Ambient AI Clinical Trial
2026년 5월 22일 업데이트: Chris Lewis, University of Washington
Evaluation of Abridge Ambient AI Technology Regarding Provider Burnout and Patient Satisfaction With the Clinical Encounter
This is a single-site pragmatic randomized control trial studying the effect of ambient artificial intelligence (AI) scribes on the delivery of medical care to patients in the ambulatory setting.
The study will last 150 days and include up to 65 providers in the intervention group.
Providers will be recruited from three medical specialties, including primary care, oncology, and urology.
The study will enroll providers and randomize them to an intervention group (access to the ambient AI scribe product) or a control group (routine patient care).
Providers will be evaluated for burnout and task load measures through digital surveys at the beginning, middle, and end of the study.
Provider electronic health record (EHR) usage data will also be evaluated for time spent documenting, time spent after hours on days with scheduled clinical care, and time between the start of the clinical encounter and signing it.
연구 개요
상태
완전한
연구 유형
중재적
등록 (실제)
139
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Washington
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Seattle, Washington, 미국, 98195
- University of Washington Medical Center
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Provider is an employee of the University of Washington Medicine.
- Clinical specialty of primary care, oncology, or urology.
- Clinical full-time equivalent (FTE) of 0.2 or greater (provider must have an outpatient clinic of at least 20% of an FTE).
- Provider is a physician or an advanced practice provider.
Exclusion Criteria:
- Trainees (e.g., medical students, residents, or fellows)
- Provider does not have access to a mobile device that is compatible with the ambient AI scribe service (e.g., Android mobile phone).
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Ambient AI scribe users
Participants in this arm will utilize the ambient AI scribe tools from Abridge.
They will otherwise continue their usual clinical activities, including providing care with trainees (e.g., medical students, residents) and multiple family members in the room.
The tool will be used exclusively in the outpatient clinical setting and only when the participant is present.
The ambient AI scribe tool integrates into the electronic health record (EHR), and the EHR's mobile app is used to collect the recording on a mobile device.
The ambient AI scribe tool is transcriptional and does not provide clinical decision support.
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Ambient artificial intelligence (AI) scribes are a clinical documentation tool that uses automated speech recognition and large-scale language models to capture and transcribe synchronous patient-provider encounters in real time. Clinicians then review, edit, and authorize the AI-generated text before finalizing the chart, ensuring necessary human oversight and medical accuracy. In this study, participants used Ambient AI scribes on mobile devices for the recordings. The ambient AI scribe will be available for the provider to use in the outpatient setting. They were not required to use the Ambient AI scribe, but could choose whether to use it and with which patients. Consent to use the device was documented for all patient encounters.
다른 이름들:
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간섭 없음: Routine patient care (no AI scribe)
These participants were not provided with the ambient AI scribe application on their mobile device.
They still had access to documentation with dictation or existing scribe services (non-AI).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Professional Fulfillment Index (PFI)
기간: Surveyed at enrollment (day 0 of pilot), midpoint (day 75), and end of pilot (day 150)
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Change in professional fulfillment and burnout, measured using the Professional Fulfillment Index (PFI), a validated 16-item self-report questionnaire.
The instrument comprises three subscales: Professional Fulfillment (6 items), Work Exhaustion (4 items), and Interpersonal Disengagement (6 items).
Items are rated on a 5-point Likert scale (0 = "Not at all true" / "Not at all" to 4 = "Completely true" / "Extremely").
Subscale scores are calculated as the mean of constituent items.
Unit of measure: mean subscale score (range 0-4) and overall burnout score (mean of Work Exhaustion and Interpersonal Disengagement subscales, range 0-4).
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Surveyed at enrollment (day 0 of pilot), midpoint (day 75), and end of pilot (day 150)
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Mean Score on NASA Task Load Index (NASA-TLX)
기간: Surveyed at enrollment (day 0 of pilot), midpoint (day 75), and end of pilot (day 150)
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Change in perceived workload, measured using the NASA Task Load Index (NASA-TLX), a validated multidimensional self-report questionnaire.
The instrument comprises six subscales: Mental Demand, Physical Demand, Temporal Demand, Performance, Effort, and Frustration.
Each subscale is rated on a 0-100 scale in 5-point increments.
Unit of measure: subscale score (range 0-100) and overall workload score, calculated as the unweighted mean of the six subscales (range 0-100).
Higher scores indicate greater perceived task workload associated with clinical documentation.
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Surveyed at enrollment (day 0 of pilot), midpoint (day 75), and end of pilot (day 150)
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Ambient AI scribe utilization rate (%)
기간: Through study completion, up to 150 days after the start of the pilot.
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Percentage of clinical encounters in which the provider used the Abridge ambient AI scribe, measured using Abridge platform usage logs cross-referenced with electronic health record (EHR) encounter data.
Unit of measure: utilization rate, calculated as (number of encounters in which Abridge was used divided by the total number of clinical encounters during the same period).
This fraction is then represented as a percentage (range 0-100%) and aggregated monthly by provider.
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Through study completion, up to 150 days after the start of the pilot.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Time Spent in the Electronic Health Record on Clinical Note Documentation (Minutes)
기간: Through study completion, up to 150 days after the start of the pilot.
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Time spent by the provider in the electronic health record on clinical note documentation activities, measured using EHR audit log data (e.g., Epic Signal Provider Efficiency Profile).
Unit of measure: minutes per scheduled clinic day on note documentation, normalized to clinical workload (clinical Full-Time Equivalent), and aggregated in 4-week windows per provider.
No patient information will be collected for this outcome measure.
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Through study completion, up to 150 days after the start of the pilot.
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Time spent in the electronic health record outside of working hours
기간: Through study completion, up to 150 days after the start of the pilot.
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Time spent by the provider in the electronic health record outside of scheduled clinic/working hours (commonly referred to as "work outside of work" or "pajama time"), measured using EHR audit log data (e.g., Epic Signal Provider Efficiency Profile).
Unit of measure: minutes per scheduled clinic day spent in the EHR outside of working hours, normalized to clinical workload and aggregated in 4-week windows per provider.
No patient information will be collected for this outcome measure.
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Through study completion, up to 150 days after the start of the pilot.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Christopher W Lewis, MD, MS, University of Washington
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2024년 12월 19일
기본 완료 (실제)
2025년 7월 4일
연구 완료 (실제)
2025년 7월 4일
연구 등록 날짜
최초 제출
2026년 4월 27일
QC 기준을 충족하는 최초 제출
2026년 5월 13일
처음 게시됨 (실제)
2026년 5월 20일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 28일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 22일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- STUDY00022081
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
All participant data will be deidentified (limited dataset), aggregated, or normalized.
Data will be managed and stored on Dryad (https://datadryad.org/), a nonprofit membership organization that is committed to making data available for research and educational reuse.
IPD 공유 기간
Data will be available for at least 10 years.
IPD 공유 액세스 기준
Data will be shared with qualified researchers whose proposed use has been approved by an institutional review board.
Request for deidentified data will be available through Dryad.
Requests for additional data can be made to the study's PI.
IPD 공유 지원 정보 유형
- 연구_프로토콜
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .