Evaluating the Use of an Artificial Intelligence Ambient Scribe in a Swiss Psychiatric Clinic: Efficiency, Documentation Quality, and Therapeutic Alliance
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 47
- 试验地点
- 8
- 主要终点
- Time spent on psychiatric documentation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Providers and patients cannot be masked. Outcome assessors for report quality (PDQI-9 specialist raters) are blinded to provider identity, group allocation, time point, and site through removal of all directly identifying information from the reports before rating. Because AI-drafted notes may exhibit recognizable structure, blinding to scribe use cannot be assumed to be complete; as a prespecified manipulation check, raters record a forced-choice guess of scribe use for every report, and guess accuracy will be reported.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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..
排除标准
- •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
研究组 & 干预措施
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.
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.
干预措施: Artificial Intelligence Ambient Scribe (Device)
结局指标
主要结局
Time spent on psychiatric documentation
时间窗: 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.
Documentation quality of initial psychiatric asessment reports
时间窗: 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.
Working Alliance
时间窗: 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.
次要结局
- Time passed from initial psychiatric assessment note creation to its completion(24 Weeks)
- Guideline-relevant information coverage and density in initial psychiatric assessment reports(24 Weeks)
- Patient-perceived empathy of mental health care providers during consultations(5 weeks pre intervention and 5 weeks during the intervention.)
- Documentation quality of ambient scribe-generated initial psychiatric assessment reports (raw AI output)(15 Weeks)
- Clinician Burnout(5 weeks in the pre-intervention period and the last Week (Week 15) of the post-intervention period.)
研究者
Maja Dobelsek, MD
Acting Consultant Psychiatrist & Head of the Wattwil Outpatient Clinic
Psychiatrie St. Gallen