Evidently Workflow Study: Randomized Evaluation of a Clinician-Facing AI Documentation Support Tool in Outpatient Specialty Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Change in Clinician Cognitive Load
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
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.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Clinician Cognitive Load
时间窗: Baseline to end of Study Month 2
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.
次要结局
- 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)
- Number of tool sessions invoked(Study Month 2)
- Number of patients with tool use(Study Month 2)
- Proportion of eligible visits with tool use(Study Month 2)
- Context of use(Study Month 2)
- Usability and fit(Study Month 2)
- Accuracy and trust(Study Month 2)
- Impact on day(Study Month 2)
- Time savings(Study Month 2)
- Impact on care(Study Month 2)
- Overall satisfaction with AI clinical summarization tool assessed by single-item Likert agreement scale(Study Month 2)
- Open-ended feedback(Study Month 2)
