Burnout, ProfessionalNCT07647159
Voice Assistant for Outpatient Neurology Visits
A study testing AI-based voice assistant Service for automated pre-filling of outpatient neurology visit protocol in EMIAS in people with Burnout, Professional and Documentation, run by Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department at 1 site in Russia.
Trial summary
Documentation duties account for a substantial portion of an outpatient physician's working time and reduce time available for direct patient interaction. Voice assistants based on automatic speech recognition and large language models are being developed to automate medical documentation across clinical specialties. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burnout, Professional, Documentation, Medical Records Systems, Computerized
- What is being tested?
- AI-based voice assistant Service for automated pre-filling of outpatient neurology visit protocol in EMIAS
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteRussia
- Study dates
- 26 Oct 2025to 30 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First-time outpatient neurology visit conducted by a participating physician according to the approved consultation script.
- Age 18 years or older.
- Signed informed consent to participate in the study.
- Signed consent to processing of personal data.
- Clinical condition that allowed the patient to complete the modified Patient Satisfaction Questionnaire 8 (PSQ-8).
Who cannot join
- Consultation longer than 45 minutes.
- Consultation shorter than 5 minutes, not requiring a full examination (e.g., prescription renewal, clarification of follow-up questions only).
- Technical failures preventing valid interpretation of the consultation or its timing (microphone failure, malfunction of the recording software, malfunction of the Service).
- Deviation from the approved consultation script.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
Moscow, 125051
About this study
Official title: Voice Assistant for Outpatient Neurology Visits Based on Artificial Intelligence Technologies: A Multicenter Prospective Pilot Study
Documentation duties account for a substantial portion of an outpatient physician's working time and reduce time available for direct patient interaction. Voice assistants based on automatic speech recognition and large language models are being developed to automate medical documentation across clinical specialties. However, such ambient AI-based services have not been systematically validated in Russian-language outpatient neurology practice integrated with a regional electronic health record platform.
This pilot, multicenter, prospective, before-after study evaluated the feasibility and preliminary effectiveness of a voice assistant Service designed to automatically pre-fill the structured outpatient neurology visit protocol in the Moscow regional medical information system (EMIAS). The Service implements a pipeline of streaming speech-to-text transcription, two-speaker diarization, and large language model-based mapping of the dialogue between the physician and the patient onto the fields of the standardized neurology examination protocol.
Read more
Five neurologists at five outpatient clinics in Moscow participated. The study comprised three stages: (1) baseline timing of consultations without the Service; (2) timing of consultations with the Service after a two-week adaptation period, with parallel evaluation of transcription and pre-fill quality and of physician and patient satisfaction; and (3) statistical analysis. Three hundred twenty consultations were timed (160 per stage). A stratified random sample of 30 audio-recording / generated-protocol pairs was used to evaluate Service quality; free-text fields were rated on a 5-domain Likert questionnaire and on a 10-point visual analogue scale, and binary fields were rated dichotomously to derive sensitivity, specificity, accuracy, Jaccard index, and false-positive rate. Patient satisfaction was assessed by the modified Patient Satisfaction Questionnaire 8 (PSQ-8); physician feedback was assessed by a custom questionnaire (including the Net Promoter Score) and by semi-structured in-depth interviews with thematic analysis using grounded theory.
The primary outcomes were the change between stages in (a) the time of focused physician attention to the patient and (b) the time spent filling and editing the protocol. Secondary outcomes addressed total consultation time, transcription quality (Word Error Rate), expert-rated quality of pre-filled fields, patient satisfaction, and physician satisfaction.
The study was conducted under the framework of the Moscow Healthcare Department experiment on the use of digital innovation technologies in health care (Order No. 153 of 21 February 2025), and was approved by the local independent ethics committee.
