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Ambient Audio-Visual Capture for Clinical Documentation and Assessment (BLACKFRAME-AV-)

10. juni 2026 opdateret af: BlackFrame.ai

Ambient Audio-Visual Capture for Clinical Documentation, Assessment and Feedback in Medical Education

AI-powered tools that automatically document clinical conversations are being adopted rapidly in outpatient settings but have not been evaluated in hospital wards. Existing tools use audio recording only, which cannot capture physical examination findings, procedural observations, or clinical safety behaviours - elements of a ward round that are visible but not audible.

This study evaluates an ambient audio-visual (AV) capture system - BlackFrame - that uses both microphone and camera to generate accurate clinical documentation and structured educational feedback in a real inpatient surgical ward setting.

Medical students and doctors in training participate in supervised ward round encounters with consenting adult inpatients. The BlackFrame AI platform generates: (a) a structured draft clinical note for the supervising clinician to review and countersign before any use in the patient record; and (b) formative feedback for the trainee, delivered within 30 minutes, covering clinical communication, examination technique, and documentation quality.

The study measures whether AI-generated feedback improves trainee clinical performance over a placement, how much documentation time is saved, and whether the system is acceptable to patients and clinicians. No AI-generated text enters the patient record without explicit clinician review and sign-off. All participation is voluntary.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

BACKGROUND

Ambient AI scribes have achieved rapid uptake in outpatient and community settings but all published evaluations use audio-only capture. The inpatient ward round is a multimodal clinical event comprising verbal exchange, physical examination, procedural assessment, and non-verbal observation. Audio-only systems are structurally incapable of capturing observable clinical elements, representing construct under-representation under the Messick validity framework.

No published study has evaluated ambient audio-visual capture in a real inpatient setting, nor measured the educational impact of AI-generated formative feedback on ward rounds.

STUDY DESIGN

Mixed-methods feasibility and educational impact study. Surgical ward round at Yeovil District Hospital as the primary study context. Up to three ambient AV capture devices deployed simultaneously in separate side rooms on each study day. Ward rounds proceed sequentially through each room, allowing up to three consented encounters per study day.

PARTICIPANTS

Trainee participants: medical students (Year 3-5) and doctors in training (FY1 through registrar/ST grade) undertaking supervised clinical activities at the study site.

Patient participants: adult inpatients (age 18 or over) able to provide informed consent, admitted under the surgical team, clinically stable at the time of approach.

TARGET SAMPLE: 60-80 consented encounters across 20-30 trainee participants and up to 80 patient participants.

INTERVENTION

On each study day, eligible patients in up to three side rooms are consented before ward rounds begin. A BlackFrame ambient AV capture device is positioned visibly in each consented patient's room prior to the ward round, with clear patient-facing signage. Devices operate autonomously once positioned and do not require operator presence during the encounter.

The surgical ward round proceeds sequentially through each side room. After each encounter the AI platform produces: (a) a structured draft clinical note for supervising clinician review and countersignature before any use in the patient record; (b) a formative feedback report for the trainee covering clinical communication, examination technique, and documentation quality, delivered within 30 minutes.

OUTCOMES

Primary: (1) Change in trainee assessment scores from baseline to end-of-placement; (2) documentation time saved with versus without AI s

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

Inclusion

Trainee participants:

  • Doctor in training (FY1 through registrar/ST grade) undertaking a supervised clinical activity at a participating NHS study site
  • Able to provide written informed consent in English

Patient participants:

  • Adult inpatient aged 18 years or over
  • Able to provide written informed consent in English
  • Admitted under a surgical team at a participating study site
  • Clinically stable at the time of approach

Exclusion

Trainee participants:

  • Unwilling to be audio-visually recorded
  • Unable to provide written informed consent
  • Any trainee where participation could create a direct conflict with a concurrent formal assessment or appraisal process at that session

Patient participants:

  • Age under 18 years
  • Unable to provide informed consent (including temporary incapacity due to acute illness, sedation, or delirium)
  • Acute clinical deterioration at the time of approach
  • Encounter involves sensitive disclosures in mental health, sexual health, or safeguarding unless a specific sub-protocol with additional consent measures is in place
  • Patient has previously declined participation and does not wish to be re-approached
  • Non-English speaking patients where no appropriate interpreter is available to support the consent process

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Trainee participants
Medical students (Year 3-5) and doctors in training (FY1 through registrar/ST grade) undertaking supervised clinical activities on the surgical ward at the study site. Participants receive AI-generated formative feedback within 30 minutes of each ward round encounter and complete baseline and follow-up clinical assessments.
Enhed: BlackFrame ambient audio-visual capture platform
Fixed camera and microphone array positioned visibly in the patient's room captures the ward round encounter. The AI platform processes the recording to generate: (a) a structured draft clinical note for supervising clinician review and countersignature; (b) a formative feedback report for the trainee covering clinical communication, examination technique, and documentation quality, delivered within 30 minutes of the encounter.
Eksperimentel: Patient participants
Adult inpatients aged 18 or over admitted under the surgical team at the study site, able to provide informed consent and clinically stable at the time of approach. Patients consent to ambient AV recording of their ward round encounter. Their care is unaffected by participation.
Enhed: BlackFrame ambient audio-visual capture platform
Fixed camera and microphone array positioned visibly in the patient's room captures the ward round encounter. The AI platform processes the recording to generate: (a) a structured draft clinical note for supervising clinician review and countersignature; (b) a formative feedback report for the trainee covering clinical communication, examination technique, and documentation quality, delivered within 30 minutes of the encounter.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean documentation time per encounter with versus without AI scribe assistance
Tidsramme: Through study completion, approximately 12 weeks
mean difference in time (minutes) to produce a clinical ward round note with versus without AI scribe assistance. Analysed using paired comparison with 95% confidence interval.
Through study completion, approximately 12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cohen's kappa between AI-generated and expert human assessment scores per checklist domain
Tidsramme: Through study completion, approximately 12 weeks
Cohen's kappa coefficient between AI-generated and independent expert human assessment scores, reported per checklist domain
Through study completion, approximately 12 weeks
Trainee-rated feedback quality score on 5-item Likert survey
Tidsramme: After first study encounter, approximately within 1 week of study enrolment
trainee-rated feedback quality, perceived fairness, and utility (5-item Likert survey)
After first study encounter, approximately within 1 week of study enrolment
Blinded expert rating of AI-assisted clinical note completeness and accuracy
Tidsramme: Through study completion, approximately 12 weeks
Structured rating score comparing AI-assisted versus standard ward round note on completeness, accuracy, and clinical safety content, rated by blinded clinical expert assessors
Through study completion, approximately 12 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

BlackFrame.ai

Samarbejdspartnere

The Cleveland Clinic
Somerset NHS Foundation Trust

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

30. november 2026

Studieafslutning (Anslået)

30. november 2026

Datoer for studieregistrering

Først indsendt

1. juni 2026

Først indsendt, der opfyldte QC-kriterier

10. juni 2026

Først opslået (Faktiske)

16. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • BF-AV-2026-01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

As per protocol

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Ingen

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