Recruiting

AI-Assisted Screening

Sponsor:

Brigham and Women's Hospital

Code:

NCT06588452

Conditions

Comparing Manual and AI Patient Screening in Heart Failure

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

RECTIFIER - a generative artificial intelligence screening tool

Manual clinical trial screening by study staff

Study Details

Brief summary:

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.

Conditions

Comparing Manual and AI Patient Screening in Heart Failure

Study ID

NCT06588452

Start date

Mar 4, 2024

Status verified date

Sep, 2024

Completion date

Sep 13, 2024

Anticipated

Primary completion date

Sep 13, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Documented diagnosis of heart failure (e.g., ICD-9 codes 428 ICD-10 codes I50 or Problem list in the electronic health record)
  • Most recent left ventricular ejection fraction (LVEF) assessed within the past 24 months
  • Seen Mass General Brigham provider within the last 24 months

Exclusion Criteria:

  • LVEF <50% currently prescribed or intolerant to an evidence-based beta-blocker, ARNI, MRA, and SGLT2i at least 50% goal dose
  • LVEF>50% currently prescribed or intolerant to SGLT2i
  • Systolic blood pressure (SBP) <90 mmHg at last measure

Study Design

Enrollment

4500 participants

Anticipated

Interventions and Outcome Measures

Arms

Manual Review Arm

Study staff manually reviews patient eligibility.

Artificial Intelligence (AI) Review Arm

AI screens for eligibility, followed by an abbreviated final review by study staff.

Interventions

RECTIFIER - a generative artificial intelligence screening tool

RECTIFIER is a large-language model based, generative artificial intelligence-enabled inclusion and exclusion criteria assessment tool.

Manual clinical trial screening by study staff

The current gold standard - study staff manually review potentially eligible patients through chart review.

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 and Locations

Central contacts

Ozan Unlu, MD

617-732-7144ounlu@bwh.harvard.edu

Alexander J Blood, MD

617-732-7144ablood3@mgb.org

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Alexander J Blood, MD, MSc

617-732-7144ablood@bwh.harvard.edu

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Sep 19, 2024

Last verified

Sep, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2024-09-19.