- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07456241
Ambient AI for Reducing Nursing Staff Documentation Time
May 27, 2026 updated by: University of Wisconsin, Madison
An EHR-Embedded Pragmatic Stepped-Wedge Clinical Trial of Ambient Artificial Intelligence to Reduce Nursing Staff Documentation Time
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Estimated)
250
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ann Wieben, PhD, RN
- Phone Number: 6082651029
- Email: wieben@wisc.edu
Study Contact Backup
- Name: Jann Pfaff, PhD, RN
- Email: jpfaff2@uwhealth.org
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53718
- Recruiting
- UW Health - East Madison Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Active Time Spent in Flowsheets per shift hour
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Active Time Spent in Flowsheets per patient per shift
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: Baseline to 22 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 22 weeks
|
|
Change in Mini-Z Subscale Scores: Supportive Work Environment
Time Frame: Baseline to 22 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 22 weeks
|
|
Change in Mini-Z (3.0) Subscale Scores: EHR Stress
Time Frame: Baseline to 22 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 22 weeks
|
|
Change System Usability Scale (SUS)
Time Frame: 11 weeks to 22 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 22 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ann Wieben, PhD, RN, University of Wisconsin, Madison
- Principal Investigator: Jann Pfaff, PhD, RN, University of Wisconsin, Madison
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 5, 2026
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Study Registration Dates
First Submitted
March 2, 2026
First Submitted That Met QC Criteria
March 2, 2026
First Posted (Actual)
March 6, 2026
Study Record Updates
Last Update Posted (Actual)
June 1, 2026
Last Update Submitted That Met QC Criteria
May 27, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026-0311
- UWMSN | Nursing | Admin (Other Identifier: UW Madison)
- Protocol Version 5/15/26 (Other Identifier: UW Madison)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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 Time Frame
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 Access Criteria
We will provide a publicly accessible GitLab link where all study materials can be downloaded
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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