- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07742761
Emergency Medicine Practitioners Overall Well-being Enhancement With Ambient AI Scribes (EMPOWER)
3. srpna 2026 aktualizováno: 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.
Přehled studie
Postavení
Aktivní, ne nábor
Podmínky
Intervence / Léčba
Typ studie
Intervenční
Zápis (Aktuální)
55
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
-
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Missouri
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St Louis, Missouri, Spojené státy, 63110
- Washington University School of Medicine
-
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
|
Experimentální: 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.
|
|
Experimentální: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Impact of an ambient AI scribe on clinician well-being and professional fulfillment
Časové okno: 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
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Assessment of the longitudinal changes in documentation burden
Časové okno: 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.
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From enrollment to the end of maintenance phase at 42 weeks
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Vyšetřovatelé
- Vrchní vyšetřovatel: Thomas Kannampallil, PhD, Washington University in Saint Louis
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Obecné publikace
- 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.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
29. dubna 2026
Primární dokončení (Odhadovaný)
1. prosince 2026
Dokončení studie (Odhadovaný)
1. července 2027
Termíny zápisu do studia
První předloženo
21. července 2026
První předloženo, které splnilo kritéria kontroly kvality
28. července 2026
První zveřejněno (Aktuální)
3. srpna 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
6. srpna 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
3. srpna 2026
Naposledy ověřeno
1. srpna 2026
Více informací
Termíny související s touto studií
Klíčová slova
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Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .