RECRUITINGOBSERVATIONAL
Manual Versus AI-Assisted Clinical Trial Screening Using Large-Language Models
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
OTHER
RECTIFIER - a generative artificial intelligence screening tool
RECTIFIER is a large-language model based, generative artificial intelligence-enabled inclusion and exclusion criteria assessment tool.
OTHER
Manual clinical trial screening by study staff
The current gold standard - study staff manually review potentially eligible patients through chart review.
Locations (1)
Brigham and Women's Hospital
Boston, Massachusetts, United States