AI ECHO INSIGHT RCT for Automated Echo Reporting (AI INSIGHT)

Kaiser Permanente

Status: Invitation-only

Conditions: Echocardiographic Software; Echocardiography, Transthoracic

Treatments: Other: Cardiologist-Only Echocardiogram Interpretation; Other: Sonographer-Assisted Echocardiogram Interpretation; Other: AI-Assisted Echocardiogram Interpretation

Study type: Interventional

Funder types: Other

Identifiers

NCT07229300

2302504

Details and patient eligibility

About

The goal of this blinded randomized controlled trial is to assess whether AI-assisted TTE interpretation can improve cardiologist efficiency and reduce interpretation variability while preserving accuracy compared to current methods in adult patients whose historical echocardiogram images were performed.

The main questions it aims to answer is to:

1. Assess overall transthoracic echocardiogram (TTE) interpretation accuracy of an AI-assisted workflow compared to standard cardiologist-only and sonographer-assisted workflows to hypothesize if AI-assisted workflow for echocardiography interpretation is non-inferior in accuracy compared to standard workflows.
2. Evaluate cardiologist interpretation time using an AI-assisted workflow compared to standard cardiologist-only and sonographer-assisted workflows to determine if an AI-assisted workflow will result in a decrease in interpretation time compared to the cardiologist-only workflow.
3. To compare interpretation consistency and reliability compared to historical reports as well as consensus reports of all finalized cardiologist reports.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥ 18 years of age
• Comprehensive transthoracic echocardiogram study performed a KPNC Medical Center.

Exclusion criteria

• Known Congenital heart disease study
• Known Ventricular assist device
• Limited transthoracic echocardiogram study
• Transesophageal echocardiogram study
• Stress echocardiogram study

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,200 participants in 3 patient groups

AI-Assisted Interpretation

Active Comparator group

Description:

In AI-prelim arm, AI provides the preliminary interpretation which is finalized by a blinded cardiologist.

Treatment:

Other: AI-Assisted Echocardiogram Interpretation

Sonographer-Assisted Interpretation

Active Comparator group

Description:

In Sonographer-prelim arm, sonographer provides the preliminary interpretation which is finalized by a blinded cardiologist.

Treatment:

Other: Sonographer-Assisted Echocardiogram Interpretation

Cardiologist-Only Interpretation

Active Comparator group

Description:

In cardiologist-prelim arm, cardiology provides the preliminary interpretation which is finalized by a blinded separate cardiologist.

Treatment:

Other: Cardiologist-Only Echocardiogram Interpretation