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.
Screening participants for clinical trials is a critical yet challenging process that requires significant time and resources. Traditionally, patient screening has been manual, relying on the diligence and judgment of study staff. However, manual screening is prone to human error and inefficiencies, contributing to high costs and prolonged trial durations. Recent advancements in natural language processing (NLP) and large language models (LLMs), such as GPT-4, offer potential solutions to improve the accuracy, efficiency, and reliability of the screening process. Retrieval-Augmented Generation (RAG)-enabled systems, like RECTIFIER, have shown promise in enhancing clinical trial screening by automating the extraction and analysis of relevant data from electronic health records (EHRs). In the investigators' previous study, RECTIFIER demonstrated high accuracy in screening patients for clinical trials, aligning closely with expert clinician reviews and outperforming manual study staff in several criteria. It underscored the potential for LLMs to transform clinical trial screening, making it more efficient and cost-effective while maintaining high standards of accuracy and reliability. However, before RECTIFIER is scaled to be used across many domains of clinical trials, it should be validated prospectively in the real-world setting to enroll patients. In the Co-Operative Program for Implementation of Optimal Therapy in Heart Failure (COPILOT-HF) trial (NCT05734690), the investigators will identify potential participants through EHR queries followed by manual review, which provides an opportunity for RECTIFIER to improve the screening process. By leveraging RECTIFIER, this study aims to evaluate the effectiveness of automated AI screening compared to traditional manual methods for enrollments of patients into an ongoing clinical trial.
Study Type
OBSERVATIONAL
Enrollment
4,500
RECTIFIER is a large-language model based, generative artificial intelligence-enabled inclusion and exclusion criteria assessment tool.
The current gold standard - study staff manually review potentially eligible patients through chart review.
Brigham and Women's Hospital
Boston, Massachusetts, United States
RECRUITINGDetermine study eligibility, analyzed using a survival analysis framework, specifically the Fine-Gray subdistribution hazards model, to account for competing risks.
Assess the likelihood of eligibility determination, comparing the AI-assisted screening group to the manual screening group accounting for the competing risk of ineligibility determination.
Time frame: Through study completion, an average of 6 months
Likelihood of achieving successful enrollment or eligibility, assessed using the hierarchical win ratio.
Compare the likelihood of achieving these outcomes between the AI-assisted and manual screening groups, using the unmatched hierarchical win ratio method comparing each patient in the AI assisted screening group to each patient in the manual screening group.
Time frame: Through study completion, an average of 6 months
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