Ambient Digital Scribes Populating Clinical Notes

NCT ID: NCT06519123

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 261 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-19
• Study Completion Date: 2025-01-30

Brief Summary

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.

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.

Conditions

Patient Satisfaction; Clinician Satisfaction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Study population - Clinicians and Patients

Clinicians will audio record 4 patient encounters on two separate days each (240 encounters).

Group Type: EXPERIMENTAL

Ambient Digital Scribes

Intervention Type: OTHER

AI technology used to populate clinical notes.

Interventions

Ambient Digital Scribes

AI technology used to populate clinical notes.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

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

Exclusion Criteria

• unable to speak and read English

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Duke University Health System

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00116295

Identifier Type: -

Identifier Source: org_study_id