- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07742761
Emergency Medicine Practitioners Overall Well-being Enhancement With Ambient AI Scribes (EMPOWER)
3 de agosto de 2026 actualizado por: Philip R.O. Payne, Washington University School of Medicine
The primary objective of the study is to investigate the impact of an ambient AI scribe on clinicians' wellness and well-being outcomes; additionally, the investigators will also explore how the use of the ambient AI scribe will lead to changes in documentation burden, clinical note characteristics and financial productivity.
Descripción general del estudio
Estado
Activo, no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
55
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
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Missouri
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St Louis, Missouri, Estados Unidos, 63110
- Washington University School of Medicine
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Must be a Clinician (attendings and advanced practice practitioners) who is part of the Emergency Medicine Department
- Must be willing to use Ambient AI as apart of their clinical practice work
Exclusion Criteria:
-Residents who are apart of the Emergency Medicine Department
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Ambient AI Scribe Intervention, Wave 1 (Step-wedge design)
Clinicians use an ambient AI scribe during patient encounters to assist with clinical documentation.
Wave 1 participants receive the intervention for 18 weeks.
Outcomes are compared before and after implementation.
|
Clinicians will use an ambient AI scribe as part of routine clinical care.
The AI scribe captures the patient-clinician conversation, generates a draft clinical note, and supports documentation in the electronic health record.
Clinicians receive training before beginning use of the AI scribe.
The intervention is introduced in three sequential waves using a stepped-wedge design, with all participants eventually receiving the intervention.
|
|
Experimental: Ambient AI Scribe Intervention, Wave 2 (Step-wedge design)
Clinicians use an ambient AI scribe during patient encounters to assist with clinical documentation.
Wave 2 participants receive the intervention for 12 weeks.
Outcomes are compared before and after implementation.
|
Clinicians will use an ambient AI scribe as part of routine clinical care.
The AI scribe captures the patient-clinician conversation, generates a draft clinical note, and supports documentation in the electronic health record.
Clinicians receive training before beginning use of the AI scribe.
The intervention is introduced in three sequential waves using a stepped-wedge design, with all participants eventually receiving the intervention.
|
|
Experimental: Ambient AI Scribe Intervention Wave 3 (Step-wedge design)
Clinicians use an ambient AI scribe during patient encounters to assist with clinical documentation.
Wave 1 participants receive the intervention for 6 weeks.
Outcomes are compared before and after implementation.
|
Clinicians will use an ambient AI scribe as part of routine clinical care.
The AI scribe captures the patient-clinician conversation, generates a draft clinical note, and supports documentation in the electronic health record.
Clinicians receive training before beginning use of the AI scribe.
The intervention is introduced in three sequential waves using a stepped-wedge design, with all participants eventually receiving the intervention.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Impact of an ambient AI scribe on clinician well-being and professional fulfillment
Periodo de tiempo: From enrollment to the end of maintenance phase at 24 weeks
|
A linear model will be used to describe the effect of Ambient tool introduction on our co-primary outcomes under the intention-to-treat framework with a random effects structure to describe within provider variability.
While high or complete survey completion rates is expected, in the event that not all surveys are completed and returned, a primary analysis on completed surveys only will be performed, and perform sensitivity analyses accounting for potentially systematic survey non-response bias using a response weighting strategy, using provider, scheduling, and patient encounter characteristics to create survey response weights (within each survey time period), then reweighting observations to account for non-response patterns.
In analyses for both co-primary outcomes, Wald type hypothesis tests for inferences on the overall Ambient treatment effect and compare p-values to 0.05 / 2 to conservatively account for multiple comparisons using Bonferroni's method will be performed.
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From enrollment to the end of maintenance phase at 24 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Assessment of the longitudinal changes in documentation burden
Periodo de tiempo: From enrollment to the end of maintenance phase at 42 weeks
|
The investigators will fit Bayesian generalized linear models with appropriate link functions and likelihood choices (ie, log and Poisson for count data, logit and Bernoulli for binary responses) to for each encounter, while accounting for serial correlation overall through time (indexed to the day) using an autoregressive modeling structure, within provider patterns using a provider level random intercept, weekday, weekend, and holiday effects using fixed effects terms, and specify a flexible interrupted time series treatment effect using a semi-parametric, thin plate spline to describe how the introduction of Ambient AI affects the relationship between providers and notes, and how that relationship evolves over time.
