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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ann Wieben, PhD, RN
  • Phone Number: 6082651029
  • Email: wieben@wisc.edu

Study Contact Backup

Study Locations

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Artificial Intelligence
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.
Other: Artificial Intelligence
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.
Other: Artificial Intelligence
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Wisconsin, Madison

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 5, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings