AI Ambient Scribe in Psychiatry

NCT07777224 | Active Not Recruiting

• 1 other identifier: S012026
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Therapeutic Alliance; Empathy; Documentation; Artificial Intelligence (AI); Efficiency of Physician Documentation; Quality Improvement; Burnout

Keywords

Artificial Intelligence; Psychiatry; Ambient Scribing

Outcome Measures

Primary Outcomes (3)

• Time spent on psychiatric documentation

  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

  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

  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.

Secondary Outcomes (5)

• 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.

Study Arms (2)

Control Group

NO INTERVENTION

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

EXPERIMENTAL

The mental health care providers in this group use an AI ambient scribe to create their clinical notes from consultations, beginning August 14, 2026.

Device: Artificial Intelligence Ambient Scribe

Interventions

Artificial Intelligence Ambient Scribe DEVICE

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.

Also known as: Artificial Intelligence

AI-Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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..

You may not qualify if:

• 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.
• \- All adult patients visiting the outpatient clinic during the data collection periods for a consultation with a participating provider
• Insufficient German proficiency (below level B2)
• Cognitive impairment precluding informed participation
• Acute psychosis, acute suicidality, mania, or intoxication
• Severe emotional distress

Sponsors & Collaborators

• Psychiatrie St. Gallen: lead
• University of St.Gallen: collaborator

Study Sites (8)

Psychiatrie St. Gallen

Heerbrugg, Canton of St. Gallen, 9435, Switzerland

Location

Psychiatrie St. Gallen

Pfäfers Dorf, Canton of St. Gallen, 7312, Switzerland

Location

Psychiatrie St. Gallen

Rorschach, Canton of St. Gallen, 9400, Switzerland

Location

Psychiatrie St. Gallen

Sankt Gallen, Canton of St. Gallen, 9000, Switzerland

Location

Psychiatrie St. Gallen

Sargans, Canton of St. Gallen, 7320, Switzerland

Location

Psychiatrie St. Gallen

Uznach, Canton of St. Gallen, 8730, Switzerland

Location

Psychiatrie St. Gallen

Wattwil, Canton of St. Gallen, 9630, Switzerland

Location

Psychiatrie St. Gallen

Wil, Canton of St. Gallen, 9500, Switzerland

Location

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Maja Dobelsek, MD

  Universität St. Gallen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Acting Consultant Psychiatrist & Head of the Wattwil Outpatient Clinic

Model Details: Nonrandomized, open-label controlled trial with parallel assignment at the level of mental health care providers, analyzed within a difference-in-differences (DiD) framework. Outcomes are measured in both groups before and during the intervention period. Providers group assignment is fixed at enrollment.

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 20, 2026
• Study Start: July 13, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 20, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CH (8)