AI Tool to Reduce Clinician Documentation Burden

NCT07498582 | Completed

• 1 other identifier: 26-0202
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

This study looks at whether a clinician-facing artificial intelligence (AI) tool can help outpatient doctors spend less time reviewing medical records and documenting care. The tool creates brief summaries of existing medical record information to support routine clinical work. This study examines how use of this tool affects clinicians' workload, time spent in the electronic health record, and overall experience with documentation. The goal is to better understand whether AI documentation support tools can improve efficiency and reduce burden for clinicians in outpatient specialty practice. Eligible UNC outpatient specialists may be invited to complete surveys and, if they qualify, are randomly assigned either to receive access to the tool (Evidently) at the beginning of the study period or to continue their usual workflow for eight weeks before receiving access. The study does not recruit patients and does not change medical care for patients.

Conditions

Health Information Technology; Electronic Health Records; Burnout, Healthcare Workers; Clinical Workflow Optimization

Keywords

clinician workload; artificial intelligence; clinical documentation; physician task load

Outcome Measures

Primary Outcomes (1)

• Change in Clinician Cognitive Load

  Cognitive load measured using the Physician Task Load (PTL) scale, adapted from the National Aeronautics and Space Administration (NASA) Task Load Index. The PTL includes four items-mental demand, physical demand, effort, and time pressure-each rated on a 0-100 scale with reference to a typical clinical workday during the past 1-2 weeks. Item scores will be summed to produce a continuous composite score ranging from 0 to 400, with higher scores indicating greater cognitive workload. The primary outcome is the clinician-level change in PTL score from baseline to the end of Study Month 2, analyzed under an intention-to-treat framework.

  Baseline to end of Study Month 2

Secondary Outcomes (16)

• Change in time in clinical review

  Baseline to Study Month 2

• Change in time outside work hours

  Baseline to Study Month 2

• Change in clinic preparation time

  Baseline to Study Month 2

• Change in new patient record review time

  Baseline to Study Month 2

• Change in burnout

  Baseline to Study Month 2

Study Arms (2)

Experimental: Evidently

EXPERIMENTAL

Clinicians randomized to the intervention arm will receive access to a clinician-facing AI clinical summarization tool (Evidently) integrated into routine clinical workflow. The intervention includes standardized onboarding and training materials (e.g., an onboarding webinar or equivalent asynchronous training, tip sheets, and on-demand implementation support). Optional personalization may be available to clinicians but is not required for participation in the study.

Behavioral: AI Clinical Summarization Tool (Evidently)

No Intervention: Control

NO INTERVENTION

Clinicians randomized to the control arm will continue usual chart review and documentation practices without access to the AI clinical summarization tool during the study period.

Interventions

AI Clinical Summarization Tool (Evidently) BEHAVIORAL

Clinicians randomized to the intervention arm will receive access to the AI clinical summarization tool following randomization and completion of baseline study procedures. Clinicians randomized to the control arm will continue usual chart review and documentation practices for the duration of the study. Participation in the study and use of the AI clinical summarization tool are voluntary. Clinicians assigned to the intervention arm are not required to use the tool as part of routine care. Use of the AI clinical summarization tool will be characterized using system-generated utilization metrics provided by the vendor. These metrics may include measures such as the number of sessions (i.e., the number of times the tool is invoked), the number of patients for whom the tool is used, and, where available, the number of customized summaries generated. All utilization measures will be aggregated at the clinician level over the study period.

Also known as: Evidently

Experimental: Evidently

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all of the following criteria:
• Attending outpatient specialists affiliated with UNCFP or UNCMG.
• At least two half-days (≥3.5 hours per session) of scheduled outpatient clinic per week.
• Primary specialty in an outpatient, patient-facing specialty practice within UNCFP or UNCMG.
• Anesthesiologists will be enrolled under the same protocol but analyzed separately due to distinct workflow characteristics.

You may not qualify if:

• Clinicians meeting any of the following criteria will be excluded:
• Trainees (e.g., residents or fellows).
• Advanced practice providers (APPs).
• Attendings whose outpatient workflows are predominantly supervisory or shared with trainees or APPs, defined as clinicians who self-report that 25% or more of outpatient clinic sessions are conducted jointly with trainees or APPs.
• Clinicians who participated in a prior Evidently pilot study.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

UNC Health

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Spencer Dorn, MD, MPH, MHA

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Clinicians are aware of their assignment. Masking is not feasible given the nature of the intervention, as clinicians will know whether or not they have access to the AI clinical summarization tool. Study outcomes include structured clinician surveys and clinician-level EHR workflow metrics derived from routine clinical operations.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a two-arm randomized controlled trial comparing access to a clinician-facing AI clinical summarization tool (Evidently), combined with standardized onboarding and implementation support, versus usual chart review and documentation practices without access to the tool. Prior to randomization, all eligible clinicians will complete baseline surveys, and six months of retrospective clinician-level electronic health record (EHR) workflow metadata (Epic Signal) will be obtained to characterize baseline workflow and support covariate-constrained randomization. In addition, limited retrospective patient-level data without direct identifiers may be used over the same period to characterize clinician workload and clinical context, including measures such as patients seen per day, visit duration, and aggregated proxies of chart complexity. These patient-level data will be aggregated at the clinician level and will not be used to identify or contact individual patients.

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: March 27, 2026
• Study Start: March 30, 2026
• Primary Completion: June 8, 2026
• Study Completion: June 8, 2026
• Last Updated: June 26, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Supporting information and deidentified individual participant data will be available beginning 9 months after publication of the primary results and continuing for up to 36 months after publication.
• Access Criteria: Investigators who wish to access deidentified individual participant data or supporting documents must (1) provide a methodologically sound research proposal, (2) obtain approval from their IRB, IEC, or REB, and (3) execute a data use/sharing agreement with the University of North Carolina at Chapel Hill. Requests should be directed to the study principal investigator. The principal investigator must confirm that the data use agreement has been fully executed and ethics approval has been granted before any data is shared.

Locations

US (1)