BurnoutNCT06605976
Evaluating the Impact of Ambient AI on Documentation Efficiency and Clinician Burnout in Primary Care Settings
A study testing DAX CoPilot Group in people with Burnout and Clinical Documentation Efficiency, run by Samaritan Health Services at 1 site in United States.
Trial summary
This clinical trial aims to evaluate the effectiveness of an ambient listening AI product, DAX CoPilot, in improving clinical documentation efficiency and reducing clinician burnout in primary care settings. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Burnout, Clinical Documentation Efficiency
- What is being tested?
- DAX CoPilot Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 13 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Licensed Clinicians: Independently licensed clinicians (MDs, DOs, NPs, PAs) who have been actively practicing at Samaritan Health Services for at least 6 months.
- Primary Care Only: Providers must have a listed specialty of family medicine, internal medicine, or pediatrics, and currently practice primarily in a primary or urgent care clinic.
- Provider has an Apple iPhone and is willing to install Epic Haiku.
Who cannot join
- Inpatient-Only Clinicians: Exclude clinicians who only, or primarily, work in inpatient settings, as documentation needs and challenges may differ significantly from those in outpatient settings.
- Trainees: Exclude medical students and residents due to their varying levels of experience and dependence on supervisory oversight.
- Minimum Outpatient Encounters: Exclude clinicians with fewer than 100 outpatient encounters per month to focus on those with a significant workload in outpatient settings.
- Android Smartphones Users: Clinicians may not use Android, or generally any non-Apple or non-iOS smartphones, given the software limitations of the selected intervention technology.
- Corrective Action: Exclude clinicians facing dismissal, corrective, or disciplinary action.
- Scheduled leave longer than 3 weeks during the study period
Trial locations and contacts
1 site in 1 country.
About this study
This clinical trial aims to evaluate the effectiveness of an ambient listening AI product, DAX CoPilot, in improving clinical documentation efficiency and reducing clinician burnout in primary care settings. Researchers will compare results from a group who was given a license to use DAX CoPilot to a group who was not given a license. Participants in the DAX group will use DAX CoPilot system for EHR documentation and participants in the control group will use use standard EHR documentation methods. Participants will also be asked to complete surveys and assessments related to their views on technology and experiences of burnout.
Read the detailed description
This pilot study aims to evaluate the effectiveness of an ambient listening AI product in improving clinical documentation efficiency and patient satisfaction, reducing clinician burnout in primary care settings, and improving operational implementation strategies by harnessing end-user psychology. Employing a randomized, prospective design, the study involved 25 clinicians who were given an ambient listening AI product (DAX CoPilot) after a 1 month baseline period and asked to use it for clinical documentation with a focus on problem-focused visits over a 3-month period, with a control group of 20 clinicians continuing traditional documentation methods. The primary outcomes include changes in documentation efficiency (measured through metrics such as time spent on documentation per patient) and clinician burnout (assessed using the validated Mini-Z 2.0 burnout inventory). Secondary outcomes involve patient satisfaction with clinicians' use of the AI tool and examining end-user technology acceptance among clinicians using a survey based on the Unified Theory of Acceptance and Use of Technology (UTAUT). The study aims to provide insights into the potential of AI-assisted documentation tools in enhancing clinical workflow and addressing the growing concern of clinician burnout.
- Conditions
- Burnout, Clinical Documentation Efficiency
- Being tested
- DAX CoPilot Group
- Keywords
- clinical documentation, burnout, scribe, ambient AI, DAX CoPilot, randomized control trial, electronic health record, acceptance and use of technology, patient satisfaction
- Medical subject headings
- Burnout, Psychological, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DAX CoPilot GroupBehavioural
Participants in this group were given a license for DAX CoPilot and asked to use it for clinical documentation.
| Study group | Role | What they receive |
|---|---|---|
| DAX CoPilot Group | Experimental | Participants in this arm were given a DAX CoPilot license and asked to use it for clinical documentation in the EHR. Receives: Behavioral: DAX CoPilot Group |
| Control group | No intervention | Participants in this arm were not given a DAX CoPilot license and were asked to use standard methods for clinical documentation in the EHR. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Documentation efficiency
Compare average documentation, workload, and InBasket metrics (tracked by Epic Signal and through a custom data pull for SHS) before and after the implementation of ambient AI among the intervention and control groups; time in notes per appointment, time in notes per scheduled day, progress note length, note composition, time outside scheduled hours, time outside of 7 AM to 7 PM, pajama time, visits closed same day, time in InBasket per appointment, InBasket message turnaround time
Measured: From baseline to the end of the 3 month experimental period
Secondary outcomes (1)
Burnout
Clinician burnout as assessed using the Mini-Z 2.0 burnout inventory
Measured: From baseline to the end of the 3 month experimental period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2024
- Study start1 May 2024
- Primary completion13 Sep 2024
- Study completion13 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnoutStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samaritan Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06605976
- Sponsor's protocol ID
- IRB23-072
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 20 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Ambient AI on Documentation Efficiency and Clinician Burnout in Primary Care Settings
- ClinicalTrials.gov ID
- NCT06605976
- Acronym / sponsor ID
- IRB23-072
- Conditions
- Burnout, Clinical Documentation Efficiency
- Keywords
- clinical documentation, burnout, scribe, ambient AI, DAX CoPilot, randomized control trial, electronic health record, acceptance and use of technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Samaritan Health ServicesUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 13 Sep 2024 (actual)
- Study completion
- 13 Sep 2024 (actual)
- First posted
- 20 Sep 2024 (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.
This clinical trial aims to evaluate the effectiveness of an ambient listening AI product, DAX CoPilot, in improving clinical documentation efficiency and reducing clinician burnout in primary care settings. Researchers will compare results from a group who was given a license to use DAX CoPilot to a group who was not given a license. Participants in the DAX group will use DAX CoPilot system for EHR documentation and participants in the control group will use use standard EHR documentation methods. Participants will also be asked to complete surveys and assessments related to their views on technology and experiences of burnout.
Detailed description
This pilot study aims to evaluate the effectiveness of an ambient listening AI product in improving clinical documentation efficiency and patient satisfaction, reducing clinician burnout in primary care settings, and improving operational implementation strategies by harnessing end-user psychology. Employing a randomized, prospective design, the study involved 25 clinicians who were given an ambient listening AI product (DAX CoPilot) after a 1 month baseline period and asked to use it for clinical documentation with a focus on problem-focused visits over a 3-month period, with a control group of 20 clinicians continuing traditional documentation methods. The primary outcomes include changes in documentation efficiency (measured through metrics such as time spent on documentation per patient) and clinician burnout (assessed using the validated Mini-Z 2.0 burnout inventory). Secondary outcomes involve patient satisfaction with clinicians' use of the AI tool and examining end-user technology acceptance among clinicians using a survey based on the Unified Theory of Acceptance and Use of Technology (UTAUT). The study aims to provide insights into the potential of AI-assisted documentation tools in enhancing clinical workflow and addressing the growing concern of clinician burnout.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized control trial
| Arm | Type | Receives |
|---|---|---|
| DAX CoPilot Group | Experimental | Behavioral: DAX CoPilot GroupParticipants in this arm were given a DAX CoPilot license and asked to use it for clinical documentation in the EHR. |
| Control group | No intervention | –Participants in this arm were not given a DAX CoPilot license and were asked to use standard methods for clinical documentation in the EHR. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Licensed Clinicians: Independently licensed clinicians (MDs, DOs, NPs, PAs) who have been actively practicing at Samaritan Health Services for at least 6 months.
- Primary Care Only: Providers must have a listed specialty of family medicine, internal medicine, or pediatrics, and currently practice primarily in a primary or urgent care clinic.
- Provider has an Apple iPhone and is willing to install Epic Haiku.
Key exclusion criteria (6 listed)
- Inpatient-Only Clinicians: Exclude clinicians who only, or primarily, work in inpatient settings, as documentation needs and challenges may differ significantly from those in outpatient settings.
- Trainees: Exclude medical students and residents due to their varying levels of experience and dependence on supervisory oversight.
- Minimum Outpatient Encounters: Exclude clinicians with fewer than 100 outpatient encounters per month to focus on those with a significant workload in outpatient settings.
- Android Smartphones Users: Clinicians may not use Android, or generally any non-Apple or non-iOS smartphones, given the software limitations of the selected intervention technology.
- Corrective Action: Exclude clinicians facing dismissal, corrective, or disciplinary action.
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 |
|---|---|---|
| DAX CoPilot GroupParticipants in this group were given a license for DAX CoPilot and asked to use it for clinical documentation. | Behavioural | DAX CoPilot Group |
Primary outcome
Documentation efficiency
Time frame: From baseline to the end of the 3 month experimental period
Compare average documentation, workload, and InBasket metrics (tracked by Epic Signal and through a custom data pull for SHS) before and after the implementation of ambient AI among the intervention and control groups; time in notes per appointment, time in notes per scheduled day, progress note length, note composition, time outside scheduled hours, time outside of 7 AM to 7 PM, pajama time, visits closed same day, time in InBasket per appointment, InBasket message turnaround time
1 secondary outcome
Burnout
Time frame: From baseline to the end of the 3 month experimental period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DAX CoPilot Group in people with Burnout and Clinical Documentation Efficiency, run by Samaritan Health Services 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 3 inclusion and 6 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: finished, as of the sponsor's last update on 20 Sep 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Documentation efficiency (time frame: From baseline to the end of the 3 month experimental period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Sep 2024.