In sensitivity analyses, evaluation of how these effects and their evolution may differ by treatment wave will be assessed.
All inferences will be based on describing the mean and 95% credible intervals for the treatment effect daily.
|
From enrollment to the end of maintenance phase at 42 weeks
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Thomas Kannampallil, PhD, Washington University in Saint Louis
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Trockel M, Bohman B, Lesure E, Hamidi MS, Welle D, Roberts L, Shanafelt T. A Brief Instrument to Assess Both Burnout and Professional Fulfillment in Physicians: Reliability and Validity, Including Correlation with Self-Reported Medical Errors, in a Sample of Resident and Practicing Physicians. Acad Psychiatry. 2018 Feb;42(1):11-24. doi: 10.1007/s40596-017-0849-3. Epub 2017 Dec 1.
- Sinsky C, Colligan L, Li L, Prgomet M, Reynolds S, Goeders L, Westbrook J, Tutty M, Blike G. Allocation of Physician Time in Ambulatory Practice: A Time and Motion Study in 4 Specialties. Ann Intern Med. 2016 Dec 6;165(11):753-760. doi: 10.7326/M16-0961. Epub 2016 Sep 6.
- Babbott S, Manwell LB, Brown R, Montague E, Williams E, Schwartz M, Hess E, Linzer M. Electronic medical records and physician stress in primary care: results from the MEMO Study. J Am Med Inform Assoc. 2014 Feb;21(e1):e100-6. doi: 10.1136/amiajnl-2013-001875. Epub 2013 Sep 4.
- Gardner RL, Cooper E, Haskell J, Harris DA, Poplau S, Kroth PJ, Linzer M. Physician stress and burnout: the impact of health information technology. J Am Med Inform Assoc. 2019 Feb 1;26(2):106-114. doi: 10.1093/jamia/ocy145.
- Lou SS, Lew D, Harford DR, Lu C, Evanoff BA, Duncan JG, Kannampallil T. Temporal Associations Between EHR-Derived Workload, Burnout, and Errors: a Prospective Cohort Study. J Gen Intern Med. 2022 Jul;37(9):2165-2172. doi: 10.1007/s11606-022-07620-3. Epub 2022 Jun 16.
- Moy AJ, Schwartz JM, Chen R, Sadri S, Lucas E, Cato KD, Rossetti SC. Measurement of clinical documentation burden among physicians and nurses using electronic health records: a scoping review. J Am Med Inform Assoc. 2021 Apr 23;28(5):998-1008. doi: 10.1093/jamia/ocaa325.
- National Academies of Sciences, Engineering, and Medicine; National Academy of Medicine; Committee on Systems Approaches to Improve Patient Care by Supporting Clinician Well-Being. Taking Action Against Clinician Burnout: A Systems Approach to Professional Well-Being. Washington (DC): National Academies Press (US); 2019 Oct 23. Available from http://www.ncbi.nlm.nih.gov/books/NBK552618/
- Afshar M, Baumann MR, Resnik F, Hintzke J, Sullivan AG, Wills G, Lemmon K, Dambach J, Ann Mrotek L, Quinn M, Abramson K, Kleinschmidt P, Brazelton TB, Leaf MA, Twedt H, Kunstman D, Patterson B, Liao F, Rasmussen S, Burnside ES, Goswami C, Gordon J. A Pragmatic Randomized Controlled Trial of Ambient Artificial Intelligence to Improve Health Practitioner Well-Being. NEJM AI. 2025 Dec;2(12):10.1056/aioa2500945. doi: 10.1056/aioa2500945. Epub 2025 Nov 26.
