SepsisNCT05953441
Artificial Intelligence Versus Human-controlled Doctor in Virtual Reality Simulation for Sepsis Team Training
A study testing AI-powered doctor in people with Sepsis, run by National University of Singapore at 1 site in Singapore.
Trial summary
The purpose of the study is to compare the effectiveness of Artificial Intelligence virtual doctor with human-controlled virtual doctor avatars on nursing students' sepsis care and interprofessional communication. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- AI-powered doctor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteSingapore
- Study dates
- 8 Aug 2022to 13 Nov 2022
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All Year 3 NUS nursing students in Academic Year 2022
- Individuals 20 years old and above; and
- Consent to be video and/or audio-recorded
Who cannot join
- Year 1, 2 and 4 NUS nursing students;
- Incapable of giving informed consent;
- Unable to understand and/or speak in English language;
- Have visual, speech, and/or hearing impairment; and
- Do not agree to be video and/or audio-recorded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Artificial Intelligence Versus Human-controlled Doctor in Virtual Reality Simulation for Sepsis Team Training: Randomized Controlled Trial
The purpose of the study is to compare the effectiveness of Artificial Intelligence virtual doctor with human-controlled virtual doctor avatars on nursing students' sepsis care and interprofessional communication.
- Conditions
- Sepsis
- Being tested
- AI-powered doctor, Human-controlled doctor avatar
- Keywords
- artificial intelligence, team training, virtual reality simulation, health care education
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-powered doctorOther
AI-powered virtual doctor
Human-controlled doctor avatarOther
Virtual doctor avatar controlled by the medical student.
| Study group | Role | What they receive |
|---|---|---|
| AI-powered group | Experimental | Participants participated in a 2-hour Virtual Reality Simulation (VRS), which consisted of 2 simulation scenarios. Participants had to perform nursing assessment and management of virtual patient, followed by communicating with an AI virtual doctor. Receives: Other: AI-powered doctor |
| Human-controlled group | Active comparator | Participants participated in a 2-hour Virtual Reality Simulation (VRS), which consisted of 2 simulation scenarios. Participants had to perform nursing assessment and management of virtual patient, followed by communicating with a doctor avatar controlled by the medical student. Receives: Other: Human-controlled doctor avatar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Sepsis Knowledge on the 18-item sepsis knowledge test immediately after interventions.
The 8-item communication knowledge and 18-item sepsis knowledge tests were developed and content validated by a multidisciplinary team comprising a medical doctor, an advanced practice nurse, and nursing academics.
Measured: Baseline and immediately after 2-hour VRS
Secondary outcomes (4)
Change from Baseline in Team Communication Knowledge on the 8-item communication knowledge test immediately after interventions.
The 8-item communication knowledge and 18-item sepsis knowledge tests were developed and content validated by a multidisciplinary team comprising a medical doctor, an advanced practice nurse, and nursing academics.
Measured: Baseline and immediately after 2-hour VRS
Change from Baseline in Team Communication Self-Efficacy on the 6-item Patient Clinical Information Exchange and Interprofessional Communication Self-Efficacy Scale immediately after interventions.
The Patient Clinical Information Exchange and Interprofessional Communication Self-Efficacy Scale is a validated and self-reported instrument using a 0-100 Likert scale, which measures participants' perceptions of self-efficacy in team communication based on the ISBAR communication strategy.
Measured: Baseline and immediately after 2-hour VRS
Sepsis Care Performance through a 15-minute video-recorded simulation-based assessment within 2 weeks of postintervention.
2 independent raters used the validated RAPIDS (Rescuing A Patient In Deteriorating Situation) tool to measure nurses' simulation performance in assessing and managing a deteriorating patient.
Measured: Within 2 weeks of postintervention.
Team Communication Performance through a 15-minute video-recorded simulation-based assessment within 2 weeks of postintervention.
2 independent raters used a validated 9-item team communication scale to assess nurses' simulation performance in communicating with doctor using the TeamSTEPPS communication strategies.
Measured: Within 2 weeks of postintervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start8 Aug 2022
- Primary completion26 Oct 2022
- Study completion13 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective 2-arm randomized controlled trial with a pretest-posttest study design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Education, Singapore
- Responsible party
- Principal investigator, Liaw Sok Ying, National University of Singapore
- Investigators
- Sok Ying Liaw, Principal investigator, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953441
- Sponsor's protocol ID
- NUS-IRB-2022-202
- Status last verified
- Jul 2023
- First submitted
- 10 Jul 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data sets collected or analyzed during the study are available from the corresponding author on reasonable request.
