Accelerating Access and Improving Imaging in Heart Failure Care (A2I2HF) Pilot Study

N/ANot Yet RecruitingNCT07624565

University of Alberta84 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

Conditions

Heart Failure

Interventions

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, * 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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Feasibility of AI Assisted Point of Care Echocardiography Implementation

Proportion of eligible patients successfully undergoing AI assisted echo assessment at the point of care.

Time frame: During the enrollment period.

Secondary Outcomes

Diagnosis of heart failure (HF) within 90 days

Time frame: 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).

Time frame: At 90 days and 1 year.

Proportion of patients with HF receiving GDMT within 90 days

Time frame: At 90 days.

Difference in ratio of the incidence of diagnoses of HF via hospital admission-based versus community-based pathways

Time frame: At 90 days.

Uptake and utilization: differential rates of uptake and utilization of AI Assisted echocardiography in the emergency department

Time frame: During the enrollment period.

Determinants of uptake and utilization of AI assisted echocardiography in the emergency department (clinician questionnaire)

Time frame: During the enrollment period.

Central Contacts

Clinical Trials Project Lead

CONTACT

1-800-707-9098 aa2i2@ualberta.ca

Data from ClinicalTrials.gov

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