Accelerating Access and Improving Imaging in Heart Failure Care (A2I2HF) Pilot Study
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Clinical Trials Project Lead
- Telefonnummer: 1-800-707-9098
- E-post: aa2i2@ualberta.ca
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske 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 studiet utformet?
Designdetaljer
- Primært formål: Diagnostisk
- Tildeling: Randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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 inngripen: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
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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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Justin Ezekowitz, MD, University of Alberta
- Hovedetterforsker: Safia Chatur, MD, Massachusetts General Hospital/Harvard Medical School and University of Alberta
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- A2I2HF
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Studerer et amerikansk FDA-regulert enhetsprodukt
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