NCT06588452 · Brigham and Women's Hospital
Manual Versus AI-Assisted Clinical Trial Screening Using Large-Language Models
(MAPS-LLM)
What this study is about
A forward-looking randomly assigned controlled trial comparing manual review and AI screening for patient eligibility determination and enrollments.
View original scientific description
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 participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 19, 2024 · Source of record for eligibility and locations