Ambient AI per Ridurre il Tempo di Documentazione del Personale Infermieristico
Uno studio clinico pragmatico a cuneo progressivo integrato nell'EHR con Intelligenza Artificiale ambientale per ridurre il tempo di documentazione del personale infermieristico
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Wisconsin
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Madison, Wisconsin, Stati Uniti, 53718
- UW Health - East Madison Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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 |
|
Sperimentale: 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 |
|
Sperimentale: 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 |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Active Time Spent in Flowsheets per shift hour
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in Active Time Spent in Flowsheets per patient per shift
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Ann Wieben, PhD, RN, University of Wisconsin, Madison
- Investigatore principale: Jann Pfaff, PhD, RN, University of Wisconsin, Madison
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2026-0311
- UWMSN | Nursing | Admin (Altro identificatore: UW Madison)
- Protocol Version 5/15/26 (Altro identificatore: UW Madison)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
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.
Periodo di condivisione IPD
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.
Criteri di accesso alla condivisione IPD
We will provide a publicly accessible GitLab link where all study materials can be downloaded
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
- CODICE_ANALITICO
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .