NCT06519123

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
261

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 25, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

September 19, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2025

Completed
Last Updated

February 14, 2025

Status Verified

September 1, 2024

Enrollment Period

4 months

First QC Date

July 19, 2024

Last Update Submit

February 13, 2025

Conditions

Keywords

Ambient Digital ScribesAICommunication

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Clinician Satisfaction as measured by level of burnout

    through study completion, an average of 2 months

  • Clinician Communication

    through study completion, an average of 2 months

Study Arms (1)

Study population - Clinicians and Patients

EXPERIMENTAL

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

Other: Ambient Digital Scribes

Interventions

AI technology used to populate clinical notes.

Study population - Clinicians and Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • able to speak and read English

You may not qualify if:

  • unable to speak and read English
  • delivering care in a clinic in which Ambient Digital Scribes are being employed
  • not delivering care in a clinic in which Ambient Digital Scribes are being employed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Health System

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Patient SatisfactionCommunication

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2024

First Posted

July 25, 2024

Study Start

September 19, 2024

Primary Completion

January 30, 2025

Study Completion

January 30, 2025

Last Updated

February 14, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations