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AI Ambient Scribe in Psychiatry (AASP)

18. august 2026 oppdatert av: 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.

Studieoversikt

Studietype

Intervensjonell

Registrering (Faktiske)

47

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: 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.
Eksperimentell: 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.
Andre navn:
  • Kunstig intelligens

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time spent on psychiatric documentation
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time passed from initial psychiatric assessment note creation to its completion
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Samarbeidspartnere

Etterforskere

  • Hovedetterforsker: Maja Dobelsek, MD, Universität St. Gallen

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

13. juli 2026

Primær fullføring (Antatt)

31. desember 2026

Studiet fullført (Antatt)

31. desember 2026

Datoer for studieregistrering

Først innsendt

6. august 2026

Først innsendt som oppfylte QC-kriteriene

18. august 2026

Først lagt ut (Faktiske)

20. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

20. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • S012026

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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