Clinician Communication Skills TrainingSOPHIENCT07409233
SOPHIE: Standardized Online Patient for Healthcare Interaction Education
A study testing SOPHIE Simulation Training in people with Clinician Communication Skills Training, run by University of Rochester at 1 site in United States.
Trial summary
This study evaluated an online simulation based educational program designed to improve clinician communication skills. Participants were clinicians and clinical trainees who completed simulated patient interactions and communication assessments as part of an educational evaluation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Clinician Communication Skills Training
- What is being tested?
- SOPHIE Simulation Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2024to 1 Jan 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants are clinicians or clinical trainees involved in patient communication as part of their professional or educational role
- Age 18 years or older
- Ability to participate in online educational activities and simulated patient encounters
- Ability to provide informed consent
Who cannot join
- Prior participation in this study
- Inability to complete the required online activities or simulated encounters
- Any condition that in the opinion of the investigator would interfere with participation or data quality
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluated an online simulation based educational program designed to improve clinician communication skills. Participants were clinicians and clinical trainees who completed simulated patient interactions and communication assessments as part of an educational evaluation. Participants were randomly assigned to receive either an AI based simulation training program or standard educational materials. Communication performance was assessed using standardized rating methods in simulated scenarios. The study did not involve patients or health related clinical interventions.
Read the detailed description
This study was a randomized educational evaluation of an AI based online simulation training program designed to support the development of clinician communication skills. Participants included clinicians and clinical trainees who routinely engage in patient communication as part of their professional roles.
Participants were randomly assigned to either the SOPHIE simulation training program or a control educational condition consisting of standard instructional materials. All participants completed simulated patient encounters that were evaluated by trained standardized patients and expert raters using structured communication assessment tools.
The primary outcomes of interest focused on communication skill performance in simulated scenarios as well as participant feedback on the educational experience. The study did not involve real patients clinical care or health related interventions and was conducted as an educational research project.
The study was approved by the institutional review board prior to participant enrollment. It was registered retrospectively in ClinicalTrials.gov at the request of a journal during manuscript preparation.
- Conditions
- Clinician Communication Skills Training
- Being tested
- SOPHIE Simulation Training, Control Educational Materials
- Keywords
- Medical education, Artificial intelligence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOPHIE Simulation TrainingBehavioural
An online simulation based educational training program that uses interactive virtual patient scenarios to support the development of clinician communication skills in simulated clinical encounters.
Control Educational MaterialsBehavioural
Standard educational content related to clinician communication skills delivered through instructional materials such as videos and readings without interactive simulation.
| Study group | Role | What they receive |
|---|---|---|
| SOPHIE Simulation Training | Experimental | Participants assigned to this arm completed an AI based online simulation training program designed to support the development of clinician communication skills. The training involved interactive virtual patient scenarios focused on communication practice in simulated clinical encounters. Receives: Behavioral: SOPHIE Simulation Training |
| Control Educational Materials | Active comparator | Participants assigned to this arm completed standard educational materials related to clinician communication skills. These materials included instructional content such as videos and readings and did not involve interactive simulation training. Receives: Behavioral: Control Educational Materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Communication Performance Improvement Score in Simulated Patient Encounters
Communication performance was assessed during simulated patient encounters using standardized rating instruments completed by trained standardized patients or expert reviewers. The mean communication performance score improvement was calculated for each participant and used to describe communication skills following the assigned educational condition.
Measured: Immediately following completion of the assigned educational condition
Secondary outcomes (5)
Immediately following completion of the assigned educational condition
A structured communication skills rating tool was used to evaluate specific communication behaviors demonstrated during simulated patient encounters. The total communication skill rating score was calculated for each participant.
Measured: Immediately following simulated patient encounter
Mean Empathy Rating Score in Simulated Encounters
Empathy was assessed during simulated patient encounters using standardized empathy rating scales completed by trained evaluators. The mean empathy rating score was calculated for each participant.
Measured: Immediately following simulated patient encounter
Mean Participant Self Reported Confidence Score
Participant confidence in communication skills was assessed using a self reported questionnaire administered after completion of the educational intervention. Mean confidence scores were calculated across questionnaire items.
Measured: Immediately following completion of the educational intervention
Mean Usability Score of the Educational Intervention
Usability of the assigned educational intervention was assessed using a standardized usability questionnaire. Mean usability scores were calculated to describe participant experience with the intervention.
Measured: Immediately following completion of the educational intervention
Total Participant Satisfaction Score
Participant satisfaction with the educational experience was assessed using a structured questionnaire. The total satisfaction score was calculated for each participant.
