Evaluating the Impact of Ambient AI on Documentation Efficiency and Clinician Burnout in Primary Care Settings

September 18, 2024 updated by: Samaritan Health Services
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.

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

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 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.
45

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
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • Samaritan Health Services

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Licensed Clinicians: Independently licensed clinicians (MDs, DOs, NPs, PAs) who have been actively practicing at Samaritan Health Services for at least 6 months.
  2. 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.
  3. Provider has an Apple iPhone and is willing to install Epic Haiku.

Exclusion Criteria:

  1. 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.
  2. Trainees: Exclude medical students and residents due to their varying levels of experience and dependence on supervisory oversight.
  3. Minimum Outpatient Encounters: Exclude clinicians with fewer than 100 outpatient encounters per month to focus on those with a significant workload in outpatient settings.
  4. 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.
  5. Corrective Action: Exclude clinicians facing dismissal, corrective, or disciplinary action.
  6. Scheduled leave longer than 3 weeks during the study period

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: Other
  • 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: DAX CoPilot Group
Participants in this arm were given a DAX CoPilot license and asked to use it for clinical documentation in the EHR.
Behavioral: DAX CoPilot Group
Participants in this group were given a license for DAX CoPilot and asked to use it for clinical documentation.
No Intervention: Control group
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 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
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
From baseline to the end of the 3 month experimental period

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
Burnout
Time Frame: From baseline to the end of the 3 month experimental period
Clinician burnout as assessed using the Mini-Z 2.0 burnout inventory
From baseline to the end of the 3 month experimental period

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: 3 months experimental period
Patient satisfaction with the experience of the clinician using DAX CoPilot via a patient survey after a visit in which it was used
3 months experimental period

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.
Samaritan Health Services

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 1, 2024

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.
September 13, 2024

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.
September 13, 2024

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).
September 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.
September 18, 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.
September 20, 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.
September 20, 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.
September 18, 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.
September 1, 2024

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.
  • IRB23-072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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