Dragon Ambient eXperience (DAX) Copilot Evaluation (DAX)

March 27, 2024 updated by: Wake Forest University Health Sciences

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.

Study Overview

Status

Status

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

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

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 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 (Actual)

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.
238

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 Locations

  • United States
    • Georgia
      • Macon, Georgia, United States, 31201
        • Atrium Health Navicent
      • Rome, Georgia, United States, 30165
        • Atrium Health Floyd
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Atrium Health
      • Laurinburg, North Carolina, United States, 28352
        • Scotland Health Care System
      • Winston-Salem, North Carolina, United States, 27157
        • Atrium Health Wake Forest Baptist

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

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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: Non-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.
Active Comparator: Intervention - Dragon Ambient eXperience (DAX)
Clinicians interacted with DAX Copilot
Other: Dragon Ambient eXperience (DAX) Copilot
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 Names:
  • Dragon Ambient eXperience (DAX)
No Intervention: No Intervention - Control group
Clinicians with standard care

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
Total EHR time
Time Frame: Month 10
Total time on EHR (during and outside of clinic sessions) per 8 hour of patient scheduled time.
Month 10
Work outside of work
Time Frame: Month 10
Time on EHR outside of scheduled patient hours per 8 hour of patient scheduled time.
Month 10
Time on encounter note documentation
Time Frame: Month 10
Hours on documentation (note writing) per 8 hour of scheduled patient time
Month 10
Completed appointment rate
Time Frame: Month 10
Total completed visits over scheduled visits
Month 10
Same day closure rate
Time Frame: Month 10
Number of visits closed on the same day over total scheduled visits
Month 10
Note length
Time Frame: Month 10
Length of note in EPIC for each visit
Month 10
Gross revenue per visit
Time Frame: Month 10
Total charged amount in each day over total completed visits on the same day
Month 10
wRVU per visit
Time Frame: Month 10
Total work relative value units (wRVU) in each day over total completed visits on the same day
Month 10

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
Provider satisfaction
Time Frame: Month 4
REDCap survey to clinicians in both groups (intervention and control) and assess their satisfaction of the new tool.
Month 4
Provider interview
Time Frame: Month 1
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.
Month 1
Patient satisfaction
Time Frame: Month 6
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.
Month 6

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.
Wake Forest University Health Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hieu Nguyen, MS - Biostatician
McKenzie Isreal, MPH - project manager
Casey Stephens, MPH - Health services researcher

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: Tsai-Ling Liu, PhD, Wake Forest University Health Sciences
  • Principal Investigator: Timothy C Hetherington, MS, Wake Forest University Health Sciences
  • Study Chair: Jeffrey A. Cleveland, MD, FAAP, Wake Forest University Health Sciences

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.
June 19, 2023

Primary Completion (Actual)

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 15, 2023

Study Completion (Actual)

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 15, 2023

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 18, 2024

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 22, 2024

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 26, 2024

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.
March 29, 2024

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.
March 27, 2024

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.
March 1, 2024

More Information

Terms related to this study

Keywords

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.
  • IRB00098063

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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