Emergency Medicine Practitioners Overall Well-being Enhancement With Ambient AI Scribes (EMPOWER)
2026年8月3日 更新者: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.
調査の概要
研究の種類
介入
入学 (実際)
55
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Missouri
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St Louis、Missouri、アメリカ、63110
- Washington University School of Medicine
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:ヘルスサービス研究
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的: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.
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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.
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実験的: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.
|
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実験的: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.
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Impact of an ambient AI scribe on clinician well-being and professional fulfillment
時間枠:From enrollment to the end of maintenance phase at 24 weeks
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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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Assessment of the longitudinal changes in documentation burden
時間枠:From enrollment to the end of maintenance phase at 42 weeks
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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
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者:Thomas Kannampallil, PhD、Washington University in Saint Louis
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年4月29日
一次修了 (推定)
2026年12月1日
研究の完了 (推定)
2027年7月1日
試験登録日
最初に提出
2026年7月21日
QC基準を満たした最初の提出物
2026年7月28日
最初の投稿 (実際)
2026年8月3日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月6日
QC基準を満たした最後の更新が送信されました
2026年8月3日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 202602161
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
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いいえ
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いいえ
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