Manual Versus AI-Assisted Clinical Trial Screening Using Large-Language Models

Conditions

• Comparing Manual and AI Patient Screening in Heart Failure

Eligibility Criteria

Sex

ALL

Age

18 Years - 90 Years

Healthy Volunteers

Accepted

Interventions

• RECTIFIER - a generative artificial intelligence screening tool — OTHER
  RECTIFIER is a large-language model based, generative artificial intelligence-enabled inclusion and exclusion criteria assessment tool.
• Manual clinical trial screening by study staff — OTHER
  The current gold standard - study staff manually review potentially eligible patients through chart review.

Study Details

A prospective randomized controlled trial comparing manual review and AI screening for patient eligibility determination and enrollments. A structured query will identify potentially eligible patients from the Mass General Brigham Electronic Data Warehouse (EDW), who will then be randomized into either the manual review arm or the AI-assisted review arm.

Key Dates

Start date

Mar 4, 2024

Status verified

Sep 2024

Primary completion

Sep 13, 2024

Completion

Sep 13, 2024

Study Design

Enrollment

4,500 participants (estimated)

Arms

• Arm: Manual Review Arm
  Study staff manually reviews patient eligibility.
• Arm: Artificial Intelligence (AI) Review Arm
  AI screens for eligibility, followed by an abbreviated final review by study staff.

Primary Outcome Measure

Determine study eligibility, analyzed using a survival analysis framework, specifically the Fine-Gray subdistribution hazards model, to account for competing risks. [ Time Frame: Through study completion, an average of 6 months ]

Central Contacts

• Ozan Unlu, MD
  617-732-7144
  [email protected]
• Alexander J Blood, MD
  617-732-7144
  [email protected]

Locations (1)

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