Ambiente KI zur Reduzierung der Dokumentationszeit des Pflegepersonals
Eine EHR-integrierte pragmatische gestufte Keil-Studie zu Ambient Artificial Intelligence zur Reduzierung der Dokumentationszeit des Pflegepersonals
The goal of this clinical trial is to learn whether using Ambient Artificial Intelligence for nursing staff documentation in an inpatient setting will reduce the time spent in flowsheet documentation and enhance nurse staffing wellbeing.
Participants will use Ambient Listening AI software to draft documentation in discrete fields.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
This pragmatic trial is being conducted to test the effectiveness of Artificial Intelligence Driven Ambient Listening software on reducing time in flowsheet documentation among Registered Nurses (RNs) and nursing assistants (NAs) in an inpatient setting. The Ambient AI software uses Automated Speech Recognition technology with Large Language Models to automatically generate discrete flowsheet values from nurse-patient conversations in real-time. The clinical trial is an examination of the impact and usability of this implementation on the workload and well-being of nurses involved in the rollout of the software pragmatic Electronic Health Record embedded design integrated into clinical workflows and the health system IT infrastructure.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Wisconsin
-
Madison, Wisconsin, Vereinigte Staaten, 53718
- UW Health - East Madison Hospital
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Willingness to engage and use ambient technology
- English speaking
- All Registered Nurses and Nursing Assistants with the study inpatient units
- Attest to completing all required training
Exclusion Criteria:
- Planned leave more than 6 weeks during study timeframe
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Versorgungsforschung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Ambient Listening Group 1
The hospital unit will be randomized and all nursing staff within the unit will have access to start using Ambient AI at week 8. |
Ambient AI software intervention is implemented into the nursing staff workflow. The software incorporates Automated Speech Recognition technology with Large Language Models to generate clinical documentation in real-time |
|
Experimental: Ambient Listening Group 2
The hospital unit will be randomized and all nursing staff within the unit will have access to start using Ambient AI at week 11. |
Ambient AI software intervention is implemented into the nursing staff workflow. The software incorporates Automated Speech Recognition technology with Large Language Models to generate clinical documentation in real-time |
|
Experimental: Ambient Listening Group 3
The hospital unit will be randomized and all nursing staff within the unit will have access to start using Ambient AI at week 14. |
Ambient AI software intervention is implemented into the nursing staff workflow. The software incorporates Automated Speech Recognition technology with Large Language Models to generate clinical documentation in real-time |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Active Time Spent in Flowsheets per shift hour
Zeitfenster: Baseline to 22 weeks
|
To assess a change in nursing staff documentation time, the change active time spent in flowsheets per shift hour with the use of the Ambient Listening tool versus usual documentation will be reported. |
Baseline to 22 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Active Time Spent in Flowsheets per patient per shift
Zeitfenster: Baseline to 22 weeks
|
To assess nursing staff documentation burden, the change in active time spent in flowsheets per patient shift will be reported. |
Baseline to 22 weeks
|
|
Change in the number of clicks or taps in Flowsheets
Zeitfenster: Baseline to 22 weeks
|
To assess nursing staff documentation burden, the change in the number of clicks or taps in flowsheets will be reported. |
Baseline to 22 weeks
|
|
Change in Amount of Overtime Charting
Zeitfenster: Baseline to 22 weeks
|
To assess nursing staff documentation burden, the change in time spent documenting after end time of assignment will be reported. |
Baseline to 22 weeks
|
|
Change in Clinician Worklife Survey (Mini-Z) Score
Zeitfenster: Baseline to 24 weeks
|
Professional Wellbeing will be assessed with the Mini Z 3.0, a 10 item tool (plus one open-ended question) designed to quickly assess clinician burnout, stress, satisfaction, and work-life drivers such as workload control, teamwork, and electronic health record (EHR) related stressors. The Mini Z survey is scored by summing responses to the first 10 items, each rated on a 1-5 Likert scale, producing a total score ranging from 10 to 50. Higher scores indicate better worklife conditions, with scores of 40 or above reflecting a "joyful" workplace. |
Baseline to 24 weeks
|
|
Change in Mini-Z Subscale Scores: Supportive Work Environment
Zeitfenster: Baseline to 24 weeks
|
Professional Wellbeing will also be assessed with Mini Z subscales. One Mini-Z subscale measures supportive work environment with 7-items (scores range from 7-35, higher scores indicate more supportive environment). |
Baseline to 24 weeks
|
|
Change in Mini-Z (3.0) Subscale Scores: EHR Stress
Zeitfenster: Baseline to 24 weeks
|
Professional Wellbeing will also be assessed with Mini Z subscales. One Mini-Z subscale measures EHR stress (scores range from 3-15, higher scores indicate more manageable EHR stress). |
Baseline to 24 weeks
|
|
Change System Usability Scale (SUS)
Zeitfenster: 11 weeks to 24 weeks
|
The SUS is a 10-item scale that assesses perceived usability of a system, in this case, the Abridge Ambient Listening Tool. It yields a single score that can range from 0-100 with higher scores indicating higher system usability. |
11 weeks to 24 weeks
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Ann Wieben, PhD, RN, University of Wisconsin, Madison
- Hauptermittler: Jann Pfaff, PhD, RN, University of Wisconsin, Madison
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Afshar M, Resnik F, Baumann MR, Hintzke J, Lemmon K, Sullivan AG, Shah T, Stordalen A, Oberst M, Dambach J, Mrotek LA, Quinn M, Abramson K, Kleinschmidt P, Brazelton T, Twedt H, Kunstman D, Wills G, Long J, Patterson BW, Liao FJ, Rasmussen S, Burnside E, Goswami C, Gordon JE. A Novel Playbook for Pragmatic Trial Operations to Monitor and Evaluate Ambient Artificial Intelligence in Clinical Practice. NEJM AI. 2025 Sep;2(9):10.1056/aidbp2401267. doi: 10.1056/aidbp2401267. Epub 2025 Aug 28.
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2026-0311
- UWMSN | Nursing | Admin (Andere Kennung: UW Madison)
- Protocol Version 5/15/26 (Andere Kennung: UW Madison)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Beschreibung des IPD-Plans
We plan to share the majority of our research documentation including the Study Protocol, Statistical Analysis Plan, Informed Consent Plan, Analytics Code, data dictionary, and de-identified survey and interview/focus group results data.
IPD-Sharing-Zeitrahmen
We will make the IPD information available in early 2027 once we have completed our analysis and are ready for publication. It will be available indefinitely.
IPD-Sharing-Zugriffskriterien
We will provide a publicly accessible GitLab link where all study materials can be downloaded
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ICF
- ANALYTIC_CODE
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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