- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07835256
Effectiveness of a Combined e-Learning and Virtual Reality Training Program for Healthcare Providers in Rheumatology
Context Matters: Training Healthcare Professionals in Communication to Maximize Placebo Effects and Minimize Nocebo Effects in Rheumatology: A Multicentre, Randomized Controlled Trial.
The goal of this clinical trial is to evaluate the effectiveness of communication training on the communication skills of the healthcare provider in the rheumatology department during consults with patients.
The main questions it aims to answer are:
- Is communication training effective in increasing the self-perceived communication skills of the healthcare provider?
- Is communication training effective in increasing the evaluation of patients on the communication skills of their corresponding healthcare provider?
Researchers will compare one group who will receive communication training to one group who will not receive any training to see if there is a significant difference in self-evaluation and patient-evaluation on their communication skills.
Participants will begin by completing a pre-test self-evaluation questionnaire, followed by communication training. After the training, they will complete a post-test self-evaluation questionnaire. Over the next eight weeks following the training, participants will gather evaluations from their patients on their communication skills during the most recent consultation.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background: Leading experts on placebo and nocebo effects agree that healthcare providers should be trained to effectively leverage expectancy effects in clinical practice. However, these practices have rarely been implemented with many healthcare providers lacking the expertise to fully take care of patient expectancies. Thus, we developed an e-Learning course and a virtual training tool that trains healthcare professionals across all disciplines to communicate with patients in a manner that maximizes placebo effects and minimizes nocebo effects.
Aim: The current study aims to evaluate the effectiveness of the combined e-Learning course and Virtual Reality training at improving expectancy-based communication within the department of rheumatology.
Method: Dutch healthcare providers (n= 52) working across rheumatology departments in the Netherlands will be stratified on specialization (e.g., rheumatologist, physician assistant, nurse specialist, medical resident or medical researcher) and randomized to either the intervention (e-Learning + VR training) or the control group (no training + e-Learning knowledge exam). The effect of the training is evaluated by a pre-post self-evaluation of clinicians (main outcome: SE12) and patient evaluations (N= 884) (secondary outcome: QQPPI).
Participants: Healthcare providers participating in the study must be active and working in the rheumatology department. Additionally, they must see patients on a regular basis.
Patients must be 18 years or older and require a mastery of spoken and written Dutch.
Intervention tools: for the communication training consists of an e-Learning course with 6 modules, including: 1) Optimizing patient-provider relationship, 2) discussing expectations, 3) discussing the treatment rationale, 4) discussing risks and side-effects, 5) explain placebo and nocebo effects and 6) expectancy-based communication during tapering. The course also includes seven case-by-case study questions and a knowledge exam consisting of 15 randomized questions at the end of the course. Participants are required to pass the test with a minimal grade of 7.
The Virtual Reality app consists of 2 modules with each a separate virtual avatar representing a patient. The app incorporates A.I. generated dialogue that is bound to the topic of the case. The training is supported by a feedback system at the end of a playthrough and is designed for multiple playthroughs in order to create a 'learning by experience' effect.
Main outcomes: The primary outcome will be determined by comparing the scores of the two study groups on the validated self-evaluation questionnaire 'SE-12' before and after the intervention.
The secondary outcome will be determined by comparing the scores of the two groups on the validated patient-evaluation questionnaire 'QQPPI'.
Exploratory outcomes: Additional outcome measures will include comparing the average scores of the intervention and control groups on the e-Learning knowledge exam, as well as tracking the score progression of healthcare providers across multiple sessions of the Virtual Reality app.
After the conclusion of the study, the control group will be offered the same training as the intervention group.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Victor Leong, MSc.
- Número de teléfono: 6 46167311
- Correo electrónico: o.v.leong@fsw.leidenuniv.nl
Ubicaciones de estudio
-
-
South Holland
-
Leiden, South Holland, Países Bajos, 2333AK
- Reclutamiento
- Leiden University
-
Contacto:
- Victor Leong, MSc
- Número de teléfono: 0646167311
- Correo electrónico: o.v.leong@fsw.leidenuniv.nl
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion criteria for healthcare providers:
- being 18 years or older
- having a good command of the Dutch language, both written and spoken.
- being a healthcare provider within the rheumatology department (e.g., rheumatologist, physician assistant, rheumatology nurse, medical resident, or medical researcher).
- regularly seeing rheumatology patients during consultations.
No exclusion criteria, except for not having regular supervisory meetings with patients with rheumatic diseases.
Inclusion criteria for patients :
- being 18 years or older
- having a good command of the Dutch language, both written and spoken
- having had a consultation with one of the participating healthcare providers (intervention or control group) within the past 8 weeks
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Communicating training group
Healthcare providers in the experimental group receive communication training consisting of an e-Learning communication course and knowledge exam of 1 hour and communication training in a virtual reality environment with a virtual avatar for 1 hour. |
An e-learning course comprising six modules, each featuring case-based questions, followed by a comprehensive knowledge exam. The course concludes with a Virtual Reality training program, which includes two immersive modules and AI-generated dialogue for an interactive learning experience. |
|
Sin intervención: No training group
Healthcare providers in the control group receive no training but have the opportunity to receive the training after the study has been concluded. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Changes in total scores from a pre-test to a post-test evaluation between the arms on the SE-12 self-evaluation questionnaire, supplemented with customized questions regarding patient expectations.
Periodo de tiempo: After inclusion into the study, which precedes the training with mostly a few weeks, a baseline assessment is done. After completing the training, a post-test evaluation is done, within approximately 2 weeks after the training.
|
The self-evaluation questionnaire consists of questions about communication skills, primarily focused on how certain the healthcare provider is in successfully performing a specific action during the consultation with a patient. The ratings are scored on a scale of one to ten, with one being very unlikely and ten being very likely. |
After inclusion into the study, which precedes the training with mostly a few weeks, a baseline assessment is done. After completing the training, a post-test evaluation is done, within approximately 2 weeks after the training.
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Score difference between arms on patient-evaluation based on the QQPPI questionnaire, supplemented with customized questions regarding expectations for the communication skills of healthcare providers during their most recent consultation.
Periodo de tiempo: Patient-evaluations will be collected over the course of eight weeks after completing the communication training by healthcare providers
|
The patient-evaluation questionnaire consists of questions about statements and assertions concerning the most recent consultation. The scale consists of five ratings, with 1 being 'I do not agree' and five being 'I fully agree'. |
Patient-evaluations will be collected over the course of eight weeks after completing the communication training by healthcare providers
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Henriët van Middendorp, PhD, Leiden University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2024-06-10-A.W.M.Evers-V1-5522
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Shared IPD will consist of pseudonymized demographic data, questionnaire results and performance on training measurements.
Marco de tiempo para compartir IPD
Data will become available after publication of the study and remain available for 10 years.
Criterios de acceso compartido de IPD
The data will be securely restricted and access will be granted upon request to the author for research purposes.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .