- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06605976
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
45
Phase
- 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
-
-
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
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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
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
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
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
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)
May 1, 2024
Primary Completion (Actual)
September 13, 2024
Study Completion (Actual)
September 13, 2024
Study Registration Dates
First Submitted
September 18, 2024
First Submitted That Met QC Criteria
September 18, 2024
First Posted (Actual)
September 20, 2024
Study Record Updates
Last Update Posted (Actual)
September 20, 2024
Last Update Submitted That Met QC Criteria
September 18, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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