AI Ambient Scribe in Psychiatry (AASP)
18 agosto 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Attivo, non reclutante
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
47
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Canton of St. Gallen
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Heerbrugg, Canton of St. Gallen, Svizzera, 9435
- Psychiatrie St. Gallen
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Pfäfers Dorf, Canton of St. Gallen, Svizzera, 7312
- Psychiatrie St. Gallen
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Rorschach, Canton of St. Gallen, Svizzera, 9400
- Psychiatrie St. Gallen
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Sankt Gallen, Canton of St. Gallen, Svizzera, 9000
- Psychiatrie St. Gallen
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Sargans, Canton of St. Gallen, Svizzera, 7320
- Psychiatrie St. Gallen
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Uznach, Canton of St. Gallen, Svizzera, 8730
- Psychiatrie St. Gallen
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Wattwil, Canton of St. Gallen, Svizzera, 9630
- Psychiatrie St. Gallen
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Wil, Canton of St. Gallen, Svizzera, 9500
- Psychiatrie St. Gallen
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Sì
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Nessun intervento: 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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Sperimentale: 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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Time spent on psychiatric documentation
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Time passed from initial psychiatric assessment note creation to its completion
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Maja Dobelsek, MD, Universität St. Gallen
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
13 luglio 2026
Completamento primario (Stimato)
31 dicembre 2026
Completamento dello studio (Stimato)
31 dicembre 2026
Date di iscrizione allo studio
Primo inviato
6 agosto 2026
Primo inviato che soddisfa i criteri di controllo qualità
18 agosto 2026
Primo Inserito (Effettivo)
20 agosto 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
20 agosto 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
18 agosto 2026
Ultimo verificato
1 agosto 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- S012026
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
NO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .