Effect of a Competence Based Medical Education Programme on Training Quality in Intensive Care Medicine. COBALIDATION TRIAL.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 38
- 试验地点
- 28
- 主要终点
- The level of competency achieved at the end of the specific training in ICM (5th year)
研究概览
简要总结
This study evaluates whether the implementation of a competency-based medical education program called CoBaTrICE (Competency Based Training program in Intensive Care in Europe) provides higher levels of competency in comparison with the current official time-based program in Intensive Care Medicine (ICM) in Spain.
The hypothesis will be confirmed or rejected through a multicenter cluster randomized trial of 14 ICU Departments from 14 academic referral hospitals located in Spain. A total of 38 trainees on the 3rd year of the specialization period will be followed during the three years of their specific training period in Intensive Care Medicine. CoBaTrICE (seven hospitals) will be compared with the current official model of training in ICM in Spain (seven hospitals), which is based on exposure to experiences through clinical rotations. The implementation of CoBaTrICE will include the three following essential elements: 1) Training the trainers; 2) Workplace-based assessments; 3)The use of an electronic portfolio.
The level of competency achieved by each participant will be determined by a simulation-based Objective Structured Clinical Exam (OSCE) performed at the end of the third year of traning (baseline) and at the end of the 5th year of training period.
详细描述
Competence Based Medical Education (CBME) stands for a shift in emphasis away from time-based programs, based solely on exposure to experiences such as clinical rotations, in favour of an emphasis on needs-based graduate outcomes authenticity, and learner-centeredness (1). The new paradigm defies the assumption that competence is achieved based on time spent on rotations and instead requires residents to demonstrate competence, what involves performing a significant number of formative assessments (2,3). The CBME model for Intensive Care Medicine (ICM) is called CoBaTrICE (Competency-Based Training in Intensive Care Medicine in Europe) (4), an international partnership of professional organisations and critical care clinicians whose ultimate aims are: to assure a high quality level education in ICM, to harmonize training in ICM without interfering with national specific regulations and to allow for free movement of ICM professionals across Europe (5). CoBaTrICE program used an international grounded approach to defining specialist competencies, and incorporated the views of 1,398 patients and relatives from 70 ICUs in eight EU countries (6). The final program includes 102 competence statements grouped into 12 domains and a definition of the level of expertise required of a safe practitioner at the end of their specialist training. CoBaTrICE has been formally adopted by 15 of 32 countries in Europe with a further 12 planning to do so, Spain is included in this latter group (7,8).
Importance:
CBME is gaining acceptance as a solution to address the challenges associated with the current time-based models of physician training. However, whether CBME programs provide better outcomes than the traditional ones is actually unknown.
Hypothesis:
The implementation of the CoBaTrICE will provide higher levels of competency in comparison with the current official time-based programme in ICM in Spain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
To determine the level of competency achieved for each participant, an Objective Structured Clinical Examination (OSCE) will be performed at the end of the 3rd (R3) and 5th (R5) year of training in ICM. The OSCE will be performed simultaneously at four accredited simulation centers. The performances will be video recorded. All the video recordings will be later rated by two blinded raters, members of the experts panel, using specific checklists which include 25 items with a detailed description of the critical performance elements, the competencies technical (diagnosis and treatment) and non-technical (communication, team leadership, resource management) associated with each item, as well as specific information about what is expected to be done by the trainee. The participants will be unknown to raters. The members of the experts panel will not be part of the staff of the participants ICU Departments.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Trainees on the 3rd year of the specialization period in Intensive Care Medicine (ICM) who are developing their training program in a Spanish general medical and surgical ICU Department of an academic referral hospital accredited to train 2 or 3 new residents in ICM per year being 3 residents the highest number per year allowed in Spain.
排除标准
- •ICU Departments accredited to train less than 2 new residents in ICM per year
- •ICU Departments where CoBaTrICE is being implemented. At present only one hospital in Spain (Hospital Universitario y Politécnico La Fe, Valencia) is formally implementing CoBaTrICE. As a consequence it has been excluded from the trial.
结局指标
主要结局
The level of competency achieved at the end of the specific training in ICM (5th year)
时间窗: Three years
The percentage of competences assessed through an Objective Structured Clinical Examination (OSCE) in which level 5 (independent practitioner) was achieved
次要结局
- Compliance with CoBaTrICE implementation in the intervention group(The two years of CoBaTrICE implementation)
- Percentage of critical performance elements completed in the OSCE.(The two years of CoBaTrICE implementation)
- The rate of acquisition of competences assessed throughout the two years of CoBaTrICE implementation.(The two years of CoBaTrICE implementation)
研究者
Alvaro Castellanos Ortega
PhD. Associated professor of the Universidad de Valencia. Director of the Intensive Care Department of the Hospital Universitario y Politécnico La Fe de Valencia
Instituto de Investigacion Sanitaria La Fe