Ambient Audio-Visual Capture for Clinical Documentation and Assessment

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorBlackFrame.ai

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Adult inpatient aged 18 years or over

Able to provide written informed consent in English

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • BlackFrame ambient audio-visual capture platform

    Device

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Trainee participantsExperimental treatment 1 intervention
Group B: Patient participantsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mean documentation time per encounter with versus without AI scribe assistance

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.

Time frame
Through study completion, approximately 12 weeks

Secondary outcomes

1

Cohen's kappa between AI-generated and expert human assessment scores per checklist domain

Cohen's kappa coefficient between AI-generated and independent expert human assessment scores, reported per checklist domain

Time frame
Through study completion, approximately 12 weeks
2

Trainee-rated feedback quality score on 5-item Likert survey

trainee-rated feedback quality, perceived fairness, and utility (5-item Likert survey)

Time frame
After first study encounter, approximately within 1 week of study enrolment
3

Blinded expert rating of AI-assisted clinical note completeness and accuracy

Structured rating score comparing AI-assisted versus standard ward round note on completeness, accuracy, and clinical safety content, rated by blinded clinical expert assessors

Time frame
Through study completion, approximately 12 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BlackFrame.ai

Lead sponsor

The Cleveland Clinic

Collaborator

Somerset NHS Foundation Trust

Collaborator

This trial is not recruiting at the moment. You can still explore other options: