Manual Versus AI-Assisted Clinical Trial Screening Using Large-Language Models
Recruiting · NCT06588452 · Observational (researchers observe without assigning treatment) · Lead sponsor: Brigham and Women's Hospital
View the official record on ClinicalTrials.gov →Interventions studied
Manual clinical trial screening by study staffRECTIFIER - a generative artificial intelligence screening tool
What this trial is about
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 can take part
Age range
18 Years to 90 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed across 1 US state.
- Brigham and Women's Hospital - Boston, Massachusetts, United States