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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Victor Leong, MSc.
- 전화번호: 6 46167311
- 이메일: o.v.leong@fsw.leidenuniv.nl
연구 장소
-
-
South Holland
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Leiden, South Holland, 네덜란드, 2333AK
- 모병
- Leiden University
-
연락하다:
- Victor Leong, MSc
- 전화번호: 0646167311
- 이메일: o.v.leong@fsw.leidenuniv.nl
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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. |
|
간섭 없음: 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
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.
기간: 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.
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
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.
기간: 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
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공동 작업자 및 조사자
협력자
협력자
수사관
수사관
- 수석 연구원: Henriët van Middendorp, PhD, Leiden University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- 2024-06-10-A.W.M.Evers-V1-5522
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Shared IPD will consist of pseudonymized demographic data, questionnaire results and performance on training measurements.
IPD 공유 기간
Data will become available after publication of the study and remain available for 10 years.
IPD 공유 액세스 기준
The data will be securely restricted and access will be granted upon request to the author for research purposes.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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