Measured: Immediately following completion of the educational intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start1 Jun 2024
- Primary completion31 Dec 2024
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinician Communication Skills TrainingStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- Participants were randomly assigned to either an AI based simulation training program or a control educational condition and completed simulated patient encounters for assessment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- James P. Wilmot Cancer Center
- Responsible party
- Principal investigator, Ehsan Hoque, University of Rochester
- Investigators
- Ehsan Hoque, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409233
- Sponsor's protocol ID
- STUDY00006689
- Acronym
- SOPHIE
- Status last verified
- Feb 2026
- First submitted
- 8 Feb 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Communication skill ratings of individual participants, as measured by expert standardized patients, will be made fully public. All data will be fully anonymized.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOPHIE: Standardized Online Patient for Healthcare Interaction Education
- ClinicalTrials.gov ID
- NCT07409233
- Acronym / sponsor ID
- SOPHIE / STUDY00006689
- Conditions
- Clinician Communication Skills Training
- Keywords
- Medical education, Artificial intelligence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- James P. Wilmot Cancer Center
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 13 Feb 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.
This study evaluated an online simulation based educational program designed to improve clinician communication skills. Participants were clinicians and clinical trainees who completed simulated patient interactions and communication assessments as part of an educational evaluation. Participants were randomly assigned to receive either an AI based simulation training program or standard educational materials. Communication performance was assessed using standardized rating methods in simulated scenarios. The study did not involve patients or health related clinical interventions.
Detailed description
This study was a randomized educational evaluation of an AI based online simulation training program designed to support the development of clinician communication skills. Participants included clinicians and clinical trainees who routinely engage in patient communication as part of their professional roles.
Participants were randomly assigned to either the SOPHIE simulation training program or a control educational condition consisting of standard instructional materials. All participants completed simulated patient encounters that were evaluated by trained standardized patients and expert raters using structured communication assessment tools.
The primary outcomes of interest focused on communication skill performance in simulated scenarios as well as participant feedback on the educational experience. The study did not involve real patients clinical care or health related interventions and was conducted as an educational research project.
The study was approved by the institutional review board prior to participant enrollment. It was registered retrospectively in ClinicalTrials.gov at the request of a journal during manuscript preparation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to either an AI based simulation training program or a control educational condition and completed simulated patient encounters for assessment.
| Arm | Type | Receives |
|---|---|---|
| SOPHIE Simulation Training | Experimental | Behavioral: SOPHIE Simulation TrainingParticipants assigned to this arm completed an AI based online simulation training program designed to support the development of clinician communication skills. The training involved interactive virtual patient scenarios focused on communication practice in simulated clinical encounters. |
| Control Educational Materials | Active comparator | Behavioral: Control Educational MaterialsParticipants assigned to this arm completed standard educational materials related to clinician communication skills. These materials included instructional content such as videos and readings and did not involve interactive simulation training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants are clinicians or clinical trainees involved in patient communication as part of their professional or educational role
- Age 18 years or older
- Ability to participate in online educational activities and simulated patient encounters
- Ability to provide informed consent
Key exclusion criteria (3 listed)
- Prior participation in this study
- Inability to complete the required online activities or simulated encounters
- Any condition that in the opinion of the investigator would interfere with participation or data quality
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 |
|---|---|---|
| SOPHIE Simulation TrainingAn online simulation based educational training program that uses interactive virtual patient scenarios to support the development of clinician communication skills in simulated clinical encounters. | Behavioural | SOPHIE Simulation Training |
| Control Educational MaterialsStandard educational content related to clinician communication skills delivered through instructional materials such as videos and readings without interactive simulation. | Behavioural | Control Educational Materials |
Primary outcome
Mean Communication Performance Improvement Score in Simulated Patient Encounters
Time frame: Immediately following completion of the assigned educational condition
Communication performance was assessed during simulated patient encounters using standardized rating instruments completed by trained standardized patients or expert reviewers. The mean communication performance score improvement was calculated for each participant and used to describe communication skills following the assigned educational condition.
5 secondary outcomes
Immediately following completion of the assigned educational condition
Time frame: Immediately following simulated patient encounter
Mean Empathy Rating Score in Simulated Encounters
Time frame: Immediately following simulated patient encounter
Mean Participant Self Reported Confidence Score
Time frame: Immediately following completion of the educational intervention
Mean Usability Score of the Educational Intervention
Time frame: Immediately following completion of the educational intervention
Total Participant Satisfaction Score
Time frame: Immediately following completion of the educational intervention
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 13 Feb 2026.
- Individual participant dataSharing planned: Yes. Communication skill ratings of individual participants, as measured by expert standardized patients, will be made fully public. All data will be fully anonymized.
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.
Ehsan Hoque, PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOPHIE Simulation Training in people with Clinician Communication Skills Training, run by University of Rochester at 1 site in United States.
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 4 inclusion and 3 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 13 Feb 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 United States. 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?
Mean Communication Performance Improvement Score in Simulated Patient Encounters (time frame: Immediately following completion of the assigned educational condition). 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 13 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.