Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000618550
Ethics application status
Approved
Date submitted
23/04/2024
Date registered
13/05/2024
Date last updated
8/11/2024
Date data sharing statement initially provided
13/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Can AI deliver empathetic medical consultations?
Scientific title
How do perceptions of clinical empathy differ when a digital human delivers a brief medical consultation compared to a human physician?
Secondary ID [1] 311984 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
lack of clinical empathy in medical consultations, especially in primary care 333600 0
Condition category
Condition code
Public Health 330284 330284 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Specific intervention: Participants watching a medical consultation delivered by a Digital Human (DH). DHs are embodied conversational agents (ECAs) whose interactions are shaped by artificial intelligence (Loveys et al., 2022). DHs possess dialogue systems, allowing them to communicate with users through text and speech-based channels (Loveys, 2021). DHs may take on various forms with animated faces or bodies, ranging from simple, cartoon-like depictions (Hudlicka, 2015) to more complex, realistic, and humanlike embodiments (Loveys, 2021). Participants will be randomly assigned to the intervention condition (medical consultations delivered by a DH), or the control condition (medical consultation delivered by a human physician).

Information for non-drug trials:
Materials used: Through qualtrics (survey platform): Participant information sheet (PIS) and consent forms for participants, videos of brief medical consultations and a questionnaire for participants to complete after watching the video they have been randomly assigned to.
Digital human training/instructional and design materials provided by Soul Machines and IBM Watson for the researchers to create and program the digital human
BMJ Clinical Review article used as an instructional material to devise the script for the medical consultations. The script was used for the consultation delivered by the human physician, which also informs the content for the consultation delivered by the digital human
Filming and electronic equipment used to record videos of the human physician and digital human interacting with an actor patient

Procedures: Firstly, through the qualtrics survey link, participants will be asked to read the PIS, sign a consent form and complete a demographic information questionnaire. Participants will be randomly assigned to one of the four conditions using the qualtrics software, and they will watch a brief video of a medical consultation (empathetic or non-empathetic) delivered by a human physician or a digital human. Next, participants will be asked to fill out a measure of empathy, rating their perceptions of the interaction. Participants will also complete measures of trustworthiness, competence, and warmth, given that these are outcomes closely related to perceptions of physician empathy and can enhance knowledge of the acceptability of digital humans compared to human physicians on multiple fronts. Participants will also be asked about their prior experiences with technology, as those with previous exposure may differ from those without prior knowledge or encounters with digital humans/virtual agents. The administering of these measures will be counterbalanced, given the possibility for the first measure to prime responses to the subsequent measures. However, counterbalancing will depend on the parameters of qualtrics.

Who will deliver the intervention and their expertise: The intervention will be delivered by a Digital Human. Participants will have access to pre-recorded videos embedded into the qualtrics survey, where they will watch the consultation they have been randomly assigned to before answering the survey questions. The digital human delivering the medical consultation will be designed and programmed using Soul Machines and IBM Watson, mirroring the content and behaviours of Dr. Anna (the human physicians) in her consultations for comparibility. The human physician delivering the medical consultation is Dr. Anna Perera, a Medical Registrar at Auckland DHB.

Mode of delivery (individual/or group): Individual, as each participant will be randomly assigned to watch either a digital human consultation or a human physician consultation based on the study protocol.

Number of times the intervention will be delievered and over what period of time: For participants assigned to the intervention conditions (Digital human videos: empathetic or non-empathetic), the intervention will be delivered only once per session. This means participants will watch the one pre-recorded video they have been randomly assigned to, lasting approximately 4.5 minutes, and then compltete the attached survey questions. Overall, it is expected that participation will take about 15-20 minutes, of which the intervention will be 4.5 minutes, delivered once per participant.

The location where the intervention occurs: the intervention is delivered through the University of Auckland (UoA) qualtrics platform. The survey link will allow participants access to one of the pre-recorded videos (filmed on the UoA campus), and the study measures.

Digital human intervention: The content of the digital human intervention will be based on the human physician videos. Dr. Anna Perera (the human physician) was consulted in designing an empathetic and non-empathetic consultation, along with a literature review. The digital human will be scripted to say the same things as Dr. Anna in her videos, to keep the content as similar as possible with minor changes to account for the modality. In sum, the digital human will vary in empathy based on the empathy or non-empathy condition. In each condition, it will ask the student actor (Tim) about his symptoms and suggest that he has a common cold based on his symptoms and provide recommendations such as taking paracetamol and decongestants. In the empathy condition, the digital human will show verbal/non-verbal behaviours indicative of empathy, such as eye contact, smiling, nodding and reflecting the actor's emotions, as well as making empathic statements. In the non-empathetic condition, the digital human will be programmed to not display these behaviours.
Intervention code [1] 328449 0
Treatment: Devices
Comparator / control treatment
the control group will comprise of the participants watching the pre-recorded videos of the human physician delivering a medical consultation (empathetic or non empathetic), instead of the digital human videos. Similar to the intervention group, the control group will watch one of the human physician videos (pre-recorded), lasting approximately 4.5 minutes, on the qualtrics platform using the survey link. They will then complete the attached measures. Similar to the intervention group, overall participation is expected to last 15-20 minutes, of which the control treatment (the human physcian videos) will be 4.5 minutes.
Control group
Active

Outcomes
Primary outcome [1] 338029 0
Differences in perceptions of clinical empathy after watching a brief medical consultation
Timepoint [1] 338029 0
once: immediately after watching the video
Secondary outcome [1] 434184 0
Differences in participants' levels of trust towards the human physician or digital human
Timepoint [1] 434184 0
Once: immediately after watching the video
Secondary outcome [2] 434185 0
differences in the perceptions of the physician's/Digital human's warmth and competence towards the actor patient in the video
Timepoint [2] 434185 0
once: immediately after watching the video
Secondary outcome [3] 441545 0
intention to adhere
Timepoint [3] 441545 0
Secondary outcome [4] 441546 0
intention to adhere
Timepoint [4] 441546 0
Just one time point, as part of the questionnaire with all the other outcomes after watching the video

Eligibility
Key inclusion criteria
Participants must be over 18 years of age. Participants must have experienced a doctor's visit in the last ten years. Participants must be able to read, speak, and write in fluent
English. Participants must have a stable internet connection and a device such as a phone or a laptop to complete the online survey.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Due to the requirement of watching a brief video, participants with uncorrected visual and hearing impairments that would prevent them from completing the required procedures will be excluded

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Yes: the student researcher determining eligibility for participants' inclusion in the trial will not be aware of which condition they will be assigned to. Participants will be randomly assigned to the digital human intervention, or the human physician videos through the qualtrics "randomizer" function. Therefore, the researcher will have no control over which condition participants are assigned to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using the randomizer tool on qualtrics
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/06/2024
Actual
4/06/2024
Date of last participant enrolment
Anticipated
Actual
15/08/2024
Date of last data collection
Anticipated
Actual
15/08/2024
Sample size
Target
136
Accrual to date
Final
124
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 26251 0
New Zealand
State/province [1] 26251 0

Funding & Sponsors
Funding source category [1] 316333 0
University
Name [1] 316333 0
The University of Auckland
Country [1] 316333 0
New Zealand
Primary sponsor type
Individual
Name
Elizabeth Broadbent
Address
Country
New Zealand
Secondary sponsor category [1] 318514 0
Individual
Name [1] 318514 0
Ruby Verma
Address [1] 318514 0
Country [1] 318514 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315143 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 315143 0
Ethics committee country [1] 315143 0
New Zealand
Date submitted for ethics approval [1] 315143 0
28/02/2024
Approval date [1] 315143 0
26/04/2024
Ethics approval number [1] 315143 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133802 0
Dr Elizabeth Broadbent
Address 133802 0
FMHS BUILDING 507 - Bldg 507, 28 PARK AVE, GRAFTON, AUCKLAND, 1023, New Zealand
Country 133802 0
New Zealand
Phone 133802 0
+64 211227977
Fax 133802 0
Email 133802 0
e.broadbent@auckland.ac.nz
Contact person for public queries
Name 133803 0
Elizabeth Broadbent
Address 133803 0
FMHS BUILDING 507 - Bldg 507, 28 PARK AVE, GRAFTON, AUCKLAND, 1023, New Zealand
Country 133803 0
New Zealand
Phone 133803 0
+64 211227977
Fax 133803 0
Email 133803 0
e.broadbent@auckland.ac.nz
Contact person for scientific queries
Name 133804 0
Elizabeth Broadbent
Address 133804 0
FMHS BUILDING 507 - Bldg 507, 28 PARK AVE, GRAFTON, AUCKLAND, 1023, New Zealand
Country 133804 0
New Zealand
Phone 133804 0
+64 211227977
Fax 133804 0
Email 133804 0
e.broadbent@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.