Read the detailed description
Rationale and evidence gap. Documentation burden is widely recognized as a leading driver of professional burnout among physicians and reduces the time available for direct patient interaction. International evidence on ambient AI scribes - systems that combine automatic speech recognition (ASR) and large language models (LLM) - shows consistent reductions in documentation time and stable or improved patient satisfaction. However, evidence specific to Russian-language outpatient neurology practice integrated with a regional electronic health record is lacking. Neurologists are among the medical specialties with the highest reported burnout rates internationally; the specifics of Russian-language medical terminology, the structured neurological examination, and integration with a regional medical information system preclude direct extrapolation of international findings.
Technical implementation of the Service. The Service implements a distributed pipeline: streaming audio capture by an EMIAS client module; REST-API transmission of audio chunks to the speech recognition service with two-speaker diarization (physician/patient) and contextual re-clarification of streaming transcripts; asynchronous routing of transcription results through Apache Kafka topics to a pre-fill subsystem; large-language-model-based mapping of the full transcript onto a JSON schema of the structured outpatient neurology examination protocol (document class code 23951) using clinical reference dictionaries (including ICD-10 via the MKB10_ACTIVE_SHORT_INFO_V2 reference table); and return of the structured pre-filled protocol to the physician's user interface for review, editing, and signing. Audio is recorded via an active HD-capsule microphone placed at the physician's workstation (OGG Vorbis, 16 kHz, ≥ 64 kbit/s, mono). A priori quality targets fixed in the technical documentation before the pilot were: Word Error Rate of streaming transcription ≤ 10 %; sensitivity, specificity, accuracy, and Jaccard index for binary protocol fields ≥ 0.9; mean expert rating on a Visual Analogue Scale ≥ 8 out of 10; share of consultations with protocol generation time ≤ 35 seconds ≥ 90 %; physician Net Promoter Score ≥ 0 %.
Methodological design choices. A non-randomized single-group before-after design was selected as appropriate for a first-line feasibility evaluation in real clinical practice: the same physicians and clinics provide their own baseline reference in Stage 1, eliminating between-physician confounding while preserving ecological validity. A two-week post-deployment adaptation period was prespecified to mitigate purely learning-curve effects on Stage 2 metrics. Timing of consultation stages was performed by trained experts of the Scientific and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Healthcare Department on the basis of three synchronized data sources for each consultation: (i) automatic EMIAS event logs from protocol creation to signing; (ii) screen recording of the physician's workstation (VocoScreen NG, version 4.01.1); and (iii) webcam recording of the physician's face and gaze direction. The tri-source synchronization reduces systematic bias common to single-source or self-reported timing studies.
Quality evaluation framework. A stratified random sample of 30 paired audio recordings and Service-generated protocols (six per physician) was used to evaluate transcription and pre-fill quality. Reference (gold-standard) transcripts were prepared manually by an expert with more than five years of experience. Free-text fields of the protocol were rated by four independent neurology experts on a five-domain Likert questionnaire (Relevance, Accuracy, Completeness, Conciseness, Linguistic correctness) and on a 10-point Visual Analogue Scale; binary fields were rated dichotomously to construct a confusion matrix and derive sensitivity, specificity, accuracy, the Jaccard index, and the false-positive (hallucination) rate. Inter-rater agreement among the four experts was quantified by Gwet's AC2, preferred over Cohen's κ for categorical classifications with asymmetric prevalence. Word Error Rate was computed in Python with the jiwer library against the reference transcripts.
Analytical approach. Quantitative between-stage comparisons used Student's t-test or the Mann-Whitney U test depending on distribution, with Pearson's χ² for categorical variables and Cohen's d as the effect-size measure (α = 0.05, two-sided). Qualitative analysis of semi-structured in-depth interviews with each participating neurologist followed the grounded theory approach of Strauss and Corbin, with open, axial, and selective coding.