- Tierney, Aaron A., et al. "Ambient artificial intelligence scribes to alleviate the burden of clinical documentation." NEJM Catalyst Innovations in Care Delivery
- Nguyen, H., Bundy, H., Carroll, T., McWilliams, A., Dharod, A., Isreal, M., Cleveland, J., Bundy, R., Hetherington, T., & Liu, T.-L. (2024). Does AI-Powered Clinical Documentation Enhance Clinician Efficiency? A Longitudinal Studynejm ai, 1(12). https://doi.org/10.1056/AIoa2400659
- Yu, H., Li, F., Gallis, J. A., & Turner, E. L. (2019). cvcrand: A package for covariate-constrained randomization and the clustered permutation test for cluster randomized trials. The R Journal, 11(2), 191-204. DOI: 10.32614/RJ-2019-027.
- Shin HS, Williams H, Braykov N, Jahan A, Meller J, Orenstein EW. The Influence of Artificial Intelligence Scribes on Clinician Experience and Efficiency among Pediatric Subspecialists: A Rapid, Randomized Quality Improvement Trial. Appl Clin Inform. 2025 Aug;16(4):1041-1052. doi: 10.1055/a-2657-8087. Epub 2025 Jul 17.
- Shah SJ, Devon-Sand A, Ma SP, Jeong Y, Crowell T, Smith M, Liang AS, Delahaie C, Hsia C, Shanafelt T, Pfeffer MA, Sharp C, Lin S, Garcia P. Ambient artificial intelligence scribes: physician burnout and perspectives on usability and documentation burden. J Am Med Inform Assoc. 2025 Feb 1;32(2):375-380. doi: 10.1093/jamia/ocae295.
- Albrecht M, Shanks D, Shah T, Hudson T, Thompson J, Filardi T, Wright K, Ator GA, Smith TR. Enhancing clinical documentation with ambient artificial intelligence: a quality improvement survey assessing clinician perspectives on work burden, burnout, and job satisfaction. JAMIA Open. 2025 Feb 21;8(1):ooaf013. doi: 10.1093/jamiaopen/ooaf013. eCollection 2025 Feb.
- Pelletier JH, Watson K, Michel J, McGregor R, Rush SZ. Effect of a generative artificial intelligence digital scribe on pediatric provider documentation time, cognitive burden, and burnout. JAMIA Open. 2025 Jul 3;8(4):ooaf068. doi: 10.1093/jamiaopen/ooaf068. eCollection 2025 Aug.
- Galloway JL, Munroe D, Vohra-Khullar PD, Holland C, Solis MA, Moore MA, Dbouk RH. Impact of an Artificial Intelligence-Based Solution on Clinicians' Clinical Documentation Experience: Initial Findings Using Ambient Listening Technology. J Gen Intern Med. 2024 Oct;39(13):2625-2627. doi: 10.1007/s11606-024-08924-2. Epub 2024 Jul 9. No abstract available.
- Ma SP, Liang AS, Shah SJ, Smith M, Jeong Y, Devon-Sand A, Crowell T, Delahaie C, Hsia C, Lin S, Shanafelt T, Pfeffer MA, Sharp C, Garcia P. Ambient artificial intelligence scribes: utilization and impact on documentation time. J Am Med Inform Assoc. 2025 Feb 1;32(2):381-385. doi: 10.1093/jamia/ocae304.
- Guo Y, Wang J, Hu D, Tam S, Gilman C, Chow E, Perret D, Pandita D, Zheng K. Evaluating ambient artificial intelligence documentation: effects on work efficiency, documentation burden, and patient-centered care. J Am Med Inform Assoc. 2026 Feb 1;33(2):273-282. doi: 10.1093/jamia/ocaf180.
- Lukac PJ, Turner W, Vangala S, Chin AT, Khalili J, Shih YT, Sarkisian C, Cheng EM, Mafi JN. A Randomized-Clinical Trial of Two Ambient Artificial Intelligence Scribes: Measuring Documentation Efficiency and Physician Burnout. medRxiv [Preprint]. 2025 Jul 11:2025.07.10.25331333. doi: 10.1101/2025.07.10.25331333.
