Context Matters: Training Healthcare Professionals in Communication to Maximize Placebo Effects and Minimize Nocebo Effects in Rheumatology: A Multicentre, Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 936
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •, 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
研究组 & 干预措施
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.
干预措施: Expectancy-based communication training for healthcare providers (Behavioral)
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.
结局指标
主要结局
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.
时间窗: 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.
次要结局
- 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.(Patient-evaluations will be collected over the course of eight weeks after completing the communication training by healthcare providers)
研究者
hvanmiddendorp
Associate professor health & medical psychology
Leiden University