- Conditions
- Burnout, Professional, Documentation, Medical Records Systems, Computerized, Speech Recognition Software, Health Services Research, Neurology
- Being tested
- AI-based voice assistant Service for automated pre-filling of outpatient neurology visit protocol in EMIAS
- Keywords
- voice assistant for clinicians, speech recognition, large language model, ambient AI, electronic health record, neurology, outpatient appointment, patient satisfaction, documentation burden, pilot study
- Medical subject headings
- Burnout, Professional, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-based voice assistant Service for automated pre-filling of outpatient neurology visit protocol in EMIASDevice
The Service is software using artificial intelligence technologies that automatically pre-fills the structured outpatient neurology visit protocol in the Moscow regional medical information system (EMIAS) based on the audio-recorded dialogue between physician and patient. The pipeline comprises: (1) streaming audio capture by the EMIAS audio-recording client module, (2) chunk-wise transmission to the speech recognition service via REST API, (3) routing of transcription results through Apache Kafka topics to the pre-fill subsystem, (4) large language model-based mapping of the full transcript onto the JSON schema of the target document using clinical reference dictionaries, and (5) return of the structured pre-filled protocol to the physician's user interface. Audio is recorded via an active HD-capsule microphone placed at the physician's workstation. The physician reviews each pre-filled field, edits when necessary and signs the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Outpatient Neurology Visits with AI Voice Assistant | Experimental | All participating neurologists conducted outpatient consultations using the Service after a two-week adaptation period. Each consultation followed the approved script; the Service captured the audio, transcribed it in real time, generated a pre-filled visit protocol via a large language model, and returned it for physician review and signing. Receives: Device: AI-based voice assistant Service for automated pre-filling of outpatient neurology visit protocol in EMIAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physician focused-attention time on the patient
Time (in minutes) of focused physician attention on the patient, including visual contact and active interaction during examination, measured from three synchronized sources (EMIAS logs, screen video, webcam video)
Measured: Up to 14 weeks: pre-intervention measurements collected per consultation during study Weeks 1-2 (Stage 1); post-intervention measurements collected per consultation during study Weeks 5-14 (Stage 2, after a 2-week adaptation period).
Change in protocol-filling time
Time (in minutes) spent filling and editing the visit protocol, including keyboard input, mouse clicks, copying and pasting, measured from the three synchronized sources.
Measured: Up to 14 weeks: pre-intervention measurements collected per consultation during study Weeks 1-2 (Stage 1); post-intervention measurements collected per consultation during study Weeks 5-14 (Stage 2, after a 2-week adaptation period).
Secondary outcomes (7)
Change in total consultation time
Total time (in minutes) from creation to signing of the visit protocol, derived from EMIAS event logs
Measured: Up to 14 weeks: pre-intervention measurements collected per consultation during study Weeks 1-2 (Stage 1); post-intervention measurements collected per consultation during study Weeks 5-14 (Stage 2, after a 2-week adaptation period).
Transcription quality (Word Error Rate, WER)
WER (%) of automatically generated transcripts versus expert reference transcripts on a stratified random sample of 30 consultations (6 per physician), computed with the jiwer Python library
Measured: Up to 14 weeks: assessed once per consultation on a stratified random sample of 30 audio recordings collected during study Weeks 5-14 (post-intervention period).
Expert-rated quality of free-text protocol fields
Mean rating of free-text protocol fields by four independent neurology experts using a modified expert evaluation questionnaire ("E-5"), scored on a 5-point Likert scale ranging from 1 ("completely disagree") to 5 ("completely agree"). Each of the "Complaints", "History of present illness", and "Recommendations" sections of 30 Service-generated protocols is rated across five domains: Relevance, Accuracy, Completeness, Conciseness (scored on an inverted scale, where higher values denote less redundant content), and Linguistic correctness. Each domain score ranges from 1 to 5; for all five domains, higher scores indicate better field quality (higher scores reflect a better outcome).
Measured: Up to 14 weeks: assessed once per protocol on a stratified random sample of 30 Service-generated protocols from consultations conducted during study Weeks 5-14 (post-intervention period).
Quality of pre-filling for binary protocol fields
Sensitivity, specificity, accuracy, Jaccard index, and false-positive (hallucination) rate for binary fields of 30 auto-generated protocols rated by four independent experts
Measured: Up to 14 weeks: assessed once per protocol on a stratified random sample of 30 Service-generated protocols from consultations conducted during study Weeks 5-14 (post-intervention period).
Overall protocol quality (Visual Analogue Scale)
Mean expert rating of the overall quality of each Service-generated visit protocol on a Visual Analogue Scale (VAS) ranging from 1 to 10. The scale anchors are 1 = "lowest possible quality" and 10 = "highest possible quality"; higher scores indicate better protocol quality (higher scores reflect a better outcome). Each of the 30 sampled Service-generated protocols is rated independently by four neurology experts; the mean of all expert ratings across protocols is reported.
Measured: Up to 14 weeks: assessed once per protocol on a stratified random sample of 30 Service-generated protocols from consultations conducted during study Weeks 5-14 (post-intervention period).
Patient satisfaction (modified PSQ-8)
Mean scores on the modified Patient Satisfaction Questionnaire 8 (PSQ-8) - an 8-item self-administered patient satisfaction instrument adapted to outpatient neurology - across seven reported domains: Comfort during the consultation; Perceived physician attention (focus on the patient versus on documentation); Understanding of the physician's explanations; Patient involvement in clinical decision-making; Trust in the prescribed treatment; Understanding of subsequent management tactics; and Knowledge of actions to take in emergency situations. Each item is rated on a 5-point Likert scale ranging from 1 ("absolutely not") to 5 ("yes, completely"). Each domain score ranges from 1 to 5; higher scores indicate greater patient satisfaction (higher scores reflect a better outcome).
Measured: Up to 14 weeks: pre-intervention questionnaires collected per consultation during study Weeks 1-2 (Stage 1); post-intervention questionnaires collected per consultation during study Weeks 5-14 (Stage 2).
Physician satisfaction (Net Promoter Score)
Net Promoter Score (NPS) for physician satisfaction with the Service, calculated from a single 0-to-10 likelihood-to-recommend question administered to each participating neurologist at the end of Stage 2. The item anchors are 0 = "would never recommend" and 10 = "would definitely recommend". Respondents are classified as Detractors (score 0-6), Passives (score 7-8), or Promoters (score 9-10). The Net Promoter Score is calculated as (% Promoters) - (% Detractors). The NPS ranges from -100 (all respondents are Detractors) to +100 (all respondents are Promoters); higher scores indicate greater physician willingness to recommend the Service (higher scores reflect a better outcome).
Measured: At the end of study (study Week 14): single measurement collected from each participating physician upon completion of Stage 2.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study start26 Oct 2025
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burnout, ProfessionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Before-After comparison: the same five neurologists and five clinics observed during Stage 1 (without the Service) and Stage 2 (with the Service), with at least 30 timed consultations per physician in each stage.
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
- Sponsor type
- University, hospital or other
- Collaborators
- Information and Analytical Center of the Moscow Healthcare Department
- Responsible party
- Sponsor
- Investigators
- Yuriy Vasilev, MD, PhD, Study director, Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647159
- Sponsor's protocol ID
- 2025-9
- Status last verified
- Jun 2026
- First submitted
- 27 May 2026
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be made publicly available due to the requirements of Federal Law No. 152-FZ of the Russian Federation "On Personal Data", the conditions of the signed informed consent forms, and the decision of the local independent ethics committee that approved the study protocol.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Voice Assistant for Outpatient Neurology Visits Based on Artificial Intelligence Technologies: A Multicenter Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT07647159
- Acronym / sponsor ID
- 2025-9
- Conditions
- Burnout, Professional, Documentation, Medical Records Systems, Computerized, Speech Recognition Software, Health Services Research, Neurology
- Keywords
- voice assistant for clinicians, speech recognition, large language model, ambient AI, electronic health record, neurology, outpatient appointment, patient satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care DepartmentUniversity, hospital or other
- Collaborators
- Information and Analytical Center of the Moscow Healthcare Department
- Study start
- 26 Oct 2025 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Documentation duties account for a substantial portion of an outpatient physician's working time and reduce time available for direct patient interaction. Voice assistants based on automatic speech recognition and large language models are being developed to automate medical documentation across clinical specialties. However, such ambient AI-based services have not been systematically validated in Russian-language outpatient neurology practice integrated with a regional electronic health record platform.