Publications
Liaw SY, Tan JZ, Bin Rusli KD, Ratan R, Zhou W, Lim S, Lau TC, Seah B, Chua WL. Artificial Intelligence Versus Human-Controlled Doctor in Virtual Reality Simulation for Sepsis Team Training: Randomized Controlled Study. J Med Internet Res. 2023 Jul 26;25:e47748. doi: 10.2196/47748.
PubMed 37494112
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence Versus Human-controlled Doctor in Virtual Reality Simulation for Sepsis Team Training: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05953441
- Acronym / sponsor ID
- NUS-IRB-2022-202
- Conditions
- Sepsis
- Keywords
- artificial intelligence, team training, virtual reality simulation, health care education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Collaborators
- Ministry of Education, Singapore
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 13 Nov 2022 (actual)
- First posted
- 20 Jul 2023 (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.
The purpose of the study is to compare the effectiveness of Artificial Intelligence virtual doctor with human-controlled virtual doctor avatars on nursing students' sepsis care and interprofessional communication.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective 2-arm randomized controlled trial with a pretest-posttest study design
| Arm | Type | Receives |
|---|---|---|
| AI-powered group | Experimental | Other: AI-powered doctorParticipants participated in a 2-hour Virtual Reality Simulation (VRS), which consisted of 2 simulation scenarios. Participants had to perform nursing assessment and management of virtual patient, followed by communicating with an AI virtual doctor. |
| Human-controlled group | Active comparator | Other: Human-controlled doctor avatarParticipants participated in a 2-hour Virtual Reality Simulation (VRS), which consisted of 2 simulation scenarios. Participants had to perform nursing assessment and management of virtual patient, followed by communicating with a doctor avatar controlled by the medical student. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All Year 3 NUS nursing students in Academic Year 2022
- Individuals 20 years old and above; and
- Consent to be video and/or audio-recorded
Key exclusion criteria (5 listed)
- Year 1, 2 and 4 NUS nursing students;
- Incapable of giving informed consent;
- Unable to understand and/or speak in English language;
- Have visual, speech, and/or hearing impairment; and
- Do not agree to be video and/or audio-recorded.
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-powered doctorAI-powered virtual doctor | Other | AI-powered group |
| Human-controlled doctor avatarVirtual doctor avatar controlled by the medical student. | Other | Human-controlled group |
Primary outcome
Change from Baseline in Sepsis Knowledge on the 18-item sepsis knowledge test immediately after interventions.
Time frame: Baseline and immediately after 2-hour VRS
The 8-item communication knowledge and 18-item sepsis knowledge tests were developed and content validated by a multidisciplinary team comprising a medical doctor, an advanced practice nurse, and nursing academics.
4 secondary outcomes
Change from Baseline in Team Communication Knowledge on the 8-item communication knowledge test immediately after interventions.
Time frame: Baseline and immediately after 2-hour VRS
Change from Baseline in Team Communication Self-Efficacy on the 6-item Patient Clinical Information Exchange and Interprofessional Communication Self-Efficacy Scale immediately after interventions.
Time frame: Baseline and immediately after 2-hour VRS
Sepsis Care Performance through a 15-minute video-recorded simulation-based assessment within 2 weeks of postintervention.
Time frame: Within 2 weeks of postintervention.
Team Communication Performance through a 15-minute video-recorded simulation-based assessment within 2 weeks of postintervention.
Time frame: Within 2 weeks of postintervention.
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 20 Jul 2023.
- Derived from this study: PubMed 37494112Liaw SY, Tan JZ, Bin Rusli KD, Ratan R, Zhou W, Lim S, Lau TC, Seah B, Chua WL. Artificial Intelligence Versus Human-Controlled Doctor in Virtual Reality Simulation for Sepsis Team Training: Randomized Controlled Study. J Med Internet Res. 2023 Jul 26;25:e47748. doi: 10.2196/47748.
- Individual participant dataSharing planned: No. The data sets collected or analyzed during the study are available from the corresponding author on reasonable request.
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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.
Sok Ying Liaw principal investigator
National University of Singapore
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-powered doctor in people with Sepsis, run by National University of Singapore at 1 site in Singapore.
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 3 inclusion and 5 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 20 Jul 2023. 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 Singapore. 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 from Baseline in Sepsis Knowledge on the 18-item sepsis knowledge test immediately after interventions. (time frame: Baseline and immediately after 2-hour VRS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05953441, which also lists 1 linked publication.
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 20 Jul 2023.