NCT06792890

A Randomized Controlled Trial of Ambient Artificial Intelligence Scribe Technologies

A Randomized Controlled Trial of Two Ambient Artificial Intelligence Scribe Technologies to Improve Documentation Efficiency and Reduce Physician Burnout

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 238 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This is a three-arm pragmatic RCT of 238 outpatient physicians at a large academic health system, randomized 1:1:1 to one of two AI scribe tools or a usual-care control group. The two-month study will observe and compare the effects of each tool prior to system-wide roll out of selected tool (anticipated Spring 2025). We will use covariate-constrained randomization to balance the arms in terms of physician baseline time in notes, survey-measured level of burnout, and clinic days per week. The primary purpose of the initiative is to improve quality, efficiency, and business operations at University of California, Los Angeles (UCLA) Health, and this initiative is not being done for research purposes. The results of this operational initiative will inform the widespread roll out of AI scribe tools across all providers within the UCLA Health System. Nevertheless, the UCLA study team plans to rigorously examine and publish the impact of this intervention across the health system, which is why the study team pre-registered the initiative.

Detailed description

This study will assess operational-oriented outcomes across all groups. Notably, all groups will eventually receive all interventions over time in this observational study of a randomized roll out of a QI initiative. Moreover, the primary purpose of this initiative is operational. In other words, based on the results of this initiative, one of these tools will be eventually selected and operationalized widely across the health system. Enrolled participants are randomized to one of three groups. Randomization was needed to overcome secular trends, seasonal and holiday effects in December, and other factors confounding the relationship between exposure to the AI tools and the outcomes. The primary aim of this study is to evaluate the impact of two ambient AI scribe technologies on clinician change from baseline time spent on EHR documentation, comparing each scribe to a control group. Secondary objectives include assessing the AI scribes' impact on clinician metrics such as burnout, physician satisfaction, and productivity. Additionally, the study team intends to perform an economic evaluation analysis of the tools to guide business decision making. The study team will also analyze physician reported effects of the AI tools on patient safety, equity, and any unintended consequences of the initiative.

Conditions

• Physician Workflow
• Artificial Intelligence (AI)

Interventions

Type	Name	Description
OTHER	Use Nabla AI Scribe tool provided	AI Scribe technologies capture physician-patient conversations to create a transcript, then summarize the transcript in the form of a clinical notes. These tools are integrated into the EHR and automatically adds the generated text to the provider note. All physicians must inform patients about the recording and obtain their verbal consent, and instances of patients declining to consent are tracked. Nabla leverages its proprietary speech-to-text to transform the conversation into a written context, combined with HIPAA compliant Large Language Models (LLM) like Azure OpenAI's GPT-4. Nabla does not store any audio.
OTHER	Use AI Scribe tool provided by Vendor B	AI Scribe technologies capture physician-patient conversations to create a transcript, then summarize the transcript in the form of a clinical notes. These tools are integrated into the EHR and automatically adds the generated text to the provider note. All physicians must inform patients about the recording and obtain their verbal consent, and instances of patients declining to consent are tracked.

Timeline

• Start date: 2024-11-04
• Primary completion: 2025-01-31
• Completion: 2025-02-28
• First posted: 2025-01-27
• Last updated: 2025-01-27

Locations

1 site across 1 country: United States