- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07813754
Teaching Doctors in Training to Reason With Artificial Intelligence (TEACH-AI)
Teaching Internal Medicine and Family Medicine Residents to Reason With Generative AI: A Multi-Site Randomized Controlled Trial (TEACH-AI)
The purpose of the TEACH-AI study is to assess whether a brief, structured workshop on artificial intelligence can improve the performance of medicine doctors in training (i.e. residents) in their diagnostic and management reasoning.
In this multi-site randomized controlled trial, internal medicine and family medicine residents are assigned either to receive an in-person workshop on safe, effective LLM use before a standardized AI-assisted assessment, or to complete the same assessment before receiving the workshop. Residents will review clinical cases that are fully synthetic, no protected health information is used, using a password protected LLM interface.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Large language models (LLMs) have rapidly entered routine use in medical education and clinical practice. Prior randomized trials have shown that, although LLMs can outperform individual clinicians on some reasoning benchmarks, providing physicians with access to an LLM does not necessarily improve their diagnostic or management performance, and LLMs alone may perform better than physician-plus-LLM teams. These findings suggest that human-AI collaboration is fraught, non-trivial and may require explicit training.
TEACH-AI is a pragmatic, multi-site, two-arm randomized controlled trial embedded within protected residency didactic time. The primary objective is to determine whether a single in-person workshop on the basics of LLMs and best practices of prompting/verification strategies improves residents' performance on an AI-assisted assessment, compared with residents who complete the simulation before receiving the workshop. All participants will ultimately receive the same workshop and the same assessment (either workshop-first vs assessment-first).
The simulation consists of multiple fully synthetic vignettes delivered via a password protected LLM interface. Residents interact freely with the LLM using natural-language prompts and then submit structured final responses regarding aspects such as leading diagnosis, differential, management plan, and/or justification. The platform will record prompts, model outputs, final answers, and timing. Vignette scoring combines correctness of the final diagnosis or management plan. Scoring is conducted by blinded faculty using standardized rubrics and then any discrepancies will be resolved through multiple rounds of discussions.
The trial will enroll up to 200 residents across four ACGME-accredited programs (internal medicine at Beth Israel Deaconess Medical Center, Stanford University, and Cambridge Health Alliance; family medicine at AdventHealth Orlando).
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Jacob M Koshy, MD, MPH
- Numer telefonu: 617-754-4677
- E-mail: jkoshy@bidmc.harvard.edu
Lokalizacje studiów
-
-
California
-
Palo Alto, California, Stany Zjednoczone, 94305
- Stanford University
-
Kontakt:
- Kevin Keet, MD
- Numer telefonu: 650-498-4559
- E-mail: kkeet@stanford.edu
-
Główny śledczy:
- Kevin R Keet, MD
-
-
Florida
-
Orlando, Florida, Stany Zjednoczone, 32804
- AdventHealth
-
Kontakt:
- Raj Mehta, MD
- Numer telefonu: 407-845-8383
- E-mail: raj.mehta.md@adventhealth.com
-
Główny śledczy:
- Raj Mehta, MD
-
-
Massachusetts
-
Boston, Massachusetts, Stany Zjednoczone, 02215
- Beth Israel Deaconess Medical Center
-
Kontakt:
- Jacob M Koshy, MD, MPH
- Numer telefonu: 617-754-4677
- E-mail: jkoshy@bidmc.harvard.edu
-
Główny śledczy:
- Jacob M Koshy, MD, MPH
-
Cambridge, Massachusetts, Stany Zjednoczone, 02139
- Cambridge Health Alliance
-
Kontakt:
- Priyank Jain, MD
- Numer telefonu: 617-665-1000
-
Główny śledczy:
- Priyank Jain, MD
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Participants must be licensed physicians and have started at least post-graduate year 1 (PGY1) of medical training.
- Training in Internal medicine or family medicine or emergency medicine.
- Able to provide informed consent and complete assessments in English.
Exclusion Criteria:
- Not currently practicing clinically.
- Resident directly involved in the design of the study, development of the workshop, or creation/piloting of the assessment vignettes.
- Resident who declines or withdraws consent.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Diagnostyczny
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Brak interwencji: Assessment-First
Participants assigned to this group will be tasked with completing the assessment using a password protected LLM interface first in advance of the workshop.
The workshop will be delivered during a scheduled mandatory didactic time slot.
|
|
|
Eksperymentalny: Workshop-first
Participants assigned to this group will be tasked with completing the assessment using a password protected LLM interface after they participate in a scheduled mandatory didactic time slot.
|
Participants will attend a workshop during their didactic time that will review various aspects of large language models including fundamentals and best practices of interacting and interpreting their outputs.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Total Score on Expert-Development Rubrics
Ramy czasowe: Within 24 hours of assessment completion.
|
The primary outcome will be the number of correct responses for all cases using select questions from expert-developed scoring rubrics.
The rubrics were developed using a Delphi consensus process by expert physicians as established by Goh et al (Nature Medicine, 2025; DOI: 10.1038/s41591-024-03456-y). The primary outcome will be analyzed at the case level, comparing performance between the randomized study groups, with a higher number of correct responses indicating a better outcome.
|
Within 24 hours of assessment completion.
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Time Spent on Management
Ramy czasowe: Within 24 hours of assessment completion.
|
Comparison of time spent per case between the two study groups.
|
Within 24 hours of assessment completion.
|
|
Prompt Count
Ramy czasowe: Within 24 hours of assessment completion.
|
Comparison of the number of resident-initiated prompts to the LLM per case between the two study groups.
|
Within 24 hours of assessment completion.
|
|
Management Reasoning Using Expert-Derived Rubrics
Ramy czasowe: Within 24 hours of assessment completion.
|
Comparison of management reasoning accuracy based on the number of correct responses per case between the two groups on expert-developed scoring rubrics.
The rubrics were developed using a Delphi consensus process by expert physicians as established by Goh et al (Nature Medicine, 2025; DOI: 10.1038/s41591-024-03456-y). The primary outcome will be analyzed at the case level, comparing performance between the randomized study groups with more correct responses indicating a better outcome.
|
Within 24 hours of assessment completion.
|
|
Diagnostic Reasoning
Ramy czasowe: Within 24 hours of assessment completion.
|
Comparison of diagnostic reasoning accuracy based on the number of correct responses per case between the two groups.
|
Within 24 hours of assessment completion.
|
Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 2026P000369
- 63901784-350738 (Inny numer grantu/finansowania: Macy Foundation)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .