- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07456241
Intelligence Artificielle ambiante pour réduire le temps de documentation du personnel infirmier
Un essai clinique pragmatique en coin échelonné intégré au DSE utilisant l'intelligence artificielle ambiante pour réduire le temps de documentation du personnel infirmier
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Wisconsin
-
Madison, Wisconsin, États-Unis, 53718
- UW Health - East Madison Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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 |
|
Expérimental: 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 |
|
Expérimental: 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 |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Active Time Spent in Flowsheets per shift hour
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Active Time Spent in Flowsheets per patient per shift
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Ann Wieben, PhD, RN, University of Wisconsin, Madison
- Chercheur principal: Jann Pfaff, PhD, RN, University of Wisconsin, Madison
Publications et liens utiles
Publications générales
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026-0311
- UWMSN | Nursing | Admin (Autre identifiant: UW Madison)
- Protocol Version 5/15/26 (Autre identifiant: UW Madison)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime 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.
Délai de partage 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.
Critères d'accès au partage IPD
We will provide a publicly accessible GitLab link where all study materials can be downloaded
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- ANALYTIC_CODE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .