AI Ambient Scribe in Psychiatry (AASP)
18 de agosto de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ativo, não recrutando
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
47
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Canton of St. Gallen
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Heerbrugg, Canton of St. Gallen, Suíça, 9435
- Psychiatrie St. Gallen
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Pfäfers Dorf, Canton of St. Gallen, Suíça, 7312
- Psychiatrie St. Gallen
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Rorschach, Canton of St. Gallen, Suíça, 9400
- Psychiatrie St. Gallen
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Sankt Gallen, Canton of St. Gallen, Suíça, 9000
- Psychiatrie St. Gallen
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Sargans, Canton of St. Gallen, Suíça, 7320
- Psychiatrie St. Gallen
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Uznach, Canton of St. Gallen, Suíça, 8730
- Psychiatrie St. Gallen
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Wattwil, Canton of St. Gallen, Suíça, 9630
- Psychiatrie St. Gallen
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Wil, Canton of St. Gallen, Suíça, 9500
- Psychiatrie St. Gallen
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Sem intervenção: 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.
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Experimental: 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.
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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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Time spent on psychiatric documentation
Prazo: 24 Weeks
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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.
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24 Weeks
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Documentation quality of initial psychiatric asessment reports
Prazo: 24 Weeks
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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.
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24 Weeks
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Working Alliance
Prazo: 5 weeks pre intervention and 5 weeks during the intervention.
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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.
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5 weeks pre intervention and 5 weeks during the intervention.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Time passed from initial psychiatric assessment note creation to its completion
Prazo: 24 Weeks
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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.
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24 Weeks
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Guideline-relevant information coverage and density in initial psychiatric assessment reports
Prazo: 24 Weeks
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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.
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24 Weeks
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Patient-perceived empathy of mental health care providers during consultations
Prazo: 5 weeks pre intervention and 5 weeks during the intervention.
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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.
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5 weeks pre intervention and 5 weeks during the intervention.
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Documentation quality of ambient scribe-generated initial psychiatric assessment reports (raw AI output)
Prazo: 15 Weeks
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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.
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15 Weeks
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Clinician Burnout
Prazo: 5 weeks in the pre-intervention period and the last Week (Week 15) of the post-intervention period.
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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.
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5 weeks in the pre-intervention period and the last Week (Week 15) of the post-intervention period.
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Maja Dobelsek, MD, Universität St. Gallen
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
13 de julho de 2026
Conclusão Primária (Estimado)
31 de dezembro de 2026
Conclusão do estudo (Estimado)
31 de dezembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
6 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
18 de agosto de 2026
Primeira postagem (Real)
20 de agosto de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
20 de agosto de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
18 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- S012026
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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