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AI Ambient Scribe in Psychiatry (AASP)

2026年8月18日 更新者:Maja Dobelsek, MD、Psychiatrie St. Gallen

Evaluating the Use of an Artificial Intelligence Ambient Scribe in a Swiss Psychiatric Clinic: Efficiency, Documentation Quality, and Therapeutic Alliance

The goal of this clinical trial is to learn if an artificial intelligence (AI) tool that listens to appointments and drafts clinical notes can help clinicians in psychiatric care. Researchers also want to know if the tool changes how patients experience their care. The study includes mental health care providers (physicians, psychologists/psychotherapists, nurses, and social workers) at Psychiatrie St. Gallen and the adult patients they see in their appointments.

The main questions it aims to answer are:

  • Does the AI tool lower the time clinicians spend writing notes?
  • Are notes written with the AI tool as good as or better than notes written without it?
  • Do patients notice a difference in their relationship with their clinician when the tool is used?

Researchers will compare clinicians who use the AI tool to clinicians who keep writing notes their usual way, before and during the intervention period, to see if writing time, note quality, and the patient-rated therapeutic relationship differ between the two groups.

Clinicians will:

Join one of two groups. One group starts using the AI tool on August 14, 2026. The other group keeps writing notes the usual way. Both groups will be observed until the end of November 2026, with note quality evaluation completed in December 2026. Clinicians who cannot contribute to all measurements may, with their consent, remain in the study for automated measurement of documentation time only.

Patients will:

  • Be invited to fill out a short, anonymous survey about their experience with their clinician.
  • Be asked to agree, in writing, that researchers may review the report from their initial assessment appointment.

研究概览

研究类型

介入性

注册 (实际的)

47

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Canton of St. Gallen
      • Heerbrugg、Canton of St. Gallen、瑞士、9435
        • Psychiatrie St. Gallen
      • Pfäfers Dorf、Canton of St. Gallen、瑞士、7312
        • Psychiatrie St. Gallen
      • Rorschach、Canton of St. Gallen、瑞士、9400
        • Psychiatrie St. Gallen
      • Sankt Gallen、Canton of St. Gallen、瑞士、9000
        • Psychiatrie St. Gallen
      • Sargans、Canton of St. Gallen、瑞士、7320
        • Psychiatrie St. Gallen
      • Uznach、Canton of St. Gallen、瑞士、8730
        • Psychiatrie St. Gallen
      • Wattwil、Canton of St. Gallen、瑞士、9630
        • Psychiatrie St. Gallen
      • Wil、Canton of St. Gallen、瑞士、9500
        • Psychiatrie St. Gallen

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

The observed study population comprises mental health care providers (physicians, psychologists/psychotherapists, nurses, and social workers) employed at Psychiatrie St. Gallen.

Provider Inclusion Criteria:

  • Readiness to use an artificial intelligence ambient scribe during patient consultations (intervention group)
  • Regular clinical consultations with adult psychiatric patients

Two outcome-specific criteria apply: contribution to the report quality outcomes requires that the provider regularly conducts new-patient intakes and writes initial psychiatric assessment reports; contribution to the patient-reported outcomes requires working in the outpatient setting. Providers who cannot or no longer wish to contribute to any actively collected outcome may, with their consent, remain enrolled for passive documentation-time measurement only; for analysis, such providers stay in the group which was fixed at enrollment..

Provider Exclusion Criteria:

  • notice of termination of the employment contract given during the data collection period
  • Working in the dementia inpatient clinic

Patients are not the observed population, but anonymous ratings of their subjective consultation experience are collected from them, and written consent for the review of initial assessment reports is obtained.

Patient Inclusion Criteria:

- All adult patients visiting the outpatient clinic during the data collection periods for a consultation with a participating provider

Patient Exclusion Criteria:

  • Insufficient German proficiency (below level B2)
  • Cognitive impairment precluding informed participation
  • Acute psychosis, acute suicidality, mania, or intoxication
  • Severe emotional distress

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
无干预:Control Group
The mental health care providers (physicians, psychologists/psychotherapists, nurses, and social workers) in this group document their consultations as usual (typing or conventional dictation), without access to the ambient scribe. Under institutional policy, all clinicians irrespective of study participation may use general-purpose AI tools for administrative and documentation support, provided no patient-identifying data are entered; the control condition is therefore defined as documentation without the ambient scribe, not as documentation without any AI assistance.
实验性的:AI-Group
The mental health care providers in this group use an AI ambient scribe to create their clinical notes from consultations, beginning August 14, 2026.
Listener Tool of the SwissGPT application (AlpineAI AG). After the patient's verbal consent, the provider records the consultation audio via mobile phone or laptop. All audio and text data are processed exclusively on AlpineAI's own GPU infrastructure located in Switzerland and are encrypted with individual keys per customer and per data type. Transcription uses the speech-to-text models Whisper 3 Turbo; from the transcript, a draft clinical note is generated by open-weight large language model Mistral Large 3 based on a standardized prompt developed for the institution. The provider transfers the generated draft note unedited into the electronic health record (ORBIS) and performs all review and editing directly in the EHR, so that the effort of correcting AI-generated drafts is captured by the automated documentation-time measurement. Audio recordings and transcripts are automatically deleted after 30 days.
其他名称:
  • 人工智能

