Nursing Documentation BurdenNCT07456241
Ambient AI for Reducing Nursing Staff Documentation Time
A study testing Artificial Intelligence in people with Nursing Documentation Burden, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nursing Documentation Burden
- What is being tested?
- Artificial Intelligence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2026to 8 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Planned leave more than 6 weeks during study timeframe
Trial locations and contacts
1 site in 1 country.
United States1 site
UW Health - East Madison Hospital
Madison, Wisconsin, 53718
About this study
Official title: 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.
Read the 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.
- Conditions
- Nursing Documentation Burden
- Being tested
- Artificial Intelligence
- Keywords
- Artificial Intelligence, Ambient Listening, Nursing, Nursing Staff, Documentation Burden, Nursing Staff Well Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial IntelligenceOther
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
| Study group | Role | What they receive |
|---|---|---|
| Ambient Listening Group 1 | Experimental | The hospital unit will be randomized and all nursing staff within the unit will have access to start using Ambient AI at week 8. Receives: Other: Artificial Intelligence |
| Ambient Listening Group 2 | Experimental | The hospital unit will be randomized and all nursing staff within the unit will have access to start using Ambient AI at week 11. Receives: Other: Artificial Intelligence |
| Ambient Listening Group 3 | Experimental | The hospital unit will be randomized and all nursing staff within the unit will have access to start using Ambient AI at week 14. Receives: Other: Artificial Intelligence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Active Time Spent in Flowsheets per shift hour
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.
Measured: Baseline to 22 weeks
Secondary outcomes (7)
Change in Active Time Spent in Flowsheets per patient per shift
To assess nursing staff documentation burden, the change in active time spent in flowsheets per patient shift will be reported.
Measured: Baseline to 22 weeks
Change in the number of clicks or taps in Flowsheets
To assess nursing staff documentation burden, the change in the number of clicks or taps in flowsheets will be reported.
Measured: Baseline to 22 weeks
Change in Amount of Overtime Charting
To assess nursing staff documentation burden, the change in time spent documenting after end time of assignment will be reported.
Measured: Baseline to 22 weeks
Change in Clinician Worklife Survey (Mini-Z) Score
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.
Measured: Baseline to 22 weeks
Change in Mini-Z Subscale Scores: Supportive Work Environment
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).
Measured: Baseline to 22 weeks
Change in Mini-Z (3.0) Subscale Scores: EHR Stress
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).
Measured: Baseline to 22 weeks
Change System Usability Scale (SUS)
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.
Measured: 11 weeks to 22 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start5 May 2026
- Primary completion28 Sep 2026
- Study completion8 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nursing Documentation BurdenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The stepped wedge design involves staggered implementation of an intervention across different hospital units over multiple time periods, allowing all nursing staff within these units to eventually receive the intervention.
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ann Wieben, PhD, RN, Principal investigator, University of Wisconsin, MadisonJann Pfaff, PhD, RN, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456241
- Sponsor's protocol ID
- 2026-0311
- Other IDs
- UWMSN | Nursing | Admin, Protocol Version 5/15/26
- Status last verified
- Sep 2026
- First submitted
- 2 Mar 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 41625485Afshar 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.
PubMed 40959192
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An EHR-Embedded Pragmatic Stepped-Wedge Clinical Trial of Ambient Artificial Intelligence to Reduce Nursing Staff Documentation Time
- ClinicalTrials.gov ID
- NCT07456241
- Acronym / sponsor ID
- 2026-0311
- Conditions
- Nursing Documentation Burden
- Keywords
- Artificial Intelligence, Ambient Listening, Nursing, Nursing Staff, Documentation Burden, Nursing Staff Well Being
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 5 May 2026 (actual)
- Primary completion
- 28 Sep 2026 (actual)
- Study completion
- 8 Oct 2026 (estimated)
- First posted
- 6 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The stepped wedge design involves staggered implementation of an intervention across different hospital units over multiple time periods, allowing all nursing staff within these units to eventually receive the intervention.
| Arm | Type | Receives |
|---|---|---|
| Ambient Listening Group 1 | Experimental | Other: Artificial IntelligenceThe hospital unit will be randomized and all nursing staff within the unit will have access to start using Ambient AI at week 8. |
| Ambient Listening Group 2 | Experimental | Other: Artificial IntelligenceThe hospital unit will be randomized and all nursing staff within the unit will have access to start using Ambient AI at week 11. |
| Ambient Listening Group 3 | Experimental | Other: Artificial IntelligenceThe hospital unit will be randomized and all nursing staff within the unit will have access to start using Ambient AI at week 14. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Planned leave more than 6 weeks during study timeframe
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artificial IntelligenceAmbient 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 | Other | Ambient Listening Group 1, Ambient Listening Group 2, Ambient Listening Group 3 |
Primary outcome
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.
7 secondary outcomes
Change in Active Time Spent in Flowsheets per patient per shift
Time frame: Baseline to 22 weeks
Change in the number of clicks or taps in Flowsheets
Time frame: Baseline to 22 weeks
Change in Amount of Overtime Charting
Time frame: Baseline to 22 weeks
Change in Clinician Worklife Survey (Mini-Z) Score
Time frame: Baseline to 22 weeks
Change in Mini-Z Subscale Scores: Supportive Work Environment
Time frame: Baseline to 22 weeks
Change in Mini-Z (3.0) Subscale Scores: EHR Stress
Time frame: Baseline to 22 weeks
Change System Usability Scale (SUS)
Time frame: 11 weeks to 22 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Background: PubMed 41625485Afshar 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.
- Background: PubMed 40959192Afshar 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Wieben, PhD, RN principal investigator
University of Wisconsin, Madison
Jann Pfaff, PhD, RN principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Intelligence in people with Nursing Documentation Burden, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Active Time Spent in Flowsheets per shift hour (time frame: Baseline to 22 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07456241, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.