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OpenEvidence Safety and Comparative Efficacy of Four LLM's in Clinical Practice

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 months later May 30, 2026 → Jul 30, 2026
Primary endpoint reworded 1 of 3 changed
See other at-risk trials from Cambridge Health Alliance

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary endpoint(s) modified
    • Secondary endpoints revised (12)
    • Study description shortened, about 1 word
    v6
  2. Minor Trial status changed: Enrolling by Invitation → Active, Not Recruiting
    • Primary completion pushed from May 30, 2026 to Jul 30, 2026
    v5
  3. Minor Primary completion pushed from Apr 30, 2026 to May 30, 2026
    • Study completion date: Sep 2026 to Sep 30, 2026
    • Study description expanded, about 2 words
    v4
  4. Minor Re-verified, no change to tracked fieldsv3
  5. Notable Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Study sites: 0 to 1
    v2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
OpenEvidence is an online tool that aggregates and synthesizes data from peer-reviewed medical studies, then producing a response to a user's questions using generative AI. While it is in use by a number of clinicians (including residents) today, there is little to no published data on whether the tool's outputs are accurate and whether this information appropriately informs clinical decision making. Similarly, a number of clinicians are turning to other large language models (LLM's) to assist in decision making when providing clinical care. While there have been a number of studies published on the accuracy of these LLM's responses to medical boards questions or clinical vignettes, there have been few studies to date examining their performance in a real world clinical setting, and even fewer comparing this performance. In this study, investigators have two goals: 1. To determine whether the use of the AI tool "OpenEvidence" leads to clinically appropriate decisions when utilized by family medicine, internal medicine, and psychiatry residents in the course of clinical practice. 2. To determine how the output of the OpenEvidence tool compares with three other commonly-used, publicly-available large language models (OpenAI's ChatGPT, Anthropic's Claude, and Google's Gemini) in answering common questions that residents have in the course of clinical practice. To accomplish study goal #1, investigators have enlisted residents in the above specialties to use the OpenEvidence tool in the course of clinical practice. In order to mitigate any safety risks, the residents will also use a typical reference tool for their question, which is referred to as the "Gold Standard" tool. These tools include PubMed and UpToDate. The residents will: 1. State their clinical question. 2. Query OpenEvidence, capturing their prompt and the OpenEvidence output for data analysis. All residents will undergo training in prompt engineering at the start of the study. 3. State their clinical conclusion based on the OpenEvidence data. 4. Query the Gold Standard Resource. 5. State their final clinical conclusion. 6. Answer a question on whether their clinical conclusion was modified by the Gold Standard reference. 7. Answer a question on whether they had any clinical safety concerns on the output from OpenEvidence. Attending physician Subject Matter Experts (SMEs) matched by specialty with at least 5 years of post-training clinical experience will then evaluate the residents' responses. 5 years was chosen based the book "Outliers" by Malcolm Gladwell, in which he asserts that 10,000 hours of focused practice is needed to achieve expertise in a field. SMEs will be asked to evaluate the residents' initial clinical questions and their conclusions based only on OpenEvidence. They will be asked to rate the clinical appropriateness of those conclusions on a scale of 1-10. For questions where the SME's rate the clinical appropriateness of the residents' conclusions poorly (\< 5/10), they will be asked to review the OpenEvidence output and answer an additional question as to whether the output was incorrect or the resident misinterpreted the output from the tool. To accomplish goal #2, the initial prompt entered by the residents into OpenEvidence will be copied by the research team into ChatGPT, Gemini, and Claude. The outputs from each tool (including OpenEvidence) will be surfaced to SMEs, who will be asked to rate each output based on accuracy, completeness, and bias. Likert scales will be used for these ratings. SMEs will also be asked an open-ended question to identify any patient safety issues from any of the outputs.
Trial Details
NCT Number NCT07199231
Lead Sponsor Cambridge Health Alliance
Conditions
(from sponsor)
AI (Artificial Intelligence), Large Language Model, Generative Artificial Intelligence
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov