Ambient Digital Scribes Populating Clinical Notes

Assessing the Impact of Ambient Digital Scribes Populating Clinical Notes on Patient and Clinician Satisfaction

The purpose of this study is to assess the impact of Ambient Digital Scribes that will automatically record clinical encounters and use AI technology to populate clinical notes. The investigators expect that when clinicians do not need to either write notes during the clinical encounter and can instead face patients when talking, several effects could result, including 1) patients report higher satisfaction with the visit 2) clinicians report less burnout, and 3) clinician-patient communication includes more evidence-based tools that indicate high quality communication.

Study Overview

• Status: Completed
• Conditions: Patient Satisfaction; Clinician Satisfaction
• Intervention / Treatment: Other: Ambient Digital Scribes

Detailed Description

Effective communication forms the foundation of high-quality care. Communication includes verbal and nonverbal channels, with nonverbal communication playing a large role in acknowledging and responding to patient concerns. Effective communication has been negatively affected by the introduction of the electronic health record and required documentation. Clinicians often attend to the computer, writing notes during the encounter, which can lead to missing emotional cues from patients. Missing this key information can leave patients feeling dismissed, not heard, and can lead to lower comprehension and adherence. Further, the amount clinicians need to document often cannot occur solely in the encounter, leading to clinicians working after hours to finish their notes. The cumulative effect of the change in communication and required documentation has been a strong predictor of burnout among clinicians.

The introduction of AI into healthcare might have a positive impact on both efficiency and communication, thus resulting in higher clinician and patient satisfaction. With the advent of Ambient Digital Scribes and AI potentially populating notes, clinicians can have the opportunity to attend fully to patients both verbally and nonverbally. Patients likely will feel more heard, valued, and can ask questions, leading to higher comprehension and adherence. Clinicians might feel the burden of documentation lifted, might be more efficient, and feel more satisfied by providing the care they desire.

To test the impact of Ambient Digital Scribes, the investigators propose a sub-study to the approved project (Pro00115827) where the investigators will audio record clinicians in usual care before they are assigned to the two different scribing programs. The investigators will assess patient outcomes, namely perceived empathy and patient satisfaction, and clinician burnout. The investigators also will code audio recorded encounters to assess: 1) reflective statements (showing active listening), 2) empathic responses to empathic opportunities, 3) patient question-asking, and 4) length of encounter.

• Study Type: Interventional
• Enrollment (Actual): 261
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Patient Inclusion Criteria:

• 18 years or older
• able to speak and read English

Patient Exclusion Criteria:

• unable to speak and read English

Clinician Inclusion Criteria:

• delivering care in a clinic in which Ambient Digital Scribes are being employed

Clinician Exclusion Criteria:

• not delivering care in a clinic in which Ambient Digital Scribes are being employed

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study population - Clinicians and Patients; Clinicians will audio record 4 patient encounters on two separate days each (240 encounters).	Other: Ambient Digital Scribes; AI technology used to populate clinical notes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-perceived clinician empathy	Patient perceived empathy will be assessed via post doctor appointment administered survey.	through study completion, an average of 2 months
Patient Satisfaction	Patient satisfaction will be assessed via post doctor appointment administered survey.	through study completion, an average of 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician Satisfaction as measured by level of burnout	Assessed by clinician-reported levels of burnout via survey.	through study completion, an average of 2 months
Clinician Communication	Communication will be coded for reflective statements (showing active listening), empathic responses to empathic opportunities, patient question-asking, and length of encounter.	through study completion, an average of 2 months

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2024
• Primary Completion (Actual): January 30, 2025
• Study Completion (Actual): January 30, 2025

Study Registration Dates

• First Submitted: July 19, 2024
• First Submitted That Met QC Criteria: July 19, 2024
• First Posted (Actual): July 25, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: AI; Communication; Ambient Digital Scribes
• Other Study ID Numbers: Pro00116295

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