Trials / Enrolling By Invitation
Enrolling By InvitationNCT07498582
AI Tool to Reduce Clinician Documentation Burden
Evidently Workflow Study: Randomized Evaluation of a Clinician-Facing AI Documentation Support Tool in Outpatient Specialty Practice
- Status
- Enrolling By Invitation
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- University of North Carolina, Chapel Hill · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Accepted
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.
Detailed 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.
Conditions
- Burnout, Healthcare Workers
- Clinical Workflow Optimization
- Health Information Technology
- Electronic Health Records
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | AI Clinical Summarization Tool (Evidently) | 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. |
Timeline
- Start date
- 2026-03-30
- Primary completion
- 2026-06-01
- Completion
- 2026-06-01
- First posted
- 2026-03-27
- Last updated
- 2026-03-27
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT07498582. Inclusion in this directory is not an endorsement.