A multicenter cluster randomized trial of 14 ICU Departments from 14 academic referral hospitals located in Spain. The participating ICUs are general medical and surgical ICUs accredited to train 3 new residents in intensive care medicine per year. Additionally, the study sites have been selected based on their research infrastructure, geographical diversity and proximity to simulation centers. CoBaTrICE has not been adopted in Spain.


CBME is gaining acceptance as a solution to address the challenges associated with the current time-based models of physician training. However, whetherCBME programmes provide better outcomes than the traditional ones is actually unknown.


The implementation of the CoBaTrICEwill provide higher levels of competency in comparison with the current official time-based programme in Intensive Care Medicine (ICM) in Spain.


1)To determine the effect of CoBaTrICE implementation on:

  1. a) The level of competence achieved by the trainees.
  2. b) The percentage of critical performance elements.
  3. c) The rate of acquisition of competences throughout the three-year specific stage (R1, R2 and R3) of training in ICM.

2) To identify gaps in performance that could be addressed in future educational interventions.

3) To investigate the reliability and feasibility of conducting simulation based assessment at multiple sites.

4) To determine compliance with CoBaTrICE and barriers to an effective implementation.


Trial Design
A multicenter cluster randomized trial.  A total of 38 trainees on the 3rd year of the specialization period (R3) will be followed during the three years of their specific training period in ICM (Stage 2). Enrolment will start on February 1, 2019, and the follow-up will end on May 31, 2021.


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 assessment (WbA); 3)The use of an electronic portfolio.

Main outcomes and measures:

  • Primary outcome

The level of competency achieved at the end of the specific training in ICM (5th year), defined as the percentage of competences assessed through an Objective Structured Clinical Examination (OSCE) in which level 4 (independent practitioner) was achieved.

  • Secondary outcomes
  1. Percentage of critical performance elements in the OSCE.
  2. The rate of acquisition of competences assessed throughout the three-years specific stage of training in ICM.
  3. Compliance with CoBaTrICE implementation in the intervention group defined as the percentage of CoBaTrICE competences assessed throughout the three-years specific stage of training in ICM.

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), 4th (R4) and 5th  (R5) year of training in ICM. The OSCE will be performed simultaneously at four accredited simulation centres. The performances will be video recorded. All the video recordings will be later rated by two blinded raters, members of the experts panel, using standardized global rating scales (GRS) which include 15 items with a detailed description of 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.


Statistical Analysis

Simulation experience, hospital and ICU department characteristics, teaching environment, engagement and satisfaction, burn-out and emotions explored through standardized surveys for tutors and residents will be included in the analysis.

Sample size: A power analysis has been performed in order to determine the minimum sample size required to detect with a power of .98 (α = .05, 1 – β = .98) a medium effect size (f = .25), requiring a minimum sample size of 38 residents (114 observations).

Duration of the study

Due to start beginning of 2019 and the follow-up will end in May 2021.

Is there any financial compensation?

No. Participation in the trial is completely voluntary.

How do I participate?

This  participation is restricted to a selection of centres in Spain.

Financial support

The project received a  €25,000 grant from ESICM after inclusion in the ESICM Trials Group portfolio.

Principal Investigator

Alvaro Castellanos Ortega MD, PhD, EDIC, MADGS,

Director del Área de Medicina Intensiva
Profesor asociado de Medicina. Universidad de Valencia

Hospital Universitario y Politécnico La Fe. Torre G-1º

Valencia, Spain


More information, please contact: research@esicm.org and castellanos_alv@gva.es