Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RECTIFIER - a generative artificial intelligence screening tool | Other | RECTIFIER is a large-language model based, generative artificial intelligence-enabled inclusion and exclusion criteria assessment tool. |
| Measure | Description | Time Frame |
|---|---|---|
| Determine 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. | Through study completion, an average of 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, an average of 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Potentially eligible patients identified through a structured query in the Mass General Brigham Enterprise Datawarehouse (EDW).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ozan Unlu, MD | Contact | 617-732-7144 | ounlu@bwh.harvard.edu | |
| Alexander J Blood, MD | Contact | 617-732-7144 | ablood3@mgb.org |
| Name | Affiliation | Role |
|---|---|---|
| Benjamin M Scirica, MD, MSc | Brigham and Women's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Manual clinical trial screening by study staff | Other | The current gold standard - study staff manually review potentially eligible patients through chart review. |
|