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Time spent on psychiatric documentation
大体时间:24 Weeks
Mean minutes spent writing clinical notes (progress notes, initial psychiatric assessment reports, and discharge letters), extracted automatically from EHR (ORBIS) audit logs as form-level editing durations, compared pre-intervention vs. during intervention between groups.
24 Weeks
Documentation quality of initial psychiatric asessment reports
大体时间:24 Weeks
Quality of initial psychiatric assessment reports rated with the Physician Documentation Quality Instrument, 9-item version (PDQI-9). Each of the 9 items is scored on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree) and summed to a total score ranging from 9 (minimum) to 45 (maximum); higher scores indicate better documentation quality. Each report is independently rated by 2 of 8 experienced mental health specialists in a balanced rotating-pair design, blinded to provider identity, group, time point, and site.
24 Weeks
Working Alliance
大体时间:5 weeks pre intervention and 5 weeks during the intervention.
Patient-rated working alliance measured with the Working Alliance Inventory-Short Revised, German patient version (WAI-SR). The 12 items are each scored on a 5-point scale (1 to 5) and summed to a total score ranging from 12 (minimum) to 60 (maximum); higher scores indicate a stronger (better) working alliance. Reported anonymously by patients after outpatient consultations. In addition to the two-sided superiority test, non-inferiority is prespecified: a lower bound of the two-sided 95% CI of the difference-in-differences estimate above -3.5 WAI-SR sum-scale points will be interpreted as evidence against a clinically relevant deterioration of the alliance.
5 weeks pre intervention and 5 weeks during the intervention.

次要结果测量

结果测量
措施说明
大体时间
Time passed from initial psychiatric assessment note creation to its completion
大体时间:24 Weeks
Calendar time from the administrative creation of the initial psychiatric assessment note in the EHR to its completion, capturing documentation backlog. This outcome is separate from total active time spent writing the note.
24 Weeks
Guideline-relevant information coverage and density in initial psychiatric assessment reports
大体时间:24 Weeks
Coverage and density of guideline-relevant psychiatric assessment content, scored by a large language model (SwissGPT) against a 71-item checklist derived from the American Psychiatric Association practice guidelines for the psychiatric evaluation of adults. Each item is scored as covered (1), partially covered (0.5), or not covered (0); report length in characters is used to compute information density.
24 Weeks
Patient-perceived empathy of mental health care providers during consultations
大体时间:5 weeks pre intervention and 5 weeks during the intervention.
Patient-perceived empathy measured with the Consultation and Relational Empathy (CARE) measure. The 10 items are each scored on a 5-point scale (1 = poor to 5 = excellent) and summed to a total score ranging from 10 (minimum) to 50 (maximum); higher scores indicate greater perceived empathy (better). Completed anonymously by patients alongside the WAI-SR. A study-specific German translation is used; its psychometric properties will be examined and reported.
5 weeks pre intervention and 5 weeks during the intervention.
Documentation quality of ambient scribe-generated initial psychiatric assessment reports (raw AI output)
大体时间:15 Weeks
AI-generated initial psychiatric assessment reports, exactly as produced by the ambient scribe and before any human correction, rated by the generating providers (intervention group only) with the Provider Documentation Summarization Quality Instrument (PDSQI-9), an LLM-adapted 9-attribute instrument screening for hallucinations, omissions, redundancy, and biased language. Each attribute is scored on a 5-point scale (1 to 5) and summed to a total score ranging from 9 (minimum) to 45 (maximum); higher scores indicate better quality of the AI-generated summary.
15 Weeks
Clinician Burnout
大体时间:5 weeks in the pre-intervention period and the last Week (Week 15) of the post-intervention period.
Work-related burnout of participating providers in both groups, measured with the German version of the Burnout Assessment Tool (BAT). The 23 core-symptom items (subscales: exhaustion, mental distance, cognitive impairment, emotional impairment) are each scored on a 5-point frequency scale (1 = never to 5 = always) and averaged to a core score ranging from 1.00 (minimum) to 5.00 (maximum); higher scores indicate more burnout symptoms (worse outcome). The 10 secondary-symptom items are scored and averaged on the same 1.00-5.00 metric, with higher scores likewise indicating a worse outcome.
5 weeks in the pre-intervention period and the last Week (Week 15) of the post-intervention period.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Maja Dobelsek, MD、Universität St. Gallen

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月13日

初级完成 (估计的)

2026年12月31日

研究完成 (估计的)

2026年12月31日

研究注册日期

首次提交

2026年8月6日

首先提交符合 QC 标准的

2026年8月18日

首次发布 (实际的)

2026年8月20日

研究记录更新

最后更新发布 (实际的)

2026年8月20日

上次提交的符合 QC 标准的更新

2026年8月18日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • S012026

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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