Automated Clinical DocumentationDAXNCT06329427
Dragon Ambient eXperience (DAX) Copilot Evaluation
A study testing Dragon Ambient eXperience (DAX) Copilot in people with Automated Clinical Documentation, run by Wake Forest University Health Sciences at 5 sites in United States.
Trial summary
AI solutions like, Dragon Ambient eXperience (DAX) Copilot (Nuance/Microsoft), hold the potential to significantly enhance provider and patient interactions and alleviate pain points that contribute to burn out. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Automated Clinical Documentation
- What is being tested?
- Dragon Ambient eXperience (DAX) Copilot
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 238 participants
- Where
- 5 sitesUnited States
- Study dates
- 19 Jun 2023to 15 Dec 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinicians specializing in family medicine, internal medicine, and general pediatrics (including physicians and advanced practice providers [APPs])
- (intervention group) showed interests in participating in Dragon Ambient eXperience (DAX) Copilot
- (control group) clinicians who opted out from Dragon Ambient eXperience (DAX) Copilot in vendor's baseline survey
- (control group) clinicians who worked in the same clinic/region as the intervention group
Who cannot join
- preceptors
- inactive DAX participants (i.e., had DAX license but never activate it)
- have the same first use and last use DAX date
- missing demographics
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Atrium Health
Charlotte, North Carolina, 28203
Scotland Health Care System
Laurinburg, North Carolina, 28352
Atrium Health Navicent
Macon, Georgia, 31201
Atrium Health Floyd
Rome, Georgia, 30165
Atrium Health Wake Forest Baptist
Winston-Salem, North Carolina, 27157
About this study
Official title: Dragon Ambient eXperience (DAX) Express Pilot Evaluation
AI solutions like, Dragon Ambient eXperience (DAX) Copilot (Nuance/Microsoft), hold the potential to significantly enhance provider and patient interactions and alleviate pain points that contribute to burn out. Atrium Health was the first healthcare system in the world to pilot Nuance's DAX Copilot intelligence (AI) enabled scribe software, which synthesizes a draft clinic note by "listening" to the conversation between a provider and patient. After 180 days of use by primary care clinicians and advanced practice providers (APPs), along with a control group, the investigators assess provider satisfaction, patient experience, and provider efficiency through qualitative and quantitative methods.
Read the detailed description
In this non-randomized stepped-wedge trial, clinicians (including physicians and advanced practice providers [APP]) specializing in family medicine, internal medicine, and general pediatrics were recruited from outpatient clinics located in North Carolina and Georgia. The intervention group was divided into 5 waves between June and August 2023 based on clinic locations. Prior to the activation of accounts, clinicians underwent a one-hour training session on DAX Copilot. Meanwhile, a comparison group comprising clinicians not utilizing DAX was recruited in five waves from locations and specialties similar to those of the intervention group. Two types of primary outcomes, electronic health record (EHR) metrics and financial metrics, were assessed after 180 days of intervention. EHR metrics include time in EHR (EHR8), work time outside of work (WOW8), time in documentation (Note8), completed appointment rate, same day closure rate, and note length. Financial metrics include gross revenue per visit and work relative value units (wRVU) per visit. Secondary outcome include provider satisfaction survey, provider interview, and patient satisfaction survey.
- Conditions
- Automated Clinical Documentation
- Being tested
- Dragon Ambient eXperience (DAX) Copilot
- Keywords
- speech-to-text, Dragon Ambient eXperience (DAX), intervention evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dragon Ambient eXperience (DAX) CopilotOther
Also called Dragon Ambient eXperience (DAX)
The tool (DAX) listens to the conversation between a clinician and patient/caregiver during their visit, provides transcriptions between different speakers for the clinician to review, edit, and included in the final EHR notes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention - Dragon Ambient eXperience (DAX) | Active comparator | Clinicians interacted with DAX Copilot Receives: Other: Dragon Ambient eXperience (DAX) Copilot |
| No Intervention - Control group | No intervention | Clinicians with standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total EHR time
Total time on EHR (during and outside of clinic sessions) per 8 hour of patient scheduled time.
Measured: Month 10
Work outside of work
Time on EHR outside of scheduled patient hours per 8 hour of patient scheduled time.
Measured: Month 10
Time on encounter note documentation
Hours on documentation (note writing) per 8 hour of scheduled patient time
Measured: Month 10
Completed appointment rate
Total completed visits over scheduled visits
Measured: Month 10
Same day closure rate
Number of visits closed on the same day over total scheduled visits
Measured: Month 10
Note length
Length of note in EPIC for each visit
Measured: Month 10
Gross revenue per visit
Total charged amount in each day over total completed visits on the same day
Measured: Month 10
wRVU per visit
Total work relative value units (wRVU) in each day over total completed visits on the same day
Measured: Month 10
Secondary outcomes (3)
Provider satisfaction
REDCap survey to clinicians in both groups (intervention and control) and assess their satisfaction of the new tool.
Measured: Month 4
Provider interview
12 semi-structured interview on clinicians in the intervention group. Each interview was facilitated using an interview guide with a semi-structured list of questions to help guide the conversation and answer the learning objectives.