This pilot, multicenter, prospective, before-after study evaluated the feasibility and preliminary effectiveness of a voice assistant Service designed to automatically pre-fill the structured outpatient neurology visit protocol in the Moscow regional medical information system (EMIAS). The Service implements a pipeline of streaming speech-to-text transcription, two-speaker diarization, and large language model-based mapping of the dialogue between the physician and the patient onto the fields of the standardized neurology examination protocol.
Five neurologists at five outpatient clinics in Moscow participated. The study comprised three stages: (1) baseline timing of consultations without the Service; (2) timing of consultations with the Service after a two-week adaptation period, with parallel evaluation of transcription and pre-fill quality and of physician and patient satisfaction; and (3) statistical analysis. Three hundred twenty consultations were timed (160 per stage). A stratified random sample of 30 audio-recording / generated-protocol pairs was used to evaluate Service quality; free-text fields were rated on a 5-domain Likert questionnaire and on a 10-point visual analogue scale, and binary fields were rated dichotomously to derive sensitivity, specificity, accuracy, Jaccard index, and false-positive rate. Patient satisfaction was assessed by the modified Patient Satisfaction Questionnaire 8 (PSQ-8); physician feedback was assessed by a custom questionnaire (including the Net Promoter Score) and by semi-structured in-depth interviews with thematic analysis using grounded theory.
The primary outcomes were the change between stages in (a) the time of focused physician attention to the patient and (b) the time spent filling and editing the protocol. Secondary outcomes addressed total consultation time, transcription quality (Word Error Rate), expert-rated quality of pre-filled fields, patient satisfaction, and physician satisfaction.
The study was conducted under the framework of the Moscow Healthcare Department experiment on the use of digital innovation technologies in health care (Order No. 153 of 21 February 2025), and was approved by the local independent ethics committee.
Detailed description
Rationale and evidence gap. Documentation burden is widely recognized as a leading driver of professional burnout among physicians and reduces the time available for direct patient interaction. International evidence on ambient AI scribes - systems that combine automatic speech recognition (ASR) and large language models (LLM) - shows consistent reductions in documentation time and stable or improved patient satisfaction. However, evidence specific to Russian-language outpatient neurology practice integrated with a regional electronic health record is lacking. Neurologists are among the medical specialties with the highest reported burnout rates internationally; the specifics of Russian-language medical terminology, the structured neurological examination, and integration with a regional medical information system preclude direct extrapolation of international findings.
Technical implementation of the Service. The Service implements a distributed pipeline: streaming audio capture by an EMIAS client module; REST-API transmission of audio chunks to the speech recognition service with two-speaker diarization (physician/patient) and contextual re-clarification of streaming transcripts; asynchronous routing of transcription results through Apache Kafka topics to a pre-fill subsystem; large-language-model-based mapping of the full transcript onto a JSON schema of the structured outpatient neurology examination protocol (document class code 23951) using clinical reference dictionaries (including ICD-10 via the MKB10_ACTIVE_SHORT_INFO_V2 reference table); and return of the structured pre-filled protocol to the physician's user interface for review, editing, and signing. Audio is recorded via an active HD-capsule microphone placed at the physician's workstation (OGG Vorbis, 16 kHz, ≥ 64 kbit/s, mono). A priori quality targets fixed in the technical documentation before the pilot were: Word Error Rate of streaming transcription ≤ 10 %; sensitivity, specificity, accuracy, and Jaccard index for binary protocol fields ≥ 0.9; mean expert rating on a Visual Analogue Scale ≥ 8 out of 10; share of consultations with protocol generation time ≤ 35 seconds ≥ 90 %; physician Net Promoter Score ≥ 0 %.
Methodological design choices. A non-randomized single-group before-after design was selected as appropriate for a first-line feasibility evaluation in real clinical practice: the same physicians and clinics provide their own baseline reference in Stage 1, eliminating between-physician confounding while preserving ecological validity. A two-week post-deployment adaptation period was prespecified to mitigate purely learning-curve effects on Stage 2 metrics. Timing of consultation stages was performed by trained experts of the Scientific and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Healthcare Department on the basis of three synchronized data sources for each consultation: (i) automatic EMIAS event logs from protocol creation to signing; (ii) screen recording of the physician's workstation (VocoScreen NG, version 4.01.1); and (iii) webcam recording of the physician's face and gaze direction. The tri-source synchronization reduces systematic bias common to single-source or self-reported timing studies.
Quality evaluation framework. A stratified random sample of 30 paired audio recordings and Service-generated protocols (six per physician) was used to evaluate transcription and pre-fill quality. Reference (gold-standard) transcripts were prepared manually by an expert with more than five years of experience. Free-text fields of the protocol were rated by four independent neurology experts on a five-domain Likert questionnaire (Relevance, Accuracy, Completeness, Conciseness, Linguistic correctness) and on a 10-point Visual Analogue Scale; binary fields were rated dichotomously to construct a confusion matrix and derive sensitivity, specificity, accuracy, the Jaccard index, and the false-positive (hallucination) rate. Inter-rater agreement among the four experts was quantified by Gwet's AC2, preferred over Cohen's κ for categorical classifications with asymmetric prevalence. Word Error Rate was computed in Python with the jiwer library against the reference transcripts.
Analytical approach. Quantitative between-stage comparisons used Student's t-test or the Mann-Whitney U test depending on distribution, with Pearson's χ² for categorical variables and Cohen's d as the effect-size measure (α = 0.05, two-sided). Qualitative analysis of semi-structured in-depth interviews with each participating neurologist followed the grounded theory approach of Strauss and Corbin, with open, axial, and selective coding.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Before-After comparison: the same five neurologists and five clinics observed during Stage 1 (without the Service) and Stage 2 (with the Service), with at least 30 timed consultations per physician in each stage.
| Arm | Type | Receives |
|---|---|---|
| Outpatient Neurology Visits with AI Voice Assistant | Experimental | Device: AI-based voice assistant Service for automated pre-filling of outpatient neurology visit protocol in EMIASAll participating neurologists conducted outpatient consultations using the Service after a two-week adaptation period. Each consultation followed the approved script; the Service captured the audio, transcribed it in real time, generated a pre-filled visit protocol via a large language model, and returned it for physician review and signing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- First-time outpatient neurology visit conducted by a participating physician according to the approved consultation script.
- Age 18 years or older.
- Signed informed consent to participate in the study.
- Signed consent to processing of personal data.
- Clinical condition that allowed the patient to complete the modified Patient Satisfaction Questionnaire 8 (PSQ-8).
Key exclusion criteria (4 listed)
- Consultation longer than 45 minutes.
- Consultation shorter than 5 minutes, not requiring a full examination (e.g., prescription renewal, clarification of follow-up questions only).
- Technical failures preventing valid interpretation of the consultation or its timing (microphone failure, malfunction of the recording software, malfunction of the Service).
- Deviation from the approved consultation script.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-based voice assistant Service for automated pre-filling of outpatient neurology visit protocol in EMIASThe Service is software using artificial intelligence technologies that automatically pre-fills the structured outpatient neurology visit protocol in the Moscow regional medical information system (EMIAS) based on the audio-recorded dialogue between physician and patient. The pipeline comprises: (1) streaming audio capture by the EMIAS audio-recording client module, (2) chunk-wise transmission to the speech recognition service via REST API, (3) routing of transcription results through Apache Kafka topics to the pre-fill subsystem, (4) large language model-based mapping of the full transcript onto the JSON schema of the target document using clinical reference dictionaries, and (5) return of the structured pre-filled protocol to the physician's user interface. Audio is recorded via an active HD-capsule microphone placed at the physician's workstation. The physician reviews each pre-filled field, edits when necessary and signs the protocol. | Device | Outpatient Neurology Visits with AI Voice Assistant |
Primary outcome
Change in physician focused-attention time on the patient
Time frame: Up to 14 weeks: pre-intervention measurements collected per consultation during study Weeks 1-2 (Stage 1); post-intervention measurements collected per consultation during study Weeks 5-14 (Stage 2, after a 2-week adaptation period).
Time (in minutes) of focused physician attention on the patient, including visual contact and active interaction during examination, measured from three synchronized sources (EMIAS logs, screen video, webcam video)
Change in protocol-filling time
Time frame: Up to 14 weeks: pre-intervention measurements collected per consultation during study Weeks 1-2 (Stage 1); post-intervention measurements collected per consultation during study Weeks 5-14 (Stage 2, after a 2-week adaptation period).
Time (in minutes) spent filling and editing the visit protocol, including keyboard input, mouse clicks, copying and pasting, measured from the three synchronized sources.
7 secondary outcomes
Change in total consultation time
Time frame: Up to 14 weeks: pre-intervention measurements collected per consultation during study Weeks 1-2 (Stage 1); post-intervention measurements collected per consultation during study Weeks 5-14 (Stage 2, after a 2-week adaptation period).
Transcription quality (Word Error Rate, WER)
Time frame: Up to 14 weeks: assessed once per consultation on a stratified random sample of 30 audio recordings collected during study Weeks 5-14 (post-intervention period).
Expert-rated quality of free-text protocol fields
Time frame: Up to 14 weeks: assessed once per protocol on a stratified random sample of 30 Service-generated protocols from consultations conducted during study Weeks 5-14 (post-intervention period).
Quality of pre-filling for binary protocol fields
Time frame: Up to 14 weeks: assessed once per protocol on a stratified random sample of 30 Service-generated protocols from consultations conducted during study Weeks 5-14 (post-intervention period).
Overall protocol quality (Visual Analogue Scale)
Time frame: Up to 14 weeks: assessed once per protocol on a stratified random sample of 30 Service-generated protocols from consultations conducted during study Weeks 5-14 (post-intervention period).
Patient satisfaction (modified PSQ-8)
Time frame: Up to 14 weeks: pre-intervention questionnaires collected per consultation during study Weeks 1-2 (Stage 1); post-intervention questionnaires collected per consultation during study Weeks 5-14 (Stage 2).
Physician satisfaction (Net Promoter Score)
Time frame: At the end of study (study Week 14): single measurement collected from each participating physician upon completion of Stage 2.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be made publicly available due to the requirements of Federal Law No. 152-FZ of the Russian Federation "On Personal Data", the conditions of the signed informed consent forms, and the decision of the local independent ethics committee that approved the study protocol.
Related trials for Burnout, Professional
Recruiting
Professional Readiness Through Emotional Preparedness (PREP)
Burnout
Enrolling by invitationObservational study
Floatation Experience in Nurses and Physicians
Burnout, Professional, Negative Affect
RecruitingObservational study
Burnout Syndrome in the Intensive Care Unit Before and During a Palliative Care Trial
Burnout Syndrome
Recruiting
Ambient AI Scribe (Voa Health) in Outpatient Clinics: Draft Notes, Documentation Burden, and Well-Being
Burnout, Professionals, Medical Records Systems, Computerized
Not yet recruitingObservational study
Physical Activity in Lawyers: Factors Affecting Musculoskeletal Pain
Musculoskeletal Pain, Physical Activity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yuriy Vasilev, MD, PhD study director
Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-based voice assistant Service for automated pre-filling of outpatient neurology visit protocol in EMIAS in people with Burnout, Professional and Documentation, run by Research and Practical Clinical Center for Diagnostics and Telemedicine Technologies of the Moscow Health Care Department at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physician focused-attention time on the patient (time frame: Up to 14 weeks: pre-intervention measurements collected per consultation during study Weeks 1-2 (Stage 1); post-intervention measurements collected per consultation during study Weeks 5-14 (Stage 2, after a 2-week adaptation period).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.