- Stults CD, Deng S, Martinez MC, Wilcox J, Szwerinski N, Chen KH, Driscoll S, Washburn J, Jones VG. Evaluation of an Ambient Artificial Intelligence Documentation Platform for Clinicians. JAMA Netw Open. 2025 May 1;8(5):e258614. doi: 10.1001/jamanetworkopen.2025.8614.
- Kanaparthy NS, Villuendas-Rey Y, Bakare T, Diao Z, Iscoe M, Loza A, Wright D, Safranek C, Faustino IV, Brackett A, Melnick ER, Taylor RA. Real-World Evidence Synthesis of Digital Scribes Using Ambient Listening and Generative Artificial Intelligence for Clinician Documentation Workflows: Rapid Review. JMIR AI. 2025 Oct 10;4:e76743. doi: 10.2196/76743.
- Gaffney A, Woolhandler S, Cai C, Bor D, Himmelstein J, McCormick D, Himmelstein DU. Medical Documentation Burden Among US Office-Based Physicians in 2019: A National Study. JAMA Intern Med. 2022 May 1;182(5):564-566. doi: 10.1001/jamainternmed.2022.0372.
- Apathy NC, Rotenstein L, Bates DW, Holmgren AJ. Documentation dynamics: Note composition, burden, and physician efficiency. Health Serv Res. 2023 Jun;58(3):674-685. doi: 10.1111/1475-6773.14097. Epub 2022 Nov 21.
- Ratanawongsa N, Matta GY, Bohsali FB, Chisolm MS. Reducing Misses and Near Misses Related to Multitasking on the Electronic Health Record: Observational Study and Qualitative Analysis. JMIR Hum Factors. 2018 Feb 6;5(1):e4. doi: 10.2196/humanfactors.9371.
- Kroth PJ, Morioka-Douglas N, Veres S, Pollock K, Babbott S, Poplau S, Corrigan K, Linzer M. The electronic elephant in the room: Physicians and the electronic health record. JAMIA Open. 2018 Jul;1(1):49-56. doi: 10.1093/jamiaopen/ooy016. Epub 2018 Jun 11.
- DiAngi YT, Stevens LA, Halpern-Felsher B, Pageler NM, Lee TC. Electronic health record (EHR) training program identifies a new tool to quantify the EHR time burden and improves providers' perceived control over their workload in the EHR. JAMIA Open. 2019 Mar 21;2(2):222-230. doi: 10.1093/jamiaopen/ooz003. eCollection 2019 Jul.
- Ahmed A, Chandra S, Herasevich V, Gajic O, Pickering BW. The effect of two different electronic health record user interfaces on intensive care provider task load, errors of cognition, and performance. Crit Care Med. 2011 Jul;39(7):1626-34. doi: 10.1097/CCM.0b013e31821858a0.
- Arndt BG, Beasley JW, Watkinson MD, Temte JL, Tuan WJ, Sinsky CA, Gilchrist VJ. Tethered to the EHR: Primary Care Physician Workload Assessment Using EHR Event Log Data and Time-Motion Observations. Ann Fam Med. 2017 Sep;15(5):419-426. doi: 10.1370/afm.2121.
- Cohen GR, Boi J, Johnson C, Brown L, Patel V. Measuring time clinicians spend using EHRs in the inpatient setting: a national, mixed-methods study. J Am Med Inform Assoc. 2021 Jul 30;28(8):1676-1682. doi: 10.1093/jamia/ocab042.
- Overhage JM, McCallie D Jr. Physician Time Spent Using the Electronic Health Record During Outpatient Encounters: A Descriptive Study. Ann Intern Med. 2020 Feb 4;172(3):169-174. doi: 10.7326/M18-3684. Epub 2020 Jan 14.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
29 de abril de 2026
Finalización primaria (Estimado)
1 de diciembre de 2026
Finalización del estudio (Estimado)
1 de julio de 2027
Fechas de registro del estudio
Enviado por primera vez
21 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
28 de julio de 2026
Publicado por primera vez (Actual)
3 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
3 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 202602161
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .