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

First listed

Sep 19, 2024

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)

Find similar trials in Boston, MA