patients successfully undergoing AI assisted echo assessment at the point of care.
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During the enrollment period.
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Diagnosis of heart failure (HF) within 90 days
Tidsramme: At 90 days.
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At 90 days.
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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).
Tidsramme: At 90 days and 1 year.
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At 90 days and 1 year.
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Proportion of patients with HF receiving GDMT within 90 days
Tidsramme: At 90 days.
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At 90 days.
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Difference in ratio of the incidence of diagnoses of HF via hospital admission-based versus community-based pathways
Tidsramme: At 90 days.
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At 90 days.
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Uptake and utilization: differential rates of uptake and utilization of AI Assisted echocardiography in the emergency department
Tidsramme: During the enrollment period.
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During the enrollment period.
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Determinants of uptake and utilization of AI assisted echocardiography in the emergency department (clinician questionnaire)
Tidsramme: During the enrollment period.
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During the enrollment period.
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Justin Ezekowitz, MD, University of Alberta
- Ledende efterforsker: Safia Chatur, MD, Massachusetts General Hospital/Harvard Medical School and University of Alberta
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- A2I2HF
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Studerer et amerikansk FDA-reguleret enhedsprodukt
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