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AI Tool to Reduce Clinician Documentation Burden (Evidently)

University of North Carolina (UNC) logo

University of North Carolina (UNC)

Status

Invitation-only

Conditions

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

Treatments

Behavioral: AI Clinical Summarization Tool (Evidently)

Study type

Interventional

Funder types

Other

Identifiers

NCT07498582
26-0202

Details and patient eligibility

About

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.

Full description

Background and aim: This is a behavioral and health-information-technology study focused on clinical workflow. It does not target a specific patient disease or condition; it evaluates whether a clinician-facing artificial intelligence (AI) tool (Evidently) that produces brief summaries of existing electronic health record information can reduce documentation burden and improve efficiency and experience for outpatient specialists.

Design: Interventional, randomized, parallel-group trial. Eligible clinicians are randomly assigned either to receive access to Evidently at the start of the study period or to continue usual documentation workflow for eight weeks before receiving access. The primary comparison window is eight weeks per arm description in the protocol.

Setting and population: Recruitment targets outpatient attending physicians affiliated with UNC Faculty Practice (UNCFP) or UNC Medical Group (UNCMG) in the United States who can consent and complete study activities in English, with age limits and inclusion of birth-assigned sex categories as specified in the approved IRB application. Participants are recruited by invitation through professional clinical channels; the study does not recruit the general public.

Eligibility (summary): Screening confirms attending physician role; UNCFP or UNCMG affiliation; primary specialty in the protocol-eligible list (for example cardiology, pulmonology, gastroenterology, neurology, oncology, surgery, or anesthesiology); at least two half-day outpatient sessions per week (each at least 3.5 hours); fewer than 25 percent of outpatient sessions jointly staffed with trainees or advanced practice providers at or above the protocol threshold; no participation in a prior Evidently pilot; and no anticipated absence from work longer than one week during the eight-week study period. Individuals who do not meet these criteria are not enrolled.

Procedures for participants: Participation includes an eligibility and baseline survey (approximately 10 to 15 minutes), randomization, use or non-use of Evidently according to assignment during the randomized period, and a brief follow-up survey. There is no monetary compensation. The consent materials describe voluntary participation, confidentiality protections, and that participation is not reported to supervisors or leadership and does not affect employment status, evaluation, or clinical responsibilities.

Outcomes (high level): Outcomes emphasize clinician-reported workload; time and effort related to reviewing and summarizing medical records and using the electronic health record; task-load and related experience measures; and, for those assigned to early access, usability and perceived impact of the tool. The study does not enroll patients and does not assign interventions to patients; any linkage of survey responses to workflow data for analysis follows the approved consent and privacy plan.

Operational identifiers needed to link survey responses to workflow systems, if collected, are described in the approved consent and are handled per institutional policies and the IRB-approved protocol.

Enrollment

150 estimated patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.
  • Clinicians with planned time away exceeding one week during the study period. Exclusion criteria will be assessed using self-report in the baseline survey, supplemented by administrative records where available (e.g., prior pilot participation or clinic volume). Clinicians meeting any exclusion criterion will not be randomized.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 2 patient groups

Experimental: Evidently
Experimental group
Description:
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.
Treatment:
Behavioral: AI Clinical Summarization Tool (Evidently)
No Intervention: Control
No Intervention group
Description:
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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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