Measured: Month 1
Patient satisfaction
Patient satisfaction on the visit - patient satisfaction surveys are collected as part of routine care, which will be accessed through Medallia. Scores range between 0 (worst) to 10 (best) with one decimal point.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2024
- Study start19 Jun 2023
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Automated Clinical DocumentationStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 238 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Hieu Nguyen, MS - Biostatician, McKenzie Isreal, MPH - project manager, Casey Stephens, MPH - Health services researcher
- Responsible party
- Sponsor
- Investigators
- Tsai-Ling Liu, PhD, Principal investigator, Wake Forest University Health SciencesTimothy C Hetherington, MS, Principal investigator, Wake Forest University Health SciencesJeffrey A. Cleveland, MD, FAAP, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329427
- Sponsor's protocol ID
- IRB00098063
- Acronym
- DAX
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2024
- Last updated
- 29 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dragon Ambient eXperience (DAX) Express Pilot Evaluation
- ClinicalTrials.gov ID
- NCT06329427
- Acronym / sponsor ID
- DAX / IRB00098063
- Conditions
- Automated Clinical Documentation
- Keywords
- speech-to-text, Dragon Ambient eXperience (DAX), intervention evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 238 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Hieu Nguyen, MS - Biostatician, McKenzie Isreal, MPH - project manager, Casey Stephens, MPH - Health services researcher
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 26 Mar 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.
AI solutions like, Dragon Ambient eXperience (DAX) Copilot (Nuance/Microsoft), hold the potential to significantly enhance provider and patient interactions and alleviate pain points that contribute to burn out. Atrium Health was the first healthcare system in the world to pilot Nuance's DAX Copilot intelligence (AI) enabled scribe software, which synthesizes a draft clinic note by "listening" to the conversation between a provider and patient. After 180 days of use by primary care clinicians and advanced practice providers (APPs), along with a control group, the investigators assess provider satisfaction, patient experience, and provider efficiency through qualitative and quantitative methods.
Detailed description
In this non-randomized stepped-wedge trial, clinicians (including physicians and advanced practice providers [APP]) specializing in family medicine, internal medicine, and general pediatrics were recruited from outpatient clinics located in North Carolina and Georgia. The intervention group was divided into 5 waves between June and August 2023 based on clinic locations. Prior to the activation of accounts, clinicians underwent a one-hour training session on DAX Copilot. Meanwhile, a comparison group comprising clinicians not utilizing DAX was recruited in five waves from locations and specialties similar to those of the intervention group. Two types of primary outcomes, electronic health record (EHR) metrics and financial metrics, were assessed after 180 days of intervention. EHR metrics include time in EHR (EHR8), work time outside of work (WOW8), time in documentation (Note8), completed appointment rate, same day closure rate, and note length. Financial metrics include gross revenue per visit and work relative value units (wRVU) per visit. Secondary outcome include provider satisfaction survey, provider interview, and patient satisfaction survey.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention - Dragon Ambient eXperience (DAX) | Active comparator | Other: Dragon Ambient eXperience (DAX) CopilotClinicians interacted with DAX Copilot |
| No Intervention - Control group | No intervention | –Clinicians with standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- clinicians specializing in family medicine, internal medicine, and general pediatrics (including physicians and advanced practice providers [APPs])
- (intervention group) showed interests in participating in Dragon Ambient eXperience (DAX) Copilot
- (control group) clinicians who opted out from Dragon Ambient eXperience (DAX) Copilot in vendor's baseline survey
- (control group) clinicians who worked in the same clinic/region as the intervention group
Key exclusion criteria (4 listed)
- preceptors
- inactive DAX participants (i.e., had DAX license but never activate it)
- have the same first use and last use DAX date
- missing demographics
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 |
|---|---|---|
| Dragon Ambient eXperience (DAX) CopilotAlso: Dragon Ambient eXperience (DAX)The tool (DAX) listens to the conversation between a clinician and patient/caregiver during their visit, provides transcriptions between different speakers for the clinician to review, edit, and included in the final EHR notes. | Other | Intervention - Dragon Ambient eXperience (DAX) |
Primary outcome
Total EHR time
Time frame: Month 10
Total time on EHR (during and outside of clinic sessions) per 8 hour of patient scheduled time.
Work outside of work
Time frame: Month 10
Time on EHR outside of scheduled patient hours per 8 hour of patient scheduled time.
Time on encounter note documentation
Time frame: Month 10
Hours on documentation (note writing) per 8 hour of scheduled patient time
Completed appointment rate
Time frame: Month 10
Total completed visits over scheduled visits
Same day closure rate
Time frame: Month 10
Number of visits closed on the same day over total scheduled visits
Note length
Time frame: Month 10
Length of note in EPIC for each visit
Gross revenue per visit
Time frame: Month 10
Total charged amount in each day over total completed visits on the same day
wRVU per visit
Time frame: Month 10
Total work relative value units (wRVU) in each day over total completed visits on the same day
3 secondary outcomes
Provider satisfaction
Time frame: Month 4
Provider interview
Time frame: Month 1
Patient satisfaction
Time frame: Month 6
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 29 Mar 2024.
- Individual participant dataSharing planned: No
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.
Tsai-Ling Liu, PhD principal investigator
Wake Forest University Health Sciences
Timothy C Hetherington, MS principal investigator
Wake Forest University Health Sciences
Jeffrey A. Cleveland, MD, FAAP study chair
Wake Forest University Health Sciences
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dragon Ambient eXperience (DAX) Copilot in people with Automated Clinical Documentation, run by Wake Forest University Health Sciences at 5 sites 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 4 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 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Total EHR time (time frame: Month 10). The study lists 8 primary outcomes in all. 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 29 Mar 2024.