- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07615621
Adaptive Real-Time Voice Virtual Patients for Clinical Communication Training (RSTM-VP)
Effects of Emotionally and Interactionally Adaptive Real-Time Voice Virtual Patients on Clinical Communication Training in Resident Physicians: A Three-Arm Randomized Controlled Trial
This study evaluated whether an emotionally and interactionally adaptive real-time voice virtual patient can improve clinical communication training for resident physicians. Communication with patients in emotionally challenging situations, such as breaking bad news, requires clinicians to deliver information clearly, recognize emotional cues, respond empathically, and maintain a coherent interaction. Standardized patient training can support these skills but is resource intensive and difficult to provide repeatedly. Real-time voice virtual patients may offer scalable practice opportunities, but simple spoken interaction alone may not provide patient responses that change meaningfully according to the learner's communication.
The adaptive virtual patient used in this study was designed to update the patient's emotional tone, openness, defensiveness, and interactional style during the conversation based on the learner's communication behavior. The study compared this adaptive virtual patient training with a non-adaptive real-time voice virtual patient and with standardized patient training.
Resident physicians were randomly assigned in a 1:1:1 ratio to one of three groups: emotionally and interactionally adaptive virtual patient training, non-adaptive virtual patient training, or standardized patient training. Participants completed two communication training sessions focused on breaking bad news. After training, participants completed learner-reported measures of perceived response contingency and patient realism. Approximately four weeks later, participants completed a mini-objective structured clinical examination using a human standardized patient to assess communication performance in a delayed near-transfer setting.
The primary outcome was the total mini-OSCE communication score at four weeks. Secondary outcomes included mini-OSCE domain scores for structured delivery, emotional responsiveness, and interactional process; learner-reported response contingency and patient realism; and expert-rated behavioral consistency and clinical credibility of virtual patient interactions.
Przegląd badań
Status
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Hunan
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Changsha, Hunan, Chiny, 410011
- The Second Xiangya Hospital of Central South University
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Resident physicians in postgraduate years 1-3.
- Participants who had received basic clinical communication training or related instruction.
- Participants who had not received systematic, specialized training in breaking bad news communication.
- Able to complete two training sessions and the four-week follow-up mini-OSCE assessment.
- Willing to participate and able to provide written informed consent.
Exclusion Criteria:
- Prior systematic training in breaking bad news, advanced communication skills, or similar specialized communication training.
- Prior participation in pilot testing or system testing related to this study.
- Unable to complete the required training sessions or follow-up assessment.
- Unwilling to have training or assessment sessions recorded for research scoring and analysis.
- Concurrent participation in another communication-skills intervention study that could affect communication performance.
- Any other condition judged by the investigators to make participation inappropriate.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Inny
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Adaptive Virtual Patient Training
Participants assigned to this arm completed two breaking-bad-news communication training sessions with an emotionally and interactionally adaptive real-time voice virtual patient.
The virtual patient updated its emotional tone, openness, defensiveness, and interactional style during the conversation based on the participant's communication behavior.
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Participants completed two breaking-bad-news communication training sessions with an emotionally and interactionally adaptive real-time voice virtual patient.
The virtual patient interacted with participants through continuous spoken dialogue and dynamically updated its emotional tone, openness, defensiveness, and interactional style based on the participant's communication behavior.
The adaptive mechanism was designed to provide behavior-contingent patient responses during the encounter.
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Aktywny komparator: Non-Adaptive Virtual Patient Training
Participants assigned to this arm completed two breaking-bad-news communication training sessions with a non-adaptive real-time voice virtual patient.
The platform, case structure, voice interaction format, and training exposure were matched to the adaptive virtual patient arm, but the patient's emotional and interactional style did not dynamically update based on participant communication behavior.
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Participants completed two breaking-bad-news communication training sessions with a non-adaptive real-time voice virtual patient.
The platform, case structure, spoken interaction format, training exposure, and communication tasks were matched to the adaptive virtual patient condition.
Unlike the adaptive condition, the virtual patient did not dynamically update its emotional or interactional state based on the participant's communication behavior.
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Aktywny komparator: Standardized Patient Training
Participants assigned to this arm completed two breaking-bad-news communication training sessions with trained standardized patients.
Cases, training objectives, session duration, and communication tasks were structurally matched to the virtual patient arms.
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Participants completed two breaking-bad-news communication training sessions with trained human standardized patients.
The cases, training objectives, session duration, and communication tasks were structurally matched to the virtual patient training conditions.
Standardized patients were trained to portray the assigned clinical communication scenarios using standardized case scripts and interactional guidance.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Four-Week Mini-OSCE Total Communication Score
Ramy czasowe: 4 weeks after completion of training
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Communication performance was assessed approximately four weeks after training using a mini-objective structured clinical examination with a human standardized patient.
The total score was based on a 9-item structured communication rating scale covering structured delivery, emotional responsiveness, and interactional process.
Each item was rated from 1 to 5, yielding a total score range of 9 to 45. Higher scores indicate better clinical communication performance.
Scores from two blinded expert raters were averaged to generate participant-level total scores.
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4 weeks after completion of training
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Four-Week Mini-OSCE Domain Scores
Ramy czasowe: 4 weeks after completion of training
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Domain scores from the four-week mini-OSCE were calculated for three communication domains: structured delivery, emotional responsiveness, and interactional process.
Each domain included three items rated from 1 to 5, yielding a domain score range of 3 to 15.
Higher scores indicate better performance in the corresponding communication domain.
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4 weeks after completion of training
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Learner-Reported Perceived Response Contingency and Patient Realism
Ramy czasowe: Immediately after training session 2 (each session was 45 minutes)
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Learner-reported interaction measures were assessed after training using 7-point Likert-scale items.
Perceived response contingency was calculated as the mean of two items evaluating whether the patient's emotional or interpersonal responses changed during the conversation and whether these changes appeared to depend on how the participant communicated.
Perceived patient realism was assessed using a single item evaluating whether the patient's emotional and interpersonal responses felt realistic for a real patient in a clinical conversation.
Higher scores indicate stronger perceived response contingency and greater perceived patient realism.
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Immediately after training session 2 (each session was 45 minutes)
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Expert-Rated Behavioral Consistency and Clinical Credibility of Virtual Patient Interactions
Ramy czasowe: Training session 2(each session was 45 minutes)
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Virtual patient interactions recorded during training session 2 were later assessed by blinded expert raters using 7-point Likert-scale items.
Behavioral consistency evaluated whether the virtual patient's emotional tone, interpersonal stance, and overall behavior remained coherent with the case background and internally consistent throughout the interaction.
Clinical credibility evaluated whether the virtual patient's emotional and interactional responses were clinically believable for a real patient in the corresponding situation.
Higher scores indicate greater behavioral consistency and clinical credibility.
This outcome was assessed only for the two virtual patient groups.
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Training session 2(each session was 45 minutes)
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Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- XY-Z0379-01
- 2026JJ50060 (Inny numer grantu/finansowania: Hunan Provincial Natural Science Foundation of China)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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