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Completed

NCT Number: NCT06519123

Ambient Digital Scribes Populating Clinical Notes

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Health System

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ambient Digital Scribes

Other

AI technology used to populate clinical notes.

Primary outcomes

  1. Patient-perceived clinician empathy

    Time frame: through study completion, an average of 2 months

    Patient perceived empathy will be assessed via post doctor appointment administered survey.

  2. Patient Satisfaction

    Time frame: through study completion, an average of 2 months

    Patient satisfaction will be assessed via post doctor appointment administered survey.

Secondary outcomes

  1. Clinician Satisfaction as measured by level of burnout

    Time frame: through study completion, an average of 2 months

    Assessed by clinician-reported levels of burnout via survey.

  2. Clinician Communication

    Time frame: through study completion, an average of 2 months

    Communication will be coded for reflective statements (showing active listening), empathic responses to empathic opportunities, patient question-asking, and length of encounter.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 25